Medication Practice Guideline by ps94506

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									      Santa Clara County
    Mental Health Department


Medication Practice Guideline
                          Michael Meade, MD
                     Chair, Department of Psychiatry
    Medical Director, Department of Mental Health & Acute Psychiatry

                            Tiffany Ho, MD
                            Medical Director
                  Outpatient Mental Health Department

                       Outpatient Psychiatrists
Syed Afroz, MD                             Roger Mateo, MD
Beena Anantharaman, MD                     Hansa Mehta, MD
Gregory Braverman, MD                      Irene McGhee, MD
Heather Colbert, MD                        Cuong Nguyen, MD
Anthony Cozzolino, MD                      Lil Nguyen, MD
Xuan Cung, PharmD                          Antonio Nolasco, MD
Susan Ditter, MD                           Meenakshi Samantaray, MD
Arthur Floreza, MD                         Sasa Strunjas, MD
Miriam Friedland, MD                       William Sueksdorf, MD
Emmeline Hazaray, MD                       Majid Talebi, RPh
Danh Huynh, MD                             Giselda Tan, MD
Farah Khan, MD                             Nam Tran, MD
Dharitri Mahapatra, MD                     Emily Wong, MD
James Manning, MD

                        Acute Care Psychiatrists

Christine Chang, MD                         Mya Kyaw, MD
Raymond Fabie, MD                           Thanhha Ngo, MD
Christine Gartner, MD                       Beverly Purdy, MD
Kenneth Gee, MD                             Mark Ritchie, MD
Lynn Giang, MD                              Robert Slater, MD
Amarjit Grewal, MD                          Yelena Sirbiladze, MD
David Johnson, MD                           Wendla Schwartz, MD
Kulsoom Khan, MD                            Clayton Tamura, MD

                  Contract Agency Medical Directors

Ali Alkoraishi, MD                          David Kilgore, MD
Ronald Diebel, MD                           Carmen Roman, MD
Glen Elliot, MD                             Owen Valentino, MD
Nhi Huynh, MD                               Bruce Wermuth, MD



Revised 1-09
                         Santa Clara County Mental Health Department
                                Medication Practice Guidelines

                                   TABLE OF CONTENTS

Title                                      Section     Number of Pages   Last Updated

Purpose                                    A                  4                2/08

Maximum Daily Dose Summary                 B                  5                1/09

Summary of Required Laboratory &
Examination                                C                  6                1/09

Outpatient Documentation Requirements      D                  2                2/08

Inpatient Documentation Requirements       E                  2                5/05

Alzheimer’s Agents                         F                  6                5/05

Antianxiety Agents                         G                  7                5/05

Antidepressant Agents                      H                  7                1/09

Antiparkinson & Antihistamine Agents       I                  3                5/05

Antipsychotic Agents - Atypical            J                  14               11/07

Antipsychotic Agents - Conventional        K                  6                9/07

Mood Stabilizers                           L                  13               1/08

Psychostimulant & ADHD Related
Agents                                     M                  6                4/08

Miscellaneous Agents
   • Alpha Agonists                        N                  3                5/05

   •    Beta Blockers                      O                  3                5/05

   •    Fixed-Ratio Combination Products   P                  1                5/05

   •    Sedative-Hypnotic Agents           Q                  3                4/08

   •    Thyroid Agents                     R                  2                5/05

   Rev. 1-09
                         Santa Clara County Mental Health Department
                                Medication Practice Guidelines

PURPOSE
The primary purpose of the Medication Practice Guidelines is to assist physicians with the tasks
of considering and implementing the best psychiatric treatment possible for Santa Clara County
mental health patients. These guidelines were developed based on the current state of
knowledge, utilizing national guidelines and algorithms, and were made available for secondary
review by SCCMHD psychiatrists prior to their adoption.

These guidelines are not meant to be absolute, but practice outside of these guidelines requires
special consideration, justification and documentation. These guidelines will not substitute for
clinical skills, dialogue and respect that are integral to good clinical practice.

Additional uses of the guidelines include:

     •   Detect and quantify patterns of care that are outside established guidelines via
         medication monitoring reviews

     •   Educate and orient new permanent, locum tenens and other temporary staff of the
         accepted parameters/expectations for clinical practice

     •   Communicate to the public on treatment standards

Treatment detected outside the established guidelines will require review of the specific
clinician’s documentation for legitimate justification and evidence of informed consent from the
patient.


IMPORTANT CONSIDERATIONS
The following general guidelines apply to the prescribing of all classes of medications:

1.       A thorough history should be documented in the chart and routinely re-evaluated as
         patient’s conditions are expected to change.

2.       Target symptoms and behavior problems to be treated should be identified and use as a
         baseline against which the patient’s improvement or lack of improvement can be
         continually reevaluated.

3.       It is generally recognized that patients often do not report or under-report misuse/abuse of
         alcohol and drugs which can have profound impact on progress of their mental health
         treatment and that co-occurring disorders are the rules rather than the exceptions.
         Therefore, it is expected that physicians routinely inquire about alcohol and drug use and
         that toxicology screens be ordered on a regular basis, when clinically indicated, even
         when patients admit to drug use. If patients abuse drugs/alcohol, physicians should refer
         them to substance abuse treatment and coordinate their care with these providers.


                                       Section A, Page 1 of 4
                          Santa Clara County Mental Health Department
                                 Medication Practice Guidelines

4.        It is generally recognized that persons with mental illness often also suffer from poor
          physical health and are poor advocates for their personal health. Therefore, it is expected
          that physicians refer patients to primary care providers and coordinate their care with
          these providers.

5.        Adequate medication doses should be used over a sufficient period of time to obtain
          desired results before polypharmacy is introduced to reduce risks to the patient.
          Polypharmacy is considered to be five or more psychiatric medications of different
          classes or two or more psychiatric medications of the same class, i.e. two atypical
          antipsychotics. Anti-dyskinetic and anti-histamine medications, beta blockers, and
          thyroid medications are not counted for this particular issue. It is recognized that cross-
          tapering of medications may take up to 90 days to accomplish.

6.        Same Class Polypharmacy (Poly-therapy):
                     A) Two or more antipsychotics i.e. one atypical plus one conventional agent
                     B) Two or more antidepressants with the same mechanism of action i.e. two
                        SSRIs or two SNRIs.
                                 - Low dose Trazodone up to 200mg which is being used as a
                                    hypnotic is excluded towards being counted in the
                                    polypharmacy.
                     C) Two or more antianxiety agents with the same mechanism of action i.e.
                        two benzodiazepines.
                     D) Two or more anticonvulsants.

             •   If using >1 of the same class agent is necessary, titrate the first agent to the
                 maximum tolerated dose, and provide clear supportive rationale for adding the
                 second agent.
             •   In addition to the above, for antipsychotics, document consultation was obtained
                 from another psychiatrist.
             •   If polypharmacy must be used beyond the period of cross-tapering (90 days) to
                 address a patient’s special needs, clearly document the necessity for such a
                 regimen,

     7.      It is recognized that severely ill patients may require combination antipsychotic drug
             therapy, (e.g. patients coming out of state hospitals and IMDs.) It is generally
             expected that the outpatient psychiatrists will re-evaluate the patients and consider
             simplification of the medication regimen when the patient is more stable. Per the
             Expert Consensus Guideline on Optimizing Pharmacologic Treatment of psychotic
             disorders, 2003: if a patient relapses whom the physician believes is compliant with
             medication, the experts recommend either switching to a different antipsychotic or
             increasing the dose of the current medication or switch to a long acting injectable
             antipsychotic prior to adding a second antipsychotic. Also, several studies have
             demonstrated that clinicians generally over estimate their patients’ adherence rate.




                                         Section A, Page 2 of 4
                      Santa Clara County Mental Health Department
                             Medication Practice Guidelines
8.    Drug holidays may be used as part of the medication regimen for some patients, when
      clinically indicated and accepted by the patient.

9.    The minimum effective dose necessary to treat the clinical condition(s) should be sought,
      especially in stable, chronic patients. This is particularly important in the treatment of the
      elderly, children, and persons with developmental disabilities, and those with known co-
      existing medical conditions.

10.   If the prescribed medication is outside of the SCVH&HS formulary (for UMDAP
      patients), the necessity for such a regimen must be documented and approval of the Non-
      Formulary Drug Request (NFDR) Form required from the Medical Director or her
      designee.

11.   If dosage levels in excess of the maximum listed in these guidelines are used, the
      necessity for such a regimen must be documented and approval of the Maximum Daily
      Dose (MDD) Exceed Request Form required from the Medical Director or her designee.

12.   Use of anti-dyskinetic agents do carry medical risks and thus should only be used when
      indicated.

13.   Because of the prevalence of substance abuse in Mental Health consumers, and the ease
      with which consumers develop a physiological and psychological dependence on
      benzodiazepines and stimulants, physicians must be mindful of minimizing the
      dependency and abuse of these medications. Caution is needed when prescribing
      benzodiazepines and additive stimulants to consumers with disorders that are associated
      with abuse of medications, such as borderline personality disorder, antisocial personality
      disorder, somatization disorder, and substance use disorders. Quantities need to be
      limited with more frequent follow up visits and documentation regarding patient
      compliance with the entire treatment plan, including coordination of care with other
      health care providers. For example, benzodiazepines are best used as short-term
      medications during the implementation of a long-term treatment plan.

14.   Weight gain can be a significant side effect of several psychiatric medications and can
      cause serious health complications. It is required that the patient’s weight/BMI be
      monitored on a regular basis per guideline for specific classes of medications. The
      psychiatrist should reevaluate the medication regimen and consider the risks/benefits of
      continuing the same regimen in patients who have gained significant weight Referral to
      a primary care physician for physical health monitoring is expected for patients who are
      overweight or have BMIs over 25.

15.   It is recognized that some psychiatric medications have been shown to be clinically
      effective yet have not received an FDA-approved indication for certain conditions. This
      is especially true for children and adolescents where FDA approval for specific
      indications is rarely available. The non-FDA use of a medication must be documented
      on the medication consent form and placed in the patient’s chart prior to initiation.




                                     Section A, Page 3 of 4
                      Santa Clara County Mental Health Department
                             Medication Practice Guidelines
        The medication practice guideline describes both the FDA approved indications as well
       as “off label” uses for medications consistent with current community practice standards,
       i.e. non-FDA labeled indications.

16.    Documentation of informed consent is necessary to initiate any treatment with psychiatric
       medications and required to be renewed every 2 years. Standardized medication consent
       forms are available (www.sccmhd.org) for the various classes of medications and should
       be signed by the patient or parent or guardian (as appropriate) and maintained in the
       patient’s chart. When prescribing psychiatric medications to patients with developmental
       disabilities, it is recommended that support persons involved in the patient’s care (e.g.
       family members, case workers, and residential care staff) be included in the informed
       consent process and that they be encouraged to sign the medication consent forms to
       document this involvement.

17.    The Department recognizes that personal physician involvement is necessary to assure
       adequate treatment of patients receiving psychotropic medications. Accordingly, the
       guidelines presume that usually the physician has examined the patient, reached his own
       diagnosis, documented the medical findings, and formulated a treatment plan when he
       prescribes or administers medication. In a system of care such as the Santa Clara County
       Mental Health Department where physicians practice under carefully developed
       medication guidelines, it is necessary and permissible for physicians to cover one another
       and to temporarily prescribe medications without having personally examined the patient,
       but based on the previous physician’s documented evaluation.


Revised: 02-08




                                     Section A, Page 4 of 4
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines
          MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
                                  Bold = Non-Formulary Status at SCVH&HS

This medication summary contains both SCVHHS formulary and non-formulary medications.
Bolded agents reflect non-formulary status at SCVHHS. The inclusion of the non-formulary
medications are intended to guide the physicians’ practices. It is not intended to encourage physicians
to prescribe non-formulary medications or to prescribe medications off-label.

Patients age 65+: Evidence and experience support that elderly patients may have greater sensitivity
to pharmacological treatments. As a result, physician should use prudence in prescribing psychiatric
medications to the elderly. When initiating medication therapy for a new start, begin at a lower dose
than standard dosage recommendation and titrate up slowly depending on the tolerability and efficacy,
taking into consideration the side effect profile for all of the patient’s medications


Patients age 5-12: Evidence and experience indicates that psychopharmacologic treatments for
children can not be extrapolated from the studies conducted in adult patients. Children and
Adolescents have different central nervous system development, exhibit different cognitive,
behavioral and affective ”norms” and are exposed to different environmental influences. All these
factors influence the response to psychopharmacological treatment, efficacy and well as tolerability.
As a result, physicians should use prudence in prescribing psychiatric medications to young children.
It is imperative that informed consent be obtained prior to initiation and following dosage
recommendations followed unless clinical situation warrants otherwise.
“non-FDA approved” means the use of the medication is currently not approved by the FDA.
In general, many psychotropic agents are not approved for use in the pediatric population.
Prescribing of psychiatric medications for children up to age 12 or adolescents up to age 17,
unless otherwise specified by the FDA, is limited to child psychiatrists or in consultation with a
child psychiatrist.

    Alzheimer's Agents
    Generic Name                Brand Name                        Adults          Adolescents & Children
    Donepezil                   Aricept                           10 mg           non-FDA approved
    Galantamine                 Reminyl                           24 mg           non-FDA approved
    Memantine                   Namenda                           20 mg           non-FDA approved
    Rivastigmine                Exelon                            12 mg           non-FDA approved
    Tacrine                     Cognex                            160 mg          non-FDA approved

    Antianxiety & Sedative/Hypnotic Agents (Updated 4-08)
    Generic Name                Brand Name                        Adults          Adolescents & Children
                                Xanax                             4 mg            non-FDA approved
    Alprazolam                  Xanax XR                          6 mg            non-FDA approved
    Buspirone                   Buspar                            90 mg           60 mg (>6 yo)
    Butabarbital                Butisol                           120 mg          non-FDA approved
    Chloral hydrate             Noctec                            2000 mg         50 mg/kg
    Chlordiazepoxide            Librium                           100 mg          30 mg (>6 yo)

                                               Section B, Page 1 of 5
A
  The MDD presented here is a general dose for all indications or otherwise specified. This information should be used as
a general guideline. For more comprehensive information, refer to your appropriate references.
B
  The MDD refers to oral dosing unless otherwise specified.
C
  References: Prescriber’s Information, Micromedex, Epocrates
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines
          MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
                                  Bold = Non-Formulary Status at SCVH&HS

    Clonazepam                  Klonopin                          4 mg            .01 - .03 mg/kg
    Clorazepate                 Tranxene; Tranxene SD             90 mg           non-FDA approved
    Diazepam                    Valium                            40 mg           10 mg (>6 mos)
                                                                                  1 mg/kg (2-12 yo);
    Diphenhydramine             Benadryl                          400 mg          50 mg (>12 yo)
    Estazolam                   Prosom                            2 mg            non-FDA approved
    Eszopiclone                 Lunesta                           2 mg            non-FDA approved
    Flurazepam                  Dalmane                           30 mg           non-FDA approved
                                Atarax (HCl); Vistaril
    Hydroxyzine                 (Pamoate)                         600 mg          2 mg/kg (<6 yo); 100 mg (>6 yo)
    Lorazepam                   Ativan                            10 mg           4 mg (>12 yo)
    Oxazepam                    Serax                             120 mg          120 mg (>12 yo)
    Quazepam                    Doral                             30 mg           non-FDA approved
    Phenobarbital               Luminal                           320 mg          6 mg/kg
    Ramelteon                   Rozerem                           8 mg            non-FDA approved
    Secobarbital                Seconal                           100 mg          5 mg/kg or 100 mg
    Temazepam                   Restoril                          30 mg           non-FDA approved
    Triazolam                   Halcion                           .5 mg           non-FDA approved
    Zaleplon                    Sonata                            20 mg           non-FDA approved
    Zolpidem                    Ambien                            10 mg           non-FDA approved
                                Ambien CR                         12.5 mg         non-FDA approved



    Antidepressant Agents (Updated 1-09)
    Generic Name                Brand Name                        Adults          Adolescents & Children
    Amitriptyline               Elavil                            300 mg          non-FDA approved
    Amoxapine                   Asendin                           600 mg          non-FDA approved
    Bupropion                   Wellbutrin, Wellbutrin XL         450 mg          non-FDA approved
                                Wellbutrin SR                     400 mg          non-FDA approved
    Citalopram                  Celexa                            60 mg           non-FDA approved
    Clomipramine                Anafranil                         250 mg          200 mg (>10 yo)
    Desipramine                 Norpramin                         300 mg          5 mg/kg
    Desvenlafaxine              Pristiq                           50 mg           non-FDA approved
    Doxepin                     Sinequan                          300 mg          non-FDA approved
    Duloxetine                  Cymbalta                          120 mg          non-FDA approved
    Escitalopram                Lexapro                           20 mg           non-FDA approved
    Fluoxetine                  Prozac                            80 mg           20 mg (>7 yo)
    Fluoxetine weekly           Prozac Weekly                     90 mg           non-FDA approved
    Fluvoxamine                 Luvox, Luvox CR                   300 mg          200 mg (8-11 yo);
                                                                                  300 mg (12-17 yo)
    Imipramine                  Tofranil                          300 mg          non-FDA approved
    Isocarboxazide              Marplan                           60 mg           non-FDA approved
    Maprotiline                 Ludiomil                          225 mg          non-FDA approved
                                               Section B, Page 2 of 5
A
  The MDD presented here is a general dose for all indications or otherwise specified. This information should be used as
a general guideline. For more comprehensive information, refer to your appropriate references.
B
  The MDD refers to oral dosing unless otherwise specified.
C
  References: Prescriber’s Information, Micromedex, Epocrates
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines
           MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
                                  Bold = Non-Formulary Status at SCVH&HS

    Mirtazapine                 Remeron                           45 mg           non-FDA approved
    Nefazodone                                                    600 mg          non-FDA approved
    Nortriptyline               Pamelor                           150 mg          non-FDA approved
    Paroxetine                  Paxil                             60 mg           non-FDA approved
                                Paxil CR                          75 mg           non-FDA approved
    Phenelzine                  Nardil                            90 mg           non-FDA approved
    Protriptyline               Vivactil                          60 mg           non-FDA approved
    Selegiline Transdermal      Emsam                             12 mg           non-FDA approved
    Sertraline                  Zoloft                            200 mg          200 mg (6-17 yo)
    Tranylcypromine             Parnate                           60 mg           non-FDA approved
    Trazodone                   Desyrel                           600 mg          non-FDA approved
    Venlafaxine                 Effexor                           375 mg          non-FDA approved
                                Effexor XR                        225 mg          non-FDA approved

    Antiparkinson Agents
    Generic Name                Brand Name                        Adults          Adolescents & Children
    Amantadine                  Symmetrel                         300 mg          non-FDA approved
    Benztropine                 Cogentin                          8 mg            .1 mg/kg (>3 yo)
    Biperiden                   Akineton                          8 mg            non-FDA approved
    Diphenhydramine             Benadryl                          200 mg          1 mg/kg (2-12 yo); 50 mg (>12 yo)
    Trihexyphenidyl             Artane                            15 mg           non-FDA approved


    Antipsychotic Agents-Atypicals (Updated 4-08)
    Generic Name                Brand Name                        Adults          Adolescents & Children
    Aripiprazole                Abilify, Abilify Dismelt          30 mg           30 mg (10-17 yo)
                                Abilify Intramuscular             30 mg           non-FDA approved
    Clozapine                   Clozaril, FazaClo ODT             900 mg          non-FDA approved
    Olanzapine                  Zyprexa, Zyprexa Zydis            20 mg           non-FDA approved
                                Zyprexa Intramuscular             30 mg           non-FDA approved
    Quetiapine                  Seroquel, Seroquel XR             800 mg          non-FDA approved
    Paliperidone                Invega                            12 mg           non-FDA approved
                                                                                  .5 mg <20 kg; 1 mg > 20kg; 6 mg
    Risperidone                 Risperdal, Risperdal M-Tab        16 mg           (10-17 yo)
                                                                  50 mg IM
                                Risperdal Consta                  q2wk            non-FDA approved
    Ziprasidone                 Geodon                            200 mg          non-FDA approved
                                Geodon Intramuscular              40 mg           non-FDA approved




                                               Section B, Page 3 of 5
A
  The MDD presented here is a general dose for all indications or otherwise specified. This information should be used as
a general guideline. For more comprehensive information, refer to your appropriate references.
B
  The MDD refers to oral dosing unless otherwise specified.
C
  References: Prescriber’s Information, Micromedex, Epocrates
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines
          MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
                                  Bold = Non-Formulary Status at SCVH&HS


    Antipsychotic Agents-Conventionals (Updated 4-08)
    Generic Name                Brand Name                        Adults          Adolescents & Children
    Chlorpromazine              Thorazine                         1000 mg         100 mg (6 mos-12 yo)
    Fluphenazine                Prolixen                          40 mg           3 mg
                                                                                  12.5 mg/wk (5-12 yo); 25 mg/wk
    Fluphenazine decanoate      Prolixen decanoate                100 mg/4wk      (>12 yo)
                                                                                  .15 mg/kg (3-12 yo & 15-40 kg); 15
    Haloperidol                 Haldol                            100 mg          mg (>12 yo)
    Haloperidol decanoate       Haldol decanoate                  450 mg/mo       non-FDA approved
    Loxapine                    Loxitane                          250 mg          non-FDA approved
    Mesoridazine                Serentil                          400 mg          non-FDA approved
    Molindone                   Moban                             225 mg          .5 mg/kg (>12 yo)
    Perphenazine                Trilafon                          64 mg           12 mg (>12 yo)
    Pimozide                    Orap                              10 mg           10 mg (>12 yo)
    Thioridazine                Mellaril                          800 mg          3 mg/kg (>2 yo)
    Thiothixene                 Navane                            60 mg           60 mg (>12 yo)
    Trifluoperazine             Stelazine                         40 mg           15 mg (6-12 yo)



    Mood Stabilizers (Updated 11-07)
    Generic Name                   Brand Name                       Adults           Adolescents & Children
    Carbamazepine ER1              Equetro                          1600 mg          non-FDA approved
    Lamotrigine2                   Lamictal                         200 mg           non-FDA approved
                     3
  Lithium carbonate                Lithium                          2400 mg          2400 mg (>2 yo)
                                   Lithobid                         1800 mg          1800 mg (>2 yo)
  Divalproex sodium4               Depakote, Depakote ER            60 mg/kg         non-FDA approved
1
  Carbamazepine (Tegretol) is not FDA approved for Bipolar Disorder. Carbamazepine extended release is available as
Tegretol XR, Carbatrol and Equetro. Only Equetro has FDA approval for Bipolar Disorder.
2
  For patients taking Lamictal and Depakote, the MDD for Lamictal is 100mg. For patients take Carbamazepine,
Phenytoin, Phenobarbital, Primidone, or Rifampin, but not taking Depakote, and Lamictal, the MDD for Lamictal is
400mg.
3
  Lithium is available as lithium carbonate, lithium carbonate ER (generic or as Lithobid 300). The brand Eskalith and
Eskalith ER has been discontinued from the US.
4
  Divalproex sodium is available as Depakote and Depakote ER. When switching from Depakote to Depakote ER, the
Depakote ER should be administered once-daily using a dose 8% to 20% higher than the total daily dose of Depakote
(Please See Table 5 in the Mood Stabilizer section for conversion chart.).




                                               Section B, Page 4 of 5
A
  The MDD presented here is a general dose for all indications or otherwise specified. This information should be used as
a general guideline. For more comprehensive information, refer to your appropriate references.
B
  The MDD refers to oral dosing unless otherwise specified.
C
  References: Prescriber’s Information, Micromedex, Epocrates
                               Santa Clara County Mental Health Department
                                      Medication Practice Guidelines
           MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
                                   Bold = Non-Formulary Status at SCVH&HS

Psychostimulant & ADHD Related Agents (Updated 09-08)
Generic Name                   Brand Name                        Adults          Adolescents & Children
Amphetamine/                   Adderall                          60 mg           40 mg (> 3 yo)
Dextroamphetamine
Amphetamine/                   Adderall XR                       20 mg           30 mg (6-12 yo);
Dextroamphetamine                                                                20 mg (13-17 yo)
Atomoxetine                    Strattera                         100 mg          1.2 mg/kg (< 70kg);
                                                                                 100 mg (> 70kg)
Dexmethylphenidate             Focalin, Focalin XR               20 mg           20 mg (> 6 yo)
Dextroamphetamine              Dexedrine1, Dextrostat,           60 mg           40 mg (> 3 yo)
                               Dexedrine spansule1
Lisdexamfetamine               Vyvanse                           70 mg           70 mg (> 6 yo)
Methamphetamine                Desoxyn                           non-FDA         25 mg (> 6 yo)
                                                                 approved
Methylphenidate                Methylin, Ritalin, Metadate       60 mg           60 mg (> 6 yo)
                               ER, Methylin ER, Ritalin SR,
                               Metadate CD, Ritalin LA
Methylphenidate                Concerta                          72 mg           54 mg (6-12 yo);
                                                                                 72 (13-17 yo)
Methylphenidate                Daytrana                          non-FDA         30 mg (6-12 yo)
                                                                 approved
Modafinil                      Provigil                          400 mg          non FDA approved
1
    Age restricted for ADHD: 4-16 yo


Alpha Agonist
Generic Name                    Brand Name                       Adults          Adolescents & Children
Clonidine                       Catapres                         .6 mg           .2 mg
Guanfacine                      Tenex                            3 mg            2 mg

Beta Blockers
Atenolol                        Tenormin                         100 mg          non-FDA approved
Metoprolol                      Lopressor                        200 mcg         non-FDA approved
Propranolol                     Inderal                          160 mg          non-FDA approved

Fixed Ratio Combinations
Generic Name                    Brand Name                       Adults          Adolescents & Children
Fluoxetine/Olanzapine           Symbyax                          12 mg/50 mg     non-FDA approved

Thyroid Agents
Generic Name                    Brand Name                       Adults          Adolescents & Children
Levothyroxine                   Synthroid                        125 mcg         3 mcg/kg (>12 yo)
Liothyronine                    Cytomel                          75 mcg          75 mcg (> 3yo)


                                               Section B, Page 5 of 5
A
  The MDD presented here is a general dose for all indications or otherwise specified. This information should be used as
a general guideline. For more comprehensive information, refer to your appropriate references.
B
  The MDD refers to oral dosing unless otherwise specified.
C
  References: Prescriber’s Information, Micromedex, Epocrates
                     Santa Clara County Mental Health Department
                            Medication Practice Guidelines
          REQUIRED LABORATORY and EXAMINATION SUMMARY
                         Bold = Non-Formulary Status at SCVH&HS

Alzheimer's Agents
Generic Name         Brand Name                Outpatient          Inpatient
Donepezil            Aricept                   No Required Lab     Standard lab on
Galantamine          Reminyl                                       admission
Memantine            Namenda
Rivastigmine         Exelon
Tacrine              Cognex



Antianxiety & Sedative/Hypnotic Agents (Updated 4-08)
Generic Name          Brand Name               Outpatient          Inpatient
                      Xanax                    No Required Lab     Standard lab on admission
Alprazolam            Xanax XR
Buspirone             Buspar
Butabarbital          Butisol
Chloral hydrate       Noctec
Chlordiazepoxide      Librium
Clonazepam            Klonopin
                      Tranxene; Tranxene
Clorazepate           SD
Diazepam              Valium
Diphenhydramine       Benadryl
Estazolam             Prosom
Eszopiclone           Lunesta
Flurazepam            Dalmane
                      Atarax (HCl); Vistaril
Hydroxyzine           (Pamoate)
Lorazepam             Ativan
Oxazepam              Serax
Quazepam              Doral
Phenobarbital         Luminal
Ramelteon             Rozerem
Secobarbital          Seconal
Temazepam             Restoril
Triazolam             Halcion
Zaleplon              Sonata
Zolpidem              Ambien
                      Ambien CR




                                      Section C, Page 1 of 6
                       Santa Clara County Mental Health Department
                              Medication Practice Guidelines
           REQUIRED LABORATORY and EXAMINATION SUMMARY
                           Bold = Non-Formulary Status at SCVH&HS

Antidepressant Agents (Updated 1-09)
Generic Name           Brand Name               Outpatient                         Inpatient
Amitriptyline          Elavil                   No Required Lab                    Standard lab on admission
Amoxapine              Asendin                  No Required Lab
                       Wellbutrin, Wellbutrin   No Required Lab
Bupropion              SR, Wellbutrin XL
Citalopram             Celexa                   No Required Lab
Clomipramine           Anafranil                No Required Lab
Desipramine            Norpramin                No Required Lab
                                                Monitor BP at baseline and after
Desvenlafaxine         Pristiq                  dose increase
Doxepin                Sinequan                 No Required Lab
                                                Monitor BP baseline and after
Duloxetine             Cymbalta                 dose increase
Escitalopram           Lexapro                  No Required Lab
Fluoxetine             Prozac                   No Required Lab
Fluoxetine weekly      Prozac Weekly            No Required Lab
Fluvoxamine            Luvox                    No Required Lab
Imipramine             Tofranil                 No Required Lab
Isocarboxazide         Marplan                  No Required Lab
Maprotiline            Ludiomil                 No Required Lab
                                                Monitor total cholesterol and
Mirtazapine            Remeron                  triglyceride annually.
Nefazodone                                      No Required Lab
Nortriptyline          Pamelor                  No Required Lab
Paroxetine             Paxil                    No Required Lab
                       Paxil CR
Phenelzine             Nardil                   No Required Lab
Protriptyline          Vivactil                 No Required Lab
Sertraline             Zoloft                   No Required Lab
Tranylcypromine        Parnate                  No Required Lab
Trazodone              Desyrel                  No Required Lab
                                                Monitor BP at baseline and after
Venlafaxine            Effexor, Effexor XR      dose increase



Antiparkinson Agents
Generic Name           Brand Name               Outpatient                         Inpatient
Amantadine             Symmetrel                No Required Lab                    Standard lab on admission
Benztropine            Cogentin
Biperiden              Akineton
Diphenhydramine        Benadryl
Trihexyphenidyl        Artane




                                        Section C, Page 2 of 6
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines
            REQUIRED LABORATORY and EXAMINATION SUMMARY
                                  Bold = Non-Formulary Status at SCVH&HS

 Antipsychotic Agents-Atypicals* (Updated 4-08)
                         Baseline     1st 4     1st 8     1st 12     Quarter (if   Annual (if        Every 5 yrs (if
                                      wks       wks        wks       WNL**)        WNL**)              WNL**)
 Weight (BMI)                X         X         X          X           X

 Waist circumference         X                                                           X
 (RECOMMENDED)
 BP                          X                              X                            X

 Fasting glucose             X                              X                            X

 Fasting lipid                X                             X                       X (1st yr)             X
*For comprehensive information on Clozaril laboratory requirement schedule, see appropriate references.
**WNL = within normal limit
Inpatient: Basic laboratory studies on admission




                                              Section C, Page 3 of 6
                               Santa Clara County Mental Health Department
                                      Medication Practice Guidelines
            REQUIRED LABORATORY and EXAMINATION SUMMARY
                                   Bold = Non-Formulary Status at SCVH&HS



Clozaril (Clozapine)
WEEKLY, EVERY OTHER WEEK (BI-WEEKLY) AND EVERY 4 WEEKS (MONTHLY) MONITORING AND
ELIGIBILITY
On May 12, 2005, the Food and Drug Administration (FDA) approved changes to Clozaril labeling allowing certain
qualified patients, under specific conditions to undergo monthly (every 4 weeks) monitoring. The revised labeling states
that patients initiated on Clozaril must have a baseline White Blood Cell (WBC) count and baseline Absolute Neutrophil
                                                                                 3                                         3
Count (ANC) before initiation of treatment. The WBC must be at least 3500/mm and the ANC must be at least 2000/mm
for initiation of therapy. During the first 6 months of therapy, patient must be monitored on a weekly basis. If acceptable
                                          3                      3
WBC and ANC values [WBC ≥ 3500/mm and ANC ≥ 2000/mm ] have been maintained during the first 6 months of
continuous therapy, the frequency of monitoring WBC and ANC values may be reduced to every other week (biweekly).
After 6 months of every other week monitoring without interruption due to leukopenia, the frequency of monitoring WBC
and ANC may be reduced to every 4 weeks (monthly).
WBC and ANC values must continue to be monitored weekly for at least 4 weeks after the discontinuation of Clozapine
regardless of monitoring frequency at the time of discontinuation.




                                                Section C, Page 4 of 6
                                Santa Clara County Mental Health Department
                                       Medication Practice Guidelines
            REQUIRED LABORATORY and EXAMINATION SUMMARY
                                     Bold = Non-Formulary Status at SCVH&HS

Antipsychotics Agents-Conventionals (Updated 4-08)
 Generic Name                  Brand Name                Outpatient                             Inpatient
 Chlorpromazine                Thorazine                 1. Weight/BMI,                         Standard lab on admission
 Fluphenazine                  Prolixin                  2. Baseline fasting glucose, lipid
 Fluphenazine decanoate        Prolixin decanoate           panel
 Haloperidol                   Haldol                    3. AIMS q 12 months
 Haloperidol decanoate         Haldol decanoate
 Loxapine                      Loxitane
 Mesoridazine                  Serentil                  1.   ECG
                                                         2.   Electrolytes
                                                         3.   Weight/BMI
                                                         4.   Baseline fasting glucose, lipid
                                                              panel
                                                         5.   AIMS q 12 months,
 Molindone                     Moban                     1.   Weight/BMI,
 Perphenazine                  Trilafon                  2.   Baseline fasting glucose, lipid
                                                              panel
                                                         3.   AIMS q 12 months
 Pimozide                      Orap                      1.   ECG
 Thioridazine                  Mellaril                  2.   Electrolytes
                                                         3.   Weight/BMI
                                                         4.   Baseline fasting glucose, lipid
                                                              panel
                                                         5.   AIMS q 12 months
 Thiothixene                   Navane                    1.   Weight/BMI,
 Trifluoperazine               Stelazine                 2.   Baseline fasting glucose, lipid
                                                              panel
                                                         3.   AIMS q 12 months



 Mood Stabilizers (Updated 1-09)
 Generic Name         Weight     Bun/           CBC       Drug            Electrolytes     LFT         Pregnancy      TSH/
 (Brand Name)                    Creatinine     w/        Serum                                        Test           T4
                                                Dif       Level
 CarbamazepineA1                 b              b,        qmx2, then      b, q12m          b,qmx2,     b,prn
 ER (Equetro)                                   qmx2      q6m                              then
                                                , then                                     q6m
                                                q6m
 Lithium              b, q3m     b,3m,6m,                 Inpt: 2x in     b,3m,6m,the                  b,prn          b,6m,
                                 then q12m                1st 10 days,    n q12m                                      then
                                                          then q2wk                                                   q12m
                                                          Outpt:
                                                          qmx2, then
                                                          q6m
 Valproate/            b, q3m                  b,         qmx2, then                       b,qmx2,    b,prn
 Divalproex                                    qmx2       q6m                              then
 (Depakote,                                    , then                                      q6m
 Depakote ER)                                  q6m
A1
   HLA-B*1502 allele screening is required before starting treatment with carbamazepine, patients with ancestry across
broad areas of Asia, including South Asian Indians. If testing is not available to the patient, carbamazepine products
should ordinarily not be used.



                                                Section C, Page 5 of 6
                      Santa Clara County Mental Health Department
                             Medication Practice Guidelines
          REQUIRED LABORATORY and EXAMINATION SUMMARY
                          Bold = Non-Formulary Status at SCVH&HS


Psychostimulant & ADHD Related Agents (Updated 10-08)
Generic Name         Brand Name              Outpatient                             Inpatient
Amphetamine/         Adderall                Children and Adolescent                Standard lab on admission
Dextroamphetamine                            • Height, Weight, Blood
Amphetamine/         Adderall XR                 Pressure, and Pulse &
Dextroamphetamine                                baseline, every 6 months, and
                                                 after dose adjustment
Atomoxetine          Strattera
                                             • Stimulants: Patients with
                                                 preexisting heart disease or
Dexmethylphenidate   Focalin, Focalin XR         symptoms suggesting
Dextroamphetamine    Dexedrine1,                 significant CVD should be
                     Dextrostat, Dexedrine       referred for consultation with
                     spansule1                   a pediatrician and/or
Lisdexamfetamine     Vyvanse                     cardiologist for possible ECG
Methamphetamine      Desoxyn                     and /or Echo prior to a
Methylphenidate      Methylin, Ritalin,          stimulant trial. If stimulants
                     Metadate ER,                are initiated, then the patient
                     Methylin ER, Ritalin        should also be followed by
                     SR, Metadate CD,            the pediatrician and/or
                     Ritalin LA                  cardiologist during the course
Methylphenidate      Concerta                    of treatment.
                                             Adult
                                             • Weight, Blood Pressure, and
Methylphenidate      Daytrana
                                                 Pulse & baseline, every 6
Modafinil            Provigil                    months, and after dose
                                                 adjustment




Alpha Agonist
Generic Name         Brand Name              Outpatient                             Inpatient
Clonidine            Catapres                Blood Pressure and Pulse prior to      Standard lab on admission
Guanfacine           Tenex                   initiating & within 1 mo after its
                                             use or after any increase in dosage


Beta Blockers
Generic Name         Brand Name              Outpatient                             Inpatient
Atenolol             Tenormin                1. ECG > 60 yo or hx of CVD            Standard lab on admission
Metoprolol           Lopressor               Blood Pressure and Pulse before
                                             initiating, then at first f/u visit,
Propranolol          Inderal                 then q 6 mos

Thyroid Agents
Generic Name         Brand Name              Outpatient                             Inpatient
Levothyroxine        Synthroid               TSH q 6 mos until normal, then q       Standard lab on admission
                                             6 mos
Liothyronine         Cytomel


                                     Section C, Page 6 of 6
                      Santa Clara County Mental Health Department
                             Medication Practice Guidelines
            OUTPATIENT DOCUMENTATION REQUIREMENTS

Note: Because of the frequent needs for cross coverage, physicians’ notes are expected to be
clearly legible.

              A.     The Physician Initial Assessment should contain all of the following:

                     1.     Date of patient contact
                     2.     Identifying data
                     3.     Reason for visit
                     4.     History of present illness
                     5.     Past psychiatric history- include prior medication trials
                     6.     Substance abuse history
                     7.     Past medical history – particular attention to prior head injuries,
                            neurological disorders, cardiac history
                     8.     Developmental history in children
                     9.     Drug allergies
                     10.    Family history of mental illness- include diagnoses and treatment
                            response if known
                     11.    Personal/Social history
                     12.    Current medications- include prescription, non-prescription, &
                            alternative remedies
                     13.    Mental status examination
                     14.    Diagnostic formulation- include all 5 axes
                     15.    Treatment plan – use Biopsychosocial model
                            A. In all patients with suicidal or homicidal ideation, or histories
                                of violence toward self or others, document a dangerousness
                                risk assessment emphasizing protective and exacerbating
                                factors.
                            B. Address risks of treatment during pregnancy or breast feeding
                                if applicable
                     16.    Consent for medications
                     17.    Release of information if necessary
                     18.    Physician signature

              B. The Physician Progress Note, for each medication visit, should contain all of
              the following:

                     1. Date (month/day/year)
                     2. Location where service was provided
                     3. Type and duration of service
                     4. Description of service related to diagnosis, symptoms, and goals of
                        treatment
                     5. Description of treatment response
                     6. Assessment of medication compliance
                     7. Assessment of medication side effects & plan to address them


                                    Section D, Page 1 of 2
                        Santa Clara County Mental Health Department
                               Medication Practice Guidelines
                       8. Assessment of laboratory data, if applicable
                       9. Documentation of reason for any change in medication regimen, if
                           applicable
                       10. Documentation of dangerousness risk assessment and plan, if
                           applicable
                       11. Treatment plan
                       12. Physician signature

                C. Physician’s Order Sheet
                      1. All new orders or changes in the patient’s medication regimen by the
                          physician are to be written here
                      2. Reserved for Physician’s order only

                D. Outpatient Prescription Forms must include, but not limited to:
                      1. 2 patient identifiers
                      2. Legible Physician’s name additional to the signature

Revised 02-08




                                      Section D, Page 2 of 2
                      Santa Clara County Mental Health Department
                             Medication Practice Guidelines
              INPATIENT DOCUMENTATION REQUIREMENTS
The Physician Initial Assessment must contain the following:

              1.     Patient identification
              2.     A brief summary or history of the present illness
              3.     Past Psychiatric history
              4.     History of substance use
              5.     Medical history and physical examination
              6.     A mental status examination which details the behavior that leads to the
                     patient being dangerous to self, others and/or gravely disabled
              7.     Diagnosis along all 5 axes of DSM-IV
              8.     Recommendations for further evaluation and treatment
              9.     Initial discharge plan
              10.    The physician will oversee the development of the multi-disciplinary
                     treatment plan, and sign off on the treatment plan, within 72 hours of
                     admission.
              11.    The treatment plan is updated as needed, but at least every seven days.

The Physician Progress Notes must:

              1.     Be entered in the medical record daily
              2.     Address current Mental Status Examination daily
              3.     Address current medications daily
              4.     Address medication side effects daily
              5.     Address pain management needs daily
              6.     Address review of laboratory or diagnostic imaging studies daily
              7.     Document the working diagnosis daily
              8.     Document treatment response daily
              9.     Document placement plans weekly, or whenever there is a change in the
                     placement plan
              10.    Document the discharge plans, including the Aftercare Plan on the day of
                     discharge

The Nursing Notes must:

              1.     Be entered in the medical record each shift
              2.     Must address each identified problem on the multidisciplinary treatment
                     plan
              3.     The RN admission note must include a full nursing assessment, including
                     the assessment of pain management needs.

The Social Services Notes must:

              1.     Document a full psychosocial evaluation within 72 hours of admission.




                                     Section E, Page 1 of 2
                       Santa Clara County Mental Health Department
                              Medication Practice Guidelines
               2.     Document the placement and progress toward placement at least every 72
                      hours
               3.     Document all changes in the placement plan, as well as the rationale for
                      changes

All Medical Record entries must be signed, dated and timed, and must be legible.

The Multidisciplinary Treatment Plan must be present and complete in the medical record by the
72nd hour following admission. There must be evidence that all disciplines participated in the
development of the plan. There must be evidence that the treatment is physician directed and
approved. The treatment plan must identify patient strengths. Patient and treatment team
identified short and long-range goals must be documented. The treatment plan must identify all
problems that will be a focus of treatment (both psychiatric and non-psychiatric medical
problems) during the admission. For each identified problem measurable objectives toward the
resolution of that problem must be identified, as well as discipline-specific interventions geared
to the problem resolution. The assessment of progress toward the measurable objectives must
occur regularly, but at least every seven days. The treatment plan must address pain
management issues for every patient.




Revised: 05-05



                                      Section E, Page 2 of 2
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines

                     ALZHEIMER’S DISEASE AGENTS

Documentation   A.     FDA approved indications (see Table 1)
Required
                       1.    Treatment of mild to moderate dementia of Alzheimer’s
                             type
                       2.    Treatment of moderate to severe dementia of Alzheimer’s
                             type

Documentation   B.     Non-FDA approved, commonly used indications
Required
                       1.    Cognitive deficits in psychotic disorders
                       2.    Lewy Body Dementia
                       3.    Vascular Dementia
                       4.    Dementia in Parkinson’s Disease (Donepezil, Galantamine,
                             Rivastigmine, Tacrine)
                       5.    Mild to moderate dementia of Alzheimer’s type
                             (Menantine)

Documentation   C.     Minimal documentation
Required
                       1.    Mini-Mental Status Examination (Folstein) at baseline and
                             following dose adjustment, <= 23 repeat every 6 months
                       2.    Screen; R/O Depression, treat depression if needed

Documentation   D.     Maximum Dosage - see Medication Summary for MDD
Required
                       1.    Hepatic or renal disease: documentation of rationale for
                             dosage
                       2.    Maximum dosage for specific agents:

                             1.     Donepezil
                                    -Maximum daily dose = 10mg
                                    -Start with 5mg/day for 4-6 weeks before increasing
                                    to 10mg/day

                             2.     Galantamine
                                    -Maximum daily dose = 24mg
                                    -Start with 4mg po bid, increase 4mg bid q4 weeks
                                    up to 12mg po bid as tolerated
                                    -Patients with Renal / Hepatic Impairment max
                                    daily dose 16mg/day (8mg po bid)
                                    -Take with food; risk of nausea, vomiting, anorexia
                                    and weight loss. Titrate slowly. If patient off meds


                             Section F, Page 1 of 5
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines
                                   for more than a few days restart with initial titration
                                   schedule

                            3.     Rivastigmine
                                   -Maximum daily dose = 12mg
                                   -Start with 1.5mg po bid, increase by 1.5mg/dose
                                   q2weeks as tolerated; up to 6mg po bid
                                   -Take with food; risk of nausea, vomiting, anorexia
                                   and weight loss. Titrate slowly. If patient off meds
                                   for more than a few days restart with initial titration
                                   schedule

                            4.     Tacrine
                                   -Maximum daily dose = 160mg
                                   -Start with 10mg po qid x 4weeks, titrate by 10mg
                                   qid q 4 weeks based on response, max. 40mg po qid
                                   -Must monitor ALT q 2 weeks x 16 weeks then q 3
                                   months

                            5.     Memantine
                                   -Maximum daily dose = 20mg
                                   -Start with 5mg po qd; increase by 5mg q week;
                                   Max: 20mg/ day; Give bid if > 5mg/day.
                                   -Lower doses if moderate renal impairment

Documentation   E.   Duration
Required
                     1.     Inadequate trial/ poor tolerance of other cholinesterase
                            inhibitors

Documentation   F.   Polypharmacy & Drug Interactions
Required
                     1.     Use of more than one anti-Alzheimer agent for period
                            greater than 60 days
                     2.     More than three other psychotropic drugs of any class
                     3.     More than two drugs with significant anticholinergic
                            properties
                     4.     Same class polypharmacy requires documentation of two-
                            physician consent
                     5.     Drugs affecting cytochrome P-450 enzymes which may
                            increase or decrease levels of anti-Alzheimer’s agent

Document        G.   Serious adverse effects
Assessment of
Following:           1.     Cardiovascular effects: syncope, bradycardia,
                            bradyarrhythmia, sick sinus syndrome, conduction
                            disturbances

                            Section F, Page 2 of 5
                     Santa Clara County Mental Health Department
                           Medication Practice Guidelines
                         2.       Seizures
                         3.       Elevation of liver transaminases
                         4.       Urinary outflow obstruction

Documentation   H.       Standard laboratory and examination requirements
Required
                         1.       For inpatient: Basic laboratory studies on admission
                         2.       For outpatient:
                                  Upon initiation of treatment (unless documented recent
                                  studies obtained elsewhere), the following studies are
                                  recommended:
                              -   Mini-Mental Status Examination
                              -   Weight and/or Body Mass Index
                              -   Fasting glucose
                              -   Fasting lipid panel
                              -   Liver function panel (LFT’s)
                              -   Complete blood count (CBC)
                              -   RPR/VDRL
                              -   B12, Folate
                              -   TSH, T4
                              -   HIV (when history suggestive of risk factors)
                              -   Panel 7
                              -   MRI /CT brain scan
                         3.       Baseline electrocardiogram (ECG) under the following
                                  conditions:
                              -   known history of cardiac arrhythmia
                              -   electrolyte abnormalities (e.g. hypokalemia,
                                  hypomagnesemia)
                              -   concomitant use of QT-prolonging agents

Documentation   J.       Relative Contraindications (requires documentation of
Required                 justification)

                         1.       Hypersensitivity
                         2.       Relative contraindications for specific agents:

                                  1.     Donepezil
                                         -hypersensitivity to piperidine derivatives

                                  2.     Galantamine
                                         -severe hepatic and /or renal impairment

                                  3.     Rivastigmine
                                         -hypersensitivity to carbamate derivatives

                                  4.     Tacrine
                                         -hypersensitivity to acridine derivatives

                                  Section F, Page 3 of 5
                        Santa Clara County Mental Health Department
                              Medication Practice Guidelines
                                          -previously developed tacrine-associated jaundice-
                                          -previously developed tacrine-associated total
                                          bilirubin > 3.0 mg/dl

                   I.       Precautions

                            1.    History of allergy to this class of drugs
                            2.    Hx. of syncope, bradycardia, bradyarrhythmia, sick sinus
                                  syndrome, conduction disturbances, CHF, or CAD.
                            3.    May increase gastric secretion. Caution when given to
                                  patients with Hx. of peptic ulcer disease, increased risk for
                                  ulcers or GI bleeding (use of NSAIDS or high dose ASA) –
                                  monitor for symptoms of active/occult bleeding
                            4.    Caution when given to patients with bronchial asthma or
                                  obstructive pulmonary disease
                            5.    Caution if low body weight, over 85 years of age or female
                            6.    Potential to cause seizures
                            7.    May exaggerate the effects of succinylcholine-type muscle
                                  relaxants during anesthesia
                            8.    Additional precautions for specific agents:

                                  1.      Galantamine
                                          -urinary obstruction

                                  2.      Menantine
                                          -concomitant use of drugs that make the urine
                                          alkaline
                                          -genitourinary conditions that raise urine pH
                                          -concomitant use of other NMDA antagonists
                                          -moderate to sever renal impairment

                                  3.      Rivastigmine
                                          -urinary obstruction
                                          -significant GI effects, including nausea, vomiting,
                                           anorexia, and weight loss

                                  4.      Tacrine
                                          -Hx. of abnormal liver function
                                          -may have vagotonic effects on the SA and AV
                                          nodes leading to bradycardia and/or heart block. Do
                                          not use if conduction abnormalities,
                                          bradyarrhythmias, or sick sinus syndrome.


Attachment: Table 1 FDA-Approved Indications and Maximum Dose
Refer to appendix for standardized treatment algorithms.
Revised: 05-05

                                   Section F, Page 4 of 5
                    Santa Clara County Mental Health Department
                          Medication Practice Guidelines

                 ALZHEIMER’S DISEASE AGENTS
FDA-Approved Indications and Maximum Dose
Table 1:

    Agent      Brand         Max dose      Mild to Moderate     Moderate to
                                              Dementia        Severe Dementia
Donepezil      Aricept         10mg                X

Galantamine    Reminyl         24mg                 X

Memantine      Namenda         20mg                                 X

Rivastigmine   Exelon          12mg                 X

Tacrine        Cognex         160mg                 X




                               Section F, Page 5 of 5
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines

                          ANTIANXIETY AGENTS

Documentation   A.   FDA Approved Indications (see Tables 1 & 2)
Required
                     1.     Management of anxiety disorders or for the short-term
                            relief of the symptoms of anxiety. Anxiety or tension
                            associated with the stress of everyday life usually does not
                            require treatment with an anxiolytic
                     2.     In acute alcohol withdrawal, anxiolytics may be useful in
                            the symptomatic relief of acute agitation, tremor,
                            impending or acute delirium tremens and hallucinosis
                     3.     Anxiolytics are a useful adjunct for the relief of skeletal
                            muscle spasm due to reflex spasm to local pathology (such
                            as inflammation of the muscles or joints, or secondary to
                            trauma); spasticity caused by upper motor neuron disorders
                            (such as cerebral palsy and paraplegia); athetosis; and stiff-
                            man syndrome.
                     4.     Convulsions: status epilepticus, absence seizures, infantile
                            spasms, simple partial and complex partial seizures
                     5.     Insomnia
                     6.     Panic disorder with or without agoraphobia
                     7.     Other: cardioversion, endoscopy and bronchoscopy,
                            enhancement of analgesia during labor and delivery,
                            preoperative sedation

Documentation   B.   Non-FDA approved, commonly used indications
Required
                     1.     Akathisia due to neuroleptic agents
                     2.     May reduce abnormal movements associated with tardive
                            dyskinesia (clonazepam)
                     3.     Sedation in severe agitation (IV)
                     4.     In mania: used concomitantly with antipsychotic or lithium
                            to control agitation; may potentiate antipsychotics and
                            decrease dosage requirements
                     5.     Depression (alprazolam)
                     6.     Mania and bipolar disorder prophylaxis (clonazepam); may
                            prevent antidepressant-induced mania and decrease rate of
                            cycling
                     7.     In schizophrenia used with antipsychotic to control
                            agitation; may potentiate antipsychotics
                     8.     Social phobia (alprazolam, clonazepam, diazepam,
                            lorazepam)




                             Section F, Page 1 of 5
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines
                     9.     Several open-label studies of alprazolam or clonazepam
                            suggest improvement in hyperarousal symptoms of PTSD
                            (but no change in avoidance, numbing, or intrusive
                            symptoms) – caution due to risk of abuse in this population
                     10.    Catatonia (parenteral and sublingual lorazepam,
                            clonazepam, diazepam)
                     11.    Myoclonus, restless leg syndrome, Tourette’s syndrome
                            (clonazepam)
                     12.    Acute dystonia (SL or IM lorazepam)
                     13.    Delirium (lorazepam); delirium tremens (diazepam)
                     14.    Neuralgic pain (clonazepam)
                     15.    Premenstrual dysphoric disorder (alprazolam)
                     16.    Control of violent outbursts, assaultive behavior
                            (clonazepam, lorazepam); used also in combination with
                            mood stabilizers, antipsychotics, or B-blockers
                     17.    Alprazolam withdrawal (clonazepam)

                     Note: The long-term use, that is, more than 4 months, of
                           anxiolytics has not been assessed by systematic clinical
                           studies. The physician should periodically reassess the
                           usefulness of the drug for the individual patient and be
                           cautious about creating psychological and physiological
                           abuse and dependence.

Documentation   C.   Minimal Documentation
Required
                     1.     All standard outpatient & inpatient requirements

Documentation   D.   Maximum Dosage – see Medication Summary for MDD
Required

Documentation   E.   Duration
Required
                     1.     More than 2 changes of psychotropic medication in any 7
                            day period

Documentation   F.   Polypharmacy* & Drug Interactions
Required
                     1.     More than one benzodiazepine is discouraged. Requires
                            clear documentation of rationale for polypharmacy.
                     2.     The longer the half-life of a benzodiazepine, the greater the
                            likelihood that the compound will have an adverse effect on
                            daytime functioning, e.g. hangover. However, with shorter
                            half-life benzodiazepines, withdrawal and anxiety between
                            doses (rebound) and anterograde amnesia are seen more
                            often



                            Section F, Page 2 of 5
                     Santa Clara County Mental Health Department
                            Medication Practice Guidelines
                           3.     Drugs that can increase levels of benzodiazepines due to
                                  inhibition of cytochrome P-450 enzymes: nefazodone,
                                  fluvoxamine, ketoconazole
                           4.     Drugs with effects that can be potentiated by
                                  benzodiazepines: any other CNS depressant

* The physician will inquire about polytherapy that might cause drug interactions and will
document this inquiry in the progress notes before initiating an antianxiety medication.


Document            G.     Serious adverse effects of benzodiazepines
Assessment of              (For side effects of SSRIs, clomipramine, and venlafaxine, refer to
Following:                 antidepressants)

                           1.     Benzodiazepines
                                  -Marked sedation or lethargy
                                  -Ataxia (especially in the elderly)
                                  -Delirium or confusion
                                  -Drowsiness
                                  -Significant withdrawal symptoms upon discontinuation
                                  -Behavioral dyscontrol
                                  -Hallucinations

                           2.     Buspirone
                                  -CVA (rare)
                                  -CHF (rare)
                                  -MI (rare)

                           3.     Chloral Hydrate
                                  -Confusion
                                  -Hallucinations
                                  -Allergic reaction (rare)
                                  -Unusual excitation (rare)

Documentation       H.     Standard laboratory and examination requirements
Required
                           1.     For inpatient: Basic laboratory studies on admission

Documentation       I.     Relative contraindications (requires documentation of
Required                   justification)
                           (For side effects of SSRIs, clomipramine, and venlafaxine, refer to
                           antidepressants)

                           1.     History of allergy to this class of drugs
                           2.     Relative contraindications for specific agents:




                                   Section F, Page 3 of 5
Santa Clara County Mental Health Department
       Medication Practice Guidelines
            1.      Benzodiazepines
                    -Age less than 12 years (unless prescribed by a
                    child psychiatrist)
                    -Age less than 6 months (diazepam)
                    -History of alcohol abuse or substance abuse
                    -History of addiction to sedative drugs
                    -Pregnancy, especially first trimester
                    -Nursing mother
                    -Narrow angle glaucoma (alprazolam, clonazepam,
                    clorazepate, diazepam)
                    -Untreated open angle glaucoma (diazepam)
                    -Concomitant itraconazole/ketoconazole
                    (alprazolam)
                    -Severe liver disease (clonazepam)
                    -Psychoses (oxazepam)

            2.      Chloral Hydrate
                    -Marked hepatic or renal impairment

J.   Precautions
     (For side effects of SSRIs, clomipramine, and venlafaxine, refer to
     antidepressants)

     1.     Benzodiazepines
            -Abrupt discontinuation
            -May cause physical and psychological dependence,
            tolerance, and withdrawal symptoms
            -Risk of abuse
            -May impair mental or physical abilities
            -Caution in elderly (alprazolam, chlordiazepoxide,
            diazepam, lorazepam)
            -Severe pulmonary disease (alprazolam, clonazepam,
            diazepam, lorazepam)
            -Impaired liver function (alprazolam, chlordiazepoxide,
            diazepam)
            -Impaired renal function (chlordiazepoxide, clonazepam)
            -Obesity (alprazolam)
            -Mentally depressed patients (chlordiazepoxide,
            clorazepate, diazepam, lorazepam, oxazepam)
            -Acute intermittent porphyria (clonazepam)
            -Uncontrolled open angle glaucoma (clonazepam)
            -Pregnancy (diazepam)
            -Tartrazine sensitivity (oxazepam)

     2.     Buspirone
            -Avoid large amounts of grapefruit juice



            Section F, Page 4 of 5
                     Santa Clara County Mental Health Department
                            Medication Practice Guidelines
                                  -Concomitant use of an MAOI
                                  -Severe renal or hepatic impairment

                           3.     Chloral Hydrate
                                  -Severe cardiac disease
                                  -Mentally depressed patients
                                  -Hx of gastritis, esophagitis, or gastric or duodenal ulcers


Attachments:
Table 1 FDA-Approved Indication for Benzodiazepines
Table 2 FDA-Approved Indication for non-Benzodiazepines




Revised: 05-05


                                  Section F, Page 5 of 5
                       Santa Clara County Mental Health Department
                              Medication Practice Guidelines

                                ANTIANXIETY AGENTS
                 FDA-Approved Indications for Benzodiazepines
Table 1:
      Agent           Brand      Anxiety/GAD OCD     Panic      Social   Posttraumatic
                                                    Disorder   Anxiety   Stress Disorder
Alprazolam           Xanax           X

Alprazolam           Xanax XR        X                 X

Chlordiazepoxide Librium             X

Clonazepam           Klonapin                          X

Clorazepate          Tranxene        X

Diazepam             Valium          X

Lorazepam            Ativan          X

Oxazepam             Serax           X




    Revised: 05-05
                           Santa Clara County Mental Health Department
                                  Medication Practice Guidelines

                                 ANTIANXIETY AGENTS
                   FDA-Approved Indications for non-Benzodiazepines
 Table 2:
   Agent                 Brand      Anxiety/GAD   OCD      Panic      Social   Posttraumatic
                                                          Disorder   Anxiety   Stress Disorder
Buspirone        Buspar                  X

Chloral          Aquachloral,            X
Hydrate          Somnote

Escitalopram     Lexapro                 X

Fluoxetine       Prozac                             X        X

Fluvoxamine      Luvox                              X

Paroxetine       Paxil                   X          X        X           X           X

Sertraline       Zoloft                             X        X           X           X

Venlafaxine      Effexor                 X                               X

Clomipramine     Anafranil                          X




        Revised: 05-05
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines

                     ANTIDEPRESSANT AGENTS
Documentation   A.   FDA Approved Indications (see Table 1)
Required
                     1.     Major depressive disorder (MDD)/Depressive disorder
                            FDA Approved in Children & Adolescents
                            • Prozac
                     2.     Premenstrual dysphoric disorder (Sarafem, Zoloft)
                     3.     Seasonal affective disorder (Wellbutrin XL)
                     4.     Generalized anxiety disorder (Sinequan, Lexapro, Paxil,
                            Cymbalta, Effexor XR)
                     5.     Social anxiety disorder (Effexor XR, Luvox CR, Paxil,
                            Zoloft)
                     6.     Panic disorder (Prozac, Paxil, Zoloft, Effexor XR)
                     7.     Bulimia nervosa (Prozac)
                     8.     Obsessive compulsive disorder (Anafranil, Prozac, Luvox,
                            Paxil, Zoloft)
                            FDA Approved in Children & Adolescents
                            • Anafranil
                            • Luvox
                            • Zoloft
                            • Prozac
                     9.     Posttraumatic stress disorder (Paxil, Zoloft)
                     10.    Others:
                            • Adjunctive therapy for MDD (Abilify)
                            • Bipolar Disorder, depressive episodes (Seroquel)

Documentation   B.   Non-FDA Approved Indications, commonly used
Required
                     1.     Various depressive disorders
                     2.     Attention deficit hyperactivity disorder
                     3.     Autism
                     4.     Eating disorders
                     5.     Dementia related behaviors such as self injury, aggression,
                            impulsiveness
                     6.     Personality disorders
                     7.     Insomnia
                     8.     Chronic fatigue syndrome
                     9.     Impulse control disorders
                     10.    Somatoform disorders
                     11.    Smoking cessation (Wellbutrin)

Documentation   C.   Minimal Documentation
Required
                     All standard outpatient & inpatient requirements


                            Section H, Page 1 of 3
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines

Documentation   D.   Maximum Dosage – see Medication Summary for MDD or
Required             Table 2

                     1.     Applicable to Bupropion only:
                            • When initiating treatment with bupropion, the dose
                                should not be increased above 300 mg until after 2
                                weeks. Bupropion (short-acting) must be prescribed in
                                divided doses not exceeding 150 mg each.
                            • Wellbutrin SR divided doses not to exceed 200 mg
                                each.
                     2.     Higher doses may be required in the treatment of OCD
                     3.     Lower starting dose may be required in panic disorder due
                            to patient sensitivity to stimulating effects

Documentation   E.   Duration
Required
                     1.     Outpatient: Document rationale when making any
                            medication change.
                     2.     Inpatient: Document rationale when making more than 3
                            changes in any 7-day period.

Documentation   F.   Polypharmacy (Refer to Purpose Section for exceptions)
Required
                     1.     If using >1 antidepressants with the same mechanism of
                            action is necessary, clearly document the necessity for such
                            a regimen and that consultation was obtained from another
                            psychiatrist.
                            i.e. 2 SSRIs or 2 SNRIs

                G.   Drug-Drug Interactions – Refer to www.epocrates.com

Document        H.   Black Box Warning
Assessment of
Following:           Antidepressants increased the risk of suicidal thinking and
                     behavior (suicidality) in children, adolescents, and young adults in
                     short-term studies of major depressive disorder (MDD) and other
                     psychiatric disorders. Short –term studies did not show an increase
                     in the risk of suicidality with antidepressants compared to placebo
                     in adults beyond age 24; there was a reduction in risk with
                     antidepressants compared to placebo in adults aged 65 and older.
                     Depression and certain other psychiatric disorders are themselves
                     associated with increases in the risk of suicide. Patients of all ages
                     who are started on antidepressant therapy should be monitored
                     appropriately and observed closely for clinical worsening,
                     suicidality, or unusual changes in behavior.


                            Section H, Page 2 of 3
                     Santa Clara County Mental Health Department
                            Medication Practice Guidelines
Documentation       I.     Standard Laboratory and Examination Requirements
Required
                           1.     For Inpatient: Basic laboratory studies on admission
                           2.     For Outpatient:
                                     • Applicable to SNRIs only:
                                         Monitor blood pressure at baseline and dose
                                         increase.
                                     • Applicable to Remeron only:
                                             Monitor total cholesterol and triglyceride
                                             annually.
                                             If Primary Care Provider is already monitoring
                                             total cholesterol and triglyceride, provide
                                             supportive documentation.
                                             From Prescriber’s Information: In US controlled
                                             studies, nonfasting cholesterol increased to >
                                             20% above the upper limits of normal in 15% of
                                             patients treated with Remeron, compared to 7%
                                             for placebo. Additionally 6% of patients treated
                                             with Remeron had nonfasting triglyceride
                                             increased to > 500mg/dL compared to 3% for
                                             placebo.

                    J.     Pregnancy and Lactation (Table 3)

                    K.     Pharmacology (Table 4)
                           1. Approximately 8% of Caucasians lack the capacity to
                              metabolize CYP2D substrates and are classified as poor
                              metabolizers (PM), whereas the rest are extensive metabolizers
                              (EM). PMs have about a 60% higher exposure to the total
                              active moieties from a given dose of Abilify compared to EMs.
                           2. Coadminstration of Abilify with known inhibitors of CYP2D6,
                              such as Prozac or Paxil in EMs, approximately doubles the
                              plasma exposure of Abilify. Coadministration of Abilify with
                              known inducers of CYP3A4, such as carbamazepine, the
                              Abilify dose may need to be doubled. Dose adjustments
                              should be considered when clinical indicated.


Attachments:
Table 1 FDA Approved Indication for Antidepressants
Table 2 Maximum Daily Dose
Table 3 Pregnancy and Lactation
Table 4 Pharmacology

Revised: 1-09




                                  Section H, Page 3 of 3
                                   Santa Clara County Mental Health Department
                                          Medication Practice Guidelines

                                   ANTIDEPRESSANT AGENTS
Table 1: FDA-Approved Indications for Antidepressants (1-09)
     Agents         Brand        MDD/           PMDD1    GAD     OCD      PD2     SAD3    PTSD       Bulimia     SAD4
                               Depression                                                            Nervosa
MAOIs
Isocarboxazid     Marplan             X
Phenelzine        Nardil              X
Selegiline        Emsam               X
Transdermal
Tranylcypromine   Parnate             X
TCAs
Amitriptyline     Elavil              X
Amoxapine         Asendin             X
Clomipramine      Anafranil                                        X5
Desipramine       Norpramin           X
Doxepin           Sinequan            X                    X
Imipramine        Tofranil            X
Maprotiline       Ludiomil            X
Nortriptyline     Pamelor             X
Protriptyline     Vivactil            X
SSRIs
Escitalopram      Lexapro            X                     X
Citalopram        Celexa             X
Fluoxetine        Prozac             X5                            X5      X                            X
                  Sarafem                        X
Fluvoxamine       Luvox                                            X
                  Luvox CR                                         X               X
Paroxetine        Paxil               X                    X       X       X       X         X
Sertraline        Zoloft              X          X                 X5      X       X         X
SNRIs
Desvenlafaxine    Pristiq             X
Duloxetine        Cymbalta            X                    X
Venlafaxine       Effexor             X
                  Effexor XR          X                    X               X       X
Others
Aripiprazole6     Abilify             X
Bupropion         Wellbutrin          X
                  Wellbutrin          X                                                                              X
                  XL
Mirtazapine       Remeron             X
Nefazodone                            X
Quetiapine7       Seroquel            X
Trazodone         Desyrel             X
      1                                     4                                     7
       Premenstrual dysphoric DO             Seasonal Affective DO                 Bipolar DO, depressive episodes
      2                                     5
       Panic DO                              Adult, Children & Adolescent
      3                                     6
       Social Anxiety DO                     Adjunctive Treatment for MDD, adults
                                Santa Clara County Mental Health Department
                                       Medication Practice Guidelines

                                ANTIDEPRESSANT AGENTS
Table 2: Maximum Daily Dose
    Agent                         Brand                    Adult           Children & Adolescents
MAOIs
Isocarboxazid         Marplan                              60 mg              non-FDA approved
Phenelzine            Nardil                               90 mg              non-FDA approved
Selegiline            Emsam                                12 mg
Transdermal                                                                   non-FDA approved
Tranylcypromine       Parnate                              60 mg              non-FDA approved
TCAs
Amitriptyline         Elavil                               300 mg             non-FDA approved
Amoxapine             Asendin                              600 mg             non-FDA approved
Clomipramine          Anafranil                            250 mg              200 mg (> 10 yo)
Desipramine           Norpramin                            300 mg             non-FDA approved
Doxepin               Sinequan                             300 mg             non-FDA approved
Imipramine            Tofranil                             300 mg             non-FDA approved
Maprotiline           Ludiomil                             225 mg             non-FDA approved
Nortriptyline         Pamelor                              150 mg             non-FDA approved
Protriptyline         Vivactil                              60 mg             non-FDA approved
SSRIs
Escitalopram          Lexapro                               20 mg             non-FDA approved
Citalopram            Celexa                                60 mg             non-FDA approved
Fluoxetine            Prozac                                80 mg               20 mg (>7 yo)
                      Prozac Weekly                         90 mg             non-FDA approved
                      Sarafem                               20 mg             non-FDA approved
Fluvoxamine           Luvox, Luvox CR                      300 mg             200 mg (8-11 yo)
                                                                              300 mg (12-17 yo)
Paroxetine            Paxil                                60 mg              non-FDA approved
                      Paxil CR                             75 mg              non-FDA approved
Sertraline            Zoloft                               200 mg              200 mg (6-17 yo)
SNRIs
Desvenlafaxine        Pristiq                               50 mg             non-FDA approved
Duloxetine            Cymbalta                             120 mg             non-FDA approved
Venlafaxine           Effexor                              375 mg             non-FDA approved
                      Effexor XR                           225 mg             non-FDA approved
Others
Aripiprazole1         Abilify                              15 mg              non-FDA approved
Bupropion             Wellbutrin, Wellbutrin XL           450 mg              non-FDA approved
                      Wellbutrin SR                       400 mg              non-FDA approved
Mirtazapine           Remeron                              45 mg              non-FDA approved
Nefazodone                                                600 mg              non-FDA approved
          2
Quetiapine          Seroquel                              600 mg              non-FDA approved
Trazodone           Desyrel                               600 mg              non-FDA approved
1
 FDA maximum dosing for the diagnosis of Adjunctive Therapy for MDD
2
 FDA maximum dosing for the diagnosis of Bipolar DO, depressive episodes
1-09
                            Santa Clara County Mental Health Department
                                   Medication Practice Guidelines

                               ANTIDEPRESSANT AGENTS
Table 3: Pregnancy Categories & Nursing Mother
 Agents            Brand         Pregnancy                         Nursing Mother
                                 Category
 Amitriptyline     Elavil           C        •   AAP: Drugs for which the effect on nursing infants is
                                                 unknown but may be of concern.
                                             •   Thomson: Infant risk cannot be ruled out.
 Amoxapine         Asendin          C                                     “
 Bupropion         Wellbutrin       C                                      “
 Citalopram        Celexa           C        Thomson: Infant risk cannot be ruled out.
 Clomipramine      Anafranil        C        • AAP: Drugs for which the effect on nursing infants is
                                                unknown but may be of concern.
                                             • Thomson: Infant risk cannot be ruled out.
 Desipramine       Norpramin        C                                      “
 Desvenlafaxine    Pristiq          C        Thomson: Infant risk cannot be ruled out.
 Doxepin           Sinequan         B                                      “
 Duloxetine        Cymbalta         C        Thomson: Infant risk cannot be ruled out.
 Escitalopram      Lexapro          C        Thomson: Infant risk cannot be ruled out.
 Fluoxetine        Prozac           C        • AAP: Drugs for which the effect on nursing infants is
                                                unknown but may be of concern.
                                             • Thomson: Infant risk cannot be ruled out.
 Fluvoxamine       Luvox            C                                      “
 Imipramine        Tofranil         C                                      “
 Isocarboxazid     Marplan          C        Thomson: Infant risk cannot be ruled out.
 Maprotiline       Ludiomil         B        Thomson: Infant risk cannot be ruled out.
 Mirtazapine       Remeron          C        Thomson: Infant risk cannot be ruled out.
 Nefazodone                         C        Thomson: Infant risk cannot be ruled out.
 Nortriptyline     Pamelor          C        • AAP: Drugs for which the effect on nursing infants is
                                                unknown but may be of concern.
                                             • Thomson: Infant risk cannot be ruled out.
 Paroxetine        Paxil            D                                      “
 Phenelzine        Nardil           C        Thomson: Infant risk cannot be ruled out.
 Protriptyline     Vivactil         C        Thomson: Infant risk cannot be ruled out.
 Selegiline        Emsam            C        Thomson: Infant risk cannot be ruled out.
 Transdermal
 Sertraline        Zoloft           C        •  AAP: Drugs for which the effect on nursing infants is
                                                unknown but may be of concern.
                                             • Thomson: Infant risk cannot be ruled out.
 Tranylcypromine   Parnate          C        Thomson: Infant risk cannot be ruled out.
 Trazodone         Desyrel          C        • AAP: Drugs for which the effect on nursing infants is
                                                unknown but may be of concern.
                                             • Thomson: Infant risk cannot be ruled out.
 Venlafaxine       Effexor          C        Thomson: Infant risk cannot be ruled out.

Rev. 1-09
                                   Santa Clara County Mental Health Department
                                          Medication Practice Guidelines

                                   ANTIDEPRESSANT AGENTS
    Table 4: Pharmacology
Agent                   Brand          Metabolism; CYP              t1/2 (hr)                         Comments
MAOIs
Isocarboxazid           Marplan        unknown                      unknown
Phenelzine              Nardil         Liver                        11.6
Selegiline              Emsam          Liver
Transdermal
Tranylcypromine         Parnate        Liver                        2.5                               active metabolites
TCAs
Amitriptyline           Elavil         Liver                        10-26                             active metabolites, incl
                                                                    (18-44 hr nortriptyline)          nortriptyline

Amoxapine               Asendin        Liver                        8 (30 hr hydroxyamoxapine)
Clomipramine            Anafranil      Liver                        32 (69
                                                                    desmethylclomipramine)
Desipramine             Norpramin      Liver                        12-27
Doxepin                 Sinequan       Liver                        6-8 (28-52 metabolite)            Active
Imipramine              Tofranil       Liver                        12-25                             Metabolite: desipramine

Maprotiline             Ludiomil       Liver                        43 (60-90                         Active metabolite
                                                                    desmethylmaprotiline)
Nortriptyline           Pamelor        Liver                        18-44                             Active metabolite
Protriptyline           Vivactil       Liver                        67-89
SSRIs
Escitalopram            Lexapro        Liver; 2D6 Inhibitor         27-32                             t1/2 ↑ 50% for elderly
                                       (weak)
Citalopram              Celexa         Liver; 2D6 Inhibitor         35
                                       (weak)
Fluoxetine              Prozac         Liver; 2D6, 3A4, 2C9/19      4-6 days (fluoxetine); 9.3 days
                                       Inhibitor                    (norfluoxetine)
Fluvoxamine             Luvox          Liver; 3A4, 2C19             15.6
                                       Inhibitor
Paroxetine              Paxil          Liver; 2D6 Inhibitor         21
Sertraline              Zoloft         Liver; 3A4, 2D6 Inhibitor    26
                                       (weak)
SNRIs
Desvenlafaxine          Pristiq        Liver                        11                                t1/2 is 23h for ESRD
Duloxetine              Cymbalta       Liver; 2D6 Inhibitor         12
                                       (moderate)
Venlafaxine             Effexor        Liver; 2D6 Inhibitor         5 (11 desmethylvenlafaxine)       Active metabolite
                                       (weak)
Others
Aripiprazole1           Abilify        Liver                        75 (2D6 Extensive                 2D6 Poor Metabolizers ↑
                                                                    Metabolizer); 146 (2D6 Poor       active drug exposure by
                                                                    Metabolizer)2                     60%
Bupropion               Wellbutrin     Liver; 2D6 Inhibitor         21
Mirtazapine             Remeron        Liver                        20-40
Nefazodone                             Liver; 3A4 Inhibitor         2-4
Trazodone               Desyrel        Liver                        Biphasic: 3-6; 5-9
    1
     Adjunctive Therapy for MDD
    2
     Poor Metabolizers lack the capacity to metabolize 2D6 substrates due to genetically dysfunctional 2D6 enzyme versus
    Extensive Metabolizers, whom have normal enzyme function.
    1-09
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines

            ANTIPARKINSON’S & ANTIHISTAMINE AGENTS

Documentation   A.   FDA approved indications
Required
                     1.    Parkinson’s Disease
                     2.    Alleviation of extrapyramidal side effects induced by
                           antipsychotic medications
                     3.    Use in prophylaxis of extrapyramidal side effects in
                           patients at high risk for these
                     4.    Tremor (benztropine)
                     5.    Insomnia (antihistamines)

Documentation   B.   Non-FDA approved, commonly used indications
Requirements
                     1.    Neuroleptic malignant syndrome (amantadine)
                     2.    Anxiety disorders (antihistamines)
                     3.    Emergency management of impulsivity and agitation

Documentation   C.   Minimal documentation
Required
                     1.    All standard outpatient & inpatient requirements
                     2.    If used for prophylaxis of extrapyramidal side effects,
                           should include documentation that patient is at high risk for
                           these

Documentation   D.   Maximum dosage – see Medication Summary for MDD
Required
                     1.    Patients age 65+ (without organic brain syndrome):
                           ½ of listed maximum dose
                     2.    Patients age 65+ (with organic brain syndrome):
                           ¼ of listed maximum dose
                     3.    Patients age 5-12: see Medication Summary

Documentation   E.   Duration
Required
                     1.    More than 2 changes of psychotropic medication in any 7
                           day period

Documentation   F.   Polypharmacy & Drug Interactions*
Required
                     1.    More than 2 drugs with significant anticholinergic
                           properties, especially thioridazine and chlorpromazine
                     2.    Any MAO inhibitor (diphenhydramine & hydroxyzine
                           only)


                            Section I, Page 1 of 3
                         Santa Clara County Mental Health Department
                               Medication Practice Guidelines
                             3.     Drugs with effects that can be potentiated: any other CNS
                                    depressant

* The physician will inquire about concomitant use of any other medications that might
cause drug interactions and will document this inquiry in the progress notes before
initiating an antiparkinson or antihistamine medication.

Document            G.       Serious adverse effects
Assessment of
Following:                   1.     Urinary retention
                             2.     Severe constipation
                             3.     Delirium
                             4.     Neuroleptic malignant syndrome (amantadine)
                             5.     Exacerbation of mental problems (amantadine)
                             6.     Increased intraocular pressure (benztropine,
                                    trihexyphenidyl)
                             7.     Paralytic ileus (benztropine)
                             8.     Heat stroke (benztropine)
                             9.     Central anticholinergic syndrome (biperiden)

Documentation       H.       Standard laboratory and examination requirements
Required
                             1.     For inpatient: Basic laboratory studies on admission

Documentation       I.       Relative contraindications (requires documentation of
Required                     justification)

                             1.     History of allergy to this class of drugs
                             2.     Angle closure glaucoma (except for amantadine)
                             3.     Prostatic hypertrophy (except for amantadine)
                             4.     Tardive dyskinesia (trihexyphenidyl)
                             5.     Age 2 for diphenhydramine
                             6.     Age less than 3 years benztropine, trihexyphenidyl
                             7.     Age less than 5 years for amantadine and biperiden
                             8.     History of seizures (amantadine only)
                             9.     Bowel obstruction (biperiden)
                             10.    Megacolon (biperiden)
                             11.    Newborns (diphenhydramine)
                             12.    Nursing mothers (diphenhydramine)

                    J.       Precautions

                             1.     Amantadine
                                    -Abrupt discontinuation may result in Parkinsonian crisis or
                                    neuroleptic malignant syndrome
                                    -Impaired mental alertness or physical coordination



                                    Section I, Page 2 of 3
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines
                           -Patients with liver disease, CHF, orthostatic hypotension,
                           seizures, untreated angle closure glaucoma, and
                           cerebrovascular disease in the elderly

                     2.    Benztropine
                           -Mental disorders
                           -Obstructive uropathy, prostatic hypertrophy
                           -Tachycardia
                           -Tardive dyskinesia

                     3.    Biperiden
                           -Cardiac arrhythmias
                           -Epilepsy
                           -Prostatism
                           -Concomitant drugs with anticholinergic actions

                     4.    Diphenhydramine
                           -Decreased mental alertness
                           -Hx of asthma, increased intraocular pressure,
                           hyperthyroidism, cardiovascular disease or HTN
                           -Stenosing peptic ulcer

                     5.    Trihexphenidyl
                           -Cardiac, liver, or kidney problems
                           -Elderly
                           -May worsen tardive dyskinesias
                           -Abrupt discontinuation may result in neuroleptic
                           malignant syndrome
                           -Obstructive disease of gastrointestinal and genitourinary
                           tracts
                           -Bladder neck obstruction
                           -Pyloroduodenal obstruction




Revised: 05-05



                            Section I, Page 3 of 3
                 Santa Clara County Mental Health Department
                        Medication Practice Guidelines

                ANTIPSYCHOTICS AGENTS - ATYPICAL


Documentation      A.    FDA approved indications
Required                 (Refer to Table 1)
                         1.     Schizophrenia
                                • In children 13-17 y.o.: Abilify & Risperdal
                         2.     Schizophrenia- Treatment-resistant (Clozapine)
                         3.     Reduction in risk of recurrent suicidal behavior in
                                Schizophrenia or Schizoaffective Disorder
                                (Clozapine)
                         4.     Bipolar Disorder: acute manic/mixed episodes
                                • In children 13-17 y.o.: Risperdal
                         5.     Bipolar Disorder: depressive/acute manic episodes
                                (Quetiapine)
                         6.     Bipolar Disorder: depressive episodes
                                (Symbyax)
                         7.     Bipolar Disorder - maintenance treatment
                                (Aripiprazole & Olanzapine)
                         8.     Bipolar Disorder: Adolescent (10-17 y.o.)
                         9.     Agitation with schizophrenia or bipolar disorder
                                (IM)
                         10.    Irritability with autistic disorder, include symptoms
                                of aggression towards others, deliberate self-
                                injuriousness, temper tantrums, and quickly
                                changing moods (Risperidone)

Documentation      B.    Non-FDA approved, commonly used indications
Required
                         1.       Dementia-related psychosis
                         2.       Psychotic depression
                         3.       Treatment resistant depression
                         4.       Augmentation in depression
                         5.       Psychosis associated with Parkinson’s disease
                         6.       Augmentation in refractory obsessive compulsive
                                  disorder
                         7.       Pervasive developmental disorders
                         8.       Tic disorders, Tourette’s syndrome and
                                  trichotillomania
                         9.       Substance induced psychosis
                         10.      Impulse control disorder
                         11.      Movement disorder (e.g. Parkinson’s disease,
                                  Huntington’s chorea)
                         12.      Addictive behaviors (e.g. smoking, alcohol abuse,
                                  drug abuse) in dual diagnosis individuals



                               Section J, Page 1 of 8
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines

                        13.      PTSD
                        14.      Early studies show some improvements in
                                 flashbacks and intrusive symptoms of treatment
                                 refractory PTSD
                        15.      Personality disorder (i.e. BPD)
                        16.      Intractable extrapyramidal side effects unresponsive
                                 to standard antiparkinson's treatment or trials of
                                 alternative atypical antipsychotics (clozapine)

Documentation     C.    Minimal documentation
Required
                        1.       All standard outpatient & inpatient requirements

Documentation     D.    Dosing Information
Required                (Refer to Medication Maximum Daily Dose (MDD) and
                        Table 2)
                        1.      “As needed” dosing of antipsychotics:
                                   • To be minimized, given lack of evidence for
                                       efficacy
                                   • Documentation of rationale for usage is
                                       required.
                                   • Documentation should include reason for
                                       using an antipsychotic instead of an
                                       alternative agent.

                        2.       Use of quetiapine for sleep disturbance:
                                    • In the absence of a clear psychotic or
                                        Bipolar Disorder, the use of quetiapine
                                        <150mg for >60 days is considered off-label
                                        usage, and requires documentation justifying
                                        rationale for the lower dosage.

                        3.       Applicable to clozapine only:
                                    • Patients age 65+ (with or without organic
                                        brain disease)
                                            -documentation of justification of dosage
                                    • Patients age 5-12: Not available

Documentation     E.    Duration of use
Required
                        1. For Outpatient: Document rationale when making any
                           medication change.
                        2. For Inpatient: Document rational when making more
                           than 3 changes in any 7-day period.




                              Section J, Page 2 of 8
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines

Documentation     F.    Polypharmacy
Required
                        1. Adequate medication doses should be used over a
                           sufficient period of time to obtain desired results before
                           polypharmacy is introduced.
                        2. Use of more than one antipsychotic agent for any
                           period greater than 90 days is discouraged.
                        3. If using >1 antipsychotic is necessary, provide clear
                           supportive rationale for adding the second antipsychotic
                           and consultation was obtained from another
                           psychiatrist.
                               i.e. one atypical plus one conventional agent

                  G.    Drug Interactions
                        (Refer to 2004 Guide to Psychiatric Drug Interaction article
                        @ www.sccmhd.org)

                        1. Physicians should be aware of drugs affecting P-450
                           enzymes which may affect levels of atypical
                           antipsychotics
                        2. Applicable to Clozapine only:
                               • Drugs that can cause significant increase in
                                   clozapine serum levels: especially SSRIs
                                   (notably fluvoxamine), phenothiazines,
                                   antiarrhythmics, quinidine
                               • Drugs with levels (or clinical effects) that are
                                   increased by clozapine: any other CNS
                                   depressant, anti-hypertensives, protein-bound
                                   drugs (warfarin, digoxin)
                               • Carbamazepine is contraindicated due to
                                   significant potential for bone marrow
                                   suppression or agranulocytosis and lowers
                                   clozapine level.
                               • Benzodiazepines use concomitant with
                                   clozapine has possible risk for respiratory
                                   depression or arrest.
                               • Nicotine and Rifampin may decrease clozapine
                                   plasma levels, resulting in a decrease in
                                   effectiveness of a previously effective clozapine
                                   dose.




                            Section J, Page 3 of 8
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines



Document          H.    Serious adverse effects
Assessment              (Refer to Table 3 for Black Box Warning and
                        Pregnancy Categories)

                        1.       Neuroleptic malignant syndrome (signs include
                                 fever, rigidity, diaphoresis, confusion, tremors,
                                 elevated CK)
                        2.       Tardive dyskinesia
                        3.       Seizure
                        4.       Hyperglycemia or diabetes
                        5.       Hyperlipidemia
                        6.       Cardiac arrhythmia
                        7.       Hyperthermia
                        8.       Syncope
                        9.       Marked sedation or lethargy
                        10.      Urinary retention
                        11.      Any significant laboratory abnormalities during
                                 treatment
                        12.      Marked hypotension (clozapine)
                        13.      WBC below 3500/mm3 or a rapid drop from
                                 previous levels:
                                     • WBC count between 3000-3500/mm3
                                         requires twice weekly CBC with differential.
                                     • WBC count drop of 3000/mm3 in one week
                                         requires a repeat CBC with differential
                                         (clozapine)
                        14.      Granulocyte count below 1500/mm3 (clozapine)
                        15.      Respiratory depression (clozapine)

Documentation     I.    Standard laboratory and examination requirements
Required                (Refer to Table 4)

                        1.       For Inpatient: Basic laboratory studies on admission
                        2.       For Outpatient: (See Atypical Antipsychotic Lab
                                 Monitoring)
                                 Upon initiation of treatment, unless recent studies
                                 obtained elsewhere are documented, the following
                                 baseline studies are required:
                                 • Blood pressure
                                 • Weight and/or body mass index calculation
                                    (BMI). Consider baseline waist/hip ratio
                                    measurement
                                 • Fasting glucose
                                 • Fasting lipid panel


                              Section J, Page 4 of 8
Santa Clara County Mental Health Department
       Medication Practice Guidelines

                • Complete blood count (CBC) (Clozapine)
        3.      Baseline electrocardiogram (ECG) is required under
                the following conditions for Geodon:
                • Known history of cardiac arrhythmia
                • Electrolyte abnormalities (e.g. hypokalemia,
                     hypomagnesemia)
                • Concomitant use of QT-prolonging agents
        4.      If signs/symptoms of tardive dyskinesia are noted,
                AIMS examination is required at least every 6
                months.
        5.      Pregnancy Category and Nursing Mother (See
                Table 3)
        6.      Applicable to Quetiapine only:
                • Consider eye examination for cataracts at
                     initiation of treatment or shortly thereafter and
                     at 6 month intervals during chronic treatment
        7.      Applicable to Clozapine only:
                • Complete baseline prior to start date
                          -CBC with differential
                          -Vital signs (BP, pulse, temp, resp) &
                          weight
                • Complete within 6 months of start date
                          -Consultation with a neurologist for patients
                          with a history of seizures or intracranial
                          disease
                • During clozapine treatment
                          -CBC with differential must be drawn
                          weekly for first 6 months of continuous
                          treatment. After 6 months of clozapine
                          treatment, CBC may be drawn every 2
                          weeks, if patient shows stable hematologic
                          profile.
                          - Patients who have been on continuous
                          Clozapine therapy for 12 months or longer
                          may qualify to be place on a monthly WBC
                          & ANC count monitoring schedule. This is
                          only permitted if all WBCs≥3500 and
                          ANCs≥2000 for the previous 12 months.
                          - Take orthostatic vital signs weekly on an
                          outpatient basis if patient shows
                          signs/symptoms of orthostasis.




             Section J, Page 5 of 8
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines



Documentation     J.    Absolute contraindications for clozapine
Required
                        1.      History of previous hypersensitivity of Clozapine or
                                any other component of this drug
                        2.      History of agranulocytosis
                        3.      History of clozapine-induced severe
                                granulocytopenia or agranulocytosis
                        4.      Myeloproliferative disorder
                        5.      Uncontrolled epilepsy
                        6.      Severe CNS depression or comatose state
                        7.      Concomitant use with other agents having a well-
                                known potential to cause agranulocytosis or
                                suppress bone marrow function
                        8.      Initial WBC count less than 4000/mm3
                        9.      Initial granulocyte count less than 1500/mm3

Documentation     K.    Relative contraindications
Required
                        1.      History of allergy to this class of drugs
                        2.      Recent myocardial infarction (within 6 weeks)
                        3.      Age less than 17 years not indicated
                        4.      If baseline ECG indicates a QTc interval > 420 ms,
                                caution using Geodon (consider cardiology
                                consultation)
                        5.      Applicable to Clozapine only:
                                    • Untreated hypertension or tachycardia
                                    • History of orthostatic hypotension
                                    • History of any serious physical illness in the
                                        prior month
                                    • Any agent with significant potential for bone
                                        marrow suppression or agranulocytosis, e.g.
                                        Carbamazepine
                                    • History of poor follow-through with
                                        frequent mandatory lab testing
                                    • Pregnancy category: B




                  L.    Precautions
                        (Refer to Table 2 for Black Box Warnings and
                        Pregnancy Categories)


                             Section J, Page 6 of 8
Santa Clara County Mental Health Department
       Medication Practice Guidelines


        1.       Use with caution in the elderly, in the presence of
                 cardiovascular disease, chronic respiratory disorder,
                 hypoglycemia, convulsive disorders
        2.       Use with caution in patients with known or
                 suspected hepatic disorder; monitor clinically and
                 measure transaminase periodically
        3.       Should be used very cautiously in patients with
                 narrow angle glaucoma or prostatic hypertrophy.
                 May lead to urinary retention (Clozaril)
        4.       Monitor if QT interval exceed 420 ms and
                 discontinue drug if patient is symptomatic or if QT
                 interval exceed 500 ms. Do not use ziprasidone in
                 patients with a history of QTc prolongation, recent
                 myocardial infarction, uncompensated heart failure,
                 or in combination with drugs known to prolong the
                 QTc interval. Patients with hypokalemia or
                 hypomagnesemia may also be at risk
        5.       Cigarette smoking is reported to induce the
                 metabolism and decrease the plasma level of
                 Clozaril and Zyprexa.
        6.       Agitation, aggression, delirium, worsening of
                 psychosis, diaphoresis and abnormal movements
                 associated with rapid Clozapine or Quetiapine
                 withdrawal (suggested to taper clozapine by 25-
                 100mg / week and quetiapine by 50-200 mg / week)
        7.       Confusion, disturbed concentration, disorientation
                 (more common with high doses or in the elderly)
        8.       Lower seizure threshold
        9.       Orthostatic Hypotension
        10.      Weight gain is common with most second
                 generation antipsychotics. Long term data is
                 limited with Ziprasidone or Aripiprazole, moderate
                 risk is seen with Quetiapine and risperidone, and
                 high risk is seen with Clozapine and olanzapine.
                 Weight gain may predispose to coronary artery
                 disease, hyperglycemia, and obstructive sleep apnea
        11.      Metabolic syndrome, also called insulin resistance
                 syndrome, consists of disturbed glucose
                 metabolism, obesity, hyperlipidemia, and
                 hypertension.
        12.      Neuroleptic malignant syndrome – rare disorder
                 characterized by muscular rigidity, tachycardia,
                 hyperthermia, altered consciousness, autonomic
                 dysfunction, and increase in CPK— can occur with
                 any class of antipsychotic agent, at any dose, and at


              Section J, Page 7 of 8
                  Santa Clara County Mental Health Department
                         Medication Practice Guidelines

                                     anytime (increased risk in hot weather). Other risk
                                     factors include polypharmacy, organic brain
                                     syndromes, mood disorders, dehydration, low serum
                                     sodium, exhaustion, and agitation.
                            13.      Lens change can occur after chronic use of
                                     quetiapine (reported incidence of 0.005%)
                            14.      Pregnancy category and Nursing mother (See
                                     Table 3)
                            15.      Applicable to Clozapine only:
                                     • Cardiomyopathy, signs and symptoms include
                                         exertional dyspnea, fatigue, orthopnea,
                                         paroxysmal nocturnal dyspnea, and peripheral
                                         edema.
                                     • Fever should be evaluated to rule out the
                                         possibility of an underlying infectious process
                                         or the development of agranulocytosis.
                                     • Pulmonary embolism, consider in those present
                                         with deep vein thrombosis, acute dyspnea, chest
                                         pain, or with other respiratory signs and
                                         symptoms.
                                     • Hepatitis
                                     • Anticholinergic toxicity: eye, gastrointestinal,
                                         and prostate.
                                     • Caution use in patients with renal or cardiac
                                         diseases.

Attachments:
Table 1: FDA-Approved Indications
Table 2: Therapeutic Dosing Range
Table 3: Black Box Warnings, Pregnancy Categories, Nursing Mother
Table 4: Laboratory Monitoring
Table 5: Formulations & Dosing Requirements
Table 6: Adverse Effect Profile
Refer to appendix for standardized treatment algorithms including Texas Medication
Algorithm.
Refer to appendix for American Diabetic Association Guidelines for use of atypical
antipsychotics.

Rev. 11-07




                                  Section J, Page 8 of 8
                                                                   Santa Clara County Mental Health Department
                                                                          Medication Practice Guideline


Table 1: FDA-Approved Indications

                         Agitation with Agitation with    Bipolar          Bipolar       Bipolar      Bipolar     Schizophrenia        Schizophrenia: Schizophrenia/S Irritability
                         schizophrenia schizophrenia      Disorder:        Disorder:     Disorder:    Disorder:                        Treatment-     AD: Reduction with autistic
                         (IM)           or bipolar        acute            with          depressive   Maintenance                      Resistant      in Risk of      disorder a
FDA Approved                            disorder (IM)     manic/mixed      depressive    episodes     monotherapy                                     Recurrent
Indicationsb                                              episodes         episodes/                                                                  Suicidal
                                                                           acute manic                                                                Behavior
                                                                           episodes

                                                                                                                  X (Adult, Kids 13-
Aripiprazole                               X              X                                           X           17yo)
Clozapine                                                                                                                              X              X
Olanzapine                                 X              X                                           X           X
Olanzapine&
Fluoxetine                                                                               X
Paliperidone                                                                                                      X
Quetiapine                                                                 X                                      X


                                                          X (Adult, Kids                                          X (Adult, Kids 13-
Risperidone                                        > 10yo)                                                    17yo)                                                   X
Ziprasidone           X                            X                                                          X
a
 Irritability includes symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.
b
    Reference: Prescribing Information (PI), Micromedex
Bolded agents reflect non-formulary status at SCVHHS.
                                              Santa Clara County Mental Health Department
                                                     Medication Practice Guidelines
Table 2: Therapeutic Dosing Range (mg/day) a
                                                                        Olanzapine&
Indications                           Aripiprazole Clozapine Olanzapine Fluoxetine  Paliperidone Quetiapine         Risperidone     Ziprasidone

Bipolar Disorder: acute manic/mixed
episodes                            15-30                   5-20                                              1-6
Bipolar Disorder: acute manic/mixed
episodes with or w/o psychotic
features                                                                                                                            80-160
                                                                                                 Depress:
                                                                                                 300 hs
Bipolar Disorder: depressive                                                                     Manic:
episodes/acute manic episodes                                                                    400-800
Bipolar Disorder: depressive
episodes                                                              6/25-12/50
Bipolar Disorder: Maintenance
monotherapy                           15-30                 5-20
Schizophrenia                         10-15                 10-15                  3-12          150-750      4-8                   40-200
Schizophrenia Treatment-Resistant                 300-600

Schizophrenia/SAD: Reduction in
Risk of Recurrent Suicidal Behavior               300-600
Irritability with autistic disorder                                                                           1mg<20kg,
(5-16y.o.)                                                                                                    2.5mg>20kg,3mg>45kg
Bolded agents reflect non-formulary status at SCVHHS.
a
  Reference: Prescribing Information, Micromedex
                                            Santa Clara County Mental Health Department
                                                   Medication Practice Guidelines

Table 3: Black Box Warnings, Pregnancy Categories, Nursing Mother
               Black Box Warning                                                                          Pregnancy Category (PC); Nursing Mother
                                                                                                          (NM)
Aripiprazole   Increase mortality in elderly patients w/ demetia-related psychosis                        PC: C
                                                                                                          NM: not know if excreted in milk, do not breast feed
Clozapine      (1) Agranulocytosis;                                                                       PC: B
               (2) Seizures;                                                                              NM: excreted in milk, do not breast feed
               (3) Myocarditis;
               (4) Other adverse cardiovascular and respiratory effects, including orthostatic
               hypotension, collapse, respiratory and/or cardiac arrest;
               (5) Increase mortality in elderly w/ dementia-related psychosis

Olanzapine     Increase mortality in elderly patients w/ demetia-related psychosis                        PC: C
                                                                                                          NM: excreted in milk, do not breast feed
Olanzapine&    (1) Suicidality in children and adolescent;                                                PC: C
Fluoxetine     (2) Increased mortality in elderly patients w/ dementia-related psychosis                  NM: excreted in milk, do not breast feed

Paliperidone   Increased mortality in elderly patients with Dementia-related psychosis                    PC: C
                                                                                                          NM: excreted in milk, do not breast feed
Quetiapine     (1) Increase mortality in elderly patients w/ demetia-related psychosis; (2) Suicidality   PC: C
               in children and adolescents                                                                NM: excreted in milk, do not breast feed
Risperidone    Increase mortality in elderly patients w/ demetia-related psychosis                        PC: C
                                                                                                          NM: excreted in milk, do not breast feed
Ziprasidone    Increase mortality in elderly patients w/ demetia-related psychosis                        PC: C
                                                                                                          NM: not know if excreted in milk, do not breast feed

Bolded agents reflect non-formulary status at SCVHHS.
                                          Santa Clara County Mental Health Department
                                                 Medication Practice Guidelines
                                           ATYPICAL ANTIPSYCHOTICS
                                       Outpatient Required Laboratory Monitoring
Table 4:      Laboratory Monitoring

                                   Baseline   1st 4 wks   1st 8 wks   1st 12 wks   Quarterly   Annually Every 5 yrs
                                                                                   (if WNL)    (if WNL) (if WNL)
             Weight (BMI)             X           X           X           X            X

             Waist circumference      X                                                           X
             (RECOMMENDED)
             BP                       X                                   X                       X

             Fasting glucose          X                                   X                       X

             Fasting lipid            X                                   X                         X        X
                                                                                               (1st year)

              *More frequent assessments may be warranted based on clinical status.

 Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes, Diabetes Care 27: 596-601, 2004.
                                        Santa Clara County Mental Health Department
                                               Medication Practice Guidelines

Table 5: Formulations and Dosing Requirements


                   Formulations                                                         Dosing Requirements
                   Tablet or capsule    Oral        Rapidly      Depot IM               Requires Requires Once-
                                        solution    dissolving                          food     titration a-day
                                                    tablet                                                 dosing

Aripiprazole       2,4,10,15,20,30      1mg/ml      Discmelt             9.75mg/1.3ml                      X
                                                    10,15
Clozapine          25, 50,100, 200                  12.5, 25,                                    X
                                                    100
Olanzapine         2.5,5,7.5,10,15,20               Zydis                10mg/1ml                          X
                                                    5,10,15,20
Olanzapine&        6/25,6/50,12/25,                                                                        X
Fluoxetine         12/50
Paliperidone       3,6,9                                                                                   X
Quetiapine         25,50,100,200,300,                                                            X         Xa
                   400, 200XR,
                   300XR
Risperidone        .25,.5,1, 2,3,4    1mg/ml        M-TAB        25,                             X         X
                                                    .5,1,2,3,4   37.5,
                                                                 50
Ziprasidone        20,40,60, 80                                          20mg/ml        Xb       X         X
Bolded agents reflect non-formulary status at SCVHHS.
a
  Bipolar Disorder Depression is administered once daily at
bedtime.
b
  Food increases aborption of Geodon up to 2-fold.
Reference: Precribing Information, Micromedex
                                        Santa Clara County Mental Health Department
                                               Medication Practice Guidelines


Table 6: Adverse Effect Profile



                           Clozapine      Risperidone   OLanzapine        Quetiapine        Ziprasidone       Aripiprazole
Sedation                   ++++           ++            +++               +++               +                 +
Anticholinergic effects    ++++           +             +++               +                 +                 +
Orthostatic hypotension    ++++           +++           +                 +++               +                 +
EPSs                       0              ++            +                 0                 +                 +
Wt gain                    ++++           ++            +++               ++                0                 0
Hyperprolactinemia         0              ++            +                 0                 +                 0
Hyperglycemia              ++++           +             +++               ++                0                 0
Hyperlipidemia             ++++           +             +++               ++                0                 0
QTc prolongation           ++             ++            +                 ++                +++               0

 Reference: Pharmacotherapy Self-Assessment Program, 5th Edition: Schizophrenia and Other Psychosis. American College of
 Clinical Pharmacy:54.
                    Santa Clara County Mental Health Department
                           Medication Practice Guidelines

                ANTIPSYCHOTICS AGENTS - CONVENTIONAL
Documentation      A.    FDA approved indications
Required
                         1.     Psychotic Disorder (Haloperidol, Thiothixene)
                         2.     Schizophrenia
                         3.     Bipolar Disorder, Manic (Chlorpromazine)
                         4.     Severe Behavioral Problems in children 6mo-12yo
                                (Chlorpromazine)
                         5.     Severe Behavioral Problems (Chlorpromazine,
                                Haloperidol)
                         6.     Tourette’s Syndrome (Haloperidol, Pimozide)
                         7.     Delirium (Haloperidol)
                         8.     Hyperactive Behavior, Short-term Treatment (Haloperidol)

Documentation      B.    Non-FDA approved, commonly used indications
Required
                         1.     Agitation
                         2.     Augmentation in refractory obsessive compulsive disorder
                         3.     Pervasive developmental disorders
                         4.     Impulse control disorder
                         5.     Other neurological conditions (e.g. ALS, Huntington’s)

Documentation      C.    Minimal documentation
Required
                         1.     All standard outpatient & inpatient requirements
                         2.     Document rationale for use of a conventional neuroleptic,
                                in lieu of an atypical agent, given the increased risk of
                                tardive dyskinesia
                         3.     Document rationale for use of mesoridazine or thioridazine
                                in lieu of another antipsychotic medication, given the
                                increased risk for cardiac arrhythmia

Documentation      D.    Maximum Dosage – see Medication Summary for MDD
Required

Documentation      E.    Duration
Required
                         1. For Outpatient: Document rationale when making any drug
                            switch.
                         2. For Inpatient: Document rational when making more than 3
                            changes in any 7-day period.


                               Section K, Page 1 of 5
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines

Documentation   F.   Polypharmacy & Drug Interactions
Required
                     1. Adequate medication doses should be used over a sufficient
                        period of time to obtain desired results before polypharmacy is
                        introduced.
                     2. Use of more than one antipsychotic agent for any period
                        greater than 90 days is discouraged.
                     3. If using >1 antipsychotic is necessary, provide clear supportive
                        rationale for adding the second antipsychotic and consultation
                        was obtained from another psychiatrist.
                            i.e. one atypical plus one conventional agent

Documentation   G.   Serious adverse effects
Assessment of
Following:
                     1.     Black Box Warning for Mesoridazine and Thioridazine:
                            Mesoridazine Besylate and Thioridazine hydrochloride
                            have been shown to prolong the QTc interval in a dose
                            related manner, and drugs with this potential, including
                            thioridazine hydrochloride, have been
                            associated with torsades de pointes-type arrhythmias and
                            sudden death. Due to its potential for significant, possibly
                            life-threatening, proarrhythmic effects, thioridazine
                            hydrochloride should be reserved for use in the treatment of
                            schizophrenic patients who fail to show an acceptable
                            response to adequate courses of treatment with other
                            antipsychotic drugs, either because of insufficient
                            effectiveness or the inability to achieve an effective dose
                            due to intolerable adverse effects from those drugs.
                     2.     Neuroleptic malignant syndrome (signs include fever,
                            rigidity, diaphoresis, confusion, tremors, elevated CK)
                     3.     Tardive dyskinesia
                     4.     Acute dystonia
                     5.     Cardiac arrhythmia or significant QTc prolongation on
                            EKG
                     6.     Convulsion
                     7.     Syncope
                     8.     Marked sedation or lethargy
                     9.     Intentional overdose
                     10.    Significant laboratory abnormalities during treatment




                            Section K, Page 2 of 5
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines



Documentation   H.   Standard laboratory and examination requirements
Required
                     1.     Weight and/or body mass index calculation (BMI)
                     2.     Basic laboratory studies on admission (inpatient only)
                     3.     Baseline fasting glucose
                     4.     Lipid panel
                     5.     Document the examination for abnormal movements with
                            the AIMS scale every twelve months
                     6.     ALL patients on Thioridazine, Mesoridazine or Pimozide
                            are required to have Electrocardiogram.
                     7.     All patients on Thioridazine and Mesoridazine are required
                            to have electrolytes panel

Documentation   I.   Relative contraindications (requires documentation of
Required             justification)

                     1.     History of allergy to this class of drugs
                     2.     Myocardial infarction within 6 weeks
                     3.     History of tardive dyskinesia
                     4.     History of cardiac arrhythmia or cardiac conduction
                            disorder or congenital QTc prolongation (thioridazine or
                            mesoridazine)
                     5.     Age less than 5 years (age 3 for haloperidol, age 2 for
                            thioridazine)
                     6.     History of neuroleptic malignant syndrome

                J.   Precautions

                     1.    Use with caution in the elderly, in the presence of
                           cardiovascular disease, chronic respiratory disorder,
                           hypoglycemia, convulsive disorders
                     2.    Use with caution in patients with known or suspected
                           hepatic disorder; monitor clinically and measure
                           transaminase periodically
                     3.    Should be used very cautiously in patients with narrow
                           angle glaucoma or prostatic hypertrophy. May lead to
                           urinary retention
                     4.    Cigarette smoking is reported to induce the metabolism and
                           decrease the plasma level of most antipsychotics
                     5.    Concomitant use of Phenothiazine and Clozapine should be
                           approached with caution because both are metabolized by
                           cytochrome P450 2D6. Lower doses may be required than
                           Section K, Page 3 of 5
                     Santa Clara County Mental Health Department
                            Medication Practice Guidelines
                                  previously prescribed for either Clozapine or
                                  Phenothiazine.
                           6.     Abrupt cessation of high doses may cause discontinuation
                                  syndrome with gastritis, nausea, vomiting, dizziness,
                                  tremors, feelings of warmth or cold, sweating, tachycardia,
                                  headache, and insomnia
                           7.     At high doses or in the elderly, can cause confusion,
                                  disturbed concentration, disorientation
                           8.     Thioridazine taken at larger than recommended doses can
                                  cause pigmentary retinopathy, which is characterized by
                                  diminution of visual acuity, brownish coloring of vision,
                                  and impairment of night vision.
                           9.     Lower seizure threshold. May occur if dose is increased
                                  rapidly
                           10.    Extrapyramidal reactions seen primarily with the high
                                  potency antipsychotics: dystonias, dyskinesias, akathisia,
                                  pseudoparkinsonism, perioral tremor, “rabbit syndrome”
                           11.    Tardive dyskinesia
                           12.    Constipation, urinary retention
                           13.    Hypotension
                           14.    EKG changes (T wave inversion, ST segment depression,
                                  QTc lengthening) may increase risk for arrhythmias.
                                  Electrolyte abnormalities including hypokalemia
                           15.    Hypomagnesemia and hypocalcemia can contribute to the
                                  development of torsades de pointes
                           16.    Sudden deaths of patients on antipsychotics is probably due
                                  to arrhythmias (rare)
                           17.    Weight gain, more common with low potency agents
                           18.    Neuroleptic malignant syndrome – rare disorder
                                  characterized by muscular rigidity, tachycardia,
                                  hyperthermia, altered consciousness, autonomic
                                  dysfunction, and increases in CPK— can occur with any
                                  class of antipsychotic agent, at any dose, and at anytime
                                  (increased risk in hot weather). Other risk factors include
                                  polypharmacy, organic brain syndromes, mood disorders,
                                  dehydration, low serum sodium, exhaustion, and agitation
                           19.    Pregnancy Category and Nursing mother: See Table 1:
                                  Adverse Drug Effects and Pregnancy Categories, Nursing
                                  Mother

Attachments:
Table 1: Adverse Drug Effects and Pregnancy Categories, Nursing Mother
Table 2: Drug Formulations
Rev. 9-07

                                  Section K, Page 4 of 5
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       Medication Practice Guidelines




           Section K, Page 5 of 5
                                             Santa Clara County Mental Health Department
                                                    Medication Practice Guidelines

    Table 1: Adverse Effect Profile, Pregnancy Categories, and Nursing Mother

                              Adverse Effect Profile                  Pregnancy Category (PC)/Nursing
                         Anticholinergic Sedation Orthostatic EPSEs Mother (NM)
                         Effects                     Hypotension
         Chlorpromazine +++              +++         +++         ++   PC: Unknown
                                                                      NM: Infant risk can not be ruled out
         Fluphenazine    +               +           +           ++++ PC: Unknown
                                                                      NM: Avoid breastfeeding
         Haloperidol     +               +           +           ++++ PC: C
                                                                      NM: Infant risk can not be ruled out
         Loxapine        ++              ++          +           +++  PC: C
                                                                      NM: Infant risk can not be ruled out
         Mesoridazine    ++++            +++         +++         ++   PC: C
                                                                      NM: Infant risk can not be ruled out
         Molindone       ++              ++          +           +++  PC: C
                                                                      NM: Infant risk can not be ruled out
         Perphenazine    ++              ++          +           +++  PC: Unknown
                                                                      NM: Infant risk can not be ruled out
         Pimozide        +               +           +           +++  PC: C
                                                                      NM: Infant risk can not be ruled out
         Thioridazine    ++++            +++         +++         ++   PC: Unknown
                                                                      NM: Infant risk can not be ruled out
         Thiothixene     ++              ++          +           +++  PC: C
                                                                      NM: Infant risk can not be ruled out
         Trifluoperazine ++              ++          +           +++  PC: Unknown
                                                                      NM: Infant risk can not be ruled out
    Key: (1) the more “+” a drug has, the more pronounced the adverse effect. (2) PC: C means “Either studies in animals have revealed adverse effects
    on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs
    should be given only if the potential benefit justifies the potential risk to the fetus.”

     References:
(1) Adapted from Tandon R: “Antipsychotic Agents,” in Current Psychotherapeutic Drugs, Second Edition. Edited by Quitkin FM, Adams DC, Bowden CL,
    et al. Philadelphia, PA, Current Medicine, 1998, pp. 120-154.
(2) Micromedex
                                Santa Clara County Mental Health Department
                                       Medication Practice Guidelines


  Table 2: Drug Formulations

                     Tablets (T) or capsule                              Rectal        Depot     IM
                     (C)                       Oral solution/syrup       Suppository   (mg/ml)   (mg/ml)
                     C: 30, 75, 150, 200
                     T: 10, 25, 50, 100, 200   Sln: 30mg/ml, 100 mg/ml
  Chlorpromazine     ER: 30, 75, 150, 200      Syr: 10mg/5ml             25, 100                      25
  Fluphenazine       T: 1, 2.5, 5, 10          Elix: 2.5mg/5ml, 5mg/ml                                2.5
  Fluphenazine dec                                                                          25
  Haloperidol        T: .5, 1, 2, 5, 10, 20
  Haloperidol dec                                                                       50,100
  Loxapine           C: 5, 10, 25, 50          25 mg/ml                                                50
  Mesoridazine       T: 10, 25, 50, 100        25 mg/ml                                                25
  Molindone          T: 5, 10, 25, 50, 100     20 mg/ml
  Perphenazine       T: 2, 4, 8, 16            16 mg/5ml                                                   5
  Pimozide           T: 1, 2
                     T: 10, 15, 25, 50, 100,
  Thioridazine       150, 200                  30 mg/ml, 100 mg/ml
  Thiothixene        C: 1, 2, 5, 10, 20
  Trifluoperazine    T: 1, 2, 5,10             10 mg/ml                                                    2


Reference: Micromedex
                  Santa Clara County Mental Health Department
                        Medication Practice Guidelines

                            MOOD STABILIZERS
Documentation   A.     FDA approved indications (see Table 1)
Required
                       1.     Acute mania associated with Bipolar Disorder
                       2.     Bipolar Disorder maintenance
                       3.     Bipolar Depression

Documentation   B.     Non-FDA approved, commonly used indications
Required
                       1.     Schizoaffective Disorders
                       2.     Treatment resistant psychosis
                       3.     Impulse Control Disorders
                       4.     Personality Disorders
                       5.     Major Depression (adjunct)
                       6.     Anxiety Disorders
                       7.     Substance Withdrawal Syndrome

                *Use of gabapentin (Neurontin) in psychiatry is considered to be non-
                formulary requiring NFDR and Medical Director’s approval.

Documentation   C.     Minimal documentation
Required
                       1.     All standard outpatient & inpatient requirements

Documentation   D.     Maximum Dosage - See Medication Summary for MDD
Required
                      1.      Dosage must be individualized according to serum levels
                              and clinical response (Lithium, Depakote, and
                              Carbamazepine extended release)
                       2.     Lamotrigine (Lamictal): Dosing recommendations should
                              be strictly followed to minimize the risk of serious rash
                              (refer to Package Insert)
                       3.     Caution in patients with renal insufficiency (Lamictal,
                              Lithium)
                       4.     Caution in patients with impaired hepatic function
                              (Carbamazepine extended release, Lamictal, Depakote)

Documentation   E.     Duration
Required
                       1. For Outpatient: Document rationale when making any
                          medication change.
                       2. For Inpatient: Document rational when making more than 3
                          changes in any 7-day period.




                                  Section L, 1 of 8
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines
Documentation   F.   Polypharmacy
Required
                     1. Adequate medication doses should be used over a sufficient
                        period of time to obtain desired results before polypharmacy is
                        introduced.
                     2. Use of more than one antipsychotic agent for any period
                        greater than 90 days is discouraged.
                     3. If using >1 mood stabilizers is necessary, provide clear
                        supportive rationale for adding the second mood stabilizer.
                        Refer to Antipsychotic (Atypical and Conventional) sections
                        for concomitant us of 2 or more antipsychotics.

                G.   Drug Interactions
                     (Refer to Atypical Antipsychotic Section for SGA, See 2004
                     Guideline to Psychiatric Drug Interactions in Appendix)
                     1.     Drugs affecting cytochrome P-450 enzymes which may
                            increase or decrease levels of Antiepileptic drugs.
                     2.     Oral Contraceptives (OC)
                                • May decrease effectiveness (Carbamazepine,
                                   Depakote, Trileptal)
                                • May decrease Lamictal concentration (may require
                                   Lamictal dosage adjustment, can potentially
                                   increase effect of Lamictal during week off of OC
                                   pills.)
                     3.     Concomitant use of Depakote and Lamictal (follow
                            standard dosing guidelines in the PI)
                     4.     Concomitant use of Aspirin, Salicylates, and Coumadin
                            with Depakote can increase risk of bleeding.
                     5.     Concomitant use of Lithium and Clozaril may
                            increase risk of EPS, CNS adverse effects, consider
                            decrease in Lithium dose.
                     6.     Drugs that can increase lithium levels and increase risk of
                            Lithium toxicity:
                                • Diuretics
                                • NSAID’s
                                • ACE inhibitors (Captopril, Enalapril)
                                • Tetracyclines,
                     7.     Drugs that can lower Lithium levels by enhancing
                            Lithium excretion:
                                • Methylxanthine bronchodilators (Aminophylline,
                                   Theophylline)
                                • Caffeine,
                                • Acetazolamide (Diamox),
                                • Urinary alkalizers (potassium citrate, sodium
                                   citrate)



                               Section L, 2 of 8
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines
                     8.     Concomitant use of Methotrexate, Sulfasalazine,
                            Triamterene, and Trimethoprime with Lamictal may
                            increase risk of blood dyscrasias due to additive antifolate
                            effect.
Document        G.   Serious adverse effects
Assessment of        For BLACK BOX Warnings see Table 3
Following:           (Refer to Atypical Antipsychotic Section for SGA)

                     1.     Marked sedation, confusion, or lethargy
                     2.     Hepatic dysfunction (Depakote, Carbamazepine)
                     3.     Bone marrow suppression: signs include fever, sore throat,
                            mouth ulcers, easy bruising, and petechiae
                            (Carbamazepine, Lamictal)
                     4.     Severe dermatologic reactions: toxic epidermal necrolysis
                            and Steven-Johnson syndrome (Lamictal, Carbamazepine,
                            Trileptal)
                     5.     Treatment with Carbamazepine in individuals with ancestry
                            across broad areas of Asia, including South Asian Indians,
                            should be screened for a particular human leukocyte
                            antigen (HLA) allele, HLA-B*1502. Dangerous or even
                            fatal skin reactions (Stevens Johnson syndrome and toxic
                            epidermal necrolysis), that can be caused by
                            Carbamazepine therapy, are significantly more common in
                            patients with HLA-B*1502. Patient who test positive
                            should not be started on Carbamazepine unless the
                            expected benefit clearly outweighs the increased risk of
                            serious skin reactions. Patients who have been taking
                            Carbamazepine for more than a few months without
                            developing skin reactions are at low risk of these events
                            ever developing from Carbamazepine.
                     6.     Coagulopathy and platelet dysfunction: signs include
                            prolonged bleeding, easy bruising, petechiae (Depakote)
                     7.     Pancreatitis (Depakote)
                     8.     Osteoporosis/Osteopenia (Depakote, Lamictal,
                            Carbamazepine)
                     9.     Polycystic ovarian syndrome (Depakote, Carbamazepine)
                     10.    Polyuria and polydipsia (Lithium)
                     11.    Renal and thyroid dysfunction (Lithium)
                     12.    Tremor
                     13.    Hypersensitivity reactions: signs include fever,
                            lymphadenopathy
                     14.    Acute multi-organ failure (Lamictal)
                     15.    Toxicity in melanin containing tissues and eyes with
                            extended use (Lamictal)
                     16.    Hyponatremia: signs include nausea, malaise, headache,
                            lethargy, confusion (Carbamazepine)



                                Section L, 3 of 8
                     Santa Clara County Mental Health Department
                           Medication Practice Guidelines
                         17.   Concomitant use of Lamictal with Depakote may increase
                               risk of Stevens-Johnson, or other potentially life-
                               threatening rashes
                         18.   Intentional overdose
                         19.   Any significant laboratory abnormalities during treatment

Documentation   H.       Standard laboratory and examination requirements (see Table2)
Required                 * Refer to Atypical Antipsychotic Medications Sections for
                                laboratory monitoring guidelines for SGA.

                         1.    For inpatient: Basic laboratory studies on admission
                         2.    For outpatient*: Upon initiation of treatment and
                               periodically, the following are required (SEE Table 2 for
                               agent specific requirements):
                                   • Drug Serum Level
                                   • Pregnancy Test
                                   • Liver function panel (LFT’s)
                                   • Complete blood count (CBC with differential and
                                       platelets)
                                   • Renal function panel (serum Creatinine/BUN and
                                       electrolytes)
                                   • Thyroid function tests (lithium)
                         3.    HLA-B*1502 allele screening is required before starting
                               treatment with carbamazepine, patients with ancestry
                               across broad areas of Asia, including South Asian Indians.
                               The patient can be sent to lab for this screening.
                                   • If the patient test positive, Carbamazepine should
                                       not be started unless the expected benefit clearly
                                       outweighs the increased risk of serious skin
                                       reactions.
                                   • If testing is not available to the patient,
                                       carbamazepine products should ordinarily not be
                                       used.

Documentation   I.       Relative contraindications (requires documentation of
Required                 justification)

                         1.    History of allergy to this class of drugs
                         2.    Pregnancy or breast-feeding (See Table 4)
                         3.    Additional relative contraindications for specific agents:
                                  • Carbamazepine (Equetro, Tegretol, Carbatrol)
                                      -Hypersensitivity to Carbamazepine or tricyclic
                                      compounds
                                      -Concomitant use of MAOIs, or use within 14 days
                                      of discontinuing MAOIs
                                      - Bone marrow suppression or history of previous


                                   Section L, 4 of 8
     Santa Clara County Mental Health Department
           Medication Practice Guidelines
                   •  Lithium (Lithium extended release, Lithobid)
                      - Impaired renal function
                      -Severe debilitation, dehydration, or sodium
                      depletion
                      -Impaired cardiovascular disease
                      -Lactation
                      -Age less than 12 years
                      -Low sodium diet
                   1. Lamotrigine (Lamictal)
                      - Hypersensitivity to Lamictal or any or its
                      compounds
                   • Olanzapine/Fluoxetine (Symbyax)
                      -History of allergy to Zyprexa or Prozac
                      -Concomitant use or use within a minimum of 5
                      weeks after discontinuation of the following:
                      MAOIs, thioridazine, and pimozide.
                      -Use of Symbyax within a minimum of 14 days of
                      MAOI discontinuation
                   • Divalproex sodium (Depakote)
                      -Hepatic disease or significant hepatic dysfunction
                      -Hypersensitivity to Depakote or any of its
                      compounds
                      -Urea cycle disorders

J.       Precautions

         1.    Abrupt discontinuation
         2.    Additional precautions for specific agents:
               • Carbamazepine
                      -Cardiac conduction disturbance or history of,
                      increased risk of atrioventricular heart block;
                      -Cardiac damage,
                      -ECG abnormalities,
                      -Increased intraocular pressure
                      - History of atypical absence seizures
                      - History of adverse hematological reaction to any
                      drug
                      - History of increase risk of bone marrow
                      suppression
                      - Kidney or liver damage
                      - Hepatic porphyria
                      - Elderly patients may cause confusion or agitation
                      - Mental illness, history; risk of latent psychosis
                      activation




                  Section L, 5 of 8
Santa Clara County Mental Health Department
      Medication Practice Guidelines
                 -Do not administer Tegretol suspension with other
                 liquid preparations due to formation of an insoluble
                 precipitate
          •   Lithium
                 -Pregnancy
                 -Protracted diarrhea, sweating, or infection with
                 increased temperatures may decrease tolerance to
                 lithium
                 - Significant cardiac disease
                 - Organic brain damage,
                 - Sodium depletion, restricted dietary salt intake, or
                 diuretic requirement may increase the possibility of
                 lithium intoxication.
                 - Do not increase lithium & antipsychotic dose at
                 same time due to risk of neurotoxicity
                 - Debilitated or elderly patients
                 - Discontinue lithium at least one week before
                 initiating electroconvulsive therapy (ECT) and
                 withhold lithium for several days after completing
                 ECT
                 - Ensure adequate fluid intake (2500 to 3000 mL)
                 and maintain normal diet and salt intake at least
                 during the stabilization period

          •   Olanzapine/Fluoxetine
                 - Bipolar disorder, increase risk of mixed or manic
                 episode
                 - Suicidal ideation and behavior or worsening
                 depression; increased risk particularly in children,
                 adolescents, and young adults in the first few
                 months of therapy or following changes in dosage.
                 - Concomitant use of drugs that affect coagulation
                 -Elderly with dementia-related psychosis; increased
                 risk of cerebrovascular adverse events (e.g., stroke,
                 transient ischemic attack) including death
                 -Cardiovascular or cerebrovascular disease or
                 conditions that may predispose patients to
                 hypotension
                 - Allergic reaction, systemic: may cause rash,
                 vasculitis
                 - May cause neuroleptic malignant syndrome
                 - May cause tardive dyskinesias
                 - May increase risk of hyperglycemia,
                 hyperlipidemia, and weight gain.
                 -Breast cancer or prolactin-dependent tumors;
                  reports of elevated prolactin levels


              Section L, 6 of 8
                        Santa Clara County Mental Health Department
                              Medication Practice Guidelines
                                            -Concomitant   use of NSAIDs, aspirin, or other
                                            drugs that affect coagulation; abnormal bleeding,
                                            particularly the gastrointestinal tract, may occur
                                           -Concomitant serotonergic drug use (serotonin
                                           precursors (tryptophan), SSRIs, serotonin-
                                           norepinephrine reuptake inhibitors); risk of
                                           serotonin syndrome, use is not recommended
                                    •   Divalproex
                                           - Concomitant use of multiple anticonvulsants
                                             increases risk of hepatotoxicity
                                           - Concomitant use of CNS depressants
                                           - Concomitant use with other agents that affect
                                           platelet function
                                           - Pancreatitis
                                           - Diabetic patients may how false-positive ketone
                                           results; Hepatic disease, history of, increased risk of
                                           hepatotoxicity
                                           - Pregnancy; increased risk of birth defects
                                           - Ataxia, cyclical vomiting, lethargy, irritability,
                                           mental retardation; possible undiagnosed urea cycle
                                           disorder, which is a contraindication
                                           - Elderly; increased incidence of adverse effects (i.e.
                                           somnolence, dehydration)
                                           - Higher doses (i.e. approximately 50 mg/kg/day);
                                           increased risk for dose-related thrombocytopenia
                                           and elevated liver enzymes
                                           -Concomitant use with Topiramate can increase risk
                                           of hyperammonemia, with or without
                                           encephalopathy

Documentation       M. Other agents used Off Label for the Treatment of Bipolar
Required                Disorder
                        Prescribing any of the agents below requires supportive
                        documentation in the Progress Notes:
                          1.      Gabapentin (Neurontin)
                          2.      Topiramate (Topamax)
                          3.      Oxcarbazepine (Trileptal)
                          4.      Tiagabine (Gabitril)
                          5.      Zonisamide (Zonegran)
                          6.      Levetiracetam (Keppra)


Attachments: Table 1:   FDA-Approved Indications
             Table 2:   Laboratory Requirements
             Table 3:   Black Box Warnings
             Table 4:   Pregnancy & Breastfeeding Categories


                                        Section L, 7 of 8
                        Santa Clara County Mental Health Department
                              Medication Practice Guidelines
                Table 5: Available Strength and Dosage Forms

References:
       1. Prescribing Information (PI)
       2. Micromedex
       3. APA’s Practice Guidelines for the Treatment of Patients with Bipolar Disorder
          revision 2004

Refer to Appendices:
       1. APA’s Practice Guidelines for the Treatment of Patients with Bipolar Disorder
           revision 2004
       2. 2004 Guide to Psychiatric Drug Interaction
       3. Metabolic Drug Interactions with Newer Antipsychotics: A Comparative Review,
           2007
       4. Pregnancy and Drug Dilemma, FDA Consumer Magazine May-June 2001

Revised: 1-09




                                       Section L, 8 of 8
                         Santa Clara County Mental Health Department
                                Medication Practice Guidelines

                            Table 1: FDA-approved Indications
                                                                       Bipolar     Bipolar
         Agent                        Brand             Bipolar Acute Maintenance Depression
Carbamazepine extended
release1                   Equetro*                            X

Lamotrigine2               Lamictal                                           X
Valproate/Divalproex4      Depakene, Depakote                 X
Aripiprazole               Abilify                            X               X
Olanzapine                 Zyprexa                            X               X
Risperidone                Risperdal                    X (kids >10yo)
Quetiapine                 Seroquel                           X                                X
Ziprasidone                Geodon                             X
Lithium3
                           Lithobid*                           X              X
Olanzapine/fluoxetine*     Symbyax*                                                            X


     * Currently Not on SCVH&HS formulary. NFDR and Medical Director's approval are required
     before initiation of medication.

     References: Prescribing Information (PI), Micromedex
     1
      Carbamazepine (Tegretol) is not FDA approved for Bipolar Disorder. Carbamazepine
     extended release is available as Tegretol XR, Carbatrol and Equetro. Only Equetro
     has FDA approval for Bipolar Disorder.
     2
      For patients taking Lamictal and Depakote, the MDD for Lamictal is 100mg. For
     patients take Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin, but not
     taking Depakote, and Lamictal, the MDD for Lamictal is 400mg.
     3
      Lithium is available as lithium carbonate, lithium carbonate ER (generic or as Lithobid
     300). The brand Eskalith and Eskalith ER has been discontinued from the US.
     4
      Divalproex sodium is available as Depakote and Depakote ER. When switching from
     Depakote to Depakote ER, the Depakote ER should be administered once-daily using a
     dose 8% to 20% higher than the total daily dose of Depakote (Please See Table 5 in the
     Mood Stabilizer section for Conversion chart.).




                                    Mood Stabilizers Rev 1-09
                                                         Santa Clara County Mental Health Department
                                                                Medication Practice Guidelines

Table 2: Laboratory Requirements A1
Agents                        Weight          Bun/Creatinine CBC w/                  Drug              Electrolytes       LFT              Pregnancy           TSH/T4
                                                             Dif                     Serum                                                 Test
                                                                                     Level B2
CarbamazepineC3                               b                     b, qmx2,         qmx2, then        b, q12m            b,qmx2, then     b,prn
                                                                    then q6m         q6m                                  q6m
Lithium                       b, q3m          b,3m,6m,then                           Inpt: 2x in 1st   b,3m,6m,then                        b,prn               b,6m, then
                                              q12m                                   10 days, then     q12m                                                    q12m
                                                                                     q2wk
                                                                                     Outpt: qmx2,
                                                                                     then q6m
Valproate/Divalproex          b, q3m                                   b, qmx2,      qmx2, then                           b,qmx2, then       b,prn
                                                                       then q6m      q6m                                  q6m
A1
   More frequent lab monitoring may be warranted based on clinical status.
B2
   More frequent drug serum level should be perform whenever there is a clinical status change or to rule out toxicity.
C3
   HLA-B*1502 allele screening is required before starting treatment with carbamazepine, patients with ancestry across broad areas of Asia, including South Asian Indians. If
testing is not available to the patient, carbamazepine products should ordinarily not be used.

Definitions:
b: Baseline
q: every
m: month
prn: as needed

References:
1. Prescribing Information (PI)
2. Micromedex
3. APA’s Practice Guideline for the Treatment of Patients with Bipolar Disorder revision 2004




                                                                      Mood Stabilizers, Rev.1-09
                                                 Santa Clara County Mental Health Department
                                                        Medication Practice Guidelines

Table 3: Black Box Warnings
                     Black Box Warnings

Carbamazepine-       •   Aplastic anemia and agranulocytosis have been reported in association with the use of Carbamazepine.
Extended             •   Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of
Release                  Carbamazepine, data are not available to estimate accurately their incidence or outcome.
                     •   Because of the very low incidence of agranulocytosis and aplastic anemia, the vast majority of minor hematologic changes observed in
                         monitoring of patients on Carbamazepine are unlikely to signal the occurrence of either abnormality. Nonetheless, complete pretreatment
                         hematological testing should be obtained as a baseline.

Lamotrigine          •   Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamotrigine.
(Lamictal)           •   Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash associated with
                         Lamotrigine.
                     •   Nearly all cases of life-threatening rashes associated with Lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However,
                         isolated cases have been reported after prolonged treatment (e.g., 6 months).
                     •   Although benign rashes also occur with Lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life
                         threatening. Accordingly, Lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related.

Lithium,             •   Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate
Lithium ER               serum lithium determinations should be available before initiating therapy.

Divalproex           •   HEPATOTOXICITY Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives. These incidents
Sodium                   usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms
(Depakote)               such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.
                     •   TERATOGENICITY Valproate can produce teratogenic effects such as neural tube defects (e.g., spina bifida). Accordingly, the use of
                         Divalproex sodium tablets in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the
                         fetus. An information sheet describing the teratogenic potential of Valproate is available for patients.
                     •   PANCREATITIS Cases of life-threatening pancreatitis have been reported in both children and adults receiving Valproate. Cases have been
                         reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea,
                         vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.

Bolded agents reflect non-formulary status at SCVH&HS.
References: Prescribing Information (PI), Micromedex



                                                              Mood Stabilizers, Rev. 11-07
                                               Santa Clara County Mental Health Department
                                                      Medication Practice Guidelines

Table 4: Pregnancy and Breastfeeding Categories
                                        Pregnancy Category              Breastfeeding Category

Carbamazepine- Extended                 D                               •    AAP Lactation Rating: Maternal medication usually compatible with breastfeeding.
Release                                                                 •    WHO Lactation Rating: Compatible with breastfeeding.
                                                                        •    Thomson Lactation Rating: Infant risk cannot be ruled out.

Lamotrigine (Lamictal)                  C                               •    Thomson Lactation Rating: Infant risk cannot be ruled out.

Lithium                                 D                               •   AAP Lactation Rating: Drugs that have been associated with significant effects on
Lithium ER                                                                  some nursing infants and should be given to nursing mothers with caution.
                                                                        •    WHO Lactation Rating: Avoid breastfeeding.
                                                                        •    Thomson Lactation Rating: Infant risk cannot be ruled out.

Divalproex Sodium (Depakote)            D                               •    AAP Lactation Rating: Maternal medication usually compatible with breastfeeding.
                                                                        •    WHO Lactation Rating: Compatible with breastfeeding. Monitor infant for side
                                                                             effects.
                                                                        •    Thomson Lactation Rating: Infant risk cannot be ruled out.


Bolded agents reflect non-formulary status at SCVH&HS.

References: Prescribing Information (PI), Micromedex
Refer to Pregnancy and Drug Dilemma in Appendix for definition of Pregnancy Category




                                                           Mood Stabilizers, Rev. 11-07
                                               Santa Clara County Mental Health Department
                                                      Medication Practice Guidelines

Table 5: Available Strength and Dosage Forms
                                                       Strengths & Dosage Forms
Carbamazepine- Extended Release                        •    Carbatrol: Oral Capsule, Extended Release: 100 MG
(Equetro)                                              •    Equetro: Oral Capsule, Extended Release: 100 MG, 200 MG, 300 MG
                                                       •    Tegretol-XR: Oral Tablet, Extended Release: 100 MG, 200 MG, 400 MG
Lamotrigine (Lamictal)                                 •    Generic: Oral Tablet, Chewable: 5 MG, 25 MG
                                                       •    Lamictal CD: Oral Tablet, Chewable: 2 MG, 5 MG, 25 MG
                                                       •    Lamictal: Oral Tablet: 25 MG, 100 MG, 150 MG, 200 MG
Lithium                                                •    Generic
Lithium ER (Lithobid)                                           o Oral Capsule: 150 MG, 300 MG, 600 MG
                                                                o Oral Tablet: 300 MG
                                                                o Oral Tablet, Extended Release: 300 MG, 450 MG
                                                                o Oral Solution: 8 MEQ/5 ML
                                                       •    Lithobid: Oral Tablet, Extended Release: 300 MG
Divalproex Sodium (Depakote)                           •   Depakote ER: Oral Tablet, Extended Release: 250 MG, 500 MG
                                                       •   Depakote: Oral Tablet, Enteric Coated: 125 MG, 250 MG, 500 MG
                                                       •   Depakote Sprinkle: Oral Capsule, Delayed Release: 125 MG
Bolded agents reflect non-formulary status at SCVH&HS.
Conversion from DEPAKOTE to DEPAKOTE ER1




References: Prescribing Information (PI), Micromedex



                                                              Mood Stabilizers, Rev. 11-07
                           Santa Clara County Mental Health Department
                                 Medication Practice Guidelines

                  PSYCHOSTIMULANT & ADHD-Related AGENTS
Documentation            A.     FDA approved indications - See Table 1
Required
                                1.      Attention Deficit/Hyperactivity Disorder (ADHD)
                                2.      Narcolepsy

Documentation            B.     Non-FDA approved, commonly used indications
Required
                                1.      Fatigue, disease related (methylphenidate)
                                2.      Obesity (mixed salt amphetamines)
                                3.      Refractory depression (methylphenidate)

Documentation            C.     Minimal documentation
Required
                                1.      All standard outpatient & inpatient requirements
                                2.      Additional documentation - school behavior, family
                                        history, developmental history, and physical examination
                                        report

Documentation            D.     Maximum dosage - See Medication Summary for MDD, or
Required                        Table 1

Documentation            E.     Duration
Required
                                1.      For Outpatient: Document rationale when making any
                                        medication change.
                                2.      For Inpatient: Document rationale when making more than
                                        3 changes in any 7-day period.

Documentation            F.     Polypharmacy*
Required
                                1.      Adequate medication doses should be used over a sufficient
                                        period of time to obtain desired results before introducing
                                        polypharmacy.
                                2.      If using >1 same class psychostimulant agent is necessary,
                                        provide clear supportive rationale for adding the second
                                        agent. Refer to section E2 for duration of use.

                         G.     Drug Interactions

                                1.      Drugs with levels (or clinical effects) that can be
                                        significantly increased by amphetamines: especially MAO
                                        inhibitors, tricyclics, sympathomimetic drugs (including


                                     Section M, Page 1 of 4
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    For more comprehensive information on the individual agent, refer to the appropriate resources.
                              Santa Clara County Mental Health Department
                                    Medication Practice Guidelines
                                        OTC products), phenobarbital, phenytoin, other
                                        anticonvulsants, warfarin, meperidine
                                  2.    Drugs with effects that can be reduced or blocked by
                                        amphetamines: antipsychotics, antihistamines,
                                        antihypertensives, adrenergic blockers

                         G.       Black Box Warnings – See Table 2

Document                 I.       Adverse Events
Assessment of
Following:                        1.    Irritability, restlessness and agitation
                                  2.    Marked sedation or lethargy
                                  3.    Dysphoria and sadness, crying and withdrawal - depression
                                  4.    Marked anorexia and weight loss
                                  5.    Marked insomnia
                                  6.    Stomachache and headache
                                  7.    Significant tachycardia (esp. w/ mixed amphetamine salt)
                                  8.    Psychotic-like thinking and behavior
                                  9.    Precipitation of involuntary motor tics or even full-blown
                                        Tourette’s syndrome
                                  10.   Drug dependence
                                  11.   Stunting of growth in long-term administration

Documentation            J.       Standard laboratory and examination requirements
Required
                                  1.    For inpatient: Basic laboratory studies on admission
                                  2.    For outpatient:
                                           a. Children and Adolescents
                                                    i. Height, weight, blood pressure and pulse at
                                                        baseline, every 6 months, and after dose
                                                        adjustment
                                                   ii. Patients with preexisting heart disease or
                                                        symptoms suggesting significant
                                                        cardiovascular disease should be referred for
                                                        consultation with a pediatrician and/or
                                                        cardiologist for possible electrocardiography
                                                        and /or echocardiography prior to a
                                                        stimulant trial. If stimulants are initiated,
                                                        then the patient should also be followed by
                                                        the pediatrician and/or cardiologist during
                                                        the course of treatment.
                                           b. Adult
                                                    i. Weight, blood pressure, and pulse at
                                                        baseline and every 6 months, and after dose
                                                        adjustment


                                     Section M, Page 2 of 4
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    For more comprehensive information on the individual agent, refer to the appropriate resources.
                           Santa Clara County Mental Health Department
                                 Medication Practice Guidelines

Documentation            K.     Contraindications (requires documentation of
Required                        justification)

                                1.      Alcohol and/or drug abuse (mixed salt amphetamines)
                                2.      History of allergy to this class of drug
                                3.      MAO-Inhibitors - during or within 14 days following the
                                        administration of MOAIs (atomoxetine, psychostimulants)
                                4.      Hyperactivity associated with psychotic symptoms
                                5.      Hyperactivity due to depression and anxiety
                                6.      Age less than 6 years (less than 3 years with
                                        dextroamphetamine)
                                7.      Hypertension
                                8.      Hyperthyroidism (mixed salt amphetamines)
                                9.      Presence of motor tics or Tourette’s syndrome
                                        (Stimulants)
                                10.     Family history of motor tics or Tourette’s syndrome
                                        (methylphenidate)
                                11.     Heart disease (psychostimulants)
                                12.     Glaucoma (atomoxetine, psychostimulants)
                                13.     Seizure disorder
                                14.     Criteria specific to adults:
                                        • Psychostimulants are to be initiated as treatment for an
                                            adult by outpatient psychiatrists only.
                                        • Documentation of ADD/ADHD diagnosis as set by
                                            DSM IV-TR.
                                        • Initiation of treatment with amphetamines or
                                            methylphenidate in an adult with Attention Deficit
                                            Disorder requires prior trials of at least one
                                            antidepressants and/or Atomoxetine.

                         L.     Warnings

                                1.      Sudden death has been reported in association with CNS
                                        stimulant treatment at usual doses in children and
                                        adolescents with structural cardiac abnormalities or other
                                        serious heart problems. Stimulant products generally
                                        should not be used in children or adolescents with known
                                        serious structural cardiac abnormalities,
                                        cardiomyopathy, serious heart rhythm abnormalities,
                                        coronary artery disease, or other serious cardiac problems
                                        that may place them at increased vulnerability to the
                                        sympathomimetic effects of a stimulant drug.
                                2.      Stimulants can cause modest increase in the average blood
                                        pressure (about 2-4 mmHg) and average heart rate (about
                                        3-6 bpm) and some individuals may have larger increases.

                                     Section M, Page 3 of 4
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                           Santa Clara County Mental Health Department
                                 Medication Practice Guidelines
                                        All patients should be monitored for larger changes in
                                        heart rate and blood pressure.
                                3.      Methylphenidate may cause leukopenia and/or anemia.
                                        Periodic CBC, differential, and platelet counts are advised
                                        during prolonged therapy.

                         M. Other agents used Off Label for the Treatment of ADHD
                              1.     Antidepressants
                                     • Bupropion (Wellbutrin)
                                     • Imipramine (Tofranil)
                                     • Nortriptyline (Pamelor)
                              2.      α2 Adrenergic agonist
                                     • Clonidine (Catapres)
                                     • Guanfacine (Tenex)

Attachments
Table 1 FDA approved Indications and Maximum Dose
Table 2 Black Box Warnings
Revised: 10-08




                                     Section M, Page 4 of 4
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    For more comprehensive information on the individual agent, refer to the appropriate resources.
                         Santa Clara County Mental Health Department
                             Medication Practice Guidelines 2005

        PSYCHOSTIMULANT & OTHER RELATEDAGENTS
                      FDA-Approved Indications and Maximum Dose
   Table 1:
      Generic Name              Brand Name                     MDD                 ADHD       Narcolepsy
                                                     Adult       Adolescent &
                                                                  Children
Amphetamine Preparations
Short-Acting
Amphetamine/
Dextroamphetamine            Adderall             60 mg         40 mg (> 3 yo)     X         X
Dextroamphetamine            Dexedrine            60 mg         40 mg (> 3 yo)     X         X
Dextroamphetamine            Dextrostat1          60 mg         40 mg (> 3 yo)     X         X
                                                  non-FDA
Methamphetamine              Desoxyn              approved      25 mg (> 6 yo)     X
Long-Acting
Amphetamine/                                                    30 mg (6-12 yo);
Dextroamphetamine            Adderall XR          20 mg         20 mg (13-17 yo)   X
                             Dexedrine
Dextroamphetamine            spansule1            60 mg         40 mg (> 6 yo)     X         X
Lisdexamfetamine             Vyvanse              70 mg         70 mg (> 6 yo)     X
Methylphenidate Preparations
Short-Acting
Dexmethylphenidate           Focalin              20 mg         20 mg (> 6 yo)     X
Methylphenidate              Methylin             60 mg         60 mg (> 6 yo)     X         X
Methylphenidate              Ritalin              60 mg         60 mg (> 6 yo)     X         X
Intermediate-Acting
Methylphenidate              Metadate ER          60 mg         60 mg (> 6 yo)     X         X
Methylphenidate              Methylin ER          60 mg         60 mg (> 6 yo)     X         X
Methylphenidate              Ritalin SR           60 mg         60 mg (> 6 yo)     X         X
Methylphenidate              Metadate CD          60 mg         60 mg (> 6 yo)     X         X
Methylphenidate              Ritalin LA           60 mg         60 mg (> 6 yo)     X         X
Long-Acting
Dexmethylphenidate           Focalin XR           20 mg         20 mg (> 6 yo)     X
                                                                54 mg (6-12 yo);
Methylphenidate              Concerta             72 mg         72 (13-17 yo)      X         X
                                                  non-FDA
Methylphenidate              Daytrana             approved      30 mg (6-12 yo)    X
Selective Norepinephrine Reuptake Inhibitor
                                                                1.2 mg/kg (<
                                                                70kg);
Atomoxetine                  Strattera            100 mg        100 mg (> 70kg)    X
Amphetamine Related
                                                               non FDA
Modafinil                    Provigil             400 mg       approved                      X
  1
    Age restricted for ADHD: 4-16 yo
  References: Physician’s Information, Micromedex, AACP Practice Parameters for the Assessment and
  Treatment of ADHD 7-07
   Revised: 09-08
                                  Santa Clara County Mental Health Department
                                         Medication Practice Guidelines

Table 2: Black Box Warnings
                  Black Box Warning

Amphetamines      Amphetamine has a high potential for abuse. Administration of amphetamines for prolonged periods of
                  time may lead to drug dependence and must be avoided.      Particular attention should be paid to the
                  possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to other, and the
                  drugs should be prescribed or dispensed sparingly.

                  Misuse of Amphetamines may cause sudden death and serious cardiovascular adverse events.

Strattera         Strattera increases suicidal ideation in short term studies in children and adolescent with ADHD. Patients
                  who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior),
                  clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need
                  for close observation and communication with the prescriber.

Methylphenidate   Methylphenidate should be given cautiously to patients with a history of drug dependence or alcoholism.
                  Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of
                  abnormal behavior.

Rev. 09/08
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines

            MISCELLANEOUS AGENTS - ALPHA-AGONISTS

Documentation   A.   FDA Approved Indications
Required
                     None

Documentation   B.   Non-FDA approved, commonly used psychiatric indications
Required
                     1.     Alcohol and opiate dependence
                     2.     Anxiety disorders
                     3.     Attention deficit hyperactivity disorder
                     4.     Autism
                     5.     Conduct disorder with & without ADHD
                     6.     Peripheral neuropathic pain & pain associated with spinal
                            cord injury
                     7.     PTSD
                     8.     Sleep disorders
                     9.     Social phobia
                     10.    Tic disorders
                     11.    Treatment resistant mood disorder

Documentation   C.   Minimal documentation
Required
                     1.     All standard outpatient & inpatient requirements

Documentation   D.   Maximum Dosage – see Medication Summary for MDD
Required
                     1.     Alpha agonist medications should not be stopped abruptly
                            due to withdrawal reactions. If prescribed for less than one
                            month, decrease Clonidine by 0.05 mg/day. If prescribed
                            for one month or longer, decrease Clonidine by 0.05 mg q 3
                            days. Guanfacine dosage should also be reduced slowly.

Documentation   E.   Duration
Required
                     1.     More than 2 changes for outpatient or 3 changes for
                            inpatient in any 7 day period

Documentation   F.   Polypharmacy & Drug Interactions
Required
                     1.     Alpha agonists may potentiate the CNS depressive effects
                            of alcohol, barbiturates, or other sedating drugs
                     2.     If a patient receiving alpha agonists is also taking tricyclic
                            antidepressants, the hypotensive effect of the alpha agonists


                            Section N, Page 1 of 3
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines
                            may be reduced, necessitating an increase in the alpha
                            agonist’s dose
                     3.     Due to a potential for additive effects such as bradycardia
                            and AV block, caution is warranted in patients receiving
                            alpha agonists concomitantly with agents known to affect
                            sinus node function or AV nodal conduction e.g., digitalis,
                            calcium channel blockers and beta-blockers

Document        G.   Serious adverse effects
Assessment of
Following:           1.     Significant orthostatic hypotension (clonidine)
                     2.     Cardiac arrhythmia (clonidine)
                     3.     Chest pain (clonidine)
                     4.     AV block (clonidine)
                     5.     CHF (clonidine)
                     6.     Rash (clonidine)
                     7.     Raynaud’s phenomenon – cold, numbness and pain in the
                            distal extremities (clonidine)
                     8.     Hepatotoxicity (guanfacine)

Documentation   H.   Standard laboratory and examination requirements
Required
                     1.     For inpatients: Basic laboratory studies on admission
                     2.     For outpatient:
                            • Blood pressure and pulse prior to initiating an alpha
                                 agonist medication and within one month after its use
                                 or after any increase in dosage

Documentation   I.   Relative contraindications (requires documentation of
Required             justification)

                     1.     Hypersensitivity

                J.   Precautions

                     1.     Abrupt discontinuation
                     2.     Cerebrovascular disease
                     3.     Recent MI
                     4.     Renal failure
                     5.     Additional precautions for specific agents:

                            1.     Clonidine
                                   -Conduction disturbances
                                   -Hemodynamic instability
                                   -Obstetric, post-partum, or perioperative pain




                            Section N, Page 2 of 3
                 Santa Clara County Mental Health Department
                        Medication Practice Guidelines
                            2.     Guanfacine
                                   -Liver disease
                                   -Severe coronary insufficiency
                                   -Sedation




Revised: 05-05



                            Section N, Page 3 of 3
                    Santa Clara County Mental Health Department
                          Medication Practice Guidelines

                MISCELLANEOUS AGENTS - BETA-BLOCKERS
Documentation      A.   FDA approved indications
Required
                        1.    Essential tremor (propranolol)
                        2.    Migraine headache (propranolol)

Documentation      B.   Non-FDA approved, commonly used indications
Required
                        1.    Anxiety (propranolol)
                        2.    Ethanol withdrawal (atenolol)
                        3.    Migraine prophylaxis (atenolol, metoprolol)
                        4.    Essential tremor (metoprolol)
                        5.    Neuroleptic-induced & SSRI-induced akathisia
                        6.    Clozapine-induced tachycardia
                        7.    Lithium-induced & valproate-induced tremor
                        8.    Adjunctive treatment for explosive disorder;
                              control of lability and agitation
                        9.    Social phobia & performance anxiety
                        10.   Augmentation in the treatment of severe depression

Documentation      C.   Minimal documentation
Required
                        1.    All standard outpatient & inpatient requirements

Documentation      D.   Maximum Dosage – see Medication Summary for MDD
Required
                        1.    Patients age 65+ or patients predisposed to orthostatic
                              hypotension, without organic brain syndrome - 1/2 of
                              listed maximum dosage
                        2.    Patients age 65+ with organic brain syndrome - 1/4 of
                              listed maximum dosage

Documentation      E.   Duration
Required
                        1.    More than 2 changes of psychotropic medications in
                              any 7 day period.

Documentation      F.   Polypharmacy & Drug Interactions
Required
                        1.    Reserpine & other catecholamine-depleting drugs - can
                              cause marked bradycardia, vertigo, syncope, orthostatic
                              hypotension
                        2.    Chlorpromazine & thioridazine - increased serum levels of
                              both the beta-blocker and the neuroleptic


                              Section O, Page 1 of 3
                     Santa Clara County Mental Health Department
                           Medication Practice Guidelines
                         3.     Thyroxine - may result in lower than expected T3 levels
                                with beta-blockers
                         4.     Cimetidine - decreases hepatic metabolism
                                and increases serum levels of beta-blockers

Documentation   G.       Serious adverse effects
Required
                         1.     Severe bradycardia
                         2.     Syncopal episode
                         3.     Severe orthostatic hypotension
                         4.     Heart block or arrhythmia

Documentation   H.       Standard laboratory and examination requirements
Required
                         1.     For inpatient: Basic laboratory studies on admission
                         2.     For outpatient:
                                • Electrocardiogram if over age 60, or patients with
                                   history of cardiovascular disease
                                • Monitoring of blood pressure and pulse before initiating
                                   a beta blocker, then again at first follow-up visit, then
                                   every 6 months

Documentation   I.       Relative contradictions (requires documentation of
Required                 justification)

                         1.     History of allergy
                         2.     Cardiogenic shock
                         3.     Overt cardiac failure
                         4.     Sinus bradycardia
                         5.     Second and third degree AV block
                         6.     Bronchial asthma or COPD (propranolol)
                         7.     Congestive heart failure (metoprolol)
                         8.     Pregnancy


                J.       Precautions

                         1.     Avoid abrupt discontinuation
                         2.     Diabetes
                         3.     Hyperthyroidism
                         4.     Congestive heart failure
                         5.     Bronchospastic disease
                         6.     Peripheral vascular disease
                         7.     Anesthesia/surgery (myocardial depression)
                         8.     Precautions for specific agents:




                                Section O, Page 2 of 3
                      Santa Clara County Mental Health Department
                            Medication Practice Guidelines
                                  1.     Atenolol
                                         -Caution with clonidine
                                         -Renal impairment

                                  2.     Metoprolol
                                         -Liver impairment

                                  3.     Propranolol
                                         -Liver or renal impairment
                                         -Myasthenic conditions
                                         -Cerebrovascular insufficiency


* The physician will inquire about polytherapy that might cause drug interactions and will
document this inquiry in the progress notes before initiating a beta-blocker.




Revised: 05-05




                                  Section O, Page 3 of 3
                 Santa Clara County Mental Health Department
                        Medication Practice Guidelines

      MISCELLANEOUS AGENTS - FIXED-RATIO COMBINATION
                       PRODUCTS
Documentation    A.     Common indications (validate by DSM-IV criteria)
Required
                        1.     Schizophrenia, with

                               a.      associated depression, and
                               b.      failure to respond to antipsychotic medication
                                       alone, and prior independent titration of the doses of
                                       perphenazine and amitriptyline (Etrafon, Triavil)

                        2.     Bipolar disorder or major depression, with

                               a.      intense anxiety, agitation or paranoia, and
                               b.      failure to respond to antidepressant medication
                                       alone, and prior independent titration of the doses of
                                       perphenazine and amitriptyline (Etrafon, Triavil) as
                                       well as olanzapine and fluoxetine (Symbyax)

                 All other requirements for both the antipsychotic and antidepressant
                 medications specified in these guidelines must be met.




Revised: 05-05




                                Section P, Page 1 of 1
                        Santa Clara County Mental Health Department
                              Medication Practice Guidelines

                           SEDATIVE-HYPNOTIC AGENTS1
Documentation         A.      FDA approved indications
Required
                              1.     Insomnia
                              2.     Sedation for an agitated patient in an inpatient setting


Documentation         B.      Non-FDA approved, commonly used indications
Required
                              1.     EPS (Benadryl)

                              For Benzodiazepine non-FDA approved use, please refer to
                              Anti-Anxiety section.

Documentation         C.      Minimal documentation
Required
                              1.     All standard outpatient and inpatient requirements

Documentation         D.      Maximum dosage – see Medication Summary for MDD
Required

Documentation         E.      Duration
Required
                              1.     For Outpatient: Document rationale when making any
                                     medication change.
                              2.     Lunesta (eszopiclone) and Rozerem (ramelteon) are the
                                     only sedative hypnotic agents approved for insomnia
                                     without a specified time limit. The other agents are
                                     approved for use limited to 35 days or less.
                              3.     For Inpatient: Document rationale when making more than
                                     3 changes in any 7-day period.

Documentation         F.      Polypharmacy

                              1.     Adequate medication doses should be used over a sufficient
                                     period of time to obtain desired results before introducing
                                     polypharmacy.
                              2.     If using >1 same class sedative-hypnotic agent is necessary,
                                     provide clear supportive rationale for adding the second
                                     agent. Refer to section E2 for duration of use.



                                     Section Q, Page 1 of 3
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Due to the heterogeneity of this class (i.e. benzodiazepine, barbiturates, non-benzodiazepine) for
more comprehensive information on the individual agent, refer to the appropriate resources.
                           Santa Clara County Mental Health Department
                                 Medication Practice Guidelines

                      G.       Drug-Drug Interactions

                               Due to the heterogeneity of this class, refer to appropriate
                               references for drug-drug interactions of individual agents.

Document              H.       Adverse Reactions
Assessment of
Followings
                               1.    Anaphylaxis and angiodema can occur as early as the first
                                     time the product is taken.
                               2.    Complex sleep-related behaviors, which may include sleep-
                                     driving, making phone calls, and preparing and eating food
                                     (while asleep or with no memory of event)
                               3.    Respiratory depression
                               4.    Agranulocytosis (Seconal, Luminal)
                               5.    Granulocytopenic disorder (rare), Leukopenia (rare)
                                     (Dalmane)
                               6.    Hepatotoxity
                               7.    CNS effects (Cognitive impairment, lack of motor
                                     coordination)

Documentation         I.       Standard laboratory and examination requirements
Required
                               1.    Inpatient: Basic laboratory studies on admission

Documentation         J.       Contraindications
Required
                               1.    History of allergy to any drug in the same class
                               2.    History of alcohol abuse or substance abuse
                               3.    History of addiction
                               4.    Sleep Apnea (Dalmane, Doral)
                               5.    Severe hepatic impairment (Halcion, Chloral Hydrate,
                                     Luminal)
                               6.    Severe renal impairment (Chloral Hydrate)
                               7.    Severe respiratory disease (Luminal)
                               8.    Pregnancy and Nursing Mothers: See Table 2 Pregnancy &
                                     Breastfeeding Categories
                               9.    Newborns or premature infants (Benadryl)
                               10.   Narrow angle glaucoma (Ativan, Valium)
                               11.   History of manifest or latent porphyria (Barbiturate)




                                     Section Q, Page 2 of 3
1
Due to the heterogeneity of this class (i.e. benzodiazepine, barbiturates, non-benzodiazepine) for
more comprehensive information on the individual agent, refer to the appropriate resources.
                        Santa Clara County Mental Health Department
                              Medication Practice Guidelines

                      K.      Precautions

                              1.     Abrupt discontinuation may cause significant withdrawal
                                     symptoms
                              2.     May cause physical and psychological dependence,
                                     tolerance, and withdrawal symptoms
                              3.     Risk of abuse
                              4.     Severe cardiac disease (Chloral Hydrate)
                              5.     Mentally depressed patients
                              6.     Elderly and debilitated patients
                              7.     History of gastritis, esophagitis, or gastric or duodenal
                                     ulcers (Chloral Hydrate)
                              8.     Patients with acute or chronic pain (Butisol)
                              9.     Tartrazine (FD&C Yellow No. 5) sensitivity with increase
                                     in patients with concomitant aspirin allergy; increased risk
                                     of allergic reactions including bronchial asthma in
                                     susceptible patients (Butisol in tartrazine preparation,
                                     Sonata, Serax)
                              10.    History of bronchial asthma, increased intraocular pressure,
                                     hyperthyroidism, cardiovascular disease or hypertension
                                     (Benadryl)
                              11.    Asthma (Atarax, Vistaril)

                      L.      Other agents used off label for the Treatment of Insomnia

                              1.     Trazodone
                              2.     Tricyclic Antidepressants

References: Prescriber’s Information


Revised: 04-08




                                     Section Q, Page 3 of 3
1
Due to the heterogeneity of this class (i.e. benzodiazepine, barbiturates, non-benzodiazepine) for
more comprehensive information on the individual agent, refer to the appropriate resources.
                   Santa Clara County Mental Health Department
                          Medication Practice Guidelines
Table 1: FDA-approved Indications & MDD

Generic              Brand                        MDD             Insomnia Sedation
                                      Adult        Children
                                    Benzodiazepine
                                                    10mg
Diazepam             Valium           40mg          (>6mo)                 X
Estazolam            Prosom           2mg           Non FDA       X
Flurazepam           Dalmane          30mg          Non FDA       X
Lorazepam            Ativan           10mg          4mg (>12yo)   X
                                                    120mg
Oxazepam             Serax            120mg         (>12yo)
Quazepam             Doral            30mg          Non FDA       X
Temazepam            Restoril         30mg          Non FDA       X
Triazolam            Halcion          .5mg          Non FDA       X
                                non-Benzodiazepine
Butabarbital         Butisol          120mg         Non FDA       X        X
                     Aquachloral,
Chloral Hydrate      Somnote          2000mg        50mg/kg       X        X
                                                    1mg/kg (2-
                                                    12yo); 50mg
Diphenhydramine      Benadryl         400mg         (>12yo)       X
Eszopiclone*         Lunesta          2mg           Non FDA       X
                                                    50mg
                     Atarax (HCl),                  (<6yo);
                     Vistaril                       100mg
Hydroxyzine          (Pamoate)        400mg         (>6yo)                 X
Phenobarbital        Luminal          320mg         6mg/kg        X        X
Ramelteon            Rozerem          8mg           Non FDA       X
                                                    5mg/kg or
Secobartibal         Seconal          100mg         100mg         X
Zaleplon             Sonata           20mg          Non FDA       X
                                      10mg
Zolpidem             Ambien, CR       (CR 12.5)                   X

*Lunesta (eszopiclone) and Rozerem (ramelteon) are the only sedative hypnotic agents
approved for insomnia without a specified time limit. The other agents are approved for
use limited to 35 days or less.




                                 Sedative-Hypnotics, 4-08
                         Santa Clara County Mental Health Department
                                Medication Practice Guidelines
Table 2: Pregnancy and Breastfeeding Categories

                                        Pregnancy
Generic                Brand            Category     Breastfeeding Category
Benzodiazepine
                                                     AAP: Drugs for which the effect on nursing
Diazepam              Valium            D            infants is unknown but may be of concern
Estazolam             Prosom            X            Thomson: Infant risk cannot be ruled out.
Flurazepam            Dalmane           X            Thomson: Infant risk cannot be ruled out.
                                                     AAP: Drugs for which the effect on nursing
Lorazepam             Ativan            D            infants is unknown but may be of concern
Oxazepam              Serax             C            Thomson: Infant risk cannot be ruled out.
                                                     AAP: Drugs for which the effect on nursing
Quazepam               Doral            X            infants is unknown but may be of concern
                                                     AAP: Drugs for which the effect on nursing
Temazepam             Restoril          X            infants is unknown but may be of concern
Triazolam             Halcion           X            Thomson: Infant risk cannot be ruled out.
non-Benzodiazepine
Butabarbital          Butisol           C            Thomson: Infant risk cannot be ruled out.
                      Aquachloral,                   AAP: Maternal medication usually compatible
Chloral Hydrate       Somnote           A            with breastfeeding.
Diphenhydramine       Benadryl          B            Thomson: Milk effects are possible.
Eszopiclone           Lunesta           C            Thomson: Infant risk cannot be ruled out.
                      Atarax (HCl),
                      Vistaril
Hydroxyzine           (Pamoate)         C            Thomson: Infant risk cannot be ruled out.
                                                     AAP: Drugs that have been associated with
                                                     significant effects on some nursing infants and
Phenobarbital          Luminal          D            should be given to nursing mother with caution.
Ramelteon              Rozerem          C            Thomson: Infant risk cannot be ruled out.
                                                     AAP: Maternal medication usually compatible
Secobartibal          Seconal           D            with breastfeeding.
Zaleplon              Sonata            C            Thomson: Infant risk is minimal.
                                                     AAP: Maternal medication usually compatible
Zolpidem               Ambien, CR*       C           with breastfeeding.
*Ambien CR is non-Formulary for SCVH&HS.




                                      Sedative Hypnotic, 4-08
                       Santa Clara County Mental Health Department
                             Medication Practice Guidelines

          MISCELLANEOUS AGENTS -THYROID MEDICATIONS
Documentation        A.     FDA approved indications
Required
                            1.     Lithium-induced hypothyroidism
                                   (T4 - levothyroxine)

Documentation        B.     Non-FDA approved, commonly used indications
Required
                            1.     Augmentation in the treatment of severe depression
                                   (T3 - liothyronine)

Documentation        C.     Minimal documentation
Required                    1.   All standard outpatient & inpatient requirements

Documentation        D.     Maximum Dosage – see Medication Summary for MDD
Required
                            1.     Patients age 65+ (without organic brain syndrome)
                                   ½ of listed maximum dosage
                            2.     Patients age 65+ (with organic brain syndrome)
                                   ¼ of listed maximum dosage

Note: Dosage of Synthroid should not be increased by more than 50 mcg at any one time, with
monitoring of TSH after at least six weeks at any particular dose, until TSH normalized.

Documentation        E.     Duration
Required
                            1.     More than 2 changes of psychotropic medication in any 7
                                   day period

Documentation        F.     Polypharmacy & Drug Interactions
Required
                            1.     Tricyclic antidepressants - possible transient cardiac
                                   arrhythmias
                            2.     Oral anticoagulants - effects are enhanced by thyroid
                            3.     Insulin - may need increased dose when adding thyroid
                            4.     Cholestyramine - impairs absorption of thyroid
                            5.     Estrogen - may alter thyroid levels
                            6.     Digoxin - toxic effects are potentiated by thyroid
                            7.     Sympathomimetics (stimulants) - can result in coronary
                                   insufficiency with thyroid-induced higher metabolic rate,
                                   especially if concomitant coronary artery disease




                                   Section R, Page 1 of 2
                         Santa Clara County Mental Health Department
                               Medication Practice Guidelines
* The physician will inquire about concomitant use of any other medication that might
cause drug interactions and will document this inquiry in the progress notes before
initiating a thyroid medication.


Document            G.       Serious adverse effects
Assessment of
Following:                   1.     Thyrotoxicosis - tachycardia, palpitations, elevated blood
                                    pressure, nervousness, diarrhea, tremors, etc.

Documentation       H.       Standard laboratory and examination requirements
Required
                             1.     For Inpatient: Basic laboratory studies on admission
                             2.     For Outpatient: Laboratory monitoring of thyroid function
                                    including TSH every 6 weeks until normalized, then every
                                    6 months

Documentation       I.       Relative contraindications (requires documentation of
Required                     justification)

                             1.     Hypersensitivity
                             2.     Untreated HTN
                             3.     Untreated thyrotoxicosis
                             4.     Adrenal cortical insufficiency
                             5.     Acute MI
                             6.     Treatment for obesity
                             7.     Relative contraindications for specific agents:

                                    1.     Levothyroxine
                                           -Untreated angina

                    J.       Precautions

                             1.     Cardiovascular disease
                             2.     Relative precautions for specific agents:

                                    1.     Levothyroxine
                                           -Elderly
                                           -Endocrine disorders

                                    2.     Liothyronine
                                           -Hypopituitarism – correct before starting therapy
                                           -Myxedema – start with low dose
                                           -Prolonged hypothyroidism
                                    THE END
Revised: 05-05


                                    Section R, Page 2 of 2

								
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