AIRSUPRA 90 ug/1
Albuterol sulfate and budesonide · AEROSOL, METERED · AstraZeneca Pharmaceuticals LP
AIRSUPRA is a aerosol, metered containing albuterol sulfate and budesonide at 90 ug/1, taken respiratory (inhalation). Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- AIRSUPRA
- Generic Name
- Albuterol sulfate and budesonide
- NDC Code (Product)
0310-9080- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 90 ug/1
- Dosage Form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA214070
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 10/02/2023
Recall History
AsttraZeneca Pharmaceuticals LP
Defective delivery system
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 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…
Contraindications
4 CONTRAINDICATIONS 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 )
Drug Interactions
7 DRUG INTERACTIONS 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 s…
Adverse Reactions
6 ADVERSE REACTIONS 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 …
Frequently Asked Questions
What is AIRSUPRA used for?
AIRSUPRA contains Albuterol sulfate and budesonide. It is a aerosol, metered taken respiratory (inhalation). Consult your doctor for specific uses.
Is AIRSUPRA a controlled substance?
AIRSUPRA is not classified as a controlled substance by the DEA.
What is the generic name for AIRSUPRA?
The generic name for AIRSUPRA is Albuterol sulfate and budesonide. There are no other listed brand versions of Albuterol sulfate and budesonide.
What is the NDC code for AIRSUPRA 90 ug/1?
The NDC (National Drug Code) for AIRSUPRA 90 ug/1 is 0310-9080, listed by AstraZeneca Pharmaceuticals LP.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)