DRUG INTERACTIONS
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Other adrenergic drugs may potentiate effect. Use with caution. ( 5.3, 7.1)
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Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 5.7, 7.2, 7.3)
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MAO inhibitors, tricyclic antidepressants and drugs that prolong QTc interval may potentiate effect on the cardiovascular system. Use with extreme caution. ( 7.4)
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Beta-blockers may decrease effectiveness. Use with caution and only when medically necessary. ( 7.5)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2013
FULL PRESCRIBING INFORMATION: CONTENTS*     
1 INDICATIONS AND USAGE
1.1 Maintenance Treatment of COPD 1.2 Important Limitations of Use 2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Asthma-Related Deaths 5.2 Deterioration of Disease and Acute Episodes 5.3 Excessive Use and Use with Other Long-Acting Beta2-Agonists 5.4 Paradoxical Bronchospasm 5.5 Cardiovascular Effects 5.6 Coexisting Conditions 5.7 Hypokalemia and Hyperglycemia 5.8 Immediate Hypersensitivity Reactions 6 ADVERSE REACTIONS
6.1 Beta2-Agonist Adverse Reaction Profile 6.2 Clinical Trials Experience 6.3 Postmarketing Experience 7 DRUG INTERACTIONS
7.1 Adrenergic Drugs 7.2 Xanthine Derivatives, Steroids, or Diuretics 7.3 Non-potassium Sparing Diuretics 7.4 MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs 7.5 Beta-blockers 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Pharmacology 14 CLINICAL STUDIES
14.1 Adult COPD Trial 16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 Maintenance Treatment of COPDPERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
1.2 Important Limitations of UsePERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)].
PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.
2 DOSAGE AND ADMINISTRATION
The recommended dose of PERFOROMIST (formoterol fumarate) Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended.
PERFOROMIST Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of PERFOROMIST Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus