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Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. There are no data on the effects of acute or chronic overdosage with VERAMYST Nasal Spray. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical trials (with dosages of up to 440 mcg/day for 2 weeks [4 times the maximum recommended daily dose]), overdose is unlikely to require any therapy other than observation.
Intranasal administration of up to 2,640 mcg/day (24 times the recommended adult dose) of fluticasone furoate was administered to healthy human volunteers for 3 days. Single-and repeat-dose trials with orally inhaled fluticasone furoate doses of 50 to 4,000 mcg have shown decreased mean serum cortisol at doses of 500 mcg or higher. The oral median lethal dose in mice and rats was > 2,000 mg/kg (approximately 74,000 and 147,000 times, respectively, the maximum recommended daily intranasal dose in adults and 52,000 and 105,000 times, respectively, the maximum recommended daily intranasal dose in children, on a mcg/m² basis).
Acute overdosage with the intranasal dosage form is unlikely since 1 bottle of VERAMYST Nasal Spray contains approximately 3 mg of fluticasone furoate, and the bioavailability of fluticasone furoate is < 1% for 2.64 mg/day given intranasally and 1% for 2 mg/day given as an oral solution.
VERAMYST Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 6/10/2015
This monograph has been modified to include the generic and brand name in many instances.
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