Dymista Overdosage

Azelastine hydrochloride: There have been no reported of azelastine hydrochloride overdosage. Acute azelastine hydrochloride overdosage is increased somnolence. Since one bottle contains approximately 17 mg of azelastine hydrochloride and single dose of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse events.
In mice given oral azelastine hydrochloride >120 mg/kg body weight (480 times of the maximum recommended human daily nasal dose based on mg/m²) caused significant mortality, preceded by tremor, convulsion, decreased muscle tone and salivation. In dogs, 10 mg/kg or 270 times of the maximum recommended human daily nasal dose (mg/m² basis) as a single dose did not reveal any overdosage signs or symptoms but 20 mg/kg dosing caused lethal.
General supportive measures should be employed if overdosage occurs because there is no specific antidote for azelastine hydrochloride.
Fluticasone propionate: 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. In contrast, oral doses 40 mg to 80 mg daily for 10 days caused hypothalamus-Pituitary-Adrenal axis suppression.
In animal studies, given high-dose fluticasone propionate via subcutaneous, oral and inhalation shown reversible thymus gland depletion and gastric ulcer.
If chronic overdose symptoms occur, fluticasone propionate should be gradually discontinued.