Formoterol Fumarate
Generic Name: formoterol fumarate
Brand Names:
Formoterol Fumarate
11 DESCRIPTION Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate.
Overview
11 DESCRIPTION Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate.
Uses
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.
Dosage
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.
Side Effects
6 ADVERSE REACTIONS Long-acting beta 2 -adrenergic agonists, such as formoterol fumarate inhalation solution, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. Formoterol fumarate inhalation solution 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 Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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) ].
Warnings
5 WARNINGS AND PRECAUTIONS • LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) • Do not initiate formoterol fumarate 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 formoterol fumarate inhalation solution or use in conjunction with other medications containing long-acting beta 2 -agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3 , 5.5 ) • Life-threatening paradoxical bronchospasm can occur. Discontinue formoterol fumarate inhalation solution immediately. 4 CONTRAINDICATIONS Use of a LABA, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [ see WARNINGS and PRECAUTIONS (5.1) ]. Formoterol fumarate inhalation solution is not indicated for the treatment of asthma.
Pregnancy
8.1 Pregnancy Risk Summary There are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Beta-agonists may interfere with uterine contractility (see Clinical Considerations).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Formoterol fumarate inhalation solution, 20 mcg/2 mL is supplied as clear, colorless sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below.
Frequently Asked Questions
What is Formoterol Fumarate used for?▼
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.
What are the side effects of Formoterol Fumarate?▼
6 ADVERSE REACTIONS Long-acting beta 2 -adrenergic agonists, such as formoterol fumarate inhalation solution, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. Formoterol fumarate inhalation solution 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 Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Formoterol Fumarate during pregnancy?▼
8.1 Pregnancy Risk Summary There are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Beta-agonists may interfere with uterine contractility (see Clinical Considerations).
What are the important warnings for Formoterol Fumarate?▼
5 WARNINGS AND PRECAUTIONS • LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) • Do not initiate formoterol fumarate 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 formoterol fumarate inhalation solution or use in conjunction with other medications containing long-acting beta 2 -agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3 , 5.5 ) • Life-threatening paradoxical bronchospasm can occur. Discontinue formoterol fumarate inhalation solution immediately. 4 CONTRAINDICATIONS Use of a LABA, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [ see WARNINGS and PRECAUTIONS (5.1) ]. Formoterol fumarate inhalation solution is not indicated for the treatment of asthma.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.