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Salbutamol
Azmasol HFA
200 Actuation- Suspension Metered Dose Inhaler
Selective Beta-2-adrenoreceptor/Antagonist
Formulation
Each actuation delivers:
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Salbutamol sulfate BP
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(Equivalent to Salbutamol) - 100 mcg
Mechanism of Action
Salbutamol produces bronchodilation through stimulation of beta2-adrenergic receptors in bronchial smooth muscle, thereby causing relaxation of bronchial muscle fibers. This action is manifested by and improvement in pulmonary function as demonstrated by spirometry measurements. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects. At therapeutic doses, salbutamol has little action on the beta1-adrenergic receptors in cardiac muscle. A measurable decrease in airway resistance is typically observed within 5 to 15minutes after inhalation of salbutamol. The maximum improvement in pulmonary function usually occurs 60 to 90 minutes after salbutamol treatment, and significant bronchodilator activity has been observed to persist for 3 to 6 hours.
Indication
Adults and Children (4 years and older):
Salbutamol Sulphate inhalation aerosol is indicated for:
• The symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis
and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor.
• The prevention of exercise-induced bronchospasm.
Pediatrics (<4 years of age):
The safety and efficacy in children below the age of 4 years has not been established.
Dosaging
Availability
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Aluminum canister with plastic metering valve and polypropylene plastic actuator with dust cap x 200 actuations
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(Box of 1’s).
Contraindication
As with other bronchodilator inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.
Potentially serious hypokalemia may result from beta2-agonist therapy primarily from parenteral and nebulized routes of administration.
Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported, usually in susceptible patients.
Other adverse reactions associated with salbutamol are nervousness and tremor. In some patients inhaled salbutamol may cause a fine tremor of skeletal muscle, particularly in the hands. This effect is common to all beta2-adrenergic agonists. Adaptation occurs during the first few days of dosing and the tremor usually disappears as treatment continues.
In addition, salbutamol, like other sympathomimetic agents, can cause adverse effects such as drowsiness, flushing, restlessness, irritability, chest discomfort, difficulty in micturition, hypertension, angina, vomiting, vertigo, central nervous system stimulation, hyperactivity in children, unusual taste and drying or irritation of the oropharynx, headache, palpitations, transient muscle cramps, insomnia, nausea, weakness and dizziness.
Immediate hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension, rash, oropharyngeal oedema, anaphylaxis and collapse have been reported very rarely. Rarely, in children, hyperactivity occurs and occasionally, sleep disturbances, hallucination or atypical psychosis have been reported.