21 Nov 2011

BAMBEC (Bambuterol) - United Kingdom

Updated: 21 Nov 2011

BAMBEC

Management of asthma, bronchospasm and/or reversible airways obstruction

BAMBEC Description, Presentation and Dosage

BAMBEC Description

BAMBEC Drug Class Description

Selective b2 -agonists (beta- agonists, beta-adrenoceptor stimulants).

BAMBEC Drug Description

Each tablet contains 10 mg Bambuterol hydrochloride Each tablet contains 20 mg Bambuterol hydrochloride

BAMBEC Generic Name

Bambuterol

BAMBEC Presentation

BAMBEC Presentation

Tablet

BAMBEC Manufacturer

AstraZeneca

Free Medical Education Resources

BAMBEC Dosage

BAMBEC Adult Dosage

Bambec is formulated as a tablet and should be taken once daily, shortly before bedtime. The dose should be individualised.

Adults: The recommended starting doses are 10 mg–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.

Significant hepatic dysfunction: Not recommended because of unpredictable conversion to terbutaline.

Moderate to severely impaired renal function (GFR < 50ml/min): It is recommended that the starting dose of Bambec should be halved in these patients.

BAMBEC Child Dosage

Until the clinical documentation has been completed, Bambec should not be used in children.

BAMBEC Elderly Dosage

Dose adjustment is not required in the elderly.

BAMBEC Precautions, Reactions and Contraindications

BAMBEC Special Precautions

BAMBEC Special Precautions

As terbutaline is excreted mainly via the kidneys, the dose of Bambec should be halved in patients with an impaired renal function (GFR LESS-THAN OR EQUAL TO (8804) 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 individualised, taking into account the possibility that the individual patient could have an impaired ability to metabolise 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 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 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 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 hyperglycaemic effects of β2-agonists, 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 and this must be considered in the treatment of the individual patient.

Unpredictable inter-individual variation in the metabolism of bambuterol to terbutaline has been shown in subjects with liver cirrhosis. The use of an alternative β2-agonist is recommended in patients with cirrhosis and other forms of severely impaired liver function.

Potentially serious hypokalaemia may result from β2-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.

Asthma patients who require treatment with Bambec must have optimum anti-inflammatory treatment with corticosteroids. The patients must be instructed to continue taking their anti-inflammatory medication after the start of treatment with Bambec, even if the asthma symptoms diminish. If a previously effective dosage regimen no longer gives the same symptomatic relief this suggests that the underlying disease has worsened. The patient should urgently seek further medical advice and a re-evaluation of the asthma treatment must be carried out. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Treatment with Bambec 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.

Bambec tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.

BAMBEC Adverse Reactions

BAMBEC Adverse Reactions

Most of the adverse reactions are characteristic of sympathomimetic amines. The intensity of the adverse reactions is dose-dependent. Tolerance to these effects has usually developed within 1-2 weeks.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (GREATER-THAN OR EQUAL TO (8805)1/10), common (GREATER-THAN OR EQUAL TO (8805)1/100 to <1/10), uncommon (GREATER-THAN OR EQUAL TO (8805)1/1000 to < 1/100), rare (GREATER-THAN OR EQUAL TO (8805)1/10,000 to < 1/1000), very rare (<1/10,000) and Not known (cannot be estimated from available data).

 

System Organ Class (SOC)

Frequency Classification

Adverse Drug Reaction

Immune system disorders

Not known

Hypersensitivity reactions including Angioedema, Urticaria, Exanthema, Bronchospasm, Hypotension and Collapse.

Metabolism and nutrition disorders

Not known

Hypokalemia

Hyperglycaemia

Psychiatric disorders

Very Common

Behavioural Disturbances, such as Restlessness

 

Common

Sleep disturbances

 

Uncommon

Behavioural Disturbances, such as Agitation

 

Not known

Dizziness

Hyperactivity

Nervous system disorders

Very common

Tremor, Headache

Cardiac disorders

Common

Palpitations

 

Uncommon

Tachycardia

Cardiac arrhythmias, e.g. Atrial Fibrillation, Supraventricular tachycardia and Extrasystoles

 

Not known

Myocardial ischemia 

Respiratory, thoracic and mediastinal disorders

Unknown

Paradoxical bronchospasm

Gastrointestinal disorders

Not known

Nausea

Musculoskeletal, connective tissue and bone disorders

Common

Muscle cramps

BAMBEC Contraindications

BAMBEC Contraindications

Bambec tablets are contraindicated in patients with a history of hypersensitivity to any of their ingredients. Bambec is presently not recommended for children due to limited clinical data in this age group.

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