PHARMACOLOGICAL CLASSIFICATION: A.10.1 Antitussives and Expectorants
PHARMACOLOGICAL ACTION: Expectorant cough mixture with a selective bronchodilatory action.
INDICATIONS: Symptomatic relief of cough associated with bronchospasm in children.
CONTRA-INDICATIONS: Hepatic and renal disease.
Hypersensitivity to any of the active ingredients.
Patients already on any other asthma medicine.
WARNINGS: If there is no improvement within twelve to twenty four hours, a doctor must be consulted immediately.
DOSAGE AND DIRECTIONS FOR USE:
Children 3 - 6 years:
2,5 mL - 5 mL three times daily.
7 years and older:
5 mL - 10 mL three times daily.
Do not exceed the prescribed dosage.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The use of this medication may cause gastric irritation, nausea and vomiting, nervousness, muscle tremor, headache, tachycardia, palpitations, fainting and flushing. Hypokalaemia may occur. BRONCHOPED should be used with caution when an increased susceptibility to sympathomimetic amines can be expected, for instance, in patients with hyperthyroidism, diabetes mellitus, ischaemic heart disease, arrhythmia or tachycardia and hypertension.
Beta2-stimulants have an arrhythmogenic potential which must be considered in the treatment of the individual patient. Cardiac toxicity may occur, including ventricular arrythmias and possible fatalities, if used without due care or in overdose.
DRUG INTERACTIONS:- Non-selective beta-blocking agents may partly or totally inhibit the effect of beta-stimulants, and may therefore worsen the asthma or bronchospasm.
Beta-stimulants should not be given to patients receiving monamine oxidase inhibitors or within fourteen days of the termination thereof.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Large doses of ammonium chloride will cause gastric irritation, profound acidosis and hypokalaemia.
Large doses of terbutaline will cause headache, anxiety, tremor, muscle cramp, palpitations and arrhythmias. A fall in blood pressure sometimes occurs.
In cases of overdose, treatment is symptomatic and supportive. Gastric lavage may be used. A beta2-antagonist may be given to reduce the effects of terbutaline, but should be administered with care and may not be given to asthmatics.
IDENTIFICATION: Dark brown clear syrup with an aniseed odour.
PRESENTATION: Amber bottles of 100 mL and 200 mL.
STORAGE INSTRUCTIONS: Store below 25°C in a well-sealed container. Protect from light. Keep out of reach of children.
REGISTRATION NUMBER: 28/10.1/0206
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Adcock Ingram Limited
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 5 November 1993
New addition to this site: April 2004
Source: Pharmaceutical Industry