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OVERDOSE
Chronic overdosage with fluticasone propionate nasal
spray may result in signs/symptoms of hypercorticism (see
PRECAUTIONS). Intranasal administration of 2 mg (10 times
the recommended dose) of fluticasone propionate twice
daily for 7 days to healthy human volunteers was well
tolerated. Single oral doses up to 16 mg have been studied
in human volunteers with no acute toxic effects reported.
Repeat oral doses up to 80 mg daily for 10 days in volunteers
and repeat oral doses up to 10 mg daily for 14 days in
patients were well tolerated. Adverse reactions were of
mild or moderate severity, and incidences were similar
in active and placebo treatment groups. Acute overdosage
with this dosage form is unlikely since one bottle of
fluticasone propionate nasal spray contains approximately
8 mg of fluticasone propionate.
The oral and subcutaneous median lethal doses in mice
and rats were >1000 mg/kg (>20,000 and >41,000
times, respectively, the maximum recommended daily intranasal
dose in adults and >10,000 and >20,000 times, respectively,
the maximum recommended daily intranasal dose in children
on a mg/m2 basis).
CONTRAINDICATIONS
Fluticasone propionate nasal spray is contraindicated
in patients with a hypersensitivity to any of its ingredients.
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