Flovent

[Fluticasone Propionate]

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FLOVENT Inhalation Aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Hypersensitivity to any of the ingredients of these preparations contraindicates their use (see DESCRIPTION).

OVERDOSAGE

Chronic overdosage may result in signs/ symptoms of hypercorticism (see PRECAUTIONS). Inhalation by healthy volunteers of a single dose of 1,760 or 3,520 mcg of fluticasone propionate inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at doses of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated.

Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups. The oral and subcutaneous median lethal doses in rats and mice were >1,000 mg/ kg (> 2,000 times the maximum human daily inhalation dose based on mg/ m 2 ).