BABUREX

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COMPOSITION:
Bambuterol hydrochloride  ......................................................................10 mg
Excipients q.s ...................................................................................... 1 tablet
(Lactose, wheat starch, green lake color, PVP K30, avicel M101, magnesium stearate).
DOSAGE FORM: Tablet .
PRESENTATION: Box of 3 blisters x 10 tablets.
PHARMACODYNAMICS: Bambuterol is a prodrug of the active adrenergic beta - receptor agonist terbutaline, which predominantly stimulates beta 2-receptors, thus producing relaxation of bronchial smooth muscle, inhibition of the release of endogenous spasmogens, inhibition of oedema caused by endogenous mediators and increased mucociliary clearance.
PHARMACOKINETICS: Approximately 20% of an oral dose of bambuterol is absorbed. After absorption, bambuterol is slowly metabolized via hydrolysis and oxidation to active terbutaline. Maximum plasma concentration of terbutaline is achieved within 2-6 hrs. The effect-duration is at least 24 hrs. The plasma half-life of bambuterol after oral administration is about 13 hrs, the plasma half-life of terbutaline is about 21 hrs. Bambuterol and its metabolites are mainly excreted via the kidneys.
INDICATIONS: Bronchial asthma. Chronic bronchitis, emphysema and other lung diseases accompanied with bronchospasm. 
CONTRAINDICATIONS: Hypersensitivity to any of the ingredients of the drug.
PRECAUTIONS: The dose of bambuterol 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. Caution should be observed in patients with thyrotoxicosis and severe cardiovascular pathology, such as ischemic heart disease, tachyarrhythmia and severe heart disease.
Additional blood glucose controls are recommended initially in diabetic patients.
Potentially hypokalemia may result from beta 2-agonist therapy; it is recommended that serum potassium levels are monitored in acute severe asthma and in concomitant treatment (see Interactions).
PREGNANCY AND LACTATION: Caution should be taken when indicating bambuterol to pregnant women and nursing mothers. Prescribe only where necessary and consider benefits versus risks.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The drug has no influence on the ability to drive and use machines.
INTERACTIONS: Bambuterol prolongs the muscle-relaxing effect of suxamethonium (succinylcholine).
Beta-receptor blocking agents may partly or totally inhibit the effect of beta-stimulants.
Hypokalemia may result from beta 2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
ADVERSE EFFECTS: Adverse reactions which have been reported, include tremor, headache, nausea, tonic muscle cramps, tachycardia and palpitations. They gradually disappear within 1 to 2 weeks of treatment.
As for all beta 2-agonist, cardiac arrhythmias, atrial fibrillation, supraventricular tachycardia and extrasystoles have been rarely reported.
Sleep disturbances, agitation, hyperactivity, restlessness, urticaria, rash have been observed.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Symptoms and signs as recorded after overdosage with bambuterol: Headache, anxiety, tremor, nausea, tonic muscle cramps, palpitations, tachycardia and cardiac arrhythmias. A fall in blood pressure sometimes occurs after terbutaline overdosage. High doses of beta 2-agonists may cause hypokalemia.
Treatment of overdosage: Usually no treatment is required. In particularly severe cases of overdosage, the following measures may be considered on a case-by-case basis: Gastric lavage and activated charcoal.
Monitor heart rate, rhythm, blood pressure, blood glucose, electrolytes, and acid-base balance. The preferred antidote is a selective beta 2-blocking agent, but beta 2-blocking drugs should be used with caution in patients with a history of bronchospasm. If the beta 2-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given. 
DOSAGE & ADMINISTRATION: Bambuterol is dosed once daily, preferably shortly before bedtime.
Adults and children aged > 6 years: The recommended initial dose is 10 mg. The dose may be increased to 20 mg after 1 - 2 weeks depending on the clinical effect.
Children aged from 2 - 5 years: The recommended dose is 5 mg.
In patients with impaired renal function (GFR £ 50 ml/ min), the recommended initial dose is 5 mg, which may be increased to 10 mg after 1-2 weeks, depending on the clinical effect.
Or as directed by the physician.
Read the directions carefully before use. Shelf-life: 24 months from the manufacturing date.
Consult the physician for more information. Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
This drug is for prescriptions only. Specifications: Manufacturer's.

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