PERFOROMIST

Information on the pharmacokinetics of formoterol (dry powder and/or inhalation solution) in plasma and/or urine is available in healthy subjects as well as patients with chronic obstructive pulmonary disease after oral inhalation of doses at and above the therapeutic dose. Urinary excretion of unchanged formoterol was used as an indirect measure of systemic exposure. Plasma drug disposition data parallel urinary excretion, and the elimination half-lives calculated for urine and plasma are simil...

14.1 Adult COPD Trial PERFOROMIST (formoterol fumarate) Inhalation Solution was evaluated in a 12-week, double-blind, placebo- and active-controlled, randomized, parallel-group, multicenter trial conducted in the United States. Of a total enrollment of 351 adults (age range: 40 to 86 years; mean age: 63 years) with COPD who had a mean pre-bronchodilator FEV 1 of 1.34 liters (44% of predicted), 237 patients were randomized to PERFOROMIST Inhalation Solution 20 mcg or placebo, administered twice daily via a PARI-LC Plus ® nebulizer with a PRONEB ® Ultra compressor. The diagnosis of COPD was base...

Long-acting beta 2 -adrenergic agonists, such as PERFOROMIST, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. PERFOROMIST is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS (5.1) ] . Most common adverse reactions ( > 2% and more common than placebo) are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-87...

Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS (5.1) ] . PERFOROMIST is not indicated for the treatment of asthma.

• Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma. ( 4 )

• LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 )
• Do not initiate PERFOROMIST Inhalation Solution in acutely deteriorating patients. ( 5.2 )
• Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. ( 5.2 )
• Do not exceed the recommended dose. Excessive use of PERFOROMIST Inhalation Solution or use in conjunction with other medications containing long...

7 DRUG INTERACTIONS

• Other adrenergic drugs may potentiate effect. Use with caution. ( 5.3 , 7.1 )
• Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 5.7 , 7.2 , 7.3 )
• MAO inhibitors, tricyclic antidepressants and drugs that prolong QTc interval may potentiate effect on the cardiovascular system. Use wit...