Company:

Sepracor

Bronchodilator (long-acting β₂-agonist)

Arformoterol 15micrograms/2mL; soln for inh.

Long-term maintenance treatment of bronchoconstriction due to COPD.

Arformoterol is the (R,R) enantiomer of formoterol, a long-acting β₂-agonist. It is twice as potent as the racemic mixture. Arformoterol is a bronchodilator that relaxes bronchial smooth muscle and inhibits the release of hypersensitivity mediators from mast cells.

Two 12-week trials involving a total of 1,456 patients were conducted to establish the safety and efficacy of arformoterol in the long-term treatment of COPD. Both studies compared 3 doses of arformoterol (15mcg twice daily, 25mcg twice daily, and 50mcg once daily) to placebo, and included the use of salmeterol aerosol 42mcg twice daily as a comparator.

In both studies, the use of arformoterol 15mcg twice daily resulted in significantly greater post-dose bronchodilation compared to placebo. This effect was maintained over 12 weeks. The use of the higher doses of arformoterol did not result in sufficient additional benefit on several endpoints (including FEV₁). After the first 15mcg dose of arformoterol, the median time to onset of bronchodilation (FEV₁ increased by 15%) occurred at 6.7 minutes, and peak bronchodilator effect was usually seen within 1–3 hrs after dosing. Patients treated with arformoterol showed improvements in peak expiratory flow rates and supplemental use of ipratropium and rescue albuterol use, compared to placebo. Tolerance to the bronchodilator effect was seen after 6 weeks of dosing, as shown by a decrease by about one third in bronchodilator effect measured by FEV₁.

By nebulizer: 15micrograms by inhalation twice daily (AM & PM). Use standard jet (eg, PARI LC PLUS) nebulizer with air compressor (eg, PARI DURA-NEB 3000). Reevaluate periodically.

Not recommended.

Not for treatment of acute attacks. Do not initiate in significantly or acutely deteriorating COPD. Concomitant other long-acting β₂-agonists.

Do not exceed recommended dose. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Hepatic impairment. Hyperthyroidism. Hypokalemia. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Monitor potassium. Prescribe a short-acting β₂-agonist for acute symptoms; monitor for increased need. Pregnancy (Cat.C). Labor & delivery. Nursing mothers.

See Contraindications. Avoid other sympathomimetics (except short-acting bronchodilators). Avoid use during or within 2 weeks of MAOIs, tricyclics, others that prolong QTc interval. Antagonized by β-blockers. K+-depleting diuretics, theophylline, aminophylline, steroids may potentiate hypokalemia.

Asthenia, fever, bronchitis, headache, GI upset, serum K+ changes, leukocytosis, nervousness, pain, tremor, flu syndrome; cardiovascular effects (eg, increased pulse rate or BP; consider discontinuing if occurs); rarely: paradoxical bronchospasm, hypersensitivity reactions; increased risk of asthma-related death.

Vials (2mL)—30

For more information call (800) 739-0565 or visit www.Brovana.com

3/28/07