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

Logo ACUGEST CO LINCTUS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACUGEST CO LINCTUS

COMPOSITION:
Each 5 mL contains:

Triprolidine Hydrochloride 1,25 mg
Pseudoephedrine Hydrochloride 30 mg
Codeine Phosphate 10 mg
Preservatives:
Methyl Hydroxybenzoate 0,12% m/v
Propyl Hydroxybenzoate 0,02% m/v
PHARMACOLOGICAL CLASSIFICATION:
A10.1 Antitussives and expectorants

INDICATIONS:
For the alleviation of cough.

CONTRA-INDICATIONS:
Persons who have previously exhibited intolerance to this product or to any of its constituents. Patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, prostatism, 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. Acute alcoholism, during an acute attack of bronchial asthma, in patients with head injuries or where the intracranial pressure is raised, in heart failure secondary to chronic lung disease and in cases of respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. Safety in pregnancy and lactation has not been established.

WARNINGS:
ACUGEST CO LINCTUS 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 and impaired mental alertness 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, psyhiatric or emotional conditions or hypertension.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years 5 to 10 mL
Children 6 to 12 years 5 mL
Children 2 to 5 years 2,5 mL
May be given three times a day.
Children 1 to 2 years 1,25 mL
three times daily on advice of a physician only.
Children under 1 year: not recommended.
Shake the bottle before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Fixed drug eruption due to pseudoephedrine, 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 patient 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.
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. In infants and children it may act as a cerebral stimulant.
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 include circulatory failure, muscle rigidity, pruritis, respiratory depression, urticaria and an antidiuretic effect.
The following side-effects may also occur: loss of appetite, reflex bradycardia, cardiac arrhythmias, cardiac arrest, confusion, dizziness, dyspnoea, fainting, fear, agitation, flushing, disturbance of glucose metabolism, irritability, miosis, dry mouth, psychotic states and weakness. 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. Prolonged use of high doses of codeine has produced dependance.
ACUGEST CO LINCTUS should be used with caution in patients with diabetes mellitus, occlusive vascular disorders (arteriosclerosis), aneurisms, myasthenia gravis and impaired renal function. ACUGEST CO LINCTUS should be used carefully in elderly and debilitated patients. Do not give together with cardiac glycosides. Do not give together with quinidine. Do not give together with tricyclic antidepressant agents.
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 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.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines. Concomitant use of ACUGEST CO LINCTUS 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 CO LINCTUS may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and beta adrenergic blocking agents.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
The effects of acute toxicity from ACUGEST CO LINCTUS may include drowsiness, weakness, inco-ordination, difficulty with micturition, respiratory depression, hypotension, agitation, irritability, convulsions, hypertension, palpitations, tachycardia and miosis. Pseudoephedrine may cause paranoid psychosis. Treatment is supportive and symptomatic.

IDENTIFICATION:
Clear red syrup with strawberry flavour.

PRESENTATION:
Amber glass bottles containing 50 mL, 100 mL, 200 mL and 500 mL.

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

REGISTRATION NUMBER:
X/10.1/2

NAME AND BUSINESS ADDRESS OF APPLICANT:
ACUPHARM (Pty) Ltd.
43 Richards Drive
Halfway House
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1991ACP 015
94H0994
Highland Print

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