International abbreviated prescribing information
Bricanyl tablets (terbutaline sulfate): tablet 2.5 mg and 5.0 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 effect has a duration of up to 8 hours.
Indications: Bronchial asthma. Chronic bronchitis, emphysema and other lung diseases where bronchospasm is a complicating factor. Pre-term labor.
Contraindications: Hypersensitivity to any of the ingredients.
Dosage: Bricanyl tablets should be used as maintenance therapy. Dosage is individual.
Bronchospasm:
Adults: In general, the recommended dose during the first 1–2 weeks is, one tablet (2.5 mg) three times a day. May be increased to 2 tablets, three times a day.
Children: 0.075 mg/kg body weight, three times a day.
Pre-term labor: The drug must be individually titrated. Initial treatment is an infusion of Bricanyl solution for injection followed by oral maintenance therapy with Bricanyl tablets.
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 trademarks are Bricalin, Bricasma, Dracanyl, and Terbasmin.
Date: April 1999. |
