Albuterol and Budesonide

AIRSUPRA is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older. AIRSUPRA is a combination of albuterol, a beta 2 -adrenergic agonist and budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.

AIRSUPRA contains both albuterol and budesonide, therefore, the mechanisms of action described below for the individual components apply to AIRSUPRA. These drugs represent two classes of medications (a short-acting selective beta 2 -adrenergic agonist and a synthetic corticosteroid) that have different effects on clinical, physiological, and inflammatory indices of asthma. Albuterol In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. Although beta 2 -adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -adrenoceptors are the predominant receptors in the heart, there are also beta 2 -adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors.

• Recommended Dosage: AIRSUPRA 180 mcg/160 mcg (administered as 2 actuations of albuterol/budesonide 90 mcg/80 mcg) by oral inhalation as needed for asthma symptoms. • Do not take more than 6 doses (12 inhalations) in a 24-hour period. • Prime inhaler prior to first use. Re-prime when inhaler has not been used for more than 7 days, is dropped, or after cleaning. • Discard when the dose counter displays 0.

AIRSUPRA is contraindicated in patients with a history of hypersensitivity to albuterol, budesonide, or any of the excipients. Hypersensitivity to albuterol, budesonide, or to any of the excipients.

• If symptoms continue after using AIRSUPRA, this may be a marker of destabilization of asthma and requires reevaluation of treatment. • If paradoxical bronchospasm occurs, discontinue AIRSUPRA immediately and institute alternative therapy. • Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular disorders. • Excessive use may be fatal. Do not exceed maximum recommended dosage. • Hypersensitivity reactions may occur. Discontinue AIRSUPRA immediately. • Use with caution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus, and ketoacidosis. • Hypokalemia may occur. • Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex). Use with caution in patients with these infections.

The following clinically significant adverse reactions are described elsewhere in labeling: • Deterioration of Asthma • Paradoxical Bronchospasm • Cardiovascular Effects • Hypersensitivity Reactions, including Anaphylaxis • Hypokalemia • Immunosuppression and Risk of Infections • Oropharyngeal Candidiasis • Hypercorticism and Adrenal Suppression • Reduction in Bone Mineral Density • Glaucoma and Cataracts • Effects on Growth in Pediatric Patients Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, dysphonia.

No formal drug interaction studies have been performed with AIRSUPRA. • Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution. May cause systemic corticosteroid effects. • Other short-acting bronchodilators: Use judiciously with other short-acting beta agonists. • Beta blockers: May decrease effectiveness of AIRSUPRA and produce severe bronchospasm. When there are no acceptable alternatives to the use of beta-adrenergic-blocking agents, consider cardioselective beta-blockers and use with caution. • Diuretics, or non-potassium-sparing diuretics: May potentiate hypokalemia or ECG changes. Consider monitoring potassium levels with concomitant use. • Digoxin: May decrease serum digoxin levels. Carefully evaluate digoxin levels with concomitant use. • Monoamine oxidase inhibitors (MAOI) and tricyclic antidepressants: Use AIRSUPRA with extreme caution with concomitant use.

Storage Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). For best results, the canister should be at room temperature before use. Exposure to temperatures above 49°C (120°F) may cause bursting. Do not use or store near heat or open flame.