International abbreviated prescribing information
Bambec tablets and Bambec oral solution (bambuterol): Tablets 10 mg and 20 mg Oral solution 1 mg/mL
See local prescribing information for full details, as prescribing information may vary from country to country.
Properties: Bambuterol is a pro-drug of the adrenergic beta-receptor agonist terbutaline, that produces relaxation of bronchial smooth muscle. The effect has a duration of at least 24 hours. Steady-state is reached after 4–5 days of treatment.
Indications: Bronchial asthma. Chronic bronchitis, emphysema, and other lung diseases, where bronchospasm is a complicating factor.
Contraindications: Hypersensitivity to any of the ingredients or to terbutaline.
Dosage: Bambec is a once-daily medication, preferably given shortly before bedtime. The dose is individual. Bambec should be used as maintenance therapy, in addition to corticosteroids, in asthma and other pulmonary diseases where bronchospasm is a complicating factor.
Adults and the elderly: In general, the recommended initial dose is 10 mg which may be increased to 20 mg after 1–2 weeks. For those patients who have previously tolerated oral beta2-agonists well, the recommended initial dose is 20 mg. For patients with an impaired renal function (GFR < 50 mL/min), the recommended initial dose is 5 mg, which may be increased to 10 mg after 1–2 weeks.
Children 2–5 years: In general, the recommended normal dose is 10 mg (10 mL) and for Oriental children, 5 mg (5 mL) due to kinetic differences.
Children 6–12 years: In general, the recommended initial dose is 10 mg (10 mL). This may be increased to 20 mg (20 mL) after 1–2 weeks. Doses above 10 mg (10 mL) are not recommended for Oriental children due to differences in kinetics.
Warnings and Precautions: In patients with liver cirrhosis, the direct use of the active metabolite, terbutaline, is preferable. Patients with impaired renal function should receive half the recommended dose. Caution in patients with thyrotoxicosis and severe cardiovascular disorder. Additional blood glucose controls are recommended initially in diabetic patients. 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: : Bambuterol prolongs the muscle-relaxing effect of suxamethonium (succinylcholine). This should also be considered for other muscle relaxants which are metabolized by plasma cholinesterase. 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.
Bambec is a registered trademark owned by Astra AB. Other trademarks are Bambutec and Oxeol.
Date: April 1999. |
