Brovana Generic Name & Formulations
Legal Class
Rx
General Description
Arformoterol tartrate 15mcg/2mL; inhalation soln.
Pharmacological Class
Long-acting beta-2 agonist (LABA).
How Supplied
Vials (2mL)—30, 60
Manufacturer
Generic Availability
YES
Brovana Indications
Indications
Long-term maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema.
Limitations of Use
Not indicated to treat acute deteriorations of COPD or for treatment of asthma.
Brovana Dosage and Administration
Adult
By nebulizer: 15mcg by inhalation twice daily (AM & PM); max 30mcg/day. Use standard jet (eg, PARI LC Plus) nebulizer with air compressor (eg, PARI DURA-NEB 3000). Reevaluate periodically.
Children
Not established.
Elderly
No dose adjustment required.
Renal Impairment
Systemic exposure to arformoterol was similar to renally impaired patients compared with demographically matched healthy individuals.
Hepatic Impairment
Should be used cautiously in patients with hepatic impairment due to increased systemic exposure in these patients.
Brovana Contraindications
Contraindications
Use of LABA without inhaled corticosteroid (ICS) in asthma.
Brovana Boxed Warnings
Not Applicable
Brovana 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 if paradoxical bronchospasm or cardiovascular effects occur. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Monitor potassium and blood glucose levels. Hepatic impairment. Pregnancy. Labor & delivery. Nursing mothers.
Brovana Pharmacokinetics
Absorption
Median steady-state peak (R,R)-formoterol plasma concentration time (tmax) was observed approximately one-half hour after drug administration.
Distribution
Binding of arformoterol to human plasma proteins in vitro was 52-65%.
Elimination
Mean terminal half-life of arformoterol was 26 hours.
Brovana Interactions
Interactions
See Contraindications. Avoid other sympathomimetics (except short-acting bronchodilators). Caution with MAOIs, tricyclics, or drugs known to prolong the QTc interval; may increase risk of arrhythmias. Antagonized by β-blockers. K+-depleting diuretics, theophylline, aminophylline, steroids may potentiate hypokalemia.
Brovana Adverse Reactions
Adverse Reactions
Pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema, lung disorder; cardiovascular effects (eg, increased pulse rate or BP, ECG changes); rarely: paradoxical bronchospasm, hypersensitivity reactions.
Brovana Clinical Trials
Brovana Note
Not Applicable
Brovana Patient Counseling
Cost Savings Program
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