To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
•
Other adrenergic drugs may potentiate effect: Use with caution ( 5.3, 7.1)
•
Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 7.2, 7.3)
•
Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non-potassium sparing diuretics may worsen with concomitant beta 2-agonists. ( 7.3)
•
Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system. ( 7.4)
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Beta-blockers: Use with caution and only when medically necessary. ( 7.5)
•
Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of BEVESPI AEROSPHERE with other anticholinergic-containing drugs. ( 7.6)
USE IN SPECIFIC POPULATIONS
•
Use in patients with severe renal impairment should be considered if the potential benefit of the treatment outweighs the risk. ( 8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: ASTHMA-RELATED DEATH
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1. Asthma-Related Death
5.2. Deterioration of Disease and Acute Episodes
5.3. Excessive Use of BEVESPI and Use with Other Long-Acting Beta2-Agonists
5.4. Paradoxical Bronchospasm
5.5. Immediate Hypersensitivity Reactions
5.6. Cardiovascular Effects
5.7. Coexisting Conditions
5.8. Hypokalemia and Hyperglycemia
5.9. Worsening of Narrow-Angle Glaucoma
5.10. Worsening of Urinary Retention
6 ADVERSE REACTIONS
6.1. Clinical Trials Experience
7 DRUG INTERACTIONS
7.1. Adrenergic Drugs
7.2. Xanthine Derivatives, Steroids, or Diuretics
7.3. Non-Potassium Sparing Diuretics
7.4. Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs
7.5 Beta-Blockers
7.6. Anticholinergics
8 USE IN SPECIFIC POPULATIONS
8.1. Pregnancy
8.2. Labor and Delivery
8.3. Nursing Mothers
8.4. Pediatric Use
8.5. Geriatric Use
8.6. Hepatic Impairment
8.7. Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1. Mechanism of Action
12.2. Pharmacodynamics
12.3. Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1. Dose-Ranging Trials
14.2. Confirmatory Trials
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
BEVESPI AEROSPHERE is a combination of glycopyrrolate and formoterol fumarate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important Limitation of Use: BEVESPI AEROSPHERE is not indicated for the relief of acu