Manufacturer: Cipla  /  Yangzhou No. 3
Distributor: Phil Pharmawealth
Contents: Salbutamol sulfate
Indications: Management of reversible airway obstruction as in asthma & in some patients w/ COPD.
Dosage: Nebulizing soln Adult & childn 2.5-5 mg. May repeat qid by nebulizer. Delivery of aerosol may be by face mask of “T” piece. Use undiluted. For prolonged delivery time, dilute w/ sterile water or normal saline for inj. MDI Adult & elderly Relief of acute asthma symptoms including bronchospasmInitially 1 inhalation as single dose. May be increased to 2 inhalations. Prevention of allergen- or exercise-induced symptoms 2 inhalations 10-15 min before exertion. Chronic therapy 2 inhalations up to qid. Max: 8 inhalations/day.
Contraindications: MDI: Hypersensitivity
Special Precautions: Hyperthyroidism, arrhythmia, tachycardia, occlusive vascular disorders eg arteriosclerosis, HTN, DM. Nebulizing soln: Thyrotoxicosis, CV diseases eg ischemic heart disease, aneurysms. Angina pectoris, closed-angle glaucoma. MDI: Myocardial insufficiency, susceptibility to QT-interval prolongation. Obstructive cardiomyopathy & other disorders where reduction in total peripheral resistance could be harmful; pheochromocytoma. Monitor plasma K conc in patients w/ severe asthma who may be at risk for hypokalemia potentiated by hypoxia & concomitant use w/ other antiasthma drugs. Pregnancy & lactation.
Side Effects / Adverse Reactions: Nebulizing soln: Small increase in heart rate, peripheral vasodilation, fine tremor of skeletal muscle. MDI: Palpitation, tachycardia & arrhythmia; anxiety, fear, restlessness, insomnia, confusion, irritability, headache, psychotic states, dyspnea, anorexia, weakness, nausea & vomiting.
Drug Interactions: Nebulizing soln: Cyclopropane, halothane, other halogenated anesth. Cardiac glycosides, quinidine, TCAs. MDI: Increased risk of hypokalemia w/ corticosteroids, diuretics or xanthines.
Pregnancy Category (US FDA): Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Therapeutic Category: Antiasthmatic & COPD Preparations
ATC Classification: R03AC02 – salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Regulatory Classification: Rx

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