PulmoCare® Easycap (Salbutamol Sulphate) dry powder inhaler is indicated for:
the symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic broncho pulmonary 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
Patients with a known or suspected hypersensitivity to any of the ingredients. Although intravenous salbutamol, and occasionally salbutamol capsules, is used in the management of premature labour uncomplicated by conditions such as placenta praevia, antepartum haemorrhage or toxaemia of pregnancy, salbutamol inhaler preparations are not appropriate for managing premature labour. Salbutamol preparation should not be used for threatened abortion during the first or second trimesters of pregnancy.
Salbutamol and other beta2 agonists should be given with caution in hyperthyroidism, myocardial insufficiency, arrhythmias, susceptibility to QT interval prolongation, hypertension, and diabetes mellitus. In severe asthma, particular caution is also required to avoid inducing hypokalemia as this effect may be potentiated by hypoxia or by concomitant administration of other anti-asthma drugs: beta2 agonists such as salbutamol are not appropriate for use alone in the treatment of severe asthma. Salbutamol and non-selective beta blockers such as Propranolol should not be prescribed
together.In the event of a previously effective dose of Salbutamol inhaler, failing to give relief for at
least three hours, the patients should be advised to seek medical advice in order that any necessary additional steps may be taken.
Salbutamol is generally well tolerated and serious toxicologic effects are few. Salbutamol may cause fine tremor of skeletal muscle (particularly of the hands), palpitations, and muscle cramps. Tachycardia, tenseness, headaches, and peripheral vasodilatation have been reported after large dose. They usually disappear with continued treatment. Hypersensitive reactions including angioedema and urticaria, bronchospasm, hypotension and collapse have been reported very rarely. As with all inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy should be instituted.
Although there is no evident data, that Salbutamol is teratogenic, it should be used in the first trimester only is absolutely essential. It is pregnancy category C. Salbutamol probably enters into the breast milk, but the concentration is unknown. However, no adverse effects have been reported in the breast-fed babies of mothers' taking the drug by inhalations.
Salbutamol should not be used with Monoamine oxidase inhibitors or tricyclic antidepressants because it may potentiate action of salbutamol on cardiovascular system. Other inhaled sympathomimetic bronchodilators or epinephrine should not be used concomitantly with salbutamol sulphate, as it may lead to deleterious cardiovascular effects. Beta-adrenergic blocking drugs, especially the non-cardio selective ones, such as propranolol, should not usually be prescribed together because may effectively antagonize the action of salbutamol. 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.
The most common signs and symptoms of overdose with salbutamol are transient beta agonistpharmacologically mediated events . Over dosage may cause tachycardia, cardiac arrhythmia, hypokalemia, hypertension and, in extreme cases, sudden death. Serum potassium levels should be monitored.
PulmoCare® Easycap must not be swallowed. Insert the Easycap in the Easyhaler® for best performance. Remove PulmoCare® Easycap capsule from the blister pack just prior to use, as Easycap exposed to moisture may not tear easily.
Avoid storage in direct sunlight or heat. Store below 30C. Keep away from children
