Combair HFA Inhaler: Each actuation delivers Salbutamol Sulphate BP 100 mcg and Ipratropium Bromide BP 20 mcg.
Combair ® HFA inhalation aerosol is a combination of Salbutamol Sulphate and Ipratropium Bromide. Salbutamol, a short acting β 2 agonist bronchodilator and Ipratropium Bromide, an anticholinergic bronchodilator produce greater bronchodilator effect when used in combination than either agent alone. It is an environment friendly inhaler which does not contain chlorofluorocarbons (CFCs) as propellant. It uses hydrofluoroalkane (HFA) as propellant which is environment friendly. This combination is expected to maximize the response to treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms, anticholinergic (parasympatholytic) and sympathomimetic.
The dosage of Combair ® HFA should be individualized according to the requirement of patient. Adults (including elderly and adolescents >12 years of age): 2 inhalations (puffs) four times a day. Additional inhalations (puffs) may be taken if required; however, maximum number of inhalations (puffs) should not exceed 12 inhalations (puffs) in 24 hours. Children and Pediatric patients: Safety and effectiveness of patients below 12 years of age have not been established. Use in hepatic or renal disease: This combination has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patients.
Beta-adrenergic blocking agents (propranolol) inhibit salbutamol and induce severe bronchospasm; other anticholinergic drugs produce additive antimuscarinic effects; non-potassium-sparing diuretics exacerbate hypokalemia; MAO inhibitors and TCAs enhance cardiovascular toxicity.
This combination inhalation aerosol is contraindicated in patients with a history of hypersensitivity to any of the ingredients, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, atropine derivatives, or soya lecithin / soybean / peanut allergy.
Common: Headache, coughing, bronchitis, dyspnea. Less Common: Pain, influenza, chest pain, nausea, pharyngitis, sinusitis, rhinitis. Rare: Tremor, muscle cramps, angioedema, urticaria, bronchospasm, hypotension.
Overdose
The effects of overdosage are expected to be related primarily to Salbutamol. Acute overdosage with ipratropium bromide by inhalation is unlikely since ipratropium bromide is not well absorbed systemically after aerosol or oral administration. Manifestations of overdosage with Salbutamol may include anginal pain, hypertension, hypokalemia, and tachycardia with rates up to 200 beats per minute. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse. Dialysis is not appropriate treatment for overdosage of salbutamol as an inhalation aerosol; the judicious use of a cardiovascular β-receptor blocker, such as metoprolol tartrate may be indicated.
Category C. Salbutamol is teratogenic in animals; use during pregnancy only if potential benefit justifies potential fetal risk. Lactation: Excretion in human milk unknown; use in lactating mothers only if benefit justifies risk.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.