Interaction with other medicinal products and other forms of interaction
Pregnancy and lactation
Effect on ability to drive and use machines
List of Excepient
Bambuterol hydrochloride 20mg.
Film coated tablet
Therapeutic Indications: Mangment of asthma, chronic bronchospasm and / or reversible airways obstruction.
Terventin is formulated as a tablet and should be taken once daily, shortly before bed-time. The dose should be individual. Adults: the recommended starting dose is 10-20mg. the 10mg dose maybe increased to 20mg if necessary after 1-2 weeks, depending on the clinical effect.
In patients who previously have tolerated oral B2-agonists well, the recommended starting dose , as well as the maintenance dose is 20 mg. Children: until the clinical documentation has been completed, terventin should be used in children. *Elderly: dose adjustment is not required in the elderly.
Significant hepatic dysfunction: not recommended because of unpredictable conversion to terbutaline.
Moderare to severly impaired renal function ( GFR < 50ml/min) : it is recommended that the starting dose of terventin should be halved in these patients.
Terventin tabletsare contraindicated in patients with a history of Hypersensitivity to any of their ingredients.
Care should be taken with patients suffering from thyrotoxicosis.
Cardiovascular effects may be seen with sympathomimetic drugs, including terventin. There is some evidence from post marketing data and published literature of rare occurrences of myocardial ischemia associated with beta agonist. Patients with underlying severe heart disease (e.g. ischemic heart disease, arrhythmia or severe heart failure) who are receiving terventin 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.
Due to hyperglycemia effects of β2-stimulants, additional blood glucose measurements are recommended initially when terventin therapy is commenced in diabetic patients.
Due to positive inotropic effects of B2- agonist these drugs should not be used in patients with hpertrophic cardiomyopathy.
B2-agonist 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 B2-agonist is recommended in patients with cirrhosis and other forms of severly impaired liver function.
Potentially serious hypokalemia may result from β2-agonist therapy.
Mainly from parental or nebulised administration. Particular caution is advised in acute severe asthma as this effect may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and/or diuretics. It is recommended that serum potassium levels are monitored in such situations.
If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Consideration should be given to the requirements for additional therapy (including increased dosage of anti-inflammatory medication). Sever exacerbations of asthma should be treated as an emergency in The usual manner. Patients with rare hereditary problems of galactose intolerance, the lapp lactose deficiency or glucose galactose malabsorbtion should not take this medicine.
Bambuterol may interact with suxamethonium (succinylcholine). A prolongation of the muscle-relaxing effect of suxamethonium of up to 2-fold has been observed in some patients after taking terventin 20mg on the evening prior to surgery. The interaction is dose-dependant. It is due to the fact that plasma cholinesterase, which inactivates suxamethonium, is partly, but fully reversibly, inhibited by bambuterol. In extreme situations, the interaction may result in a prolonged apnoea time wich maybe of clinical importance.
Beta-receptor blocking agents (including eye drops) especially non selective ones, may partly or totally inhibit the effect of beta-stimulants.
Therefore, terventin tablets andthose non-selective B-blockers should not normally be administered concurrently.
Terventin should be used with caution in patients receiving other sympathomimetics.
Hypokalemia may result from β2-agonist therapy and may be potentiated by concomitant treatment with xanthin derivatives, corticosteroids and diuretics.
Unless there are compelling reasons , avoid in pregnancy, lactation and women of child bearing potential who are not taking adequate contraceptive precautions.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1000 to < 1/100), rare ( 1/10,000 to < 1/1000), very rare (<1/10,000) and Not known (cannot be estimated from available data).
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.
System Organ Class (SOC)
Adverse Drug Reaction
Immune system disorders
Hypersensitivity reactions including Angioedema, Urticaria,Exanthema, Bronchospasm, Hypotension and Collapse.
Metabolism and nutrition disorders
Behavioural Disturbances, such as Restlessness
Behavioural Disturbances, such as Agitation
Nervous system disorders
Cardiac arrhythmias, e.g.
Atrial Fibrillation,Supraventricular tachycardia and Extrasystoles
Myocardial ischemia (see section 4.4)
Respiratory, thoracic and mediastinal disorders
Musculoskeletal, connective tissue and bone disorders
Overdosing may result in high levels of terbutaline
The signs and symptoms prescribed here recorded after terbutaline overdose.
Possible signs and symptoms: headache, anxiety, tremor, nausea, cramps, palpations, tachycardia, cardiac arrhythmias. A fall in blood pressure sometimes occurs.
Laboratory findings: hypokalemia, Hyperglycemia and lactic acidosis sometimes occur.
Overdosage of terventin is also likely to cause a prolonged inhibition of plasma cholinesterase.
Mild and moderate cases: reduce the dose.
Severe cases: administration of activated charcoal if ingestion is recent. Determination of acid base balance, blood sugar and electrolytes. Monitoring of heart rate and rhythm and blood pressure.
Metabolic changes should be corrected. A cardio selective B-blocker (e.g. metoprolol) is recommended for the treatment of haemodynamically significant cardiac arrhythmias. The B-blocker should be used with care because the possibility of inducing bronchoconstriction. Serum potassium levels should be monitored. If the B2- mediated vasodilatation contributes significantly to the fall in blood in blood pressure, a volume expander should be given.
Pharmacodynamic properties: Pharmacotherapeutic group: selective β2-agonists, bambuterol,
Bambuterol is an active precursor of the selective β2-adrenergic agonist terbutaline. Bambuterol is the bis-dimethylcarbamate of terbutaline, and is present in the formulation as a 1:1 racemate.
After oral administration of bambuterol to guinea pigs, a sustained protective effect was achieved against histamine-induced bronchoconstriction. At equipotent doses, the duration of the relaxing activity was more prolonged than after plain terbutaline. Bambuterol, or the monocarbamate ester, did not exert any smooth muscle relaxing properties. The bronchoprotective effects seen after oral administration of bambuterol are related to the generation of terbutaline, as were the secondary effects (effects on other organs). Pharmacokinetic properties: On average, 17.5% of an oral dose is absorbed. Approximately 70–90% of the absorption occurs in the first 24 hours.
Bambuterol is metabolised in the liver and terbutaline is formed by both hydrolysis and oxidation. After absorption from the gut, about 2/3 of terbutaline is first-pass metabolised, bambuterol escapes this first-pass metabolism. Of the absorbed amount, about 65% reaches the circulation. Bambuterol therefore has a bioavailability of about 10%.
Protein binding of bambuterol is low, 40–50% at therapeutic concentrations.
The terminal half-life of bambuterol after an oral dose is 9–17 hours.