Dilator20 mg

Bambuterol hydrochloride is an oral bronchodilator used for the maintenance treatment of:

• Bronchial asthma, including nocturnal asthma
• Chronic obstructive pulmonary disease (COPD) with reversible airway obstruction or bronchospasm

Bambuterol is a maintenance (regular, once-daily) treatment and is not intended for the relief of acute asthma attacks or sudden bronchospasm, for which a fast-acting inhaled bronchodilator should be used instead.

Contains Dilator 20 mg as the active ingredient, available as oral tablets, commonly in 10 mg and 20 mg strengths, and as an oral solution in some markets.

Bambuterol is an oral prodrug of terbutaline, a bronchodilator that relaxes the muscles around the airways to make breathing easier. Because it is converted to active terbutaline gradually and predominantly in the lungs, it has a prolonged duration of action that allows once-daily dosing, typically taken in the evening to help control nighttime and early-morning asthma symptoms. It is generally used as an additional option for patients whose symptoms are not fully controlled by inhaled therapy alone, or who have difficulty using an inhaler correctly.

Therapeutic Class: Bronchodilator (Long-acting Beta-2 Agonist)

Bambuterol is an inactive, site-specific prodrug that is converted to active terbutaline predominantly in the lungs, via a pathway involving inhibition of plasma cholinesterase. This targeted activation gives bambuterol a longer duration of bronchodilator action than terbutaline itself, supporting once-daily dosing. There is unpredictable inter-individual variation in the rate of this conversion.

• Take one tablet just before bedtime, with a drink of water
• May be taken with or without food
• If a dose is missed, take it as soon as remembered unless it is almost time for the next dose - do not double the dose to make up for a missed one
• Continue using any other prescribed asthma medicines, including inhaled anti-inflammatory (preventer) treatment, unless directed otherwise by your doctor

The following should be assessed by a healthcare professional before combining with bambuterol:

• Monoamine oxidase inhibitors (MAOIs), which may cause hypertensive crisis and other adverse effects when combined with bambuterol
• Beta-blockers, which may partly or totally inhibit the bronchodilator effect of bambuterol
• Suxamethonium (succinylcholine), whose muscle-relaxing effect is prolonged by bambuterol, since bambuterol reversibly inhibits plasma cholinesterase (which normally breaks down suxamethonium) by up to four times
• Halothane and other halogenated anaesthetics, which increase the risk of cardiac arrhythmias when combined with beta-2 agonists
• Other sympathomimetic bronchodilators, which may increase cardiovascular side effects when combined

Common side effects

• Headache
• Tremor (shakiness)
• Restlessness or nervousness
• Palpitations or increased heart rate
• Muscle cramps

Less common but serious side effects (seek medical attention)

• Chest pain or irregular heartbeat
• Signs of a severe allergic reaction: rash, swelling, difficulty breathing
• Worsening breathing difficulty despite treatment - contact a doctor promptly, as this may indicate the asthma is not adequately controlled

Pregnancy

Data on bambuterol use in pregnancy are limited; use should only occur if the treating doctor considers it necessary, weighing the potential benefit against any possible risk.

Breastfeeding

Specific data on bambuterol use during breastfeeding are limited; use should be discussed with a healthcare professional.

• Use with caution in patients with genetic deficiencies of plasma cholinesterase, since bambuterol's activation and cholinesterase-inhibiting effects may be altered.
• Use with caution in patients with severe cardiovascular disease, hyperthyroidism, or diabetes mellitus, given the cardiovascular and metabolic effects of beta-2 agonists.
• Treatment should not be started or the dose increased during an acute exacerbation of asthma; severe asthma exacerbations require emergency treatment in the usual manner.
• Consideration should be given to the need for additional therapy, including increased anti-inflammatory (preventer) medication, if bronchodilator use needs to increase.
• Caution should be applied in patients predisposed to angle-closure glaucoma.
• Bambuterol tablets contain lactose and should be avoided in patients with rare hereditary problems of galactose intolerance or glucose-galactose malabsorption.

Overdose may cause exaggerated beta-2 agonist effects, such as tremor, headache, palpitations, rapid heart rate, and, in severe cases, cardiac arrhythmias or a drop in blood potassium. Suspected overdose requires prompt medical evaluation; treatment is generally supportive, including cardiac monitoring, provided in a medical facility.

Store at room temperature, protected from moisture and light, as directed on the product label. Keep out of reach of children.

• Elderly: Use with the same starting dose and caution regarding cardiovascular effects as other adults.
• Renal impairment: Dose reduction is required in patients with severely impaired renal function.
• Hepatic impairment: Contraindicated in patients with hepatic impairment, cirrhosis, or severely impaired liver function.

Bambuterol is used as ongoing maintenance therapy for asthma or COPD, for as long as clinically needed, with regular medical review to assess symptom control and the need for dose adjustment or additional anti-inflammatory therapy.

Drug Class: Long-acting beta-2 adrenergic agonist (oral prodrug of terbutaline)

After conversion to terbutaline in the lungs, bambuterol stimulates beta-2 adrenergic receptors in airway smooth muscle, causing the muscles around the airways to relax. This widens (dilates) the airways, easing airflow and relieving symptoms such as wheezing, chest tightness, and breathlessness associated with asthma and COPD.

Bambuterol tablets are not generally recommended for use in young children; where oral bronchodilator therapy is considered necessary in a child, this should be guided by a pediatric specialist, with dosing based on the specific product's own labeling.