Pharmacist-Notes-For-POM-Guid

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					    Pharmacist Notes

          For

Pharmacist Only Medicines
    Counselling Guide
                                                        CONTENTS


Condition                                                                                                          Page

Eye Infections.............................................................................................        3
              Sulphacetamide Eye Drops


Cough...........................................................................................................   6
                 Sedating Antihistamines
                 Choline Theophyllinate + Guaiphenesin


Insomnia........................................................................................................   15
                Diphenhydramine
                Doxylamine Succinate
                Salicylamide + Diphenhydramine


Mouth Ulcers.................................................................................................      19
             Triamcinolone Oral Paste


Pain — Musculoskeletal..............................................................................               23
            Diclofenac


Pain — Migraine............................................................................................ 25
             Paracetamol + Metoclopramide


Thrush — Oral............................................................................................... 28
            Miconazole
            Nystatin


Thrush — Vaginal.........................................................................................          32
            Imidazole & Nystatin Vaginal Creams/Pessaries
            Fluconazole Tablets


Warts.............................................................................................................. 37
                   Podophyllin


Appendix Australian Categorisation of Drugs for use in Pregnancy....                                               40




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© Pharmacy Guild of New Zealand (Inc) 2006
                                      Eye Infections
                               Sulphacetamide Eye Drops


Any symptoms involving the eyes require careful assessment. While some
problems involving the eye can be safely and effectively treated with OTC
medicines, others should be referred for further investigation or treatment with
prescription medicines.

Red, sore eyes are invariably due to conjunctivitis, keratitis or blepharitis.

Conjunctivitis

Types
• Bacterial — Usually affects both eyes. Redness, painful gritty sensation, with
   a sticky discharge, eyelids often stuck together on awakening. Usually self-
   limiting, clearing after 7 – 10 days. However treatment can shorten the
   duration of the infection, increase patient’s comfort and prevent spread of the
   infection.
• Allergic — Redness, intense itching, eyelid swelling, dark rings under eyes,
   watery discharge, typically seasonal in nature or patient has a history of
   allergies. Consider oral or topical antihistamines, or sodium cromoglycate
   drops.
• Viral — Redness, soreness, with a clear watery discharge. There may be
   other viral symptoms present, eg fever or sore throat.

Keratitis
Inflammation of the cornea, usually with symptoms of deep pain and
photophobia in addition to red-eye. There may be a discharge and vision may be
affected.

Blepharitis
Chronic inflammation and crusting of the eyelids and eyelashes. Symptoms
include itching, and red, inflamed eyelids.

Who is the patient?

Although sulphacetamide eye drops may be used in infants from 2 months of
age babies showing signs of conjunctivitis particularly in the first 4 weeks of life
should be referred immediately to a doctor. Conditions such as Congenital
(Infantile) Glaucoma or Chlamydia or gonococcal infections picked up from the
mother during birth may produce symptoms of conjunctivitis in an infant and if
not treated promptly can be potentially sight threatening. Chlamydia or
gonococcal infection can be life threatening in an infant if it spreads
systemically.1 2

Blocked tear ducts are common an infants but don’t usually produce symptoms
until about 3 –12 weeks after birth while chlamydial or gonococcal infections
produce symptoms within a few days to a week from birth.

1
 McKellar M. Sinister paediatric eye conditions. New Zealand GP. 17 Oct.2001:p27
2
 Wagner R. Eye infections and abnormalities: Issues for the paediatrician.
Contemporary Pediatrics. June 1997
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© Pharmacy Guild of New Zealand (Inc) 2006
Elderly people are more prone to eye problems such as dry eye and are more
likely to be taking medicines that affect the eye.

Symptoms?

The following symptoms require referral to a medical practitioner to exclude
more serious eye conditions:
• Pupils appear abnormal, ie very small or large and/or irregular in shape
   (suggests internal eye disease).
• Inflammation around the iris only (suggests iritis).
• Blurred or altered vision can be a symptom of viral conjunctivitis, acute
   glaucoma, iritis or keratitis. Any loss of vision requires immediate referral.
• Pain in and/or around the eye may indicate glaucoma. Severe pain can
   indicate glaucoma, iritis or a corneal ulcer.
• Symptoms present that are not consistent with bacterial conjunctivitis eg
   nausea and vomiting (can indicate acute glaucoma and requires immediate
   medical treatment).
• Photophobia.

Contact lens wearer?

Inadequate care of lenses can cause a build up of microorganisms and dirt
resulting in eye infections and eye discomfort.
You need to find out:
• If the daily care regime is adequate.
• If the lenses have been allowed to dry out (suggest lubricating drops or
   artificial tears).
• If the lens storage container is cleaned regularly and when it was last
   replaced (ideally at least every 6 months).
• If the lenses worn are disposable ones, when they were last replaced.

Note: Contact lenses should not be worn during treatment with sulphacetamide
eye drops. It is safe to wear lenses again 24 hours after the last sulphacetamide
drops were used.

Other health problems?

Glaucoma
• Patient is likely to be using eye drops, some of which can cause an eye
   irritation
• A painful red eye is one of the symptoms of acute glaucoma and urgent
   medical attention may be required. Refer if glaucoma has been diagnosed but
   the patient hasn’t had the condition checked recently.

Diabetes
• Retinopathy, cataracts, and glaucoma are conditions commonly associated
   with diabetes. Eyes should be checked 2 yearly.

 Rheumatoid arthritis
• May be associated with Sjogren’s Syndrome, a condition that causes dryness
   of the mouth and eyes due to an insufficiency in the glands that supply tears
   and saliva.




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© Pharmacy Guild of New Zealand (Inc) 2006
Pregnant?

Be aware that systemic absorption of medicines can occur after medicines have
been used in the eye. When administered systemically, sulphonamides cross the
placenta and may cause jaundice and haemolytic anaemia in the newborn.3

Breastfeeding?

Sulphacetamide is known to enter breast milk following systemic administration,
but it is not known exactly what levels enter breast milk following ophthalmic
application. While it is reasonable to expect that levels would be low, bear in
mind that there is a small risk of systemically administered sulphonamides
producing kernicterus 4 (a condition due to high levels of bilirubin that can affect
the brain) in infants of lactating mothers.

Taking any medicines?

Systemic medicines can affect the eyes in a number of ways. Anticholinergics,
tricyclic antidepressants, B-blockers, atropine, isotretinoin, some diuretics and
sedating antihistamines can dry the eyes. Vigabatrin (Sabril) can cause visual
field defects. Cataract is reported to have occurred after unduly prolonged
treatment of eye conditions with topical corticosteroids.

Other eye drops being used?

•   Incorrect usage, storage, or using eye drops after the expiry date may
    predispose to eye irritation or infection.
•   Steroid eye drops - possibility of a rise in intra-ocular pressure in a small
    number of people or a lesser rise in intra-ocular pressure in more people
    when used for longer than a few weeks. Long term use has been associated
    with thinning of the cornea.
•   Sulphacetamide is anionic so can cause precipitation if used with other eye
    drops (most other eye drops are cationic).

Allergies to medicines?

As there is a risk of cross sensitivity, people who have had a reaction to
sulphonamides, frusemide, thiazide diuretics, sulphonylureas or carbonic
anhydrase inhibitors should not use sulphacetamide eye drops. 5




3
  Data sheet. Acetopt eye drops. July 1999
4
  Briggs G, Freeman R, Yaffe S. Drugs in Pregnancy and Lactation. 6th Ed. 2002
5
  American Pharmaceutical Association. Drug Information Handbook. 9th Ed. 2001-
2002:1143
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© Pharmacy Guild of New Zealand (Inc) 2006
                                             Cough
                     Choline Theophyllinate + Guaiphenesin
                            Sedating Antihistamines

Coughing is a protective reflex action caused when the airway is irritated or
obstructed. Coughs are usually classified as acute or chronic and the duration of
a cough is an important factor in differential diagnosis.

Acute cough — The origin is usually a viral respiratory tract infection and the
duration is generally two weeks or less. An acute cough is often associated with
other symptoms of upper respiratory tract infection.

Chronic cough — A cough that lasts for more than two weeks can be
considered chronic. Potential causes are:
   - Post nasal drip
   - Sinusitis
   - Bronchitis
   - Asthma
   - Gastro-oesophageal reflux
   - Smoking
   - Congestive heart failure
   - Emphysema
   - Lung cancer
   - Side effects of medication eg ACE Inhibitors


Assessing a cough

Who is the treatment for?

Refer if the patient is a child under 2 years of age. Coughing in infants and very
young children may be an indication of
• asthma (persistent dry cough which is worse at night)
• congenital abnormality where milk gets into the airway during feeding
• an inhaled object
• the result of a near choking episode

What is the cough like?

Type of cough:
A productive cough is chesty and produces phlegm/sputum. It should be
encouraged as secretions retained in the lower respiratory tract impair breathing
and can cause infection. Clear sputum is generally uninfected, but thick, yellow
or green secretions may indicate an infection.

A non-productive cough is dry and tickling and usually caused by throat
irritation. It serves no physiological purpose and may be suppressed.6
If short of breath and wheezing with a dry cough the patient may have early
presentation of asthma.

Many smokers have a chronic cough which is worse in the mornings.


6
    Stenson N. Coughs and Colds. IPU Review 2005;10:25-31
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© Pharmacy Guild of New Zealand (Inc) 2006
Croup
Suspect croup if the patient is a child with a continuous cough that sounds like a
barking seal. The cough may begin at night after the child has been sleeping but
may occur during the day as well. The child may also have troubled breathing.7

Whooping cough
Can appear in people of all ages but is most serious in infants. Initial symptoms
are similar to those of a cold lasting for 1 to 2 weeks followed by a cough. The
cough may follow the distinctive pattern of bursts of coughing followed by a
deep gasp, producing a ‘whooping’ sound but this is not always the case.
Infants and young children appear very distressed and may turn blue as a result
of breathing difficulty or vomit as a result of intense coughing.

Phlegm/Sputum

The presence and nature of sputum can be a useful indicator of the cause of the
cough and need for further investigation.

•   A yellow- green or brown colour may indicate bacterial infection. Rust
    coloured phlegm is characteristic of pneumonia.
•   Phlegm with a foul odour may be associated with bronchitis or pneumonia.
•   Blood in the phlegm can be due to a relatively minor problem such as a burst
    capillary following a violent bout of coughing or a more serious problem such
    as tuberculosis or lung cancer.
•   A cough that comes on suddenly is accompanied by severe breathlessness
    and produces clear or pink frothy phlegm may be due to left ventricular
    failure.

How long has the cough been present?

The majority of coughs are self-limiting. Coughs lasting longer then 10-14 days
may need further investigation.

Recently had a cold, flu or allergy?

Most coughs presenting in a pharmacy are caused by viral upper respiratory
tract infections and are accompanied by other cold symptoms. Chronic rhinitis
or sinusitis resulting in post nasal drip is also a common cause of cough.
Further questioning is important if a cough cannot be linked to a cold, flu or
allergy.

In a child with a cough that began suddenly, ask if it is associated with a
particular event such as a near choking episode.

Any other symptoms?

•   Shortness of breath or chest pain — any patient experiencing shortness of
    breath or chest pain should be referred for further assessment to exclude
    conditions such as bronchitis, pleurisy, pneumonia, tuberculosis or lung
    cancer.

7
 Virtual Childrens Hospital:
http://www.vh.org/pediatric/patient/pediatrics/cqqa/cough.html
Medline Plus: http://www.nlm.nih.gov/medlineplus/print/ency/article/003072.htm
http://familydoctor.org/858.xml?printxml all accessed 31.10.2005
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© Pharmacy Guild of New Zealand (Inc) 2006
•   Wheezing can be a symptom of bronchitis especially in children, of asthma or
    heart failure.
•   A persistent high temperature for 3 days or more may indicate the presence
    of bacterial infection.
•   Extreme tiredness accompanied by loss of appetite and fever can be
    symptoms of pneumonia.

Smoker?

Many smokers have a chronic cough. Apart from the obvious intervention to
assess the smoker’s readiness to quit, look for any change to the cough as an
indication that there is a more serious cause.

Any other health conditions?

A child who is experiencing a chronic cough and is under the care of a specialist
for any reason or who has asthma or gastro-oesophageal reflux should be
referred to their GP.

Heart failure
One of the symptoms that a patient with heart failure may experience is a
chronic cough that occurs especially when he/she is lying flat in bed. Worsening
cough may be an indication of drug therapy failure.

Epilepsy
Because there have been occasional reports of convulsions in patients taking
antihistamines, Martindale cautions against recommending antihistamines to
patients with epilepsy.

Diabetes
In short term acute conditions, the amount of sugar in cough medicines is now
considered unimportant when used for short periods, since diabetic control is
often upset during infections.8

Gastro oesophageal reflux
Gastro oesophageal reflux is a common cause of coughing.




8
 Blenkinsopp A&J, Paxton P. Symptoms in the Pharmacy. Blackwell Publishing. Oxford.
2005:37
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© Pharmacy Guild of New Zealand (Inc) 2006
Taking any medicines?

Medicines which can cause coughing as a side effect:
• ACE Inhibitors eg captopril, cilazapril, enalapril, lisinopril, perindopril,
  quinapril, trandolapril
• Angiotensin II blockers eg. losartan

Other advice

Humidity eases coughing. A steamy bathroom or steam inhalations with or
without additives like menthol or eucalyptus may help to moisten throat
secretions, soothe irritated airways and diminish cough.

Demulcents such as glycerine, lemon and honey are popular for their soothing
effects. They do not contain any active ingredients and although they have high
syrup content, their pleasant taste makes them suitable for children.

Maintaining a high fluid intake helps to hydrate the lungs.

Children who are regularly exposed to second hand smoke have more difficulty
recovering from upper respiratory tract infections and are more prone to chronic
coughs.




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© Pharmacy Guild of New Zealand (Inc) 2006
SEDATING ANTIHISTAMINES

Reclassification of sedating antihistamines

The Medicines Classification Committee decided that all sedating antihistamines
should be reclassified to Pharmacist Only Medicines, effective from 8 September,
2005.

However a sedating antihistamine in combination with one or more active
ingredients for the treatment of coughs, colds or influenza, where at least one of
the active ingredients is a sympathomimetic decongestant or the antihistamine
is the bedtime dose of a day/night pack and the labelling of the combination
product has no indications for children aged under two years remains as a
pharmacy only medicine.

A further reclassification on 14 September 2006 saw sedating antihistamines
with indications for children under two years of age reclassified to Prescription
Medicines. The medicines affected by this reclassification were Dimetapp Infant
Drops (Brompheniramine) and Demazin Infant drops (Chorpheniramine)

Thus the following cough and cold medicines containing sedating antihistamines
are restricted medicines:

Benadryl original syrup, Benadryl Nightime Syrup              Diphenhydramine
Diphenhydramine chesty mucus cough syrup HMG
Tixylix linctus                                               Promethazine

Active ingredients of reclassified medicines

Demazin Syrup                       Chlorpheniramine maleate 1.25mg
                                    Phenylephrine HCL 2.5mg per 5 mls
Benadryl Original                   Diphenhydramine HCL 12.5mg per 5 mls
Benadryl Nightime Syrup             Diphenhydramine HCL 12.5mg
                                    Dextromethorphan hydrobromide per 5 mls
Tixylix Linctus                     Promethazine HCL 1.5mg
                                    Pholcodine citrate 1.5mg per 5 mls

Mode of action of sedating antihistamines

The mechanism of the antitussive action of sedating antihistamines may involve
reduction in cholinergic nerve transmission or be due to their sedative effects.9
Antihistamines should not be used to treat productive coughs because reduction
in bronchial secretions may cause the formation of viscous plugs.

The sedative effects of antihistamines may prove troublesome for daytime use,
but may be a short-term advantage for night coughs.
 Non-sedating antihistamines are less effective in the symptomatic treatment of
coughs and colds because of their less pronounced anticholinergic actions.10




9
  Martindale: The Complete Drug Reference. Electronic version, Accessed 6 December
2005
10
   Blenkinsopp A&J, Paxton P. Symptoms in the Pharmacy 2005:36
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© Pharmacy Guild of New Zealand (Inc) 2006
Overdosage

Overdosage with sedating antihistamines is associated with antimuscarinic,
extrapyramidal and CNS effects. In children CNS stimulation can dominate over
CNS depression, causing excitement. When sedative effects do occur, they are
most apparent at the start of treatment and often diminish after a few days of
administration. 11

Taking any other medicines?

Sedating antihistamines have additive effects with alcohol and other CNS
depressants.

MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines.

Need to be alert during the day or maintain good motor coordination?

Products containing sedating antihistamines should be avoided during the day if
the patient will be driving, operating machinery or undertaking any other activity
that requires alertness and good motor coordination.




11
  Martindale. The Complete Drug Reference. Electronic version. Accessed 6 December
2005
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© Pharmacy Guild of New Zealand (Inc) 2006
CHOLINE THEOPHYLLINATE + GUAIPHENESIN

Reclassification of theophylline

In November 2000 the Medicines Reclassification Committee recommended that
liquid oral theophylline be reclassified to Pharmacist Only Medicine in
preparations containing 2% or less. The decision was based on the movement
towards harmonisation with Australian medicines classification, the narrow
therapeutic index, and the potential safety concerns, which call for advice to be
provided on the safe and effective use of theophylline containing medicines. 12

Brondecon and Broncelix were affected by this reclassification.

Choline theophyllinate 1.57mg is approximately equivalent in theophylline
content to 1mg of anhydrous theophylline. 13 Therefore 50mg of choline
theophyllinate is approximately equivalent to 32 mg of theophylline.

Brondecon Elixir contains 200mg of choline theophyllinate per recommended
adult dose of 20ml. This is equivalent to 128mg theophylline per adult dose.

Broncelix contains 150mg choline theophyllinate per recommended adult dose of
10ml. This is equivalent to 96mg theophylline per adult dose.

Theophylline’s narrow therapeutic index

Theophylline has a narrow margin between the therapeutic dose and the toxic
dose. Brondecon and Broncelix deliver a relatively small dose of theophylline
when taken at the recommended doses; however there is a potential risk of
toxicity for people in whom the theophylline half-life is increased.

Theophylline is metabolised by the liver. Its clearance and consequently its half-
life are affected by a variety of factors including age of the patient, disease
states, and concurrent drug therapy.

Who is the treatment for?

Although there is great variability in theophylline half-life between individuals,
the half-life is generally greater in elderly people due to slower hepatic
clearance. Elderly people are also more at risk of adverse reactions or toxicity
due to the higher incidence of concomitant disease and drug use.




12
   Medsafe. Medicines Reclassification Committee. Minutes of the 24th meeting, Nov.
2000.
13
   Adis International. New Ethicals Compendium, 7th Edition, 2000:261-262.


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© Pharmacy Guild of New Zealand (Inc) 2006
Other health problems?

Medicines containing theophylline derivatives should be used with caution in
people with:
• Hepatic impairment ( cirrhosis, acute hepatitis, cholestasis)
• Cardiac disease or severe hypertension – may cause dysrhythmias and/or
   worsen pre-existing arrhythmia. Decreased theophylline clearance may occur
   in people with heart failure.
• Peptic ulcers – theophylline increase gastric secretion
• Hyperthyroidism – may be exacerbated by theophylline.
• Viral infections – as theophylline clearance may be retarded in acute, viral
   infections possibly due to increased interferon production during the acute
   febrile response.
• Pulmonary disease – chronic obstructive lung disease, pneumonia and acute
   viral respiratory disease have been associated with reduced theophylline
   clearance.

Refs14, 15

Taking any other medicines?

Look for
• Medicines that may cause a cough as an adverse effect eg. ACE inhibitors and
   Beta-blockers although this type of cough is typically irritating and non-
   productive.
• Other theophylline containing medicines or Xanthines eg. caffeine (in large
   doses) which with the additive effect of choline theophyllinate may cause
   toxicity.
• Medicines with the potential to increase the plasma concentration of
   theophylline.


Medicines with the potential to increase the plasma theophylline
concentration

Allopurinol (in large doses ie. ≥            Quinolone derivatives (ciprofloxacin,
600mg/day)                                   norfloxacin)
Cimetidine                                   Propafenone
Disulfiram                                   Diltiazem, verapamil
Erythromycin, clarithromycin                 Oral contraceptives (combined)
Isoniazid                                    Interferon alpha
Mexiletine
(Reference sources 9, 10, 16 )

•    Theophyllines may antagonise or inhibit the effects of benzodiazepines,
     carbamazepine, and erythromycin.
•    Theophylline may enhance lithium excretion.
•    The mean half-life of theophylline in smokers is shorter than in non-smokers.


14
   Martindale. The Complete Drug Reference. Electronic version. Accessed 6 December
2005
15
   British National Formulary 41, March 2001.
16
   American Pharmaceutical Association. Drug Information Handbook. 6th Edition,
1998 – 99.
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© Pharmacy Guild of New Zealand (Inc) 2006
Pregnant or breastfeeding?

Theophylline crosses the placenta and also enters breast milk. The Australian
Drug Evaluation Committee lists both theophylline derivatives and guaiphenesin
as category A 17 ie Drugs which have been taken by a large number of pregnant
women and women of childbearing age, without any proven increase in the
frequency of malformations or other direct or indirect harmful effects on the
foetus having been observed.

There have been reports of theophylline causing irritability in breastfed infants. 15
The Brondecon data sheet advises that the safe use of Brondecon during
lactation has not been established.

Adverse effects

Adverse effects to theophylline are usually related to the plasma concentration.
At the recommended doses, side effects from Brondecon and Broncelix in
otherwise healthy people should be minimal.

The most common side effects are gastric irritation and headache. Gastric
irritation can be minimised by taking the dose immediately after food.

Signs of theophylline overdose

Insomnia, anorexia, anxiety, nausea, vomiting, convulsions, palpitations,
hypotension, tachycardia and cardiac arrhythmias.




17
  Australian Drug Evaluation Committee. Prescribing medicines in pregnancy. 4th
Edition, 1999:38
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© Pharmacy Guild of New Zealand (Inc) 2006
                                             Insomnia
                    Diphenhydramine, Doxylamine Succinate
                        Salicylamide+ Diphenhydramine


Definition

A sleep disorder or difficulty exists when the inability to sleep well produces
impaired daytime functioning or excessive sleepiness. This difficulty typically
takes the form of waking unrefreshed, difficulty falling asleep, frequent night-
time awakenings or awakening too early.18 Many people have never discussed
their sleep difficulties with their doctor, so direct questioning about the pattern
and possible cause is important.

Duration

Insomnia is classified as
• Transient – lasting 2 to 3 days
• Short term – lasting up to 3 weeks and typically due to emotional trauma or
   physical illness
• Chronic – occurring most nights for more than 3 weeks

Refer all chronic cases to the GP for further evaluation.

Factors that contribute to insomnia

         •   Stress
         •   Anxiety/depression
         •   Shift work or change in surrounding environment
         •   Sleep/wake schedule changes eg jet lag
         •   Having a high intake of beverages containing caffeine
         •   Medication side effects
         •   Alcohol - the sleep cycle is disturbed by continuous or heavy alcohol
             consumption
         •   Uncomfortable sleep environment eg room too hot or too cold,
             uncomfortable bed, noisy
         •   Snoring associated with sleep apnoea
         •   Chronic health conditions involving pain, breathing difficulties, frequent
             night time urination or depression

Who is the treatment for?

Irregular sleep patterns are common in babies and toddlers but these can
usually be modified using sleep retraining techniques. Suggesting a self help
book or referral to the local Plunket nurse for assistance may be appropriate.
People over 60 years of age may need less sleep at night, especially those who
have daytime naps. For some, all that may be needed is reassurance that they
are having sufficient sleep. As sleep physiology changes with age, older people
spend less time in deep sleep, the duration of sleep becomes shorter and sleep
becomes shallower. Older people tend to be more easily woken by noise and
other environmental factors.


18
     Gowan J, Roller L. Practical Disease State Management for Pharmacists. 2004: 21
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© Pharmacy Guild of New Zealand (Inc) 2006
Some patients may need treatment for an underlying problem in order to sleep
better. Sleep can be disrupted by conditions where pain or discomfort is a factor
such as angina, oesophageal reflux, arthritis, or cancer, conditions where
breathing difficulties are common such as asthma, heart failure, and COPD, or
other conditions such as hyperthyroidism, and Parkinson’s disease.

One of the reasons that sedating antihistamines used to treat insomnia are
classified as Pharmacist Only Medicines is the risk of tolerance developing. An
initial focus on sleep hygiene and careful explanation that sedating anti-
histamines are for short-term use are therefore important.

When recommending treatment for an older patient bear in mind that older
people are more susceptible to the adverse effects of sedating antihistamines
and may be more prone to hangover like effects of sedating antihistamines.

Warning signs for referral

•     Insomnia is chronic – occurring on most nights and lasting a month or more19
•     Patient feels under stress or could be depressed
•     Patient is taking prescription medicines which may interfere with sleep
•     Male patient wakes often to go to the toilet which may indicate prostate
      problems
•     Patient has untreated respiratory, pain, cardiovascular or gastro-intestinal
      disease symptoms
•     Patient experiences sleep apnoea

Taking any medicines?

The following medicines and substances may contribute to sleep disturbance:

Alcohol, decongestants, buproprion, SSRIs, MAOIs, tricyclic antidepressants,
thyroid supplements, calcium channel blockers, beta blockers, appetite
suppressants, theophylline, caffeine, corticosteroids, dopamine agonists,
phenytoin.

Sedating antihistamines may enhance the sedative effects of CNS depressants
including alcohol and increase the anticholinergic effects of other anticholinergic
medicines or medicines with anticholinergic properties such as tricyclic
antidepressants and some antiparkinson medicines.

Allergies to medicines?

Salicylamide, an ingredient in Calm U has the same adverse effects as aspirin
therefore it is not recommended for asthmatics sensitive to aspirin.

Pregnancy and breast-feeding

While only Calm-U has an Australian Drug Evaluation Committee category
suggesting it be avoided in pregnancy (because of the aspirin-like ingredient
salicylamide), it is preferable to consider non-pharmacological advice in the first
instance for any pregnant woman experiencing sleep difficulties.



19
     National Heart, Lung and Blood Institute. Facts about Insomnia. 1995: 1
                                                                                  16
© Pharmacy Guild of New Zealand (Inc) 2006
Diphenhydramine and doxylamine are both classified as Category A 20 i.e. Drugs
which have been taken by a large number of pregnant women and women of
childbearing age without any proven increase in the frequency of malformations
or other direct or indirect harmful effects on the foetus having been observed.

Sedating antihistamines may inhibit lactation due to their anticholinergic actions.
Small amounts of antihistamines are distributed in human breast milk so their
use is generally not recommended because of the risk of adverse effects such as
unusual excitement, irritability or sedation in the infant.

Other health problems?

Careful questioning regarding other conditions will provide enough information to
determine whether the sleeping difficulty is primary or secondary to another
health problem and whether using a sedating antihistamine is likely to pose any
risks.

Glaucoma – The anticholinergic effect of sedating antihistamines can increase
intra-ocular pressure.

Prostate enlargement – The anticholinergic side effects of sedating
antihistamines may cause urinary retention thus exacerbating prostate
problems.

Epilepsy - There have been occasional reports of convulsions in people taking
antihistamines therefore they should be used with caution in people with
epilepsy.

Liver disease - Avoid sedating antihistamines in severe liver disease, and
exercise caution in mild to moderate liver disease as metabolism of the
antihistamine may be impaired.

Stenosing peptic ulcer - This predisposes the patient to an increased risk of
gastrointestinal obstruction. Agents with anticholinergic properties such as
diphenhydramine reduce the tone and motility of the gastrointestinal tract and
thus increase the risk of worsening/contributing to gastrointestinal obstruction.

What treatments have already been used?

If a drug has been used successfully and appropriately before, suggest the
same. Ensure that the patient is aware of advice and lifestyle changes that
make a difference.

Management of insomnia

Insomnia can be managed in two ways
   1. Non-pharmacological ie advice on sleep hygiene, relaxation, lifestyle
      factors
   2. Pharmacological ie sedating medication




20
  Australian Drug Evaluation Committee. Prescribing Medicines in Pregnancy. 4th
Edition. 1999:40
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© Pharmacy Guild of New Zealand (Inc) 2006
Non-Pharmacological advice

An important first step in the counselling of a patient with insomnia is to educate
the patient in non-pharmacological ‘sleep hygiene’, i.e. habits which encourage
good sleep.
• Establish a regular sleep schedule, going to bed and getting up at the same
  time every day
• Keep the bedroom dark, quiet and comfortable
• Do not eat, watch TV or work in bed. It increases stress
• If unable to sleep, get out of bed and do something to take your mind off
  sleeping
• Do not exercise close to bed time as it may increase alertness
• Relax before bed with soft music, mild stretching, yoga or pleasurable reading
• Avoid caffeine drinks (cola, energy drinks, tea, coffee, chocolate) in the hours
  before bed time
• Do not eat heavy meals before bedtime
• Turn away the clock to minimise anxiety
• Warmth induces sleep by relaxing the muscles and increasing the brain
  temperature21




General Reference Sources

•     Blenkinsopp, A. & J. & Paxton, P. Symptoms in the pharmacy. 5th Ed. 2005:
      279-285
•     Gowan, J & Roller, L. Practical disease state management for pharmacists.
      2004:21-26
•     Li Wan Po, A. & Li Wan Po, G. OTC Medications. 2nd Ed. 1997: 202-203
•     Pharmaceutical Society of Australia. Counselling guide for non-prescription
      medicines. 2003. 19-21
•     Pharmacy Today. Healthcare handbook. 2004: 114-115, 240




21
     Gowan, J & Roller, L. Practical disease state management for pharmacists. 2004: 22
                                                                                          18
© Pharmacy Guild of New Zealand (Inc) 2006
                                        Mouth Ulcers
                                Triamcinolone Oral Paste


Mouth ulcers are seen in all age groups from childhood onwards and are slightly
more common in females. There are three main clinical types of mouth ulcer:
1. Minor aphthous ulcers
2. Major aphthous ulcers
3. Herpetiform ulcers

Minor aphthous ulcers are either round or oval, often crater-like, usually small
(< 5mm) in diameter and appear suddenly either singly or in groups. The centre
of the ulcers is yellowish grey and the outside edge may be surrounded by a
reddish halo. They occur most commonly on the lining mucosa of the cheeks,
lips and underside of the tongue and are usually painful. These ulcers usually
heal within 7 to 14 days.

Major aphthous ulcers are not as common, and are larger (> 1 cm diameter).
These ulcers are quite deep and painful and are slower to heal some taking a
month or more.

Herpetiform ulcers have a herpes-like appearance, are small pinpoint ulcers
(<1mm) and generally occur in clusters of up to 100. They affect the same
areas as aphthous ulcers and also the gums and floor of the mouth. They
generally heal within about a month although new ulcers may appear before the
old ones heal. A fever and a general feeling of being unwell may accompany
herpetiform ulcers. Patients with herpetiform ulcers should be referred to a
medical practitioner.

Contributing factors

Trauma and stress
Mouth ulcers often follow local trauma or injury to the oral mucosa. Injury may
be caused by broken teeth, poor fitting dentures, irritation from braces, sharp-
edged foods such as potato chips, or accidental self-biting.

Mouth ulcers are often preceded by periods of emotional stress.

Systemic diseases, immune disorders and nutritional deficiencies
Occasionally recurrent mouth ulcers may be associated with gastrointestinal
problems including Crohn’s disease, ulcerative colitis, GORD, and coeliac
disease. Links to deficiencies in iron, folic acid and Vitamin B12 have been
identified.

Mouth ulcers occur often in people with immune deficiencies due to bone marrow
damage eg leukaemia, viral infection eg HIV, bacterial infection eg TB,
autoimmune disease eg systemic lupus or as a result of radiation therapy to the
head /neck or chemotherapy.

Irritant or allergenic foods
For some individuals the development of mouth ulcers may be related to eating
certain foods. Foods that have been implicated include wheat, nuts, citrus fruit,
tomatoes, strawberries, and cheese.


                                                                               19
© Pharmacy Guild of New Zealand (Inc) 2006
Ulcers elsewhere?

Ulcers on other mucous membranes such as the genital area or the eyes require
urgent referral.

Other symptoms?

Accompanying symptoms such as fever, fatigue, muscle and joint pain, swollen
lymph nodes, and weight loss could indicate a systemic condition such as lupus
erythematosus and should be referred. The autoimmune skin diseases bullous
pemphigoid and pemphigus vulgaris present as blistering skin eruptions that
may also involve ulceration of the mouth.

How long have the ulcers been present?

A patient with any mouth ulcer lasting more than two to three weeks should be
referred to his or her doctor for further investigation to exclude malignancy or
other serious conditions.

Other health problems?

As a precaution patients with diabetes, tuberculosis, or peptic ulcers should not
be treated with any corticosteroid preparation unless on the advice of a doctor.
Corticosteroids have the potential to exacerbate peptic ulcers or tuberculosis and
alter glucose metabolism. These effects are more likely to occur when
triamcinolone paste is used for prolonged periods.

Triamcinolone oral paste is contraindicated in the presence of fungal, viral or
bacterial infections of the mouth or throat. 22 The normal defensive responses of
the oral tissues are depressed in patients receiving topical corticosteroid
therapy.

Anyone with weight loss associated with the ulcer(s) due to the inability to eat
should be referred.

Pregnant?

The Australian Drug Evaluation Committee lists triamcinolone as Category A23, ie
drugs which have been taken by a large number of pregnant women and women
of childbearing age without any proven increase in the frequency of
malformations.

However the product information provided by the manufacturer of Kenalog in
Orabase recommends that their product not be used during pregnancy unless
the doctor or dentist feels that the benefits outweigh the risks. As mouth ulcers
can be a symptom of nutritional deficiency or a blood disorder it is advisable to
refer a pregnant patient with mouth ulcers to her doctor.




22
  Data sheet. Oracort Paste,Topical. April 1998
23
  Australian Drug Evaluation Committee. Prescribing medicines in pregnancy. 4th
Edition. 1999:24
                                                                                   20
© Pharmacy Guild of New Zealand (Inc) 2006
Breastfeeding?

There is limited data on excretion of triamcinolone into breast milk. In general
corticosteroids are excreted in small amounts.

Taking any medicines?

Drug induced mouth ulcers can be caused two ways:
1. Direct contact between the drug and the oral mucosa
2. As a result of blood dyscrasias ie agranulocytosis, aplastic anaemia,
   thrombocytopenia

For a drug to cause mouth ulcers through direct contact requires prolonged
exposure to drugs such as potassium chloride, aspirin, captopril and pancreatic
enzyme preparations. 24 Patients taking these medicines should be instructed to
swallow the tablets/capsules as quickly as possible.

Drug induced blood dyscrasias usually present with a number of clinical
symptoms which may include mouth ulcers. Signs of possible blood problems
include constant flu-like symptoms, sore throat, fever, chills, swollen glands and
lack of energy. Secondary infection with candida is common.

Drugs reported to have caused blood dyscrasias such as aplastic anaemia,
agranulocytosis or thrombocytopenia include:
Ace inhibitors, antiarrythmics, antibacterials, anticonvulsants, antihistamines,
antimalarials, antirheumatics, antithyroid drugs, antivirals, cytotoxics, diuretics,
psychotropics, and sulphonylureas.25

Feverfew, a herbal remedy popular for treating headache has been has been
known to cause mouth ulcers.26 This seems to be a problem when people take
the raw leaf rather than an encapsulated formulation.

Systemic effects

The small amount of steroid released when triamcinolone oral paste is used as
recommended makes systemic effects very unlikely. However systemic effects
are possible when topical corticosteroid preparations are used in the mouth for
prolonged periods.

Adverse effects

Adverse effects are unlikely unless use of the product is prolonged.




24
   Barrons R. Treatment strategies for recurrent oral aphthous ulcers. Am J Health-
System Pharm. 2001;58(01):41-53
25
   Walker R, Edwards C. Drug-induced blood disorders. Clinical Pharmacy and
Therapeutics. Chapter 46.1994
26
   University of Maryland Medical Centre. Alternative/Complementary medicine.
http://www.umm.edu/altmed/ConsHerbs/Feverfewch.html Accessed 28 Feb 2006
                                                                                      21
© Pharmacy Guild of New Zealand (Inc) 2006
General Reference Sources

•   Kenalog in Orabase CMI and Product Information. Bristol – Myers Squibb
    Australia
•   Scully, C, Shotts, R. Mouth ulcers and other causes of orofacial soreness and
    pain. BMJ:2000;321: 162-165
•   Oracort. CMI. http;// www.medsafe.govt.nz/Consumers/cmi/o/oracort.htm




                                                                                22
© Pharmacy Guild of New Zealand (Inc) 2006
                           PAIN – MUSCULOSKELETAL
                                             Diclofenac


Who is the patient?

NSAIDs should be used with caution in the elderly due to the increased risk of
serious side effects.27 In this group of patients the lowest possible dose should
be used.

Severity/location/duration/causes of pain?

Pain that is severe and/or causes mobility problems is an indication for referral.
Middle to upper back pain with no history of injury or strain could indicate kidney
problems and should be referred.

Using the 1 — 10 scale of pain intensity is a useful tool for gauging the severity
of pain. Ask the patient how bad the pain is on a scale of 1 to 10 where 1 is
very mild and 10 is unbearable.

Note; like other NSAIDs diclofenac may mask signs and symptoms of infection
due to its pharmacodynamic properties.28 If you suspect there may be infection
present refer the patient for medical attention.

Other health problems?                (Always ask about asthma, GI disturbances)

•    Asthma
     Between 8 — 20% of adult asthmatics experience bronchospasm following
     ingestion of aspirin or other NSAIDs. Asthmatics with chronic rhinitis or a
     history of nasal polyps are at greater risk.29

•    Stomach ulcers
     Diclofenac may aggravate existing problems.

•    Heart, kidney or liver disease
     Prostaglandins play an important part in maintaining renal blood flow.
     Diclofenac inhibits prostaglandins synthesis therefore particular caution is
     required in patients with impaired cardiac or renal function, the elderly,
     patients taking diuretics, and before or after major surgery. 28

•    High blood pressure
     May be exacerbated by diclofenac.

•    Bowel disease eg Crohn’s disease or ulcerative colitis
                                                                         29
     Diclofenac should only be given under close medical supervision.

Note: Do not give diclofenac to someone who is dehydrated due to the potential
risk of renal damage.



27
   British National Formulary (BNF) 41. September 2001
28
   Data Sheet. Voltaren. September 1999.
http://www.medsafe.govt.nz/Profs/Datasheet/v/Voltarentab.htm
29
   Sturtevant J. NSAID – induced bronchospasm – A common and serious problem.
Prescriber Update No 18, June 1999
                                                                                    23
© Pharmacy Guild of New Zealand (Inc) 2006
Allergies to medicines or previous reactions to aspirin or other NSAIDs?

Reactions such as bronchospasm / asthma, shock, urticaria, or acute rhinitis
after taking diclofenac indicate sensitivity. As cross sensitivity is possible,
diclofenac should not be taken by people who have had an adverse reaction to
any NSAID including aspirin. 28

Pregnant or breastfeeding?

Not recommended during pregnancy. Australian Drug Evaluation Committee
Category C30, ie drugs which, owing to their pharmacological effects, have
caused or may be suspected of causing harmful effects on the human foetus or
neonate without it causing malformations. These effects may be reversible.

The Voltaren data sheet states that following oral doses of 50mg every 8 hours
diclofenac passes into breast milk in such small quantities that no undesirable
effects on the infant are expected. This is confirmed by the BNF where it states
that the amount that passes into breast milk is too small to be harmful.

Potential drug interactions

Some medicines which may interact with diclofenac

Interacting medicine                         Effect
Digoxin                                      Increased plasma levels of digoxin
ACE inhibitors                               Hypotensive effect may be decreased
Lithium                                      Excretion of lithium reduced
Methotrexate                                 Excretion of methotrexate reduced
Diuretics                                    Diclofenac may inhibit diuretic effect
Potassium sparing diuretics                  Serum potassium levels may increase
Cyclosporin                                  Increased risk of nephrotoxicity
Warfarin                                     Anticoagulant effect possibly enhanced
Heparin                                      risk of bleeding
Other NSAIDs (incl aspirin)                  Increase in undesirable adverse effects
Corticosteroids                              Increased risk of GI ulceration
Sulphonylureas                               Possible enhanced effect of sulphonylurea
Quinolone antibacterials                     Possible increased risk of convulsions

(Reference sources       28, 29,31
                                     )

Alcohol should not be taken at the same time as diclofenac due to the potential
to increase GI irritation.




30
   Australian Drug Evaluation Committee. Prescribing medicines in pregnancy. 4th
Edition. 1999:21
31
   American Pharmaceutical Association. Drug Information Handbook. 9th Ed. 2001-2002
                                                                                     24
© Pharmacy Guild of New Zealand (Inc) 2006
                                   PAIN - MIGRAINE
                           Paracetamol + Metoclopramide


The key to clinical evaluation of an acute headache is to make sure that all
potentially serious causes of the symptoms are ruled out.

Who is the treatment for?

While children as young as five can get migraines it is advisable to refer children
with migraine symptoms to a doctor for the initial diagnosis.

Any patient over 45 with a migraine-like headache or a headache that is
different from their usual headaches should be referred, as it could be a warning
of something more serious.

A patient over 50 presenting with persistent severe frontal or temporal pain
combined with feeling generally unwell should be referred immediately. These
symptoms could indicate temporal arteritis, a condition in which the arteries that
run through the temples become inflamed. Temporal arteritis generally affects
older patients and because the blood vessels to the eyes are also affected, it can
lead to blindness if left untreated. 32

Any other symptoms?

Common migraine symptoms include:
Throbbing pain usually on one side of the head only and made worse by physical
activity, nausea and vomiting, and sensitivity to light and/or noise.

Some sufferers experience symptoms known as aura up to an hour before the
migraine pain starts. These can often include visual changes such as seeing
flashing lights, zigzag lines or blind spots. In addition there may be numbness or
sensory symptoms such as tingling in the arm, tongue or side of the face and
the sufferer may have difficulty speaking.

Many people also get a warning prior to the aura that an attack is coming. They
may feel irritable and withdrawn, crave certain foods, or yawn a lot.

Migraines typically last from 4 to 72 hours.

Refer anyone with the following symptoms for medical assessment 33:
• Sudden, severe pain accompanied by nausea/vomiting – possible sub
   arachnoid haemorrhage
• Severe frontal or temporal pain in a patient > 50
• Nausea, vomiting, fever, stiff neck – may be symptoms of meningitis
• Drowsiness, double vision, limb weakness/loss of feeling, pins and needles –
   possibly a serious neurological condition
• Eye pain, visual disturbance, nausea vomiting – could be glaucoma
• Headache triggered by exertion, coughing or bending
• A change in headache pattern
• New onset of headaches from middle age onwards
• Any headache that follows a head injury


32
     Blenkinsopp A&J, Paxton P. Symptoms in the Pharmacy. 3rd Ed. 1998
                                                                                 25
© Pharmacy Guild of New Zealand (Inc) 2006
What is the pain like?

For a useful indication of how bad the pain is ask the patient to rank the pain on
a scale of one to ten where one is mild and ten is unbearable.

Migraine triggers

A wide variety of food, environmental and lifestyle factors are known to trigger
migraines. Most migraine sufferers know what their ‘triggers’ are and it makes
sense to avoid these if at all possible. If the triggers haven’t been identified a
good idea is to keep a headache diary recording the characteristics, date, length,
pre-headache symptoms, of the migraine plus the foods eaten and the
environment immediately prior to the attack.

Common triggers include:

Dietary                            Environmental               Lifestyle
Alcohol                            Strong odours eg paint or   Too little/too much sleep
Chocolate                          perfume                     Stress
Caffeine                           Bright or flashing lights   Missed meals
(excess or withdrawal)             Sunlight
Dairy products                     Loud noises
Citrus fruit                       Weather changes
Foods containing additives
(eg nitrites, sulphites or
MSG)
Artificial sweeteners
Fermented, pickled foods
                                                                      (Reference source33)

In some women migraine attacks may be associated with the menstrual cycle.

Other health problems?

Metoclopramide should not be recommended for patients who:
• Have had recent gastro-intestinal surgery - the increase in gastric motility
   may affect healing.34
• Have phaeochromocytoma (non-cancerous catecholamine secreting tumour
   of the chromaffin tissues that causes secondary hypertension) - may cause
   acute hypertensive response. 35
• Have severe renal impairment – increased risk of extrapyramidal reactions.35

In alcoholics or patients with chronic liver disease paracetamol doses may need
to be lowered due to the increased risk of liver damage. 36




33
   Nordenberg T. United States Food and Drug Administration. Heading off migraine
pain.
http://www.fda.gov/fdac/features/1998/398_pain.html
34
   Data Sheet. Paramax. June 1999
http://www.medsafe.govt.nz/Profs/Datasheet/p/Paramaxtab.htm
35
     British National Formulary (BNF) 41. 2001
                                                                                           26
© Pharmacy Guild of New Zealand (Inc) 2006
Taking any medicines?

•    Check that the patient is not taking any other medications containing
     paracetamol that would result in ’double dosing’.
•    Keep in mind that the absorption of any concurrently administered oral
     medication may be modified by the effect of metoclopramide on gastric
     motility.
•    Refer immediately any patient on combined oral contraceptives who has an
     unusually severe or prolonged headache. Refer also any patient who has
     had migraines in the past but since taking a combined oral contraceptive has
     experienced an increase in the number, severity or length of migraines.
•    Since extrapyramidal reactions may occur with both metoclopramide and
     phenothiazines, taking both together may increase the risk of such adverse
     reactions.
•    Headaches are a common adverse effect of many medicines. Medicines that
     have been particularly implicated include vasodilators (nitrates, calcium
     channel blockers, alpha-adrenoceptor blockers), oestrogen and oral
     contraceptives.

Pregnant or breastfeeding?

Both paracetamol and metoclopramide are listed as category A by the Australian
Drug Evaluation Committee 36, ie drugs which have been taken by a large
number of pregnant women and women of childbearing age without any proven
increase in the frequency of malformations or other direct or indirect harmful
effects on the foetus having been observed.

The Paramax data sheet states that ‘adequate human data on use during
pregnancy is not available. However, animal studies have not identified any risk
to pregnancy or embryo-foetal development’.

Adequate human data on use of Paramax during lactation is not available. 35

Adverse effects of paracetamol and metoclopramide

Adverse reactions to Paramax are uncommon.
In rare cases extrapyramidal reactions such as tremor dystonias and dyskinesias
have been reported with metoclopramide especially in children and young
adults. 36 The incidence increases with high doses > 50mg/kg body weight per
day, and prolonged use. 35

Drowsiness, restlessness, acute depression and diarrhoea have been reported in
some people taking metoclopramide.




36
  Australian Drug Evaluation Committee. Prescribing medicines in pregnancy. 4th
Edition. 1999: 13 & 20
                                                                                  27
© Pharmacy Guild of New Zealand (Inc) 2006
                                        Thrush - Oral
                                    Miconazole, Nystatin


Candidiasis (thrush) in the mouth appears as curd like white or cream slightly
raised patches on the inside of the mouth, gums and/or tongue. The patches
are relatively easily removed to reveal a red, raw underlying base which may be
tender.

Oral candidiasis is predominately caused by candida albicans although other
related candida species may be involved. Candida is an opportunistic organism
that invades when the conditions for growth are optimal. Predisposing factors
for oral candidiasis infection are those that alter the immune status of the host
or alter the oral mucosal environment such as:
• Infancy or old age
• Serious underlying disease eg blood dyscrasias, advanced cancer, or HIV
    infection
• Poorly controlled diabetes
• Radiation therapy to the head/neck
• Xerostomia (dry mouth) due to disease such as cystic fibrosis or Sjorgren’s
    syndrome, salivary gland malfunction, or medication
• Dentures (poor fit or infrequent cleaning)
• Malnutrition, or iron, folic acid , or B-vitamin deficiencies
• Heavy smoking
• Using inhaled corticosteroids
• Taking broad spectrum antibiotics or immunosuppressant drugs

Who is the treatment for?

Infant
Oral thrush is frequently seen in babies. Newborn infants often pick up candida
from the mother during the birth process. Thrush can also pass through the
baby’s digestive system and cause a fungal nappy rash. Reinfection from the
mother’s nipples during feeding may occur. To prevent this, a small amount of
the oral antifungal medicine being given to the baby can be applied to the
mother’s nipples. Babies bottles, teats and pacifiers should be well sterilised
between use to prevent reinfection.

Adult
Oral thrush in adults however should be considered abnormal and in most cases
indicative of a depressed immune system.

Any other area affected?

•   If a baby has oral thrush check whether the nappy area is affected also. If it
    is, treat both oral thrush and thrush of the nappy area at the same time. If
    the baby is breastfed advise the mother to check her nipples and treat if
    necessary.

•   If a woman has oral thrush ask if she has vaginal thrush as well. Both sites
    should be treated at the same time with appropriate medication.




                                                                                   28
© Pharmacy Guild of New Zealand (Inc) 2006
Denture wearer?

Poor fitting dentures may predispose to oral thrush and the patient should be
referred to the dentist.

Denture wearers should remove dentures before taking each dose of oral
antifungal medicine to allow contact with all areas of the oral mucosa and gums.
As an additional measure, the Daktarin Oral Gel package insert advises denture
wearers to apply a thin layer of gel directly to the dentures after removing them
in the evening, leave the gel on overnight and wash it off in the morning.

Taking any medicines?

Medicines that dry the mouth may predispose to oral thrush. Classes of
medicines that commonly cause dry mouth include:

Anorexiants                        eg   Phentermine, diethylpropion
Anticholinergics                   eg   Hyoscine, oxybutynin, benztropine
Antidepressants                    eg   Tricyclics, MAOIs
Antiparkinson agents               eg   Selegeline
Antipsychotics                     eg   Lithium, pimozide, clozapine, thioridazine
Decongestants                      eg   Pseudoephedrine
Diuretics                          eg   Frusemide, amiloride
Muscle relaxants                   eg   Baclofen
Opiates                            eg   Methadone, morphine
Retinoids                          eg   Isotretinoin
Sedating antihistamines            eg   Dextrochlorpheniramine, trimeprazine, cyclizine
(Reference source BNF)

Other medicines that can predispose to oral thrush:

•   Broad spectrum antibiotics
•   Immunosuppressants eg cyclosporin, methotrexate, azothiaprine,
    corticosteroids.
•   Inhaled corticosteroids - Candidiasis of the mouth and throat occurs in some
    patients who use inhaled corticosteroids. Patients should be advised to rinse
    the mouth each time after using the inhaler. Using a spacer device may help
    minimise oral thrush in some susceptible patients.

Treatment choices

Topical antifungals are suitable for uncomplicated localised candidiasis in people
with normal immune function. Systemic antifungals are usually indicated in
cases of disseminated disease and/or immunocompromised patients. Pharmacist
Only Medicines for treating fungal infections of the mouth fall into two groups:
1. Imidazoles — eg miconazole oral gel
2. Polyenes — eg nystatin oral suspension or pastilles

Nystatin is not absorbed from the GI tract when used buccally so medicine
interactions are not a concern. However when miconazole is used locally in the
mouth a small amount may be absorbed so potential interactions need to be
considered.




                                                                                          29
© Pharmacy Guild of New Zealand (Inc) 2006
Medicines which may interact with miconazole

Miconazole depresses the metabolism and clearance of drugs metabolised by the
cytochrome P450 (CYP3A4) systems. This can result in an increase and/or
prolongation of the effects, including side effects of these drugs.

The chart below lists a number of potential interactions between miconazole oral
gel and other medicines. It should be noted that there is documented evidence
for only some of the interactions. Others listed are theoretical, and based on
documented interactions involving ketoconazole or itraconazole rather than
miconazole.

Use your clinical judgement when advising patients about these potential
interactions.

Medicines which may interact with Miconazole

Interacting medicine                             Effect
Warfarin                                         Increased anticoagulant effect
Cisapride                                        Metabolism of cisapride may be inhibited
                                                    risk of cardiac arrhythmias
Cyclosporin                                      Metabolism of cyclosporin is slowed
Sulphonylurea hypoglycaemics                     Increased plasma levels of sulphonylureas
                                                 may potentiate the hypoglycaemic affect
Phenytoin                                        Metabolism of phenytoin is slowed
Terfenadine, astemizole                          Metabolism of these drugs may be
                                                 inhibited    risk of cardiac arrhythmias
Simvastatin, lovastatin                          Metabolism of these drugs may be
                                                 inhibited risk of myopathy
Alprazolam                                       Metabolism of these drugs may be
Buspirone                                        inhibited resulting in an elevated plasma
Carbamazepine                                    levels
Triazolam (oral)
Midazolam (intravenous)
Methyprenisolone
Quinidine
Pimozide
Rifabutin
Sildenafil
Vinca Alkaloids, Busulphan, docetaxel
Tacrolimus                                       Metabolism of tacrolimus may possibly be
                                                 slowed
Amphotericin B                                   In combination with miconazole has an
                                                 antagonistic effect on antifungal activity
(Reference sources37,38 )

The data sheet recommends that if Daktarin Oral Gel and anticoagulants are to
be used concomitantly the anticoagulant effect should be carefully monitored
and titrated. Similarly it recommends monitoring phenytoin levels if it is to be
used at the same time as miconazole.




37
     Data sheet. Daktarin Oral Gel. October 2000
38
     Stockley I. Drug Interactions. 4th Edition. 1996
                                                                                          30
© Pharmacy Guild of New Zealand (Inc) 2006
Pregnant?

Miconazole and Nystatin are both listed by the ADEC as category A 39, ie drugs
which have been taken by a large number of pregnant women and women of
childbearing age without any proven increase in the frequency of malformations
or other direct or indirect harmful effects on the foetus having been observed.

Breastfeeding?

Miconazole – there is no data available on the excretion of miconazole in human
milk the manufacturer advises caution. However levels are expected to be
negligible. Advise the mother to observe the infant for any adverse side effects
such as nausea or vomiting.

Nystatin – It is not known whether nystatin is excreted into human breast milk
but as it is poorly absorbed from the GI tract40,41, excretion into breast milk
would be expected to be insignificant.




General Reference Sources

•    Firriolo F. Oral Candidiasis. University of Louisville School of Dentistry.
     http:// www.dentalcare/soap/intermed/oralcan.htm
•    Family Doctor. Oral thrush in newborns –A Parents Guide.
     http:// www.familydoctor.co.nz/conditions
•    New Zealand Dermatological Society. Patient Information. Oral Candidiasis
     http:// www.dermnet.org.nz/dna.fungi/ocan.html




39
   Australian Drug Evaluation Committee. Prescribing medicines in pregnancy. 4th
Edition. 1999: 13 & 20
40
   Data sheet. Mycostatin Oral. May 2004
41
   Data sheet. Nilstat. May 2002
                                                                                   31
© Pharmacy Guild of New Zealand (Inc) 2006
                                      Thrush Vaginal
            Imidazole and Nystatin Vaginal Creams/Pessaries
                        Fluconazole Oral Tablets

Vulvovaginal candidiasis (VVC) is a common condition caused by an overgrowth
of the micro-organism Candida albicans. Candida is normally found in the vagina
at low levels, but does not usually lead to symptoms of thrush unless the vaginal
environment changes or the balance of candida and normal vaginal flora is
upset, allowing candida overgrowth to occur.

Factors that can contribute to the over-growth of Candida include:
• Broad spectrum antibiotic use
• Oral contraceptive use (those with high oestrogen content)
• Systemic corticosteroid use
• Pregnancy
• Treatment with immunosuppressant drugs
• Immunosuppression from disease eg HIV
• Iron deficiency
• Poorly controlled diabetes
• Using toiletries such as soaps or bath products that cause irritation or upset
   the normal pH of the vagina
• Trauma to the vagina e.g. poorly lubricated sexual intercourse
• Wearing tight pants or synthetic underwear
• Hormonal changes during menstrual cycles

Who is the treatment for?

Vaginal thrush is rare before puberty or in post menopausal women because the
high levels of circulating oestrogen necessary to create the conditions (vaginal
glycogen production) that favour growth of candida albicans are lacking.
Therefore patients who have not yet reached puberty or are over 60 years
should be referred. In these two age groups vaginal infections are more likely to
be bacterial rather than fungal and in older women the possibility of malignancy
needs to be ruled out. In girls under the age of 16 referral is advisable as
thrush like symptoms are likely to be caused by poor hygiene, contact
dermatitis, threadworms, diabetes or bacterial infections and the possibility of
sexual abuse as the source of vaginal infection may need to be investigated.

Vaginal discharge and other symptoms

There are other common conditions that produce similar symptoms to VVC eg
bacterial vaginosis, trichomoniasis and contact dermatitis.

Typical symptoms of thrush include:

•   Thick, white cottage cheese like discharge
•   Itching/irritation of the vagina and vulva
•   Burning/pain on passing urine if the infection is severe

Typical symptoms of Bacterial Vaginosis (Gardnerella):

•   Thin, grey-white to yellow discharge
•   Discharge has a musty, fishy odour


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© Pharmacy Guild of New Zealand (Inc) 2006
Typical symptoms of Trichomoniasis:

(Some women do not have any symptoms at all but where symptoms are
present they may include)
• Green frothy discharge
• Painful urination

The presence of sores, blisters or ulcers is not generally associated with thrush
and may be a sign of genital herpes.

Symptoms such as back or lower abdominal pain, fever, abnormal or irregular
menstrual bleeding, blood stained discharge or painful urination are not typical
of candida infection and the patient should be referred to her GP.

Keep in mind the possibility of STIs, especially if the patient has a history of STIs
or could have been exposed to a partner with an STI.
                                                     42
Risk factors for the presence of STIs include

•    Age under 25 years
•    No condom use
•    Change of sexual partner in the past three months
•    Frequent change of sexual partner or multiple contacts
•    Symptoms in partner – eg painful urination
•    Previous STI
•    Symptoms suggest complications of an STI

Should male sexual partners be treated?

Unlike the vagina, the skin of the penis does not provide ideal conditions for the
growth of candida. Current thinking on whether male sexual partners of women
who suffer from recurrent bouts of thrush should be routinely treated supports
only treating the male partner if he is experiencing symptoms such as local
itching or skin irritation of the penis. 43,44

Pregnant?

Vaginal thrush is common during pregnancy. Hormonal changes during
pregnancy increase the amount of glycogen in the vagina which encourages the
proliferation of candida.

Counselling pregnant women on OTC treatment for thrush

There is some debate over whether a pregnant woman with symptoms of vaginal
thrush should be referred to her doctor for confirmation of diagnosis or whether
pharmacists should go ahead and sell an OTC treatment. Essentially it is up to
the pharmacist’s professional judgement, taking into consideration:
   a) the patient’s history, specific clinical circumstances and evidence to
      support safety and efficacy of the product in pregnancy;

42
   Mitchell H. Vaginal Discharge, causes, diagnosis and treatment. ABC of Sexually
Transmitted Infections. BMJ 29 May 2004;328:1306-1308
43
   Sparrow M. Vaginal thrush and its association with the male partner. New Zealand
Pharmacy July 1997: 31-34
44
   Ringdahl E. Treatment of recurrent vulvovaginal candidiasis. American Family
Physician. June 2000
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© Pharmacy Guild of New Zealand (Inc) 2006
     b) the patient’s agreement to accept the pharmacist’s recommendation after
        receiving adequate information on risk v benefit.

Keep the following points in mind when deciding on your course of action:
   • If this is the first time the woman has experienced symptoms typical of
      vaginal thrush, she should be referred to her doctor (this applies to non-
      pregnant women also).
   • While systemic absorption from vaginal application of imidazole
      antifungals is relatively low, the data sheets for the topical vaginal
      products carry a precaution that these products should be used in the first
      trimester of pregnancy only under the supervision of a medical
      practitioner and when the physician considers its use essential to the
      welfare of the patient.45,46
   • Gestational diabetes may predispose a pregnant woman to vaginal thrush.
   • If the woman has a previous history of STIs or is at risk of STIs then
      referral to confirm diagnosis is advisable as STIs that remain untreated
      can cause birth defects, pre-term birth, low birth weight or be passed on
      the to the infant at birth.

It should be noted that the Diflucan datasheet and consumer medicines
information (CMI) recommend that a pregnant woman should consult her doctor
before taking Diflucan.

Safety of imidazole and triazole antifungal products during pregnancy

Note that the use of applicator administered creams or pessaries is not
recommended during pregnancy.

Topical Imidazoles

The Australian Drug Evaluation Committee classifications of these medicines for
use during pregnancy are
   - Clotrimazole, econazole and miconazole — Category A
      Drugs that have been taken by a large number of pregnant women and
      women of childbearing age without any proven increase in the frequency
      of malformations

Oral Fluconazole

When the New Zealand Medicines Classification Committee considered the safety
of fluconazole in pregnancy they concluded that the risks associated with a
single 150mg dose would be minimal.47 This view is supported by the Australian
Drug Evaluation Committee. The ADEC provides the following guidance:

‘Single dose therapy (150mg) does not appear to cause adverse pregnancy
effects. Repeated doses of fluconazole (400-800mg daily) have been
associated with a consistent pattern of birth defects similar to those seen in
animal studies.’ 48


45
   Data sheet. Pevaryl Pessaries. November 2003
46
   Data sheet. Clotrimaderm Vaginal Cream. April 1998
47
   Minutes of the 31st meeting of the Medicines Classification Committee.
48
   Australian Drug Evaluation Committee. Prescribing Medicines in Pregnancy. 4th Edition.
1999:30
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© Pharmacy Guild of New Zealand (Inc) 2006
The manufacturer of Diflucan recommends that pregnant women check with
their doctor before taking Diflucan.

Breastfeeding?

Oral fluconazole is excreted in breast milk so is not recommended in nursing
mothers.49

Intravaginal imidazole products are considered safe to use by women who are
breastfeeding. As systemic absorption of these products via the intravaginal
route is relatively low, secretion into breast milk is likely to be low. 50,51

Taking any medicines?

•     Creams containing local anaesthetic that are applied vaginally can sometimes
      cause a sensitivity reaction that resembles symptoms of thrush.
•     Broad-spectrum antibiotics are well known for causing vaginal thrush in
      susceptible women.

Interactions

Because fluconazole is an inhibitor of the cytochrome P450 system, particularly
the CYP2C and to a lesser extent the CYP3A isoforms, it can potentially affect the
metabolism of other drugs. While interactions are unlikely to be clinically
significant with single doses of fluconazole, monitoring may be advisable in some
situations. 50

While clinical drug interactions with single dose fluconazole are unlikely, the
following drugs either have the potential to or have been documented as
interacting with fluconazole (with repeated or high doses): Cisapride;
terfenadine; astemizole; midazolam; phenytoin; theophylline; sulphonylureas;
warfarin; rifabutin; zidovudine; cyclosporine; tacrolimus.
                                                            50
The use of fluconazole with cisapride is contraindicated.

Effect of antifungal formulations on condoms and diaphragms

Vegetable and mineral oils in the bases of antifungal creams or pessaries may
damage the latex rubber of condoms and diaphragms thereby reducing their
contraceptive efficacy.

Allergies to medicines?

The use of oral fluconazole is contraindicated in people who have had a previous
allergic reaction to any azole antifungal formulation.

Although systemic absorption from vaginal imidazoles is only 3 to 10% this could
be enough to cause a reaction in people sensitive to azole compounds. Therefore
the use of topical azoles should be avoided in people who have had an allergic
response to the oral formulations.


49
     Data sheet. Diflucan May 2004
50
     Data sheet. Gyno Pevaryl. May 1999
51
     Data sheet. Clocreme. January 1999
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© Pharmacy Guild of New Zealand (Inc) 2006
Side effects

Fluconazole oral
Common side effects: headache; nausea; abdominal pain; dyspepsia; diarrhoea.

Symptoms of allergic reaction include: swelling of the face, lips or tongue;
breathing difficulties; severe skin rash/itching; fast or irregular heartbeat.

Treatment choice

Topical nystatin requires a longer treatment period (two weeks) than topical
azoles; however it can be useful in women who have failed to respond to azole
antifungals.

Oral v topical treatment

A Cochrane review of 17 randomised controlled trials reporting 19 oral versus
intra-vaginal antifungals showed that both dosage forms are equally effective
when observed at short-term or long-term follow up.52

Factors to consider when recommending a suitable treatment include efficacy of
course, but also safety, cost and patient preference.

The convenience of a single dose oral product is a factor that is likely to
influence patient preference.




52
   Watson MC, Grimshaw JM, Bond CM, Mollison J, Ludbrook A. Oral versus intra-vaginal
imidazole and triazole antifungal treatment of uncomplicated vulvovaginal candidiasis
(thrush). Cochrane Review. The Cochrane Library, Issue 2, 2004
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© Pharmacy Guild of New Zealand (Inc) 2006
                                              WARTS
                                             Podophyllin


Warts and varrucae are caused by Human Papilloma Viruses (HPV). There are
over 60 types of HPV and a variety of different presentations.

Warts are more common in children and teenagers than in adults and are spread
by direct contact or self infection (auto-inoculation). If a wart is picked or
scratched viral particles can be spread to other areas.

Types of warts

Common warts            Seen on the fingers, backs of hands, around the nails and on
                        the legs. Usually have a rough ‘cauliflower like’ surface. Can
                        occur at the site of a scratch or injury.
Plantar warts           Located on the soles of the feet. The pressure of walking on
                        them flattens them and pushes them into the skin. Can be
                        painful. When plantar warts grow in clusters they are known
                        as mosaic warts. There may be pinpoint black dots visible
                        (clotted blood vessels).
Flat warts              Small smooth growths that appear in groups, most often on
                        the face.
Anogenital warts        Occur in the anogenital region including the mucosal surface
                        of the vagina, anus or urethra. Often transmitted sexually.
Filoform warts          Long narrow thin growths that commonly appear on the
                        eyelids face or neck.
(Ref sources53,54)

Who has the wart?

Warts on children and teenagers often disappear without treatment. In adults
warts are less likely to disappear spontaneously. Treatments containing
Podophyllin should not be used in young children.55,56

Has the wart changed in appearance?

Skin cancers are sometimes mistaken for warts so ask about the history of the
wart particularly any change in appearance ie shape, size, colour and if there
has been any bleeding.

How long has the wart been there?

Around 65% of warts disappear without treatment within two years.




53
     Dept of Dermatology, St Vincent’s Hospital. Dermatology within the Pharmacy. 1998
54
     NZ Dermatological Society Website, Dermnet. www.dermnet.org.nz
55
     Martindale. The Complete Drug Reference. Micromedex via www.pgnz.org.nz
56
     Data Sheet. Posafilin. New Ethicals Compendium. 8th Edition 2004
                                                                                         37
© Pharmacy Guild of New Zealand (Inc) 2006
Location?

Refer
• Warts on the face as self treatment may lead to scarring.
• Warts in the anogenital region require medical referral for examination,
   diagnosis and treatment.
• Warts covering a large area or multiple warts.
• Any wart-like lesion that changes colour or size.

Other health problems?

•     Diabetes – patients with diabetes should not attempt self treatment as it
      often results in damage to surrounding skin. A patient with peripheral
      neuropathy may not feel skin damage and poor circulation may be associated
      with delayed healing and a greater risk of infection.
•     Immunosuppression - patients should not attempt self treatment, as
      healing may be impaired.

Pregnant or breastfeeding?

Wart treatments containing podophyllin should not be used by women who are
pregnant or considering pregnancy. Cases of congenital malformations following
the topical use of podophyllin during pregnancy have been reported.57

Podophyllin paints and ointments should not be used during breastfeeding.56

Action already taken?

Refer if self treatment for three months or more has been unsuccessful.

Applying podophyllin

Podophyllin is very irritant to the skin so protection of the surrounding healthy
skin is important. Vaseline or zinc ointment applied to the skin around the wart
can be used with podophyllin paint but zinc oxide plaster with a hole cut in it is
recommended if podophyllin ointment is being used.

      •   Soften the wart in a bath or bowl of hot soapy water. Remove any hard
          skin from the surface of the wart using a pumice stone or emery board.
      •   Protect the surrounding skin by applying Vaseline or zinc oxide plaster.
          Apply the podophyllin product directly to the wart.
      •   Do not apply to healthy skin.
      •   Do not apply to broken skin.
      •   If treatment makes the area sore, stop treatment until discomfort settles
          then try again.
      •   Repeat the treatment daily if using paint or every 2-3 days if using
          ointment, removing dead skin between applications.

To treat or not to treat?

Warts may regress spontaneously and non-treatment is an option especially in
children. Treatment does however stop the spread to other sites. Non-treatment


57
     Briggs G, Freeman R, Yaffe S. Drugs in Pregnancy and Lactation. 5th Edition. 1998
                                                                                         38
© Pharmacy Guild of New Zealand (Inc) 2006
is not recommended for patients with large, rapidly multiplying or painful warts
or warts that have been present for more than two years.

Only a small number of warts should be treated at any one time due to the risk
of systemic toxicity. 56




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© Pharmacy Guild of New Zealand (Inc) 2006
                                             APPENDIX



 Australian Categorisation of Drugs for use in Pregnancy
Australian Drug Evaluation Committee. Prescribing Medicines in Pregnancy. 4th Edition.
1999.


A: Drugs which have been taken by a large number of pregnant women and
women of childbearing age without any proven increase in the frequency of
malformations or other direct or indirect harmful effects on the foetus having
been observed.

B1: Drugs which have been taken by only a limited number of pregnant women
and women of childbearing age without an increase in the frequency of
malformation or other direct or indirect harmful effects on the human foetus
having been observed. Studies in animals have not shown evidence of an
increased occurrence of foetal damage.

B2: Drugs which have been taken by only a limited number of pregnant women
and women of childbearing age without an increase in the frequency of
malformations or other direct or indirect harmful effects on the human foetus
having been observed. Studies in animals are inadequate or may be lacking, but
available data show no evidence of an increased occurrence of foetal damage.

B3: Drugs which have been taken by only a limited number of pregnant women
and women of childbearing age without an increase in the frequency of
malformations or other direct or indirect harmful effects on the human foetus
having been observed. Studies in animals have shown evidence of an increased
occurrence of foetal damage, the significance of which is considered uncertain in
humans.

C: Drugs which, owing to their pharmacological effects, have caused or may be
suspected of causing harmful effects on the human foetus or neonate without
causing malformations. These effects may be reversible.

D: Drugs which have caused, are suspected to have caused or may be expected
to cause, an increased incidence of foetal malformations or irreversible damage.
These drugs may also have adverse pharmacological effects.

X: Drugs which have such a high risk of causing permanent damage to the
foetus that they should not be used in pregnancy or when there is a possibility of
pregnancy.




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© Pharmacy Guild of New Zealand (Inc) 2006

				
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