Dymista Overdosage

With the nasal route of administration, overdose reactions are not anticipated.
DYMISTA nasal spray contains both azelastine and fluticasone propionate; therefore, the risks associated with overdosage for the individual components apply to DYMISTA.
With the nasal route of administration, overdosage reactions to azelastine are not anticipated. To date, there has been only one report of incorrect usage: a 2-year-old boy drank approximately 10 mL of azelastine nasal spray. This led to a burning sensation in the nose and mouth and to spontaneous vomiting, these events lasting 5-10 minutes. Pulse rate, blood pressure and respiration were normal and stable, and a normal pupil reaction was found. No tissue damage in the mouth or throat occurred. The boy recovered completely.
In the event of overdosage after accidental oral uptake, disturbances of the central nervous system (including drowsiness, confusion, coma, tachycardia and hypotension) are to be expected based on the results of animal experiments. Symptomatic and supportive treatment should be instigated as there is no known antidote.
Contact the Poisons Information Centre on 13 11 26 for advice on management of overdose.
There are no data available on the effects of acute or chronic overdosage with fluticasone propionate nasal spray. Intra-nasal administration of 2,400 μg fluticasone per day (i.e. 12 times the recommended dose) for four days to healthy human volunteers caused a small degree of suppression of adrenal steroid production.
Suppression of adrenal steroid production may give rise to typical signs and symptoms of Cushing's disease, such as buffalo hump, puffiness of face, hypertension and elevated blood glucose. If such a condition were to occur, care should be taken to wean the patient slowly off the steroid due to the probability of adrenal impairment. Recovery from impaired adrenocortical function caused by prolonged steroid therapy is usually slow and has been known to last up to 12 months.