"The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing "...
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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:
- Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity to any of the ingredients of FLOVENT HFA contraindicates their use [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DESCRIPTION]
Last reviewed on RxList: 8/23/2013
This monograph has been modified to include the generic and brand name in many instances.
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