Bambec Special Precautions





Full Prescribing Info
Special Precautions
As terbutaline is excreted mainly via the kidneys, the dose of Bambuterol hydrochloride (BAMBEC) should be halved in patients with an impaired renal function (GFR ≤50 mL/min).
In patients with liver cirrhosis, and probably in patients with other causes of severely impaired liver function, the daily dose must be individualized, taking into account the possibility that the individual patient could have an impaired ability to metabolize bambuterol to terbutaline. Therefore, from a practical point of view, the direct use of the active metabolite, terbutaline (Bricanyl), is preferable in these patients.
As for all β2-agonists, caution should be observed in patients with thyrotoxicosis.
Cardiovascular effects may be seen with sympathomimetic drugs, including Bambuterol hydrochloride (BAMBEC). There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bambuterol hydrochloride (BAMBEC) should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Although Bambuterol hydrochloride (BAMBEC) 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.
Due to the hyperglycemic effects of β2-agonists, additional blood glucose controls are recommended initially in diabetic patients.
Potentially serious hypokalemia may result from β2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalemic effect may be potentiated by concomitant treatments (see Interactions). It is recommended that serum potassium levels are monitored in such situations.
Patients with persistent asthma who require maintenance therapy with β2-agonists, should also receive optimal anti-inflammatory therapy e.g. inhaled corticosteroids, leukotriene receptor antagonists. These patients must be advised to continue taking their anti-inflammatory therapy after the introduction of Bambuterol hydrochloride (BAMBEC) even when symptoms decrease. Should symptoms persist, or if treatment with β2-agonists needs to be increased, this indicates a worsening of the underlying condition and warrants a reassessment of the therapy.
Effects of ability to drive and use machines: Bambuterol hydrochloride (BAMBEC) does not affect the ability to drive or use machines.
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