INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DIMETAPP® PAEDIATRIC ELIXIR

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

DIMETAPP® PAEDIATRIC ELIXIR

COMPOSITION:
Each 5 mL contains:
       
Brompheniramine Maleate        1,00 mg
       
Phenylephrine Hydrochloride        2,50 mg
       
Phenylpropanolamine Hydrochloride        2,50 mg
        Alcohol        2,5 % v/v

Preservative:
        Sodium Benzoate        0,1 % m/v

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the common cold, including nasal decongestants and antihistamines.

PHARMACOLOGICAL ACTION:
The combination has antihistaminic and sympathomimetic properties.

INDICATIONS:
For the relief of symptoms associated with colds and influenza such as nasal congestion and sniffing.

CONTRA-INDICATIONS:
Dimetapp Paediatric Elixir is contra-indicated in patients sensitive to any of the ingredients and in infants or neonates. It should not be given to patients whose sensitivity to small doses of sympathomimetic substances is manifested by sleeplessness, dizziness, light headaches, weakness, tremulousness or cardiac arrhythmia. It should not be given concomitantly with any mono-amine-oxidase inhibitor, or within 14 days of stopping such treatment. Contra-indicated in most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed-angle glaucoma.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Children:
        6 - 12 years:        5 - 10 mL three to four times daily.
        2 - 5 years:        5 mL three to four times daily.
        6 months - 2 years:        2,5 mL three times daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Brompheniramine maleate may cause sedation, lassitude, dizziness and inco-ordination. Paradoxical central nervous system stimulation may occur, especially in children, with insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations and convulsions. Antimuscarinic effects include dry mouth, thickened respiratory-track secretions and tightness of the chest, blurred vision, urinary difficulty and retention, and reduction in tone and motility of the gastro-intestinal tract resulting in constipation and increased gastric reflux.

Other gastro-intestinal disturbances include nausea, vomiting, diarrhoea and epigastric pain. Hypersensitivity reactions and cross-sensitivity to related medicines may occur as well as side-effects such as hypotension, tinnitus, headache and paraesthesias. Blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia have been reported.

Brompheniramine maleate should be used with care in conditions such as closed-angle glaucoma, urinary retention, prostatic hypertrophy, pyloroduodenal obstruction, epilepsy and severe cardiovascular disorders.

Interactions:
Brompheniramine maleate may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and neuroleptics and it may have an additive antimuscarinic action with other antimuscarinic medicines, such as atropine and tricyclic antidepressants. MAOIs may enhance the antimuscarinic effects of brompheniramine maleate.

It has been suggested that antihistamines could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics and it may suppress positive skin test result and should be stopped several days before the test.

Phenylpropanolamine and phenylephrine may cause giddiness, headache, nausea, vomiting, reduced appetite, sweating, thirst, hypersalivation, tachycardia, precordial pain, palpitations, difficulty in micturition, urinary retention, muscular weakness and tremors, anxiety, fear, confusion, psycotic states, restlessness and insomnia. Hypertension and ventricular arrhythmias may occur. In patients with prostatic enlargement it may cause difficulty in micturition.

Phenylpropanolamine and phenylephrine should be given with caution to patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics. The effect of phenylpropanolamine and phenylephrine is diminished by guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may diminish the effect of guanethidine and may increase the possibility of arrhythmias in digitalised patients.

Prolonged use may lead to rebound congestion.

Use with caution in patients with diabetes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage with brompheniramine maleate may be fatal especially in infants and children in whom the main symptoms are central nervous stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults the usual symptoms are central nervous depression with drowsiness, coma and convulsions. Hypotension may also occur.

Symptoms of overdosage with phenylpropanolamine and phenylephrine may include rapid pulse and respiration, disorientation, elevated blood pressure, tachycardia, mydriasis, headache, excitation of the central nervous system, nausea, vomiting and anorexia. Treatment is essentially symptomatic and supportive. Immediate depletion of the stomach should be induced through emesis and gastric lavage.

IDENTIFICATION:
Pale red-brown coloured liquid with odour and flavour of grapes.

PRESENTATION:
Bottles of 100 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store below 25 °C.
Keep away from direct sunlight.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
P/5.8/239

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 September 1983

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