Skip to content
ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Long-acting beta-2 agonist (oral prodrug of terbutaline) Pregnancy: UK SPC §4.6. Pregnancy: although no teratogenic effects have been observed in animals after administration of bambuterol, caution is recommended during the first trimester of pregnancy. Beta-agonists for asthma and other pulmonary diseases should be used with caution at the end of pregnancy because of the tocolytic effect. Transient hypoglycaemia has been reported in newborn preterm infants after maternal beta-2 agonist treatment. Breast-feeding: it is unknown whether bambuterol or intermediary metabolites are excreted in human breast milk; terbutaline, the active metabolite of bambuterol, is excreted in breast milk, but at therapeutic doses of terbutaline no effect on breastfed newborns/infants is anticipated. A decision must be made whether to discontinue breast-feeding or to discontinue Bambec therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Bambuterol

Brand names: Bambec

Bambuterol is an oral long-acting beta-2 agonist prodrug of terbutaline used for bronchodilation in asthma and reversible airways obstruction.

Adult dose

Dose: ASTHMA / reversible airways obstruction (the page's primary indication), adults: the recommended starting doses are 10 mg–20 mg once daily. 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 beta-2 agonists well, the recommended starting dose, as well as the maintenance dose, is 20 mg. The dose should be individualised.
Route: Oral — Bambec is formulated as a tablet
Frequency: Once daily, shortly before bedtime
Max: 20 mg once daily — the highest dose §4.2 states for adults (it is both the top of the 10 mg–20 mg starting range and the stated maintenance dose for patients who have previously tolerated beta-2 agonists well). The SPC does not use the word 'maximum' or give any separate ceiling. In moderate to severely impaired renal function (GFR < 50 ml/min) the STARTING dose should be halved.
SCOPE: this is the whole of the adult §4.2 posology — the label carries no other indication or route. MANDATORY CO-THERAPY, §4.2 verbatim: 'Patients must receive optimal anti-inflammatory therapy (e.g. inhaled corticosteroids, leukotriene receptor antagonists) when using Bambec for management of asthma.' §4.4 repeats this and adds that patients must be instructed to continue taking their anti-inflammatory medication after starting Bambec. ELDERLY: dose adjustment is not required in the elderly. HEPATIC IMPAIRMENT: in significant hepatic dysfunction Bambec is NOT RECOMMENDED because of unpredictable conversion to terbutaline; §4.4 adds that unpredictable inter-individual variation in the metabolism of bambuterol to terbutaline has been shown in subjects with liver cirrhosis, that in liver cirrhosis and probably other causes of severely impaired liver function the daily dose must be individualised, and that the direct use of the active metabolite terbutaline is preferable in these patients. RENAL IMPAIRMENT: 'Moderate to severely impaired renal function (GFR < 50 ml/min): It is recommended that the starting dose of Bambec should be halved in these patients' (§4.4 states GFR ≤ 50 mL/min for the same halving, as terbutaline is excreted mainly via the kidneys). PAEDIATRIC: §4.2 states 'Until the clinical documentation has been completed, Bambec should not be used in children', and §4.3 that 'Bambec is presently not recommended for children due to limited clinical data in this age group' — no paediatric dose exists in this label, so paedDose is null. NOT A TOCOLYTIC: although Bambec is not indicated for the treatment of premature labour, bambuterol is metabolised to terbutaline, and terbutaline should not be used as a tocolytic agent in patients with pre-existing ischaemic heart disease or significant risk factors for it (§4.4).

Dose adjustments

Renal

Halve the starting dose. §4.2: 'Moderate to severely impaired renal function (GFR < 50 ml/min): It is recommended that the starting dose of Bambec should be halved in these patients.' §4.4: 'As terbutaline is excreted mainly via the kidneys, the dose of Bambec should be halved in patients with an impaired renal function (GFR ≤ 50 mL/min).'

Hepatic

Not recommended in significant hepatic dysfunction. §4.2: 'Significant hepatic dysfunction: Not recommended because of unpredictable conversion to terbutaline.' §4.4: in liver cirrhosis, and probably in 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; the use of an alternative beta-2 agonist is recommended in patients with cirrhosis and other forms of severely impaired liver function, and the direct use of the active metabolite terbutaline is preferable in these patients.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Children — §4.3: 'Bambec is presently not recommended for children due to limited clinical data in this age group'; §4.2: 'Until the clinical documentation has been completed, Bambec should not be used in children'
  • Hypertrophic cardiomyopathy — §4.4: 'Due to the positive inotropic effects of beta-2 agonists these drugs should not be used in patients with hypertrophic cardiomyopathy' (a §4.4 prohibition, not a §4.3 contraindication)
  • Significant hepatic dysfunction — not recommended, because conversion to terbutaline is unpredictable (§4.2)
  • Caution rather than contraindication, from §4.4: thyrotoxicosis; underlying severe heart disease (ischaemic heart disease, arrhythmia or severe heart failure); diabetes mellitus; and acute severe asthma, where the hypokalaemic risk may be augmented by hypoxia

Side effects

  • Most adverse reactions are characteristic of sympathomimetic amines; their intensity is dose-dependent, and tolerance to these effects has usually developed within 1–2 weeks
  • Very common — tremor, headache
  • Very common — behavioural disturbances, such as restlessness
  • Common — sleep disturbances; uncommon — behavioural disturbances such as agitation; not known — dizziness, hyperactivity
  • Common — palpitations; uncommon — tachycardia, and cardiac arrhythmias e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles
  • Not known — myocardial ischaemia; there is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists
  • Common — muscle cramps
  • Not known — hypokalaemia, hyperglycaemia
  • Not known — hypersensitivity reactions including angioedema, urticaria, exanthema, bronchospasm, hypotension and collapse
  • Unknown — paradoxical bronchospasm
  • Not known — nausea

Monitoring

  • Serum potassium — §4.4: 'Potentially serious hypokalaemia may result from beta-2 agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatments... It is recommended that serum potassium levels are monitored in such situations.'
  • Blood glucose — additional blood glucose controls are recommended initially in diabetic patients, due to the hyperglycaemic effects of beta-2 agonists (§4.4)
  • Cardiac symptoms — patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) 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 (§4.4)
  • Continued anti-inflammatory therapy — asthma patients on Bambec must have optimum anti-inflammatory treatment (e.g. inhaled corticosteroids, leukotriene receptor antagonists) and must be instructed to continue it after starting Bambec (§4.2, §4.4)
  • Review at 1–2 weeks when starting on 10 mg, which is the interval at which §4.2 allows an increase to 20 mg depending on clinical effect
  • NOTE: §4.4 was cut at the source-fetch limit part-way through the anti-inflammatory-therapy paragraph, and §4.5 (interactions) was not retrieved at all in this bundle — read both from the SPC

Clinical monograph

How it works

It is hydrolysed in the body to terbutaline, which stimulates beta-2 adrenoceptors on airway smooth muscle to produce prolonged bronchodilation.

Prescribing in practice

  • It is metabolised via plasma cholinesterase, so dose reduction and caution are needed in renal impairment and in patients with low cholinesterase activity.
  • As a long-acting beta-2 agonist it should not be used for relief of acute symptoms.
  • Caution applies in cardiovascular disease, hyperthyroidism and diabetes as with other beta-2 agonists.

Monitoring

Monitor symptom control, heart rate and serum potassium, with particular care in renal impairment.

Counselling the patient

  • Take once at night as directed and keep a separate reliever inhaler for sudden symptoms.
  • Report tremor, palpitations or worsening breathlessness.

Evidence & guidelines

Its action reflects conversion to terbutaline, a well-characterised beta-2 agonist; renal dosing caution is documented in the SPC.

Reference: SmPC Bambec; BTS/SIGN Asthma Guideline 158 (2019); NICE NG80; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Pathways