FORMOTEROL FUMARATE- formoterol fumarate dihydrate solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)

Beschikbaar vanaf:

Mylan Pharmaceuticals Inc.

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. 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 treat asthma. The safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. 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. There are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated

Product samenvatting:

Formoterol Fumarate Inhalation Solution is supplied as a 2 mL 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. Carton of 30 individually wrapped unit-dose vials, NDC 0378-1631-93 Carton of 60 individually wrapped unit-dose vials, NDC 0378-1631-91 Storage and Handling: Prior to dispensing to the patient:   Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat. After dispensing to the patient:  Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

FORMOTEROL FUMARATE- FORMOTEROL FUMARATE DIHYDRATE SOLUTION
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FORMOTEROL FUMARATE
INHALATION SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FORMOTEROL FUMARATE INHALATION SOLUTION.
FORMOTEROL FUMARATE INHALATION SOLUTION, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Formoterol fumarate inhalation solution is a long-acting beta
-adrenergic agonist (beta -agonist) indicated
for:
•
Important limitations of use:
•
•
DOSAGE AND ADMINISTRATION
For oral inhalation only.
•
•
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit-dose vial for nebulization); 20 mcg/2 mL
solution (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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ADVERSE REACTIONS
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.
2
2
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)
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)
One 20 mcg/2 mL vial every 12 hours (2)
For use with a standard jet nebulizer (with a facemask or mouthpiece)
connected to an air
compressor (2)
Use of a LABA, including formoterol fumarate inhalation solution,
without an inhaled corticosteroid is
contraindicated in patients with asthma. (4)
LABA as monotherapy (without inhaled corticosteroid) for asthma
increases the risk of serious
asthma-related events. (5.1)
Do not initiate fo