International abbreviated prescribing information
Bricanyl solution for nebulization (terbutaline sulfate): inhalation solution 2.5 mg/mL and 10 mg/mL
See local prescribing information for full details, as prescribing information may vary from country to country.
Properties: Inhaled adrenergic agonist which predominantly stimulates beta2-receptors, thus producing relaxation of bronchial smooth muscle. The effect starts within a few minutes and has a duration of up to 6 hours.
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 solution for nebulization is used with a nebulizer. Dosage is individual.
Body weight > 20 kg: 5 mg is inhaled up to 4 times in 24 hours.
Body weight < 20 kg: 2.5 mg is inhaled up to 4 times in 24 hours.
Warnings and Precautions: The patient’s inhalation technique should be regularly checked. The patient should seek medical advice if a previously effective dosage regimen no longer gives the same relief. 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. In rare cases, through unspecified mechanisms, drugs for inhalation may cause bronchospasm.
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 Bricanyl Respules and Terbasmin.
Date: April 1999. |
