"The U.S. Food and Drug Administration today approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of "...
Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. Inhalation by healthy volunteers of a single dose of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Doses of 1,320 mcg administered to healthy human volunteers twice daily for 7 to 15 days were 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.
No deaths were seen in mice given an oral dose of 1,000 mg/kg (approximately 2,300 and 11.000 times the MRHD for adults and children aged 4 to 11 years, respectively, on a mg/m basis). No deaths were seen in rats given an oral dose of 1,000 mg/kg (approximately 4,600 and 22.000 times the MRHD in adults and children aged 4 to 11 years, respectively, on a mg/m² basis).
The use of FLOVENT HFA is contraindicated in the following conditions:
Last reviewed on RxList: 8/23/2013
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