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:

Rhodes Pharmaceuticals L.P.

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, 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. Risk Summary There are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmen

Product samenvatting:

Formoterol fumarate inhalation solution 20 mcg/ 2 mL is supplied as a 2 mL sterile clear, colorless 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 42858-094-35 Carton of 60 individually wrapped unit dose vials, NDC 42858-094-62 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:

Abbreviated New Drug Application

Productkenmerken

FORMOTEROL FUMARATE - FORMOTEROL FUMARATE DIHYDRATE SOLUTION
RHODES PHARMACEUTICALS L.P.
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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
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Formoterol Fumarate Inhalation Solution is a long-acting beta
-adrenergic agonist (beta -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)
DOSAGE AND ADMINISTRATION
For oral inhalation only.
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)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit dose vial for nebulization); 20 mcg/2 mL
solution (3)
CONTRAINDICATIONS
Use of a LABA, including Formoterol Fumarate, without an inhaled
corticosteroid is contraindicated in
patients with asthma. (4)
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
-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
-agonists, can result in clinically