Classes
DEA Class; Rx
Common Brand Names; Bevespi Aerosphere
- Anticholinergics, Respiratory;
- Beta2 Agonists;
- Respiratory Inhalant Combos;
- COPD Agents
Description
Combination of an inhaled long-acting antimuscarinic agent (LAMA), (glycopyrrolate) with a long-acting beta-2 adrenergic agonist (LABA), (formoterol)
Used in adults for the maintenance treatment of COPD, including chronic bronchitis and/or emphysema
Not indicated for the relief of acute bronchospasm or for the treatment of asthma
Indications
Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema)
Contraindications
Hypersensitivity
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication; not indicated for the treatment of asthma
Adverse Effects
- Cough (4%)
- Urinary tract infection (2.6%)
- Arthralgia (<2%)
- Chest pain (<2%)
- Tooth abscess (<2%)
- Muscle spasms (<2%)
- Headache (<2%)
- Oropharyngeal pain (<2%)
- Vomiting (<2%)
- Pain in extremity (<2%)
- Dizziness (<2%)
- Anxiety (<2%)
- Dry mouth (<2%)
- Fall (<2%)
- Influenza (<2%)
- Fatigue (<2%)
- Acute sinusitis (<2%)
- Contusion (<2%)
Warnings
Do not use more often than recommended, at higher doses than recommended, or in combination with additional therapy containing a LABA because of risk of overdose; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic medicines; patients using drug should not use another medicine containing a LABA for any reason
Can produce paradoxical bronchospasm that may be life-threatening; treat immediately with an inhaled, short-acting bronchodilator, discontinue therapy, and institute alternative therapy
Immediate hypersensitivity reactions have been reported after administration of formoterol or glycopyrrolate; if signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips, and face), urticaria, or skin rash, therapy should be stopped at once and alternative treatment considered
Therapy should be used with caution in patients with narrow-angle glaucoma; prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (eg, eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema); instruct patients to consult a physician immediately should any of these signs or symptoms develop
Pregnancy and Lactation
There are no well-controlled human trials that have investigated the effects on preterm labor or labor at term; because beta 2 agonists may potentially interfere with uterine contractility, drug should be used during labor only if potential benefit justifies potential risk
There are no available data on effects of glycopyrrolate, or formoterol fumarate on breastfed child or milk production
There are no available data on presence of glycopyrrolate or formoterol fumarate in human milk
Maximum Dosage
36 mcg/day of glycopyrrolate and 19.2 mcg/day of formoterol via oral inhalation (i.e., 2 inhalations twice daily of Bevespi Aerosphere).
36 mcg/day of glycopyrrolate and 19.2 mcg/day of formoterol via oral inhalation (i.e., 2 inhalations twice daily of Bevespi Aerosphere).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.