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DYMISTA contains both azelastine hydrochloride and fluticasone propionate; therefore, the risks associated with overdosage for the individual components described below apply to DYMISTA.
There have been no reported overdosages with azelastine hydrochloride. Acute azelastine hydrochloride overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence, since one (1) 23 g bottle of DYMISTA contains approximately 23 mg of azelastine hydrochloride. Clinical trials in adults with single doses of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse events. General supportive measures should be employed if overdosage occurs. There is no known antidote to DYMISTA. Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, DYMISTA should be kept out of the reach of children.
Chronic fluticasone propionate overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND 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 fluticasone propionate 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 (1) 23 g bottle of DYMISTA contains approximately 8.5 mg of fluticasone propionate.
None.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/9/2015
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