Clinical Information
Gen. Code and Des.
81399 fluticasone propion/salmeterol INHALATION AER PW BAS 55-14 MCG
GCN and Des.
48489 fluticasone propion/salmeterol INHALATION AER PW BAS 55-14 MCG
Strength
55-14 MCG
Dose Form
AEROSOL POWDER, BREATH ACTIV WITH SENSOR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
48100808 ORALLY INHALED PREPARATIONS (STEROIDS)
68040000 ADRENALS
48120412 SELECT.BETA-2-ADRENERGIC AGONIST(RESPIR)
12120812 SELECTIVE BETA-2-ADRENERGIC AGONISTS
Active Ingredients
3593 fluticasone propionate 80474142
4037 salmeterol xinafoate 94749083
Inactive Ingredients
2432 lactose 64044515
8922 milk
These highlights do not include all the information needed to use AIRDUO® DIGIHALER® safely and effectively. See full prescribing information for AIRDUO DIGIHALER.
AIRDUO DIGIHALER (fluticasone propionate and salmeterol) inhalation powder, for oral inhalation use
Initial U.S. Approval: 2000
INDICATIONS AND USAGE
AirDuo Digihaler is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta2-adrenergic agonist (LABA), indicated for treatment of asthma in patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). (1)
Limitations of Use: Not indicated for the relief of acute bronchospasm. (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
Starting dosage is based on prior asthma therapy and disease severity. (2.2)
1 inhalation of AirDuo Digihaler 55/14 mcg, 113/14 mcg, or 232/14 mcg twice daily. (2.2)
Do not use with a spacer or volume holding chamber. (2.2)
AirDuo Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events for transmission to mobile App. Use of the App is not required for administration of medication to the patient. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg of fluticasone propionate/salmeterol in each actuation. (3)
AirDuo Digihaler contains a built-in electronic module. (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. (4)
Severe hypersensitivity to milk proteins or any ingredients of AirDuo Digihaler. (4)
WARNINGS AND PRECAUTIONS
LABA monotherapy increases the risk of serious asthma-related events. (5.1)
Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.2)
Do not use in combination with an additional medicine containing LABA because of risk of overdose. (5.3)
Localized infections: Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. (5.4)
Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infection, or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.5)
Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to AirDuo Digihaler. (5.6)
Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue AirDuo Digihaler slowly. (5.7)
Paradoxical bronchospasm: Discontinue AirDuo Digihaler and institute alternative therapy if paradoxical bronchospasm occurs. (5.9)
Use with caution in patients with cardiovascular or central nervous system disorders because of beta adrenergic stimulation. (5.11)
Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.12)
Monitor growth of pediatric patients. (5.13)
Close monitoring for glaucoma and cataracts is warranted. (5.14)
Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. (5.15, 5.17)
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.16)
ADVERSE REACTIONS
Most common adverse reactions (greater than or equal to 3%): nasopharyngitis, oral candidiasis, headache, cough and back pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Avoid strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): May increase risk of systemic corticosteroid and cardiovascular effects. (7.1)
Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. (7.2)
Beta�'blockers: Use with caution. May block bronchodilatory effects of beta�'agonists and produce severe bronchospasm. (7.3)
Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non�'potassium�'sparing diuretics may worsen with concomitant beta�'agonists. (7.4)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor for systemic corticosteroid effects. (8.6)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2022
