FLOVENT DISKUS- fluticasone propionate powder, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

Available from:

GlaxoSmithKline LLC

INN (International Name):

FLUTICASONE PROPIONATE

Composition:

FLUTICASONE PROPIONATE 100 ug

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm. The use of FLOVENT DISKUS is contraindicated in the following conditions: Risk Summary There are insufficient data on the use of FLOVENT DISKUS in pregnant women. There are clinical considerations with the use of FLOVENT DISKUS in pregnant women. (See Clinical Considerations.) In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m2 basis. (See Data.) However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on

Product summary:

FLOVENT DISKUS 50 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0600-02). FLOVENT DISKUS 100 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0602-02). FLOVENT DISKUS 250 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0601-02). Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. FLOVENT DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard FLOVENT DISKUS 6 weeks (50-mcg strength) or 2 months (100- and 250-mcg strengths) after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Authorization status:

New Drug Application

Summary of Product characteristics

FLOVENT DISKUS- FLUTICASONE PROPIONATE POWDER, METERED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLOVENT DISKUS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLOVENT DISKUS.
FLOVENT DISKUS (FLUTICASONE PROPIONATE INHALATION POWDER), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
FLOVENT DISKUS is an inhaled corticosteroid (ICS) indicated for:
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Important limitation:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Inhalation powder: Inhaler containing fluticasone propionate (50, 100,
or 250 mcg) as a powder formulation
for oral inhalation. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence >3%) include upper
respiratory tract infection or
inflammation, throat irritation, sinusitis, rhinitis, oral
candidiasis, nausea and vomiting, gastrointestinal
discomfort, fever, cough, bronchitis, and headache. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Maintenance treatment of asthma as prophylactic therapy in patients
aged 4 years and older. (1)
Not indicated for relief of acute bronchospasm. (1)
For oral inhalation only. (2.1)
Starting dosage is based on prior asthma therapy and disease severity.
(2.2)
Treatment of asthma in patients aged 12 years and older: 100 mcg twice
daily up to a maximum
recommended dosage of 1,000 mcg twice daily. (2.2)
Treatment of asthma in patients aged 4 to 11 years: 50 mcg twice daily
up to a maximum
recommended dosage of 100 mcg twice daily. (2.2)
Primary treatment of status asthmaticus or acute episodes of asthma
requiring intensive measures.
(4)
Severe hypersensitivity to milk proteins or demonstrated
hypersensitivity to fluticasone propionate.
(4)
_Candida albicans_ infection of the mouth and pharynx may occur.
Monitor patients period