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Bevespi Aerosphere Generic Name & Formulations
Legal Class
Rx
General Description
Glycopyrrolate 9mcg, formoterol fumarate 4.8mcg; per inhalation; metered-dose inhaler.
Pharmacological Class
Anticholinergic + long-acting beta-2 agonist (LABA).
How Supplied
Inhalation aerosol—10.7g (120 inh)
Manufacturer
Generic Availability
NO
Bevespi Aerosphere Indications
Indications
Maintenance treatment of COPD.
Limitations of Use
Not indicated for relief of acute bronchospasm or for treatment of asthma.
Bevespi Aerosphere Dosage and Administration
Adult
2 inhalations twice daily (in the AM + PM). Max 2 inhalations twice daily.
Children
Not established.
Bevespi Aerosphere Contraindications
Contraindications
Use of LABA without inhaled corticosteroid (ICS) in asthma.
Bevespi Aerosphere Boxed Warnings
Not Applicable
Bevespi Aerosphere Warnings/Precautions
Warnings/Precautions
LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acute deteriorating COPD. Not for relief of 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 bronchospasms or 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. Labor & delivery. Nursing mothers.
Bevespi Aerosphere Pharmacokinetics
See Literature
Bevespi Aerosphere Interactions
Interactions
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.
Bevespi Aerosphere Adverse Reactions
Adverse Reactions
UTI, cough; paradoxical bronchospasm, hypersensitivity reactions, cardiovascular effects.
Bevespi Aerosphere Clinical Trials
See Literature
Bevespi Aerosphere Note
Not Applicable
Bevespi Aerosphere Patient Counseling
See Literature
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