International abbreviated prescribing information
Bricanyl prolonged release tablets (terbutaline sulfate): prolonged release tablets 5 mg, 7.5 mg
See local prescribing information for full details, as prescribing information may vary from country to country.
Properties: Adrenergic agonist which predominantly stimulates beta2-receptors, thus producing relaxation of bronchial smooth muscle. The tablets have a duration of action that allows a 12-hour dosing interval.
Indications: Bronchial asthma. Chronic bronchitis, emphysema, and other lung diseases where bronchospasm is a complicating factor.
Contraindications: Hypersensitivity to any of the ingredients.
Dosage: Bricanyl prolonged release tablets should be used as maintenance therapy. Dosage is individual.
Adults and children > 12 years: Recommended daily maintenance dose 10–15 mg, given twice daily.
Children 5–12 years: Recommended daily maintenance dose 10 mg, given twice daily.
Warnings and Precautions: Caution in patients with thyrotoxicosis and severe cardiovascular disorder. Additional blood glucose controls are recommended initially in diabetics. The hypokalemic effect of beta2-agonists may be potentiated by concomitant treatments (see Interactions). Particular caution is recommended in acute severe asthma. Serum potassium levels should be monitored in those situations.
Pregnancy and lactation: As with other drugs administered during pregnancy, the benefits for the mother should be weighed against the risks for the fetus.
Undesirable effects: Tremor, headache, tonic muscle cramps, and palpitations have been recorded. Tolerance to these effects usually develops within 1–2 weeks. Urticaria and exanthema may occur. Sleep and behavioral disturbances have been observed.
Interactions: The effect of beta-agonists may be inhibited by beta-receptor blocking agents (especially those which are non-selective). Concomitant treatment with xanthines, steroids, or diuretics may potentiate hypokalemia.
Legal category: On medical prescription.
Further information is available on request from AstraZeneca.
Bricanyl is a registered trademark owned by Astra AB. Other names of the product are Bricanyl Depot, Bricanyl Durettes, Bricanyl Duriles, Bricanyl Durules, Bricanyl LP, Bricanyl Retard, Bricanyl SA, Terbasmin Durules.
Date: April 1999. |
