BRICANYL Tablet Ref.[7930] Active ingredients: Terbutaline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK

Therapeutic indications

For bronchodilation: Terbutaline is a selective beta2-adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and other bronchopulmonary disorders in which bronchospasm is a complicating factor.

Posology and method of administration

Posology

When used as maintenance therapy the patient should also receive optimal anti-inflammatory therapy, e.g. inhaled corticosteroids, leukotriene receptor antagonists.

Bricanyl Tablets have a duration of action of 7 to 8 hours. The minimum recommended dosage interval is therefore 7 hours.

Adults

During the first 1-2 weeks, 2.5mg (half a tablet) 3 times in a 24-hour period is recommended. The dose may then be increased to 5mg (1 tablet) 3 times in a 24-hour period to achieve adequate bronchodilation.

Elderly

Dosage as for Adults.

Paediatric population (7-15 years)

The starting dose should normally be 2.5mg (half a tablet) 2 times in 24 hours. However, in some patients, the dose may need to be increased to 2.5mg 3 times in 24 hours.

Method of administration

For oral use.

Overdose

Possible symptoms and signs

Headache, anxiety, tremor, nausea, tonic cramp, palpitations, tachycardia, arrhythmia. A fall in blood pressure sometimes occurs.

Laboratory findings: hypokalaemia, hyperglycaemia and lactic acidosis sometimes occur.

Management

Mild and moderate cases

Reduce the dose.

Severe cases

Gastric lavage, administration of activated charcoal. Determination of acid-base balance, blood sugar and electrolytes, particularly serum potassium levels. Monitoring of the heart rate and rhythm and blood pressure. Metabolic changes should be corrected. A cardioselective β-blocker (e.g. metoprolol) is recommended for the treatment of arrhythmias causing haemodynamic deterioration. The β-blocker should be used with care because of the possibility of inducing bronchoconstriction: use with caution in patients with a history of bronchospasm. If the beta2-mediated reduction in the peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.

Shelf life

36 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Glass bottles and Securitainers of 100 and 500 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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