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Basic Drug Info
Drug Name:Fluticasone Propionate
Manufacturer:E. FOUGERA and CO.
Other Info:

Psoriasis Studies: In 2 vehicle-controlled studies, Fluticasone Propionate Cream, 0.05% applied twice daily was significantly more effective than the vehicle in the treatment of moderate to severe psoriasis.

The investigator's global evaluation after 28 days of treatment is shown in Table 3.Table 3: Physician's Assessment of Clinical Response Fluticasone Propionate Cream.

0.05%Vehicle Study 1(n = 59)Study 2(n = 74)Study 1(n = 66)Study 2(n = 75) The clinical signs of psoriasis were scored on a scale of 0 = absent, 1 = mild, 2= moderate, and 3= severe.

The mean improvements over baseline in the clinical signs at the end of treatment are shown in Table 4. Cleared8%1%3%1% Excellent29%28%11%17% Good27%34%20%28% Fair27%15%33%25% Poor7%22%24%27% Worse2%0%9%1% Table 4: Clinical Signs: Mean Improvements Over Baseline Fluticasone Propionate Cream.

0.05%Vehicle Study 1Study 2Study 1Study 2 Atopic Dermatitis Studies: In 2 controlled 28-day studies.

Fluticasone Propionate Cream, 0.05% once daily was equivalent to Fluticasone Proprionate Cream, 0.05% twice daily in the treatment of moderate to severe eczema.

The investigator's global evaluation after 28 days of treatment is shown in Table 5. ErythemaThickening Scaling1.191.221.531.071.171.390.550.810.950.840.971.21 Table 5: Physician's Assessment of Clinical Response Fluticasone Propionate Cream, 0.05%Once DailyFluticasone Propionate Cream, 0.05%Twice Daily Study 1(n = 64)Study 2(n = 106)Study 1(n = 65)Study 2(n = 100) The clinical signs and symptoms of atopic dermatitis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe.

The mean improvements over baseline at the end of treatment are shown in Table 6. Cleared30%20%48%21% Excellent42%32%32%50% Good17%26%5%12% Fair3%14%6%10% Poor5%3%8%4% Worse3%6%2%3% Table 6: Clinical Signs and Symptoms: Mean Improvements Over Baseline Fluticasone Propionate Cream, 0.05%Once DailyFluticasone Propionate Cream.

0.05%Twice Daily Study 1Study 2Study 1Study 2 Erythema1.71.51.81.7 Pruritus2.11.62.11.7 Thickening1.61.31.61.5 Lichenification1.21.21.21.3 Vesiculation0.50.40.50.5 Crusting0.60.70.80.8



Clinical Trials:


Indications and Usage

Fluticasone Propionate Cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Fluticasone Propionate Cream, 0.05% may be used with caution in pediatric patients 3 months of age or older.

The safety and efficiency of drug use for longer than 4 weeks in this population have not been established.

The safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients below 3 months of age have not been established.
Dermatologic disorders -- impairment of health or a condition of abnormal functioning of the skin.

Contraindications
Fluticasone Propionate Cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Branded Drugs
The following US Branded drugs contain Fluticasone Propionate


FLOVENT -- GLAXOSMITHKLINE

FLOVENT HFA -- GLAXO GROUP LTD DBA GLAXOSMITHKLINE

CUTIVATE -- ALTANA INC

CUTIVATE -- NYCOMED US INC

FLOVENT DISKUS 100 -- GLAXOSMITHKLINE

FLOVENT DISKUS 250 -- GLAXOSMITHKLINE

FLOVENT DISKUS 50 -- GLAXOSMITHKLINE

FLONASE -- GLAXOSMITHKLINE

ADVAIR HFA -- GLAXOSMITHKLINE

ADVAIR DISKUS 100/50 -- GLAXOSMITHKLINE

ADVAIR DISKUS 250/50 -- GLAXOSMITHKLINE

ADVAIR DISKUS 500/50 -- GLAXOSMITHKLINE


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