formoterol fumarate 20 ug/2mL
formoterol fumarate · SOLUTION · Lupin Pharmaceuticals, Inc.
formoterol fumarate is a solution containing formoterol fumarate at 20 ug/2mL, taken respiratory (inhalation). Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- formoterol fumarate
- Generic Name
- formoterol fumarate
- NDC Code (Product)
70748-261- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 20 ug/2mL
- Dosage Form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA215053
- Marketing Start
- 11/28/2022
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Novartis Pharmaceuticals Corp.
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Novartis Pharmaceuticals Corp.
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Novartis Pharmaceuticals Corp.
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Formoterol fumarate 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: Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) Formoterol fumarate inhalation solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD 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 Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS ( 5.2 )]. Formoterol fumarate inhalation solution is not indicated to tr…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of 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. Formoterol fumarate 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 formoterol fumarate 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 formoterol fumarate inhalation solution delivered from non-compressor based nebulizer systems have not been established. Formoterol fumarate 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 b…
Contraindications
4 CONTRAINDICATIONS Use of a LABA, including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS ( 5.1 )]. Formoterol fumarate is not indicated for the treatment of asthma. Use of a LABA, including formoterol fumarate, 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 worsened by …
Adverse Reactions
6 ADVERSE REACTIONS Long-acting beta 2 -adrenergic agonists, such as formoterol fumarate, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. Formoterol fumarate 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 Micro Labs USA Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to formoterol fumarate 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 cann…
Frequently Asked Questions
What is formoterol fumarate used for?
formoterol fumarate contains formoterol fumarate. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.
Is formoterol fumarate a controlled substance?
formoterol fumarate is not classified as a controlled substance by the DEA.
What is the generic name for formoterol fumarate?
The generic name for formoterol fumarate is formoterol fumarate. There are 11 other brand versions of formoterol fumarate.
What is the NDC code for formoterol fumarate 20 ug/2mL?
The NDC (National Drug Code) for formoterol fumarate 20 ug/2mL is 70748-261, listed by Lupin Pharmaceuticals, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)