Generic Name and Formulations:
Glycopyrrolate 9mcg, formoterol fumarate 4.8mcg; per inhalation; metered-dose inhaler.
Company:
AstraZeneca Pharmaceuticals
 
Select therapeutic use: Asthma/COPD
Indications for BEVESPI AEROSPHERE:
Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema.

Limitations Of use:
Not for the relief of acute bronchospasm or for the treatment of asthma.

Adult:
2 inhalations twice daily (in the AM + PM). Max 2 inhalations twice daily.

Children:
Not established.

Contraindications:
LABA use in asthma patients without use of long-term control medication.

Warnings/Precautions:
LABAs increase risk of asthma-related death. Not recommended for treating asthma. Do not initiate in patients during acutely deteriorating or potentially life-threatening COPD episodes. Not for treating acute symptoms. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Discontinue immediately and treat if paradoxical bronchospasm or immediate hypersensitivity reactions occur; use alternative therapy. Cardiovascular disorders (eg, coronary insufficiency, cardiac arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Hepatic disease; monitor. Severe renal impairment or ESRD requiring dialysis. Pregnancy (Cat.C). Labor & delivery. Nursing mothers: not recommended.

Interactions:
Not for use with other drugs containing LABAs. Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Concomitant xanthine derivatives, steroids, or diuretics may potentiate hypokalemia. Caution with non-K+-sparing diuretics. Extreme caution with MAOIs, tricyclics, or others that prolong QTc interval. Antagonized by β-blockers; if needed, use cardioselective agents if no acceptable alternatives. Additive effects with concomitant other anticholinergic-containing drugs; avoid.

Pharmacological Class:
Anticholinergic + long-acting beta-2 agonist.

Adverse Reactions:
UTI, cough; paradoxical bronchospasm, hypersensitivity reactions, cardiovascular effects.

Generic Availability:
NO

How Supplied:
Inhalation aerosol—10.7g (120 inh)