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					   Santa Clara County
 Mental Health Department




Medication Practice Guidelines

            2008
                          Outpatient Psychiatrists

                           Tiffany Ho, MD
                           Medical Director
             Santa Clara County Mental Health Department
                 828 South Bascom Avenue, Suite 200
                          San Jose, CA 95128

Syed Afroz, MD                                 James Manning, MD
Fred Berge, MD                                 Roger Mateo, MD
Gregory Braverman, MD                          Hansa Mehta, MD
Heather Colbert, MD                            Irene McGhee, MD
Anthony Cozzolino, MD                          Hansa Mehta, MD
Xuan Cung, PharmD                              Antonio Nolasco, MD
Susan Ditter, MD                               Cuong Nguyen, MD
Hao Duong, MD                                  Richard Nunes, MD
Arthur Floreza, MD                             Meenakshi Samantaray, MD
Miriam Friedland, MD                           Yelena Sirbiladze, MD
Emmeline Hazaray, MD                           William Sueksdorf, MD
Danh Huynh, MD                                 Majid Talebi, BA, MPA
Nhi Huynh, MD                                  Giselda Tan, MD
Neal Jacobi, MD                                Nam Tran, MD
Mya Kyaw, MD                                   Emily Wong, MD

                         Acute Care Psychiatrists

                           Michael Meade, MD
                     Chairman, Department of Psychiatry

Christine Chang, MD                            Tao Nguyen, MD
Raymond Fabie, MD                              Terry Osback, MD
Christine Gartner, MD                          Beverly Purdy, MD
Kenneth Gee, MD                                Anil Sharma, MD
Lynn Giang, MD                                 Robert Slater, MD
Amarjit Grewal, MD                             Clayton Tamura, MD
David Johnson, MD                              Gilda Versales, MD
Thanhha Ngo, MD

                 Contract Agency Medical Directors

Ali Alkoraishi, MD                              Julius Fu, MD
Lisa Cullins, MD                                Owen Valentino, MD
Ronald Diebel, MD                               Bruce Wermuth, MD
                                                Manoj Waikar, MD

                               Revised 05/07
                         Santa Clara County Mental Health Department
                                Medication Practice Guidelines

                                   TABLE OF CONTENTS

Title                                      Section     Number of Pages   Last Updated

Purpose                                    A                  4                5/05

Maximum Daily Dose Summary                 B                  6                11/07

Outpatient Documentation Requirements      C                  2                5/05

Inpatient Documentation Requirements       D                  2                5/05

Alzheimer’s Agents                         E                  6                5/05

Antianxiety Agents                         F                  7                5/05

Antidepressant Agents                      G                  11               5/05

Antiparkinson’s & Antihistamine Agents     H                  3                5/05

Antipsychotic Agents - Atypical            I                  14               11/07

Antipsychotic Agents - Conventional        J                  6                9/07

Mood Stabilizers                           K                  13               1/08

Psychostimulants                           L                  6                5/05

Miscellaneous Agents
   • Alpha Agonists                        M                  3                5/05

   •    Beta Blockers                      N                  3                5/05

   •    Fixed-Ratio Combination Products   O                  1                5/05

   •    Hypnotic Agents                    P                  3                5/05

   •    Thyroid Agents                     Q                  2                5/05

Appendices:
                         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

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+: document rationale justifying dosage selected

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.


Generic name                       Brand Name                 Adults            Adolescents & Children

Alzheimer’s Agents:

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:

Alprazolam*                        Xanax                4 mg                            non-FDA approved
Alprazolam*                        Xanax XR             6 mg                            non-FDA approved
Buspirone                          Buspar               90 mg                           5-20 mg
Chloral hydrate                    Noctec               2000 mg                         1000mg
Chlordiazepoxide                   Librium              100 mg                          30mg
Clonazepam                         Klonopin             4 mg                            0.25-4mg
Clorazepate                        Tranxene,            60 mg                           60mg
                                            Section B, Page 1 of 6
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
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines

        MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
                                   Tranxene SD
Generic name                       Brand Name                 Adults            Adolescents & Children

Diazepam                           Valium                     40 mg                     1-10mg
Flurazepam                         Dalmane                    30 mg                     non-FDA approved
Lorazepam                          Ativan                     10 mg                     0.25-4 mg
Temazepam                          Restoril                   30 mg                     15 mg
Triazolam                          Halcion                    0.5 mg                    Unavailable
Zolpidem                           Ambien                     10 mg                     Unavailable

*In panic disorder, can prescribe alprazolam (Xanax or Xanax XR) up to 10 mg


Generic name                       Brand Name                 Adults            Adolescents & Children

Antidepressant Agents:

Amitriptyline                      Elavil                              300 mg           non-FDA approved
Amoxapine                          Asendin                             600 mg           non-FDA approved
Buproprion                         Wellbutrin,Wellbutrin XL            450 mg                 37.5-225 mg
                                   Wellbutrin SR                       400 mg           non-FDA approved
Citalopram                         Celexa                              40 mg            non-FDA approved
Clomipramine                       Anafranil                           250 mg                 25-100 mg
Desipramine                        Norpramin                           300 mg                 5 mg/kg/day
Doxepin                            Sinequan                            300 mg           non-FDA approved
Duloxetine                         Cymbalta                            60 mg            non-FDA approved
Escitalopram                       Lexapro                             20mg             non-FDA approved
Fluoxetine                         Prozac                              80 mg                  10-20mg
Fluoxetine 40 mg                   Prozac
Fluoxetine weekly                  Prozac weekly                       90 mg            non-FDA approved
Fluvoxamine                        Luvox                               300 mg                 25-200 mg
Imipramine                         Tofranil                            300 mg                 10-75 mg
Isocarboxazid                      Marplan                             60 mg            non-FDA approved
Maprotiline                        Ludiomil                            225 mg           non-FDA approved
Mirtazapine                        Remeron                             45 mg                  15-30 mg
*Nefazodone                        Serzone                             600 mg                 100-300 mg
Nortriptyline                      Pamelor                             150 mg           non-FDA approved
Paroxetine                         Paxil                               60 mg                  10-20 mg
Paroxetine                         Paxil CR                            75 mg            non-FDA approved
Phenelzine                         Nardil                              90 mg            non-FDA approved


                                               Section B, Page 2 of 6
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
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines

        MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
Generic name                       Brand Name                 Adults            Adolescents & Children

Protriptyline              Vivactil            60 mg                                    non-FDA approved
Sertraline                 Zoloft              200 mg                                   25-100mg
Tranylcypromine            Parnate             60 mg                                    non-FDA approved
Trazodone                  Desyrel             600 mg                                   25-50 mg
Venlafaxine                Effexor             375 mg                                   12.5-37.5 mg
Venlafaxine                Effexor XR          225 mg                                   non-FDA approved
*Serzone: removed from the US market in May 2004

Antiparkinson Agents:

Amantadine                         Symmetrel                  300 mg                    200mg
Benztropine                        Cogentin                   8 mg                      0.5-4 mg
Biperiden                          Akineton                   8 mg                      .16 mg/kg/day
Diphenhydramine                    Benadryl                   200 mg                    15-50 mg
Trihexyphenidyl                    Artane                     15 mg                     1-10 mg


Generic name                       Brand Name                 Adults            Adolescents & Children

Antipsychotic Agents – Atypicals (Updated 11-07):

Aripiprazole              Abilify, Abilify Dismelt            30 mg                     Schizophrenia
                                                                                        30 mg (13-17yo)
Clozapine                 Clozaril                            900 mg                             “
Olanzapine                Zyprexa, Zyprexa Zydis              20 mg                              “
Olanzapine                Zyprexa Intramuscular               20mg                               “
Paliperidone              Invega                              12mg                      Non-FDA approved
Quetiapine                Seroquel, Seroquel XR               800 mg                             “
Risperidone               Risperdal, Risperdal M-Tab          16 mg                     Irritability in
                                                                                        autistic disorder (5-16yo):
                                                                                        .5 mg < 15-20kg
                                                                                        1 mg > 20 kg
                                                                                        Schizophrenia:
                                                                                        6 mg (13-17yo)
                                                                                        Bipolar:
                                                                                        6 mg (10-17yo)
Risperidone LA            Risperdal Consta                    50mg IM q2wk              non-FDA approved
Ziprasidone               Geodon                              200mg                              “
Ziprasidone IM            Geodon Intramuscular                40mg                               “
                                               Section B, Page 3 of 6
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
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines

        MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
Antipsychotic Agents – Conventional (Updated 9-07):

Generic name              Brand name                          Adults            Adolescent &Children

Chlorpromazine            Thorazine                           1000 mg    50-100mg (6 mos-12yo)
                                                                         200mg (>12-<18yo)
Fluphenazine              Prolixin                            40 mg      1-3 mg
Fluphenazine dec          Prolixin dec                        100mg q4wk 12.5mg qwk (5-12 yo)
                                                                         25mg qwk (>12 yo)
Haloperidol               Haldol                              100 mg     .15mg/kg/day (3-12 yo&15-40kg)
                                                                         15mg (>12yo)
Haloperidol dec           Haldol dec                          450 mg/mo non-FDA approved
Loxapine                  Loxitane                            250 mg     non-FDA approved
Mesoridazine              Serentil                            400 mg     non-FDA approved
Molindone                 Moban                               225 mg     .5mg/kg/day (>12yo)
Perphenazine              Trilafon                            64 mg      12 mg (>12yo)
Pimozide                  Orap                                10 mg      10 mg (>12yo)
Thioridazine              Mellaril                            800 mg     3mg/kg/day (>2yo)
Thiothixene               Navane                              60 mg      60 mg (>12yo)
Trifluoperazine           Stelazine                           40 mg      15 mg (6-12yo)

Mood Stabilizers (Updated 11-07):

Carbamazepine ER1                  Equetro                    1600 mg           non-FDA approved
Lamotrigine2                       Lamictal                   200 mg            non-FDA approved
Lithium3                                                      2400 mg           2400 mg
Lithium extended release           Lithobid                   1800 mg           1800 mg
Divalproex4                        Depakote,                  60 mg/kg/day      non-FDA approved
                                   Depakote ER
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

                                               Section B, Page 4 of 6
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
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines

        MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY
than the total daily dose of Depakote (Please See Table 5 in the Mood Stabilizer section for
Conversion chart.).

Generic name                       Brand Name                 Adults            Adolescents & Children

Psychostimulants:

Atomoxetine                        Strattera                  100 mg                    0.5-1.2 mg/Kg
Dexmethylphenidate                 Focalin                    20 mg                     2.5-20 mg
Dextroamphetamine                  Dexedrine                  60 mg                     2.5-40 mg
Dextroamphetamine/                 Adderall                   60 mg                     2.5-40mg
Amphetamine
Dextroamphetamine/                 Adderall XR                30mg                      30 mg
Amphetamine
Methamphetamine                    Desoxyn              25 mg                           25 mg
Methylphenidate                    Concerta             54 mg                           18-54 mg
Methylphenidate                    Metadate CD,         60 mg                           2.5-60 mg
                                   Methylin, Methylin ER,
                                   Ritalin, Ritalin LA,
                                   Ritalin SR, Metadate ER
Pemoline                           Cylert               112.5 mg                        18.75 mg

Miscellaneous Agents:
Alpha Agonists:

Clonidine                          Catapres                   0.6 mg                    0.05-0.2 mg
Guanfacine                         Tenex                      3mg                       0.5-2 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 Combination Products:

Fluoxetine/Olanzapine              Symbyax                    12mg/50 mg                non-FDA approved




                                               Section B, Page 5 of 6
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
                              Santa Clara County Mental Health Department
                                     Medication Practice Guidelines

        MAXIMUM DAILY DOSE (MDD)A,B,C: MEDICATION SUMMARY


Generic name                       Brand Name                 Adults            Adolescents & Children

Thyroid Agents:
Levothyroxine                      Synthroid                  200 mcg                   6 mcg/kg/day
Liothyronine                       Cytomel                    100 mcg                   75 mcg

Other:

Modafinil                          Provigil                   400 mg                    non-FDA approved


    •    Bold = Non-Formulary Status at SCVH&HS
    •    Reference for Pediatric doses = Am. Academy of Child & Adolescent psychiatry
         (AACAP)




                                               Section B, Page 6 of 6
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
                      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 C, 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 C, 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 D, 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 D, 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 E, 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 E, 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 E, 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 E, 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 E, 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 depression
                     2.    Prophylaxis of recurrent major depressive disorder
                     3.    Treatment of secondary depression in other mental
                           illnesses, e.g. schizophrenia, dementia
                     4.    Depressed phase of bipolar disorder
                     5.    Premenstrual dysphoric disorder
                     6.    Generalized anxiety disorder
                     7.    Obsessive compulsive disorder
                     8.    Panic disorder with or without agoraphobia
                     9.    Social phobia
                     10.   Posttraumatic stress disorder
                     11.   Bulimia nervosa
                     12.   Enuresis

Documentation   B.   Non-FDA approved, commonly used indications
Required
                     1.    Dysthymia
                     2.    Atypical depression
                     3.    Major depressive disorder in patients with comorbid
                           medical conditions, e.g. poststroke depression, myocardial
                           infarction, Alzheimer’s disease
                     4.    Seasonal affective disorder
                     5.    Postpartum depression
                     6.    Melancholic depression
                     7.    Generalized anxiety disorder
                     8.    Panic disorder
                     9.    Social Phobia
                     10.   Obsessive compulsive disorder
                     11.   Posttraumatic stress disorder
                     12.   Attention deficit hyperactivity disorder
                     13.   Autism
                     14.   Binge eating disorder
                     15.   Self injurious behavior, aggression, impulsive behavior and
                           behavior disturbances of dementia and borderline
                           personality disorder
                     16.   May aid in smoking cessation and the treatment of affective
                           disorders (e.g. cocaine)
                     17.   Insomnia
                     18.   Chronic fatigue syndrome




                           Section G, Page 1 of 9
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines
Documentation   C.   Minimal documentation
Required
                     1.    All standard outpatient & inpatient requirements
                     2.    Pregnancy during first trimester
                     3.    Nursing mothers who can be managed off medication
                     4.    Non-formulary drugs – document rationale in chart for use
                           and document appropriate administrative approval
                     5.    Off-label use - documents rationale in chart for use
                           Indicates on the patient consent the “off-label” status

Documentation   D.   Maximum dosage – see Medication Summary for MDD
Required
                     1.    Applicable to MAOIs only:
                               • Patients age 65+ (without organic brain syndrome):
                                   ½ of listed maximum dose
                               • Patients age 65+ (with organic brain syndrome):
                                   ¼ of listed maximum dose
                               • Patients age 5-12: see Medication Summary
                     2.    Applicable to SSRIs only:
                               • SSRIs have flat dose response curves, i.e.
                                   approximately 75% of patients respond to the low
                                   dose. Do not increase the dose till steady state is
                                   reached (4 weeks for fluoxetine and 1 week for
                                   other drugs)
                               • SSRI dosage should be decreased by up to 50% in
                                   patients with hepatic impairment as plasma levels
                                   can increase up to 3-fold
                               • Clearance of paroxetine and sertraline reduced in
                                   renal disease
                     3.    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.
                     4.    Tolerance to therapeutic effects seen in some patients after
                           months of treatment
                     5.    Higher doses may be required in the treatment of OCD
                     6.    Lower starting dose may be required in panic disorder due
                           to patient sensitivity to stimulating effects
                     7.    Intermittent dosing (during luteal phase of the menstrual
                           cycle) found effective for the treatment of premenstrual
                           dysphoric disorder



                           Section G, Page 2 of 9
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines
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.    Applicable to SSRIs only:
                               • Combining two SSRIs is not recommended.
                               • Combining a TCA with an SSRI is not
                                   Recommended
                               • Drugs that can be increased by SSRIs due to
                                   inhibition of cytochrome P-450 enzymes:
                                   tricyclics, phenothiazines, Clozapine
                               • Drugs that can cause “Serotonin Syndrome”
                                   reaction (signs include hyperreflexia, ataxia,
                                   delirium, hyperthermia, diaphoresis, muscle
                                   rigidity) when combined with SSRIs: MAO
                                   Inhibitors, sumatriptan (Imitrex), tramadol (ultram),
                                   possibly lithium
                     2.    Applicable to MAOIs only:
                               • MAOIs in combination with drugs that have a risk
                                   of hypertensive crisis: decongestants, epinephrine
                                   and its congeners, any psychostimulant
                               • MAOIs in combination with drugs that can have
                                   exaggerated hypotensive effects: any
                                   antihypertensive medication
                               • MAOIs in combination with drugs that have a risk
                                   of severe toxicity: meperidine (Demerol)
                     3.    More than 1 antidepressant without documented
                           justification (exceptions are the use of trazodone,
                           amitriptyline, doxepin or imipramine as hypnotics in
                           combination with another antidepressant)
                     4.    Drugs that can be increased when combined with
                           nefazodone or fluvoxamine: alprazolam, triazolam,
                           diazepam
                     5.    Drugs with reduced effectiveness when combined with
                           tricyclics: clonidine, guanethadine
                     6.    Drugs with risk of atropine-like toxicity: other anti-
                           cholinergic medications
                     7.    Drugs with effects that can be potentiated by
                           antidepressants: any other CNS depressants
                     8.    Drugs with a general risk of increased toxicity: any other
                           antidepressant or MAO inhibitor, carbamazepine,
                           antihistamines



                           Section G, Page 3 of 9
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines
                     9.     Contraindicated with nefazodone or fluvoxamine due to
                            risk of cardiac arrhythmia: pimozide

Document        G.   Serious adverse effects
Assessment of
Following:           1.     Applicable to SSRIs only:
                               • SSRI: psychosis or panic reaction may occur
                               • Slowing of sinus node reported with fluoxetine;
                                  caution in sinus node disease and in patients with
                                  serious left ventricular impairment
                               • SSRIs: abrupt withdrawal from high doses may
                                  cause a discontinuation syndrome consisting of
                                  dizziness, lethargy, nausea, vomiting, diarrhea,
                                  headache, fever, sweating, chills, malaise,
                                  incoordination, insomnia, vivid dreams, myalgia,
                                  paresthesias, electric shock like sensations, anxiety,
                                  agitation, crying, irritability, confusion, slowed
                                  thinking, disorientation. Therefore, these
                                  medications should be withdrawn gradually after
                                  prolonged use. Taper antidepressants no more
                                  rapidly than 25% per week and monitor for
                                  recurrence of depressive symptoms
                               • Use of SSRIs with other serotonergic agents may
                                  result in a hypermetabolic Serotonin Syndrome –
                                  usually occurs within 24 hours of medication
                                  initiation, overdose, or change in dose. Symptoms
                                  include: nausea, diarrhea, chills, sweating,
                                  dizziness, elevated temperature, elevated blood
                                  pressure, palpitations, increased muscle tone with
                                  twitching, tremor, myoclonic jerks, hyperreflexia,
                                  unsteady gait, restlessness, agitation, excitation,
                                  disorientation, confusion, and delirium; may
                                  progress to rhabdomyolysis, coma and death
                     2.     Applicable to MAOIs only:
                               • Marked sedation or lethargy
                               • Hypertensive crisis reaction (signs
                                  include headache, neck stiffness, nausea, vomiting,
                                  sweating, photophobia)
                               • Agitation or restlessness
                               • Confusion
                               • Coma
                     3.     Applicable to tricyclics only:
                              • Urinary retention
                              • Syncope
                     4.     Applicable to mirtazapine only:



                            Section G, Page 4 of 9
                Santa Clara County Mental Health Department
                       Medication Practice Guidelines
                               •   Agranulocytosis (warning signs include fever, sore
                                   throat, mouth ulcers, easy bruising)
                     5.    Applicable to venlafaxine only:
                               • Hypertension (especially if dose greater than 300
                                   mg daily)
                     6.    Black box warning: Adult and pediatric patients may
                           experience worsening of depression, emergence of
                           suicidality, and unusual changes in behavior, whether or
                           not they are being treated with antidepressants. Physicians,
                           families and caregivers should monitor patients for
                           suicidality as well as anxiety, agitation, panic attacks,
                           insomnia, irritability, hostility, aggressiveness, impulsivity,
                           akathisia (psychomotor restlessness), hypomania, mania,
                           and other unusual changes in behavior.
                     7.    Precipitation of hypomania or mania, less frequent if
                           patient receiving lithium
                     8.    Psychosis, hallucinosis, or delirium during treatment
                     9.    Heart block or arrhythmia, especially in children &
                           adolescents

Documentation   H.   Standard laboratory and examination requirements
Required
                     1.    For inpatient: Basic laboratory studies on admission
                     2.    For outpatient:
                           Applicable to MAOIs only:
                              • Electrocardiogram for patients over age 60 or with
                                  history of cardiovascular disease.
                              • Tyramine-restricted diet.
                           Applicable to tricyclics only:
                              • Electrocardiogram for patients over age 60 or with
                                  history of cardiovascular disease and for all children
                                  under age 18.
                              • EKG should be repeated after dosage regulation for
                                  children under age 18 on tricyclics.
                           Applicable to trazadone only:
                              • Electrocardiogram for patients over age 60 or with
                                  history of cardiovascular disease and for all children
                                  under age 18.
                           Applicable to venlafaxine only:
                              • Monitoring of blood pressure if dose greater than
                                  300 mg daily.

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

                     1.    History of allergy


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       Medication Practice Guidelines
     2.    Concomitant use of monoamine oxidase inhibitors
     3.    Relative contraindications for specific agents:

           1.     Bupropion
                  - History of seizure disorder or eating disorder
                  (bulimia or anorexia nervosa)
                  -Patients undergoing abrupt discontinuation of
                  alcohol or sedatives
                  -Combination with Zyban

           2.     Duloxetine
                  -Uncontrolled narrow angle glaucoma

           3.     Nefazodone
                  -Previous withdrawal due to liver damage
                  -Concomitant use of cisapride, pimozide, triazolam,
                  or carbamazepine

           4.     MAOIs
                  -Concomitant use of sympathomimetic drugs
                  -Cerebrovascular or cardiovascular disorders
                  -Myocardial infarction within 6 weeks
                  -Foods with high tyramine content
                  -Hx of liver disease
                  -Severe renal impairment (isocarboxazid)
                  -Pheochromocytoma
                  -Concomitant use of excessive caffeine
                  -Age less than 12 years
                  -Pregnancy and nursing mothers

           5.     SSRIs
                  -Concomitant use of thioridazine

           6.     Trazodone
                  -Myocardial infarction within 6 weeks
                  -Premature ventricular contractions or arrhythmias
                  on EKG

           7.     Tricyclics
                  -Myocardial infarction within 6 weeks
                  -Evidence of cardiac conduction delay on EKG
                  -Premature ventricular contractions or arrhythmias
                  on EKG
                  -Seizures (maprotiline)
                  -Concomitant use with cisapride (amitriptyline,
                  protriptyline)



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       Medication Practice Guidelines
                       -Glaucoma (doxepin)
                       -Urinary retention (doxepin)

J.     Precautions

       1.      Gradual dose reduction is recommended to minimize
               symptoms of withdrawal reactions
       2.      Sucicidality in children and Adolescents:

Black Box Warning; Antidepressants increased the risk of suicidal
thinking and behavior (suicidality) in short-term studies in children and
adolescents with Major Depressive Disorder (MDD) andother psychiatric
disorders. Anyon considering the use of (Insert established name) or any
other antidepressant in a child or adolescent must balance this risk with the
clinical need. Patients who are started on therapy should be observed
closely for clinical worsening, suicidality, or unusual changes in behavior.
Families and caregivers should be advised of the need for close
observation and communication with the prescriber. (Insert established
name) is not approved for use in pediatric patients. (for more information
please visit the FDA’s website and refer to the appendix).

       2.      Relative contraindications for specific agents:

               1.      Bupropion
                       -Medications that lower seizure threshold
                       (hypoglycemics or insulin, use of OTC stimulants
                       and anorectics, opiates, or cocaine)
                       -Excessive alcohol or sedative use
                       -HTN, MI, or unstable heart disease
                       -Hepatic or renal impairment

               2.      Duloxetine
                       -Concomitant use of serotonergic agents
                       -Controlled narrow angle glaucoma
                       -Hx of seizures
                       -Pregnancy, third trimester
                       -Severe renal impairment

               3.      MAOIs
                       -Epileptic patients
                       -Concomitant use of drug that decrease the seizure
                       threshold
                       -Hypertensive crisis
                       -Hyperthyroidism
                       -Postural hypotension
                       -Pregnancy



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       Medication Practice Guidelines
           4.     Mirtazapine
                  -Heart disease
                  -Liver or renal impairment
                  -Phenylkeonuria (ODT contains phenylalanine)
                  -Pregnancy
                  -Seizures
                  -Hypotension


           5.     Nefazodone
                  -Concomitant use of alprazolam or triazolam
                  -Liver disease
                  -Hx of seizures
                  -Postural hypotension
                  -Priapism

           6.     SSRIs
                  -withdrawal reactions can occur on stopping or
                  reducing treatments. Common symptoms of
                  withdrawal reactions include dizziness, numbness
                  and tingling, nausea and vomiting, headache,
                  sweating, anxiety, and sleeping difficulties. Doses
                  should be slowly tapered to minimize symptoms
                  and risks, especially with paroxetine and
                  - Due to reports of neonatal complications with
                  antidepressants, physicians should carefully
                  consider the potential risks and benefits when
                  treating pregnant women with an SSRI during the
                  third trimester. There have also been reports of
                  premature births in pregnant women exposed to
                  SSRIs
                  -Drowsiness/fatigue, headache, anxiety, and nausea
                  are common adverse events (>5%) leading to
                  dropout with immediate-release SSRIs.

           7.     Trazodone
                  -Cardiac disease
                  -Pregnancy or lactation

           8.     Tricyclics
                  -Cardiovascular disease
                  -Pregnancy
                  -Use in geriatrics
                  -Hx of urinary retention or glaucoma
                  -Liver impairment (amitriptyline, amoxapine,
                  imipramine, maprotiline)



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                            Medication Practice Guidelines
                                         -Renal disease (amoxapine, imipramine,
                                         maprotiline)
                                         -Patients with schizophrenia
                                         -Hyperthyroidism

                                  9.     Venlafaxine
                                         -Appetite/weigh changes
                                         -Glaucoma
                                         -Hx of seizures
                                         -SIADH
                                         -Liver or renal impairment
                                         -Recent MI or unstable heart disease


Attachments:
Table 1 FDA Approved Indication for Antidepressants

Revised: 05-05




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                                               Santa Clara County Mental Health Department
                                                      Medication Practice Guidelines

                                               ANTIDEPRESSANT AGENTS
                                           FDA-Approved Indications for Antidepressants
  Table 1:
     Agent       Brand      Depression   Prophylaxis   Secondary Depression Premenstrual GAD OCD    Panic     Social PTSD Anorexia/
                                             of        Depression in Bipolar dysphoric             Disorder   Phobia       Bulimia
                                          Recurrent                Disorder   disorder
                                            MDD
MAOIs
Isocarboxazid   Marplan         X
Phenelzine      Nardil          X
Tranlycypromine Parnate         X

TCAs
Amitriptyline   Elavil          X
Amoxapine       Asendin         X
Clomipramine    Anafranil                                                                    X
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          X                                               X            X        X                       X
Fluvoxamine     Luvox                                                                        X
Paroxetine      Paxil           X                                               X        X   X        X         X     X
Sertraline      Zoloft          X                                               X            X        X         X     X
                                                Santa Clara County Mental Health Department
                                                       Medication Practice Guidelines




  Agent         Brand      Depression   Prophylaxis of   Secondary    Depression   Premenstrual   GAD   OCD    Panic     Social   PSD   Bulemia
                                          Recurrent      Depression   in Bipolar    dysphoric                 Disorder   Phobia
                                            MDD                        Disorder      disorder
SNRIs
Duloxetine    Cymbalta         X
Venlafaxine   Effexor          X                                                                   X                       X

Others
Bupropion     Wellbutrin       X
Mirtazapine   Remeron          X
Nefazodone    Serzone          X
Trazodone     Desyrel          X
Bupropion     Wellbutrin       X




   Revised: 05-05
                 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 H, 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 H, 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 H, 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



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                        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.




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                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, clearly
                           document the necessity for such a regimen and that
                           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 I, 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



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       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.




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                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 I, 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 I, 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.




                                  Section I, 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 J, Page 1 of 4
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                       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, clearly document the
                        necessity for such a regimen and that 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 J, Page 2 of 4
                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 J, Page 3 of 4
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                            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


                                  Section J, Page 4 of 4
                                             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.




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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)



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                     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)



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                         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.    Before starting treatment with Carbamazepine, patients
                               with ancestry across broad areas of Asia, including South
                               Asian Indians, should be screened for the HLA-B*1502
                               allele. 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.

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
                                  • Lithium (Lithium extended release, Lithobid)
                                      - Impaired renal function
                                      -Severe debilitation, dehydration, or sodium
                                      depletion


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                      -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
                      -Do not administer Tegretol suspension with other
                      liquid preparations due to formation of an insoluble
                      precipitate
               • Lithium
                      -Pregnancy



                   5 of 8
Santa Clara County Mental Health Department
      Medication Practice Guidelines
                 -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
                 -Concomitant use of NSAIDs, aspirin, or other
                 drugs that affect coagulation; abnormal bleeding,
                 particularly the gastrointestinal tract, may occur




              6 of 8
                        Santa Clara County Mental Health Department
                              Medication Practice Guidelines
                                           -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
             Table 5:   Available Strength and Dosage Forms

References:


                                        7 of 8
                      Santa Clara County Mental Health Department
                            Medication Practice Guidelines
      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: 11-07




                                       8 of 8
                         Santa Clara County Mental Health Department
                                Medication Practice Guidelines

                            Table 1: FDA-approved Indications
                                                                             BP         BP
         Agent                         Brand               BP 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.).




                                           Revised: 2007
     Mood Stabilizers Table 1
                                                          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
                                                                                      LevelB2
Carbamazepine                                  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.

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




                                                                                 Revised: 2007
Mood Stabilizers: Table 2
                                                 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


                                                                        Revised 2007
Mood Stabilizers: Table 3
                                               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




                                                                    Revised 2007
Mood Stabilizers: Table 4
                                               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


                                                                      Revised 2007
Mood Stabilizers: Table 5
                       Santa Clara County Mental Health Department
                             Medication Practice Guidelines

                          PSYCHOSTIMULANT AGENTS

Documentation        A.     FDA approved indications (see Table 1)
Required
                            1.     Attention Deficit/Hyperactivity Disorder (ADHD)
                                   (Note that DSM-IV criteria require that some hyperactive,
                                   impulsive or inattentive symptoms that cause impairment
                                   were present before age 7 years)
                            2.     Narcolepsy

Documentation        B.     Non-FDA approved, commonly used indications
Required
                            1.     Fatigue, disease related (methylphenidate, pemoline)
                            2.     Obesity (dextroamphetamine, dextroamphetamine/
                                   amphetamine, methamphetamine)
                            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.     Dosing - see Medication Summary for MDD
Required
                            1.     Dextroamphetamine: 5 - 60 mg/day
                            2.     Dextroamphetamine/Amphetamine (adderall): 2.5- 40
                                   mg/day (adderall XR): 5 – 30mg/day
                            3.     Methamphetamine: 2.5 – 25mg/day
                            4.     Methylphenidate:10-60mg/day, (concerta: 18-54mg/day)
                            5.     Dexmethylphenidate: 5 – 20mg/day
                            6.     Pemoline*: 37.5 – 112.5mg/day

*Pemoline should not ordinary be considered as first line drug therapy because of its
association with life threatening hepatic failure.

Documentation        E.     Duration
Required
                            1.     More than 4 years of uninterrupted use without drug-free
                                   periods as long as weekends and vacations or 3-6 months
                                   drug holiday
                            2.     More than 1 change of central stimulant in any 7 day period



                                   Section L, Page 1 of 5
                     Santa Clara County Mental Health Department
                           Medication Practice Guidelines
Documentation      F.     Polypharmacy* & Drug Interactions
Required
                          1.     Any other drug of this class
                          2.     More than 5 other psychotropic drugs of any class
                          3.     Drugs with levels (or clinical effects) that can be
                                 significantly increased by amphetamines: especially MAO
                                 inhibitors, tricyclics, sympathomimetic drugs (including
                                 OTC products), phenobarbital, phenytoin, other
                                 anticonvulsants, warfarin, meperidine
                          4.     Drugs that can cause significant increase in levels or
                                 clinical effects of amphetamines: tricyclics, MAO
                                 inhibitors
                          5.     Drugs with effects that can be reduced or blocked by
                                 amphetamines: antipsychotics, antihistamines,
                                 antihypertensives, adrenergic blockers

* Requires clear documentation of rationale for polypharmacy. Same class polypharmacy
requires Medical Director approval.

Document           G.     Serious adverse effects
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 (especially with
                                 dextroamphetamine)
                          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
                          12.    Liver failure (pemoline)

Documentation      H.     Standard laboratory and examination requirements
Required
                          1.     For inpatient: Basic laboratory studies on admission
                          2.     For outpatient:
                                 • Height and weight every 6 months, blood pressure
                                    reading and pulse every 3 months with amphetamines
                                 • CBC, differential, and platelet count every year (for
                                    prolonged therapy of methylphenidate)
                                 • LFTs at baseline and every 2 weeks (pemoline)




                                 Section L, Page 2 of 5
                     Santa Clara County Mental Health Department
                           Medication Practice Guidelines
Documentation   I.       Relative contraindications (requires documentation of
Required                 justification)

                         1.    Alcohol and/or drug abuse (adderall, dextroamphetamine,
                               methamphetamine)
                         2.    History of allergy to this class of drug
                         3.    MAO-Inhibitors - during or within 14 days following the
                               administration of MOAIs (atomoxetine,
                               dexmethylphenidate dextroamphetamine,
                               dextroamphetamine/amphetamine, methamphetamine,
                               methylphenidate)
                         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 (dextroamphetamine/amphetamine,
                               dextroamphetamine, methamphetamine)
                         9.    Presence of motor tics or Tourette’s Syndrome
                               (dexmethylphenidate, methylphenidate)
                         10.   Family history of motor tics or Tourette’s Syndrome
                               (methylphenidate)
                         11.   Heart disease (dextroamphetamine/amphetamine,
                               Dextroamphetamine, methamphetamine)
                         12.   Glaucoma (atomoxetine, dextroamphetamine/amphetamine,
                               dextroamphetamine, dexmethylphenidate,
                               methamphetamine, methylphenidate)
                         13.   Seizure disorder
                         13.   Pre-existing liver disease (pemoline)
                         14.   Pregnancy or breast feeding
                         16.   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.
                               • 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.

                J.       Precautions
                         1.    Alcohol and/or drug abuse
                         2.    Long-term suppression of growth in children
                         3.    Additional precautions for specific agents:

                               1.      Atomoxetine


                                Section L, Page 3 of 5
Santa Clara County Mental Health Department
      Medication Practice Guidelines
                 -liver dysfunction
                 -cardiovascular or cerebrovascular disease –
                 increased risk for increasing BP and HR
                 -hypotension
                 -urinary retention or bladder dysfunction
                 -poor-metabolizer

          2.     Dexmethylphendiate
                 -seizure history
                 -HTN
                 -may worsen symptoms of behavior disturbance and
                 thought disorder in psychotic children
                 -may cause visual disturbances

          3.     Dextroamphetamine
                 -children with attention deficit disorders and
                 concomitant Tourette’s syndrome
                 -mild HTN
                 -motor and phonic tics or Tourette’s syndrome in
                 pediatric patients
                 -may worsen symptoms of behavior disturbance and
                 thought disorder in psychotic children
                 -sensitivity to tartazine

          4.     Dextroamphetamine/ Amphetamine
                 -psychosis
                 -abrupt discontinuation
                 -may precipitate motor and phonic tics and
                 Tourette's syndrome
                 -mild to severe HTN
                 -structural cardiac abnormalities

          5.     Methamphetamine
                 -psychosis
                 -abrupt discontinuation

          6.     Methylphenidate
                 -seizure disorder
                 -pre-existing HTN, HF, recent MI, hyperthyroidism
                 -pre-existing severe GI narrowing, risk for
                 obstructive symptoms
                 -psychotic patients

          7.     Pemoline
                 -life-threatening hepatic failure
                 -significantly impaired renal failure



          Section L, Page 4 of 5
                     Santa Clara County Mental Health Department
                           Medication Practice Guidelines
                                        -concomitant use with antiepileptics
                                        -concomitant use of other stimulants
                                        -may precipitate motor and phonic tics and
                                        Tourette's syndrome
                                        -may worsen symptoms of behavior disturbance and
                                        thought disorder in psychotic children


Attachment
Table 1 FDA approved Indications and Maximum Dose




Revised: 05-05




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

                     PSYCHOSTIMULANT AGENTS
             FDA-Approved Indications and Maximum Dose
Table 1:
        Agent               Brand       Max dose      ADHD      Narcolepsy
Atomoxetine              Strattera       100mg          X

Dexmethylphenidate       Focalin         20mg           X

Dextroamphetamine        Dexedrine       60mg           X           X

Dextroamphetamine/       Adderall        60mg           X           X
Amphetamine

                         Adderall XR     30mg           X
Methamphetamine          Desoxyn         25mg           X

Methylphenidate          Concerta        54mg           X           X
                         Metadate        60mg           X           X
                         CD,
                         Metadate
                         ER,
                         Methylin,
                         Methylin ER,
                         Ritalin,
                         Ritalin LA,
                         Ritalin SR
Pemoline                 Cylert         112.5mg         X




Revised: 05-05
                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 M, 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 M, 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 M, 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 N, 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 N, 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 N, 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 O, Page 1 of 1
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines

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

                     FDA approved agents for insomnia: diphenhydramine, chloral
                     hydrate, amobarbital, butabarbital, pentobarbital, phenobarbital,
                     secobarbital, flurazepam, lorazepam, triazolam, temazepam,
                     quazepam, eszopiclone, zaleplon, zolpidem, zolpidem (Ambien
                     CR,) ramelteon.

Documentation   B.   Non-FDA approved, commonly used indications
Required
                     1.     Agitation
                     2.     Alcohol withdrawal
                     3.     Anxiety
                     4.     Mania, alternative agent
                     5.     Sedation maintenance

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.     More than 2 changes of psychotropic medication in any 7
                            day period
                     2.     Continuous treatment for more than 7 days without
                            documentation of continued need and benefit

Documentation   F.   Polypharmacy* & Drug Interactions
Required
                     1.     More than one benzodiazepine
                     2.     More than three other psychotropic medications of any
                            class
                     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
                            hypnotics/sedatives: any other CNS depressant


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

*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 a hypnotic medication.

Document            G.       Serious adverse effects
Assessment of
Followings:                   1.    Prolonged lethargy
                              2.    Ataxia (especially in the elderly)
                              3.    Delirium or confusion
                              4.    Paradoxical excitement
                              5.    Respiratory depression
                              6.    Intentional overdose
                              7.    Significant withdrawal symptoms upon discontinuation
                              8.    Hallucinations
                              9.    Anaphylaxis
                              10.   Agranulocytosis
                              11.   Hepatic damage

Documentation       H.       Standard laboratory and examination requirements
Required
                             1.     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.     Age less than 12 years
                             3.     History of alcohol abuse or substance abuse
                             4.     History of addiction to sedative/hypnotic drugs
                             5.     Severe hepatic impairment
                             6.     Severe renal impairment
                             7.     Pregnancy, especially first trimester
                             8.     Nursing mothers
                             9.     Newborns or premature infants
                             10.    Excitation in young children
                             11.    Narrow angle glaucoma
                             12.    Hx of asthma, increased intraocular pressure,
                                    hyperthyroidism, cardiovascular disease or hypertension
                             13.    Pyloroduodenal obstruction
                             14.    Stenosing peptic ulcer
                             15.    Symptomatic prostatic hypertrophy
                             16.    Hx of manifest or latent porphyria
                             17.    Marked respiratory disease

                    J.       Precautions



                                    Section P, Page 2 of 3
                 Santa Clara County Mental Health Department
                       Medication Practice Guidelines

                     1.    Abrupt discontinuation
                     2.    May cause physical and psychological dependence,
                           tolerance, and withdrawal symptoms
                     3.    Risk of abuse
                     4.    May impair mental or physical abilities
                     5.    Caution with sleep apnea
                     6.    Hepatic impairment
                     7.    Severe renal impairment
                     8.    Respiratory impairment
                     9.    Severe cardiac disease
                     10.   Mentally depressed patients
                     11.   Hx of gastritis, esophagitis, or gastric or duodenal ulcers
                     12.   Concurrent MAOI
                     13.   Bladder neck obstruction
                     14.   Patients with acute or chronic pain
                     15.   Borderline hypoadrenal function




Revised: 02-06



                            Section P, Page 3 of 3
                       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 Q, 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 Q, Page 2 of 2

				
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