in patients with cardiovascular or central nervous systemdisorders because of beta adrenergic stimulation. (5.11)
Decreases in bone mineral density: Monitor patients with major risk factorsfor 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 (reported in greater than or equal to 3% ofpatients) include nasopharyngitis, oral candidiasis, headache, cough and backpain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact TevaRespiratory, LLC at 1-888-483-8279 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Usenot recommended. May increase risk of systemic corticosteroid andcardiovascular effects. (7.1)
Monoamine oxidase inhibitors and tricyclic antidepressants: Use withextreme caution. May potentiate effect of salmeterol on vascularsystem. (7.2)
Beta-blockers: Use with caution. May block bronchodilatory effects ofbeta-agonists and produce severe bronchospasm. (7.3)
Diuretics: Use with caution. Electrocardiographic changes and/orhypokalemia associated with non-potassium-sparing diuretics may worsenwith 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 FDAapproved
patient labeling.
Revised: 07/2019
----------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Recommended Dosage
2.3 Cleaning the Inhaler
2.4 Dose Counter and Storage of Inhaled Events Data
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Status Asthmaticus
4.2 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.1 Serious Asthma-Related Events - Hospitalizations, Intubations,Death
5.2 Deterioration of Disease and Acute Episodes
5.3 Excessive Use of AirDuo Digihaler and Use with Other LongActingBeta2-Agonists
5.4 Local Effects of Inhaled Corticosteroids
5.5 Immunosuppression
5.6 Transferring Patients from Systemic Corticosteroid Therapy
5.7 Hypercorticism and Adrenal Suppression
5.8 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors
5.9 Paradoxical Bronchospasm and Upper Airway Symptoms
5.10 Hypersensitivity Reactions, Including Anaphylaxis
5.11 Cardiovascular and Central Nervous System Effects
5.12 Reduction in Bone Mineral Density
5.13 Effect on Growth
5.14 Glaucoma and Cataracts
5.15 Eosinophilic Conditions and Churg-Strauss Syndrome
5.16 Coexisting Conditions
5.17 Hypokalemia and Hyperglycemia
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience in Asthma
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Inhibitors of Cytochrome P450 3A4
7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants
7.3 Beta-Adrenergic Receptor Blocking Agents
7.4 Non-Potassium-Sparing Diuretics
8 USE IN SPECIFIC POPULATION |
