Bamstad

Rx

Indications

• Bamstad is indicated for management of asthma, bronchospasm and/or reversible airways obstruction in adults.

Dosage

• Adults:
  The recommended starting doses are 10 – 20 mg.
  The 10 mg dose may be increased to 20 mg if necessary after 1 – 2 weeks, depending on the clinical effect.
  In patients who have previously tolerated β2-agonists well, the recommended starting dose, as well as maintenance dose, is 20 mg.
• Elderly:
  Dose adjustment is not required in the elderly.
• Hepatic impairment:
  Not recommended for patients with significant hepatic dysfunction because of unpredictable conversion to terbutaline.
• Renal impairment:
  The starting dose should be halved in patients with moderate to severely impaired renal function (GFR ≤ 50 ml/minute).
• Paediatric:
  Not recommended because the clinical documentation has not been completed.

Usage

• Bamstad is administered orally, once daily, shortly before bedtime.

• Hypersensitivity to the active substance(s) or to any of the ingredients.
• Paediatric population.

• Very common:
  Behavioural disturbances (such as restlessness),  tremor, headache.
• Common:
  Sleep disturbances, palpitation, muscle cramps.

• In patients with liver cirrhosis, and probably in patients with other causes of severely impaired liver function, the daily dose must be individualised, taking into account the possibility that the individual patient could have an impaired ability to metabolise bambuterol to terbutaline. Therefore, the direct use of terbutaline is preferable in these patients.
• Caution should be observed in patients with thyrotoxicosis, patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure).
• Bamstad is not indicated for the treatment of premature labour. it should be noted that bambuterol is metabolised to terbutaline and that terbutaline should not be used as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.
• Additional blood glucose controls are recommended initially in diabetic patients.
• Due to the positive inotropic effects of β2-agonists these drugs should not be used in patients with hypertrophic cardiomyopathy.
• β2-agonists may be arrhythmogenic .
• The use of an alternative β2-agonist is recommended in patients subjects with liver cirrhosis and other forms of severely impaired liver function.
• Potentially serious hypokalaemia may result.
• Asthma patients who require treatment with Bamstad must have optimum anti-inflammatory treatment. The patients must be instructed to continue taking their anti-inflammatory medication after the start of treatment with Bamstad, even if the asthma symptoms diminish. Treatment with Bamstad must not be begun or the dose increased during an acute exacerbation of the asthma. Severe exacerbations of asthma should be treated as an emergency in the usual manner.
• Precaution should be applied when treating patients predisposed to angle closure glaucoma.
• Bamstad tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Caution is recommended during the first trimester of pregnancy, for asthma and other pulmonary diseases should be used with caution at the end of pregnancy. A decision must be made whether to discontinue breast-feeding or to discontinue Bamstad therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.