formoterol fumarate

FORMOTEROL FUMARATE

Manufacturer: Lupin Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The recommended dose is one 20 mcg unit-dose vial administered twice daily by nebulization. Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease or asthma. Use of a LABA, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma.

Key Clinical Findings and Indications

Long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD)
Not indicated to treat acute deteriorations of chronic obstructive pulmonary disease or asthma

Important Safety Information

Warning

Use of a LABA, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma

Contraindications

Use of a LABA, including formoterol fumarate inhalation solution, without an inhaled corticosteroid in patients with asthma

Adverse Reactions

Diarrhea
Nausea
Nasopharyngitis
Dry mouth
Vomiting
Dizziness
Insomnia

Dosing Recommendations

General Guidance

A total daily dose greater than 40 mcg is not recommended

COPD

Adult Dose

One 20 mcg unit-dose vial administered twice daily by nebulization

Pediatric Dose

Not indicated for use in children

Special Population Considerations

Pregnancy

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

Nursing Mothers

Pediatric Use

Formoterol fumarate inhalation solution is not indicated for use in children
The safety and effectiveness of formoterol fumarate inhalation solution in pediatric patients have not been established

Geriatric Use

Of the 586 subjects who received formoterol fumarate inhalation solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over
No overall differences in safety or effectiveness were observed between these subjects and younger subjects