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Logo ACUGEST DM SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACUGEST DM SYRUP

COMPOSITION:
Each 5 mL contains:
Triprolidine hydrochloride 1,25 mg
Pseudoephedrine hydrochloride 30,00 mg
Dextromethorphan HBr 10,00 mg
Ethyl Alcohol 9,6% v/v
Preserved with:
Methyl hydroxybenzoate 0,12% m/v
Propyl hydroxybenzoate 0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants

PHARMACOLOGICAL ACTION:
ACUGEST DM
has cough suppressant properties.

INDICATIONS:
ACUGEST DM
is indicated for alleviation of cough.

CONTRA-INDICATIONS:
ACUGEST DM
should not be administered to patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, thyrotoxicosis, bladder dysfunction, narrow angle glaucoma and phaeochromocytoma.
Patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment, ephedrine and other sympathomimetic agents as a hypertensive response may result.
Patients who have previously exhibited intolerance to it or any of its constituents. Safety in pregnancy and lactation has not been established.
Contra-indicated in asthmatic patients during an attack of asthma.

WARNINGS:
ACUGEST DM
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 not drive, climb dangerous heights or operate machinery as impaired decision-making could lead to accidents.
Do not use this product without consulting a doctor or pharmacist if you are presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or hypertension.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years 10 mL
Children 6 to 12 years: 5 mL
Children 2 to 5 years: 2,5 mL
Should be given three times daily.
Children 6 months to 2 years: 1,25 mL three times daily on advice of a physician only.
The dosage must not be exceeded.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sedation or insomnia may occur.
Side-effects attributed to dextromethorphan are nausea, vomiting, drowsiness, excitation, mental confusion, dizziness and gastro-intestinal disturbance.
Fixed drug eruption due to pseudoephedrine HCl, taking the form of erythematous nummular patches, and lichenoid skin eruption due to triprolidine have been reported.
Pseudoephedrine may give rise to side-effects such as giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia.
Pseudoephedrine may cause hypertension resulting in intracranial haemorrhage.
Pseudoephedrine should be given with caution to patients with organic heart disease, cardiac decompensation, or angina of effort and in patients receiving digitalis.
In patients with prostatic enlargement, it may increase difficulty with micturition. Other side-effects of pseudoephedrine include agitation, anginal pain, especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrhythmias, cardiac arrest, confusion, dizziness, dyspnoea, fainting, fear, flushing, disturbance of glucose metabolism, irritability, miosis, dry mouth, psychotic states, tachycardia, vaso-constriction which may result in hypertension, cerebral haemorrhage and pulmonary oedema and weakness.
ACUGEST DM should be used with caution in patients with diabetes mellitus, and with occlusive vascular disorders (arteriosclerosis). Use carefully in elderly and debilitated patients.
Triprolidine can cause sedation varying from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, colic, and epigastric pain, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness, and weakness of the hands. Symptoms of cerebral stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Large doses may precipitate fits in epileptics. Allergy, anaphylaxis and dermatological reactions may occur. Blood dyscrasias, including agranulocytosis and haemolytic anaemia have been reported.
Other side-effects include deepening coma, extrapyramidal effects, leucopenia, and photosensitisation of the skin.
ACUGEST DM should be used with caution in patients with cardiovascular disease, glaucoma, liver impairment, prostatic hypertrophy and urinary retention. Elderly patients are more susceptible to the central nervous system depressant and hypnotic effects and the positive results of skin tests may be suppressed.
Antitussive agents should not be administered to patients with productive coughs. Dextromethorphan should not be given to patients in, or at risk of developing respiratory failure.
INTERACTIONS:
Pseudoephedrine should be used with caution in patients receiving chloroform, cyclopropane, halothane, or other halogenated anaesthetics. The effects of pseudoephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may also diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients.
Triprolidine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives, and tranquillisers. The effects of anticholinergic drugs, such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of triprolidine. Triprolidine may affect the metabolism of drugs in the liver. Concomitant use of ACUGEST DM with sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants, or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines, may cause a rise in blood pressure largely because of interaction with pseudoephedrine.
Because of its pseudoephedrine content, ACUGEST DM may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and beta-adrenergic blocking agents.
Monoamine oxidase inhibitors may enhance the anticholinergic effects. The warning signs of damage caused by ototoxic agents may be masked.
Do not give together with quinidine.
Do not give together with tricyclic antidepressant agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms may include drowsiness, weakness, inco-ordination, difficulty with micturition, respiratory depression, irritability, convulsions, hypertension, palpitations and gastro-intestinal disturbances.
Treatment is supportive and symptomatic.
Triprolidine intoxication may lead to ataxia, death from respiratory failure and respiratory collapse. Overdosage may be fatal, especially in infants and children in whom main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Respiratory depression can be treated with naloxone. Treatment is supportive and symptomatic.

IDENTIFICATION:
Clear red syrup with strawberry flavour.

PRESENTATION:
Amber glass bottles containing 100 mL, and 200 mL.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/10.1/4

NAME AND BUSINESS ADDRESS OF APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Apotex SA (Pty) Ltd.
C/o Watt and Fleming Streets
Meadowdale Ext. 1

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 May 1991
        PX4/3

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