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

Logo PHENSEDYL COUGH LINCTUS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PHENSEDYL COUGH LINCTUS

COMPOSITION:
Each 5 mL contains the following:
Promethazine Hydrochloride         3,6 mg
Codeine Phosphate         9,0 mg
Ephedrine Hydrochloride         7,2 mg

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussive and Expectorants.

INDICATIONS:
Alleviation of cough.

CONTRA-INDICATIONS:
This product should not be used in children under 2 years of age because the safety of such use has not been established.
Safety in pregnancy and lactation has not been established. Contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. Should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease. It is also contra-indicated in the presence of acute alcoholism, head injuries, and conditions in which intracranial pressure is raised.
Contra-indicated in patients taking mono-amine oxidase inhibitors or within 14 days of stopping such treatment.

WARNINGS:
The use of 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 against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 5 to 10 mL three times a day.
Children: 2 - 5 years: 2,5 mL (a half medicine measureful) two to three times a day.
5 - 10 years: 2,5 mL (a half medicine measureful) to 5 mL (one medicine measureful) two to three times a day.
Over 10 years: 5 mL (one medicine measureful) to 10 mL (two medicine measurefuls) two to three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Promethazine hydrochloride:
The most common side-effect of promethazine is sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness and inco-ordination. Sedative effects, when they occur, may diminish after a few days of treatment.
Paradoxical CNS stimulation may occur especially in children, with insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations, and convulsions. In high doses, CNS stimulation may be attributed to antimuscarinic activity. Extrapyramidal symptoms may develop.
Other adverse effects include dry mouth, thickened respiratory tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, a reduction in tone and motility of the gastro-intestinal tract resulting in constipation and increased gastric reflux; at high doses, transient bradycardia followed by tachycardia with palpitations and arrhythmias; also at high doses, CNS stimulation. In addition, constipation and gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or epigastric pain have occurred. Anorexia has been observed with some antihistamines.
Systemic or topical therapy with antihistamines may produce hypersensitivity reactions, particularly of the skin, and cross-sensitivity to related drugs may occur. Photosensitivity has been reported. Blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia, and thrombocytopenia, have been reported; these may have an immune basis.
Other adverse effects that have been reported with antihistamines include hypotension, tinnitus, headache and paraesthesias.
Jaundice has been reported and extrapyramidal effects may occur at high doses.
Codeine Phosphate:
The most common side-effects of codeine phosphate are nausea, vomiting, constipation, drowsiness and confusion; tolerance generally develops with long-term use, but not to constipation. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Dry mouth sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, hallucinations, and miosis may also occur.
These effects tend to occur more commonly in ambulant patients than in those at rest in bed and in those without severe pain. Raised intracranial pressure occurs in some patients. Muscle rigidity has been reported following high doses. The euphoric activity of codeine and similar compounds has led to their abuse.
Larger doses produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur, especially in infants and children. Excitement may occur
Ephedrine Hydrochloride:
Central effects of ephedrine include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, and psychotic states. Appetite may be reduced and nausea and vomiting may occur.
Effects on the cardiovascular system are complex. Stimulation of the alpha-adrenergic receptors produces vasoconstriction with resultant hypertension. The rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of beta
1-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest; hypotension with dizziness and fainting, and flushing, may occur.
Other effects that may occur with ephedrine include difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism, sweating, and hypersalivation. Headache is also common.
Precautions:
False negative and positive results have been reported with some pregnancy tests.
Elderly patients are also more susceptible to many adverse effects of promethazine, including antimuscarinic effects, sedation, and hypotension.
Promethazine should be used with care in conditions such as closed-angle glaucoma, urinary retention, prostatic hypertrophy, or pyloroduodenal obstruction.
Other adverse effects of promethazine suggest caution in patients with epilepsy, severe cardiovascular disorders, or in those with liver disorders. Promethazine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and neuroleptics. MAOIs may enhance the antimuscarinic effects of promethazine and promethazine has an additive antimuscarinic action with other antimuscarinic agents, such as atropine and tricyclic antidepressants. It has been suggested that promethazine could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics.
Promethazine may suppress positive skin test results and should be stopped several days before the test.
Codeine phosphate should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock, or inflammatory or obstructive bowel disorders. It should be used with caution in patients with myasthenia gravis.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants, and phenothiazines.
In patients with prostatic enlargement, ephedrine may increase difficulty with micturition.
Ephedrine should be used with caution in patients who may be particularly susceptible to its effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms. Anginal pain may be precipitated in patients with angina pectoris.
Care is also required when ephedrine is given to patients with diabetes mellitus or closed angle glaucoma.
Ephedrine may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy. Interactions of ephedrine with alpha- and beta-blocking drugs may be complex.
An increased risk of arrhythmias may occur if ephedrine is given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Ephedrine should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as it may cause ventricular fibrillation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See "Side-effects and Special Precautions" above. Treatment is symptomatic and supportive.

IDENTIFICATION:
An orange-brown coloured liquid, with a characteristic odour, mainly of chloroform and banana.

PRESENTATION:
Bottles of 100 mL

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
Keep out of reach of children.

REFERENCE NUMBER:
G603 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Aventis Pharma (Pty) Ltd
2 Bond Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1974

        PL2-A0001
        Britepak

New addition to this site: May 2004
Source: Community Pharmacy

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