Asmalin ® HFA Inhaler: Each puff delivers Salbutamol Sulphate BP equivalent to Salbutamol 100 µg.
Salbutamol is a selective beta2-adrenoceptor agonist. At therapeutic doses, it acts on the beta2-adrenoceptors of bronchial smooth muscle, with little or no action on the ß1 adrenoceptors of cardiac muscle. Salbutamol provides short acting (4-6 hours) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction. It also has an anti-inflammatory effect on mast cells causing inhibition of release of bronchoconstrictor mediators including histamine, neutrophil chemotactive factor (NCF) and prostaglandin D2.
Bronchospasm:
Asmalin HFA Inhaler is indicated for the treatment or prevention of bronchospasm in bronchial asthma and for the treatment of reversible airways obstruction associated with bronchitis and emphysema.
Exercise-Induced Bronchospasm:
Asmalin HFA Inhaler may be used to relieve attacks of acute dyspnoea and may also be taken prophylactically before exertion or to prevent exercise-induced Bronchospasm.
Administer by oral inhalation only; shake well before each spray.
Salbutamol and non-selective beta-blocking drugs such as propranolol should generally not be prescribed together. Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics, and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
Asmalin ® HFA Inhaler is contraindicated in patients with a history of hypersensitivity to salbutamol or any other components.
Salbutamol is generally well tolerated. Few side effects have been observed during inhalation. There are tremor, anxiety, muscle cramps, headache, palpitation, a compensatory small increase in heart rate, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles), tachycardia may occur in some patients. Mouth and throat irritation may occur with inhaled salbutamol.
Use in pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies of Asmalin® HFA Inhaler or salbutamol sulfate in pregnant women. Asmalin® HFA Inhaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether the components of Asmalin® HFA Inhaler are excreted in human milk. Caution should be exercised when Asmalin® HFA Inhaler is administered to a nursing woman.
Use in children: The safety and effectiveness of Asmalin® HFA Inhaler in children 4 years of age and older have been established.
Paradoxical Bronchospasm
Inhaled salbutamol sulfate can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Asmalin
®
HFA Inhaler
should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
Cardiovascular Effects
Asmalin
®
HFA Inhaler,
like all other beta2-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, Asmalin
®
HFA Inhaler
may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical relevance of these findings is unknown. Therefore, Asmalin
®
HFA Inhaler
,
like all other sympathomimetic amines, should be used with caution in patients with underlying
cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of salbutamol sulfate inhalation aerosol, as demonstrated by cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Discontinue Asmalin
®
HFA Inhaler if immediate hypersensitivity reactions occur.
Coexisting Conditions
Asmalin
®
HFA Inhaler, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous salbutamol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
Pressurized canister. Do not puncture, break or burn even when apparently empty. Store below 30 C, keep in dry place & protect from light. Keep away from eyes. Keep away from children. To be dispensed only on or by the prescription of a registered physician.