Perforomist 20 ug/2mL
formoterol fumarate dihydrate · SOLUTION · Viatris Specialty LLC
Perforomist is a solution containing formoterol fumarate dihydrate at 20 ug/2mL, taken respiratory (inhalation). Manufactured by Viatris Specialty LLC.
Key Facts
- Brand Name
- Perforomist
- Generic Name
- formoterol fumarate dihydrate
- NDC Code (Product)
49502-605- Manufacturer
- Viatris Specialty LLC
- Strength
- 20 ug/2mL
- Dosage Form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA022007
- Marketing Start
- 10/01/2007
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PERFOROMIST Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: • 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. ( 1.1 ) Important limitations of use: • PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) • PERFOROMIST Inhalation Solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD PERFOROMIST (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 Use PERFOROMIST 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 safet…
Dosage & Administration
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 ® nebulizer (with a facemask or mouthpiece) and the PRONEB ® Ultra compressor. The safety and efficacy of PERFOROMIST Inhalation Solution delivered from non-compressor based nebulizer systems have not been established. PERFOROMIST Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded. If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and…
Contraindications
4 CONTRAINDICATIONS 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 )
Drug Interactions
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 with extreme caution. ( 7.4 ) • Beta-blockers may decrease effectiveness. Use with caution and only when medically necessary. ( 7.5 ) 7.1 Adrenergic Drugs If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol may be potentiated [see WARNINGS AND PRECAUTIONS (5.3 , 5.5 , 5.6 , 5.7) ]. 7.2 Xanthine Derivatives, Steroids, or Diuretics Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists [see WARNINGS AND PRECAUTIONS (5.7) ]. 7.3 Non-potassium Sparing Diuretics The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsen…
Adverse Reactions
6 ADVERSE REACTIONS 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 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta 2 -adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis. 6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compar…
Frequently Asked Questions
What is Perforomist used for?
Perforomist contains formoterol fumarate dihydrate. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.
Is Perforomist a controlled substance?
Perforomist is not classified as a controlled substance by the DEA.
What is the generic name for Perforomist?
The generic name for Perforomist is formoterol fumarate dihydrate. There are 6 other brand versions of formoterol fumarate dihydrate.
What is the NDC code for Perforomist 20 ug/2mL?
The NDC (National Drug Code) for Perforomist 20 ug/2mL is 49502-605, listed by Viatris Specialty LLC.