airsupra

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. ( 2.1 ) • Do not take more than 6 doses (12 inhalations) in a 24-hour period. ( 2.1 ) • Prime inhaler prior to first use. Re-prime when inhaler has not been used for more than 7 days, is dropped, or after cleaning. ( 2.2 ) • Discard when the dose counter displays 0. ( 2.3 ) 2.1 Recommended Dosage and Administration The recommended dosage of AIRSUPRA is albuterol 180 mcg and budesonide 160 mcg (administered as 2 actuations of AIRSUPRA [albuterol/budesonide 90 mcg/80 mcg]) as needed for asthma symptoms by oral inhalation. Do not take more than 6 doses (12 inhalations) in a 24-hour period [see Warnings and Precautions (5.4) ] . 2.2 Priming Before Use • Priming AIRSUPRA is essential to ensure appropriate drug content in each actuation. Prime AIRSUPRA before using for the first time. To prime AIRSUPRA, release 4 sprays into the air away from the face, shaking well before each spray. • AIRSUPRA must be re-primed when the inhaler has not been used for more than 7 days, is dropped, or after cleaning. To re-prime AIRSUPRA, release 2 sprays into the air away from the face, shaking well before each spray. 2.3 Dose Counter The canister has an attached dose indicator (also known as puff indicator) which indicates how many…

The following clinically significant adverse reactions are described elsewhere in labeling: • Deterioration of Asthma [see Warnings and Precautions (5.1) ] • Paradoxical Bronchospasm [see Warnings and Precautions (5.2) ] • Cardiovascular Effects [see Warnings and Precautions (5.3) ] • Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions (5.5) ] • Hypokalemia [see Warnings and Precautions (5.7) ] • Immunosuppression and Risk of Infections [see Warnings and Precautions (5.8) ] • Oropharyngeal Candidiasis [see Warnings and Precautions (5.9) ] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.10) ] • Reduction in Bone Mineral Density [see Warnings and Precautions (5.11) ] • Glaucoma and Cataracts [see Warnings and Precautions (5.12) ] • Effects on Growth in Pediatric Patients [see Warnings and Precautions (5.14) ] Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, dysphonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.…

AIRSUPRA is contraindicated in patients with a history of hypersensitivity to albuterol, budesonide, or any of the excipients [see Warnings and Precautions (5.5) , Description (11) ] . Hypersensitivity to albuterol, budesonide, or to any of the excipients. ( 4 )

AIRSUPRA contains both albuterol and budesonide; therefore, the risks associated with overdosage for the individual components described below apply to AIRSUPRA. Albuterol The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/minute, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, and metabolic acidosis). Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of AIRSUPRA. Treatment consists of discontinuation of AIRSUPRA together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of AIRSUPRA. Budesonide If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur [see Warnings and Precautions (5.10) ] .

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

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. ( 7.1 ) • Other short-acting bronchodilators: Use judiciously with other short-acting beta agonists. ( 7.2 ) • 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. ( 7.3 ) • Diuretics, or non-potassium-sparing diuretics: May potentiate hypokalemia or ECG changes. Consider monitoring potassium levels with concomitant use. ( 7.4 ) • Digoxin: May decrease serum digoxin levels. Carefully evaluate digoxin levels with concomitant use. ( 7.5 ) • Monoamine oxidase inhibitors (MAOI) and tricyclic antidepressants: Use AIRSUPRA with extreme caution with concomitant use. ( 7.6 ) 7.1 Inhibitors of Cytochrome P450 3A4 The main route of metabolism of corticosteroids, including budesonide, a component of AIRSUPRA, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the co-administration of AIRSUPRA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.11) ] . 7.2 Use with Other Short-Acting Bronchodilators AIRSUPRA contains the short-acting beta-agonist, albuterol. Therefore, concomitant use of additional beta-agonists with AIRSUPRA should be used judiciously to prevent beta-agonist overdose. 7.3 Beta-Blockers Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol, a component of AIRSUPRA, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic-blocking agents in these patients. In this setting, consider cardioselective beta-blockers, although they should be administered with caution. 7.4 Diuretics The ECG changes and/or hypokalemia which may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of AIRSUPRA with non-potassium-sparing diuretics. Consider monitoring potassium levels. 7.5 Digoxin Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and AIRSUPRA. 7.6 Monoamine Oxidase Inhibitors or Tricyclic Antidepressants AIRSUPRA should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.