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

Logo BENYLIN BRONCHOSPECT (Solution)
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BENYLIN BRONCHOSPECT (Solution)

COMPOSITION:
Each 5 mL contains:
Terbutaline sulphate         1,5 mg
Guaifenesin         66,5 mg
Preservative: Sodium benzoate         0,3% m/v

PHARMACOLOGICAL CLASSIFICATION:
A: 10.1 Antitussives and Expectorants.

PHARMACOLOGICAL ACTION:
Benylin Bronchospect is an expectorant cough mixture with selective bronchodilatory action.

INDICATIONS:
For symptomatic relief of cough associated with bronchospasm in children.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Patients with acute porphyria. Patients already on any other asthma preparation.
Benylin Bronchospect should not be given to patients receiving monoamine oxidase inhibitors or within fourteen days of stopping such treatment.
Safety in pregnancy and lactation has not been established.

WARNING:
If there is no improvement within 12-24 hours, a doctor must be consulted immediately.

DOSAGE AND DIRECTIONS FOR USE:
Children: 3 –6 years: 2,5 mL –5 mL (a half to one medicine measure) three times daily.
  7 years and older: 5 mL –10 mL (one to two medicine measures) three times daily.
Consult your doctor if there is no improvement at the recommended dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Terbutaline sulphate:
Central nervous system
Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, and psychotic states. Appetite may be reduced.
Nausea and vomiting may occur.
Cardiovascular
These are complex and usually include vasoconstriction with resultant hypertension or gangrene.
Cerebral haemorrhage and pulmonary oedema.
Stimulation of beta1-adrenergic receptors of the heart may produce tachycardia, cardiac arrhythmias, anginal pain, palpitations, cardiac arrest.
Stimulation of beta2-adrenergic receptors may produce hypotension with dizziness and fainting, and flushing. Hypokalaemia may occur.
Other effects
Difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism including changes in blood sugar concentrations, sweating, and hypersalivation. Headache is common.
Guaifenesin:
Gastro-intestinal discomfort has been reported. Very large doses cause nausea and vomiting.
Special precautions:
Benylin Bronchospect should be used with caution when an increased susceptibility to beta2-adrenergic stimulation can be expected, for instance, in patients with hyperthyroidism, ischaemic heart disease, arrhythmia and tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, aneurysms, or closed-angle glaucoma. Anginal pain may be precipitated in patients with angina pectoris. Caution should be exercised in patients who have recently suffered heart attacks and in patients with uncontrolled diabetes mellitus.
Terbutaline sulphate may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy.
Benylin Bronchospect should be used with caution in patients receiving other sympathomimetics.
Interactions:
Interactions of sympathomimetics with alpha- and beta-blocking agents may be complex.
Concurrent use of non-selective beta-blocking agents such as propranolol, may partially or totally inhibit the beta-stimulating effect of Benylin Bronchospect. Such products are, however, not recommended in asthma as they may precipitate bronchospasm.
Concurrent use with other bronchodilators (theophylline, catecholamine) can intensify the anti-obstructive effect of Benylin Bronchospect. An intensification or increase in side-effects (e.g. tachycardia) must also be expected.
An increased risk of arrhythmias may occur if Benylin Bronchospect is given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants.
The glucose-lowering effect of diabetic agents may decrease with concurrent use of Benylin Bronchospect. A dose adjustment of the diabetic agents may be necessary.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Very large doses of guaifenesin cause nausea and vomiting. Large doses of terbutaline will cause tachycardia, palpitations, arrythmias, restlessness, anxiety, muscle cramps, and pronounced tremor. Gastrointestinal complications, including nausea and vomiting may occur. A fall in blood pressure sometimes occur.
Treatment
Symptomatic and supportive. Gastric lavage may be used. A beta2-antagonist may be given to reduce the effects of terbutaline, but should be given with care because of the possibility of inducing bronchoconstriction and may not be given to asthmatics.

IDENTIFICATION:
A clear, colourless solution with a butter-toffee/menthol taste and odour.

PRESENTATION:
Amber glass bottles of 200 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
31/10.1/0487

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, Division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road,
Retreat
7945
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 August 2000

        Revised: DRAFTJUL02;OCT00;SEP99;AUG96

Updated on this site: February 2005
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005