ACUTUSSIVE EXPECT ADULT

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACUTUSSIVE EXPECT ADULT

COMPOSITION:
Per 5 mL

	Triprolidine hydrochloride	1,25 mg
	Pseudoephedrine hydrochloride	20 mg
	Guaiphenesin	100 mg
	Codeine phosphate	7,5 mg

Preserved with:

	Methyl hydroxybenzoate	0,12% m/v
	Propyl hydroxybenzoate	0,02% m/v
	Contains Alcohol	6,7% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants.

INDICATIONS:
For the alleviation of cough.

CONTRA-INDICATIONS:
ACUTUSSIVE EXPECT ADULT should not be administered to patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, thyrotoxicosis, prostatism, bladder dysfunction, narrow angle glaucoma, and phaeochromocytoma.
Persons who have previously exhibited intolerance to it or to any of its constituents.
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.
Acute alcoholism, during the acute attack of bronchial asthma, head injuries and where the intracranial pressure is raised. Heart failure secondary to chronic lung disease. Respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion.

WARNINGS:
The use of ACUTUSSIVE EXPECT ADULT may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be warned against taking charge of vehicles, or operating machinery where loss of concentration may lead to accidents.
The safety of ACUTUSSIVE EXPECT ADULT during pregnancy and lactation has not been established.
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: 5 to 10 mL three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pseudoephedrine may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, pre-cordial pain, palpitation, difficulty with micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Hypertension and ventricular arrhythmias may occur. Pseudoephedrine HCl should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort. In patients with prostatic enlargement, it may cause difficulty with micturition. Other side-effects of pseudoephedrine include agitation, loss of appetite, reflex bradycardia cardiac arrest, contusion dizziness dyspnoea, fainting, fear, blushing, disturbance of glucose metabolism, irritability, dry mouth, psychotic states, vasoconstriction which may result in hypertension, cerebral haemorrhage and pulmonary oedema, and weakness. Fixed drug eruption due to pseudoephedrine HCl, taking the form of erythematous nummular patches has been reported.

ACUTUSSIVE EXPECT ADULT should be used with caution in patients with aneurisms, cardiac arrhythmias (e.g. tachycardia), diabetes mellitus and occlusive vascular disorders (arteriosclerosis). It should be used carefully in elderly and debilitated patients. Tolerance may develop when given to asthmatics for their asthmatic effects.

The most common side-effects of triprolidine HCl are sedation varying from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation and epigastric pain. Headache, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty with micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands may occur. Large doses may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Blood dyscrasias, including agranulocytosis and haemolytic anaemia may occur. The effects of atropine and tricyclic antidepressants may be enhanced by triprolidine HCl. Triprolidine HCl may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of drugs in the liver. Lichenoid skin eruption due to triprolidine HCl has been reported.

Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitation, orthostatic hypotension, hyperthermia, restlessness, changes of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Other side-effects of codeine include antidiuretic effects, circulatory failure, deepening coma, confusion, drowsiness, euphoria, hypotension, muscle rigidity, pruritus, respiratory depression and urticaria. Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients. Codeine should be used with caution in patients with myasthenia gravis and impaired kidney function. Prolonged use of high doses of codeine has produced dependence.

Guaiphenesin may cause gastro-intestinal discomfort and may cause nausea and vomiting. it may interfere with diagnostic measurements of 5-hydroxy-indoleacetic acid and vanillylmandelic acid.

INTERACTIONS:
ACUTUSSIVE EXPECT ADULT should be used with caution in patients taking other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psycho-stimulants, or antihypertensive agents, as this may cause a rise in blood pressure largely because of interaction with pseudoephedrine HCl. The effect of a single dose of ACUTUSSIVE EXPECT ADULT on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

The antibacterial agent, furazolidone is known to cause a dose related inhibition of monoamine oxidase. ACUTUSSIVE EXPECT ADULT and furazolidone should not be taken together.

The effect of ACUTUSSIVE EXPECT ADULT due to pseudoephedrine HCl, are diminished by guanethidine, reserpine, methyldopa and may be diminished by tricyclic antidepressants.

The effect of atropine and tricyclic depressants may be enhanced by triprolidine HCl. Triprolidine may enhance the central nervous system sedative effects of alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Triprolidine HCl may mask the warning symptoms of damage caused by ototoxic agents.

The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.

Long term use of anticonvulsants and oral steroid contraceptives cause an increase in the first pass metabolism or clearance rate and may prevent attainment of therapeutic levels.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
For symptoms of overdosage see side-effects.
Symptoms of pseudoephedrine HCl overdosage may include paranoid psychosis, delusions and hallucinations. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear orange-yellow syrup with menthol odour and taste.

PRESENTATION:
100 and 200 mL amber glass bottles.

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

REGISTRATION NUMBER:
X/10.1/10

NAME AND BUSINESS ADDRESS OF THE APPLICANT
ACUPHARM (PTY) LTD
43 Richards Drive
Halfway House
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15 July 1991
Davbar Dbn.