Company:

Dey, L.P.

Long acting β₂-agonist

Formoterol (as fumarate) 20mcg/2mL; soln for inh.

Long-term maintenance treatment of COPD-associated bronchoconstriction.

Perforomist is a solution formulation of the long-acting β₂-agonist, formoterol fumarate, which is administered by inhalation via nebulization. It acts as a bronchodilator by stimulating β₂ receptors in the lung. However, it may have cardiac effects due to the presence of β₂ receptors in the heart. The activity of formoterol and related drugs are due in part to the stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of ATP to cyclic AMP. This in turn causes increases in the levels of cyclic AMP, which causes the relaxation of bronchial smooth muscle along with anti-inflammatory effects.

A 12-week, randomized, double-blind, placebo- and active-controlled study was conducted to assess the efficacy of Perforomist in treating adults diagnosed with COPD-associated bronchoconstriction. Perforomist 20mcg twice daily resulted in significantly greater post-dose bronchodilation, compared to a placebo, at endpoint. Patients treated with Perforomist used less rescue albuterol during the trial compared to patients treated with placebo. In this study, 78% of patients had an increase of 15% from baseline FEV₁ after the first dose of Perforomist. In these patients, the median time to onset of bronchodilation was 11.7 minutes. The median time to peak effect was 2 hours after dosing. The effect of Perforomist did not decrease after 12 weeks.

20micrograms (1 vial) by nebulizer twice daily (AM & PM). Use standard jet nebulizer (eg, PARI-LC Plus [with face-mask or mouthpiece]) and air compressor (eg, Proneb Ultra compressor). Perforomist does not need to be diluted before nebulization. It should not be mixed with other drugs.

Not recommended.

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

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

See Contraindications. Caution with MAOIs, tricyclics, others that prolong QTc interval (may cause ventricular arrhythmias). Antagonized by β-blockers. K⁺-depleting diuretics, xanthines, steroids may potentiate hypokalemia. Caution with other adrenergics.

GI upset, nasopharyngitis, dry mouth, dizziness, insomnia; ECG changes or cardiovascular effects (eg, increased BP, tachycardia; consider discontinuing if occur); hypokalemia, hyperglycemia, metabolic acidosis; rarely: paradoxical bronchospasm, increased risk of asthma-related death.

Single-use vials (2mL)—60

For more information call (800) 755-5560 or visit www.Perforomist.com.

9/25/07