Ryaltris Overdosage

There have been no reported overdosages with RYALTRIS. Accordingly, no data on the effects of acute or chronic overdosage with RYALTRIS are available. RYALTRIS contains both olopatadine hydrochloride and mometasone furoate; therefore, the risks associated with overdosage for the individual components described as follows are expected to apply to RYALTRIS.
Acute overdosage with this dosage form is unlikely since one 30-day (240-metered doses) bottle of RYALTRIS contains approximately 160 mg of olopatadine hydrochloride and 6 mg of mometasone furoate.
Olopatadine Hydrochloride: Symptoms of antihistamine overdose may include drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to olopatadine hydrochloride. Should overdose occur, symptomatic or supportive treatment is recommended, taking into account any concomitantly ingested medications.
No mortality was observed in rats at an intranasal dose of 3.6 mg/kg (approximately 6, 5 and 7 times the MRHD for adults, adolescents ≥12 years of age, and children 6-11 years of age, respectively, by intranasal administration on a mg/m² basis) or in dogs at an oral dose of 5 g/kg (approximately 28,000, 24,000 and 30,000 times the MRHD for adults, adolescents ≥12 years of age, and children 6-11 years of age, respectively, by intranasal administration on a mg/m² basis). The oral median lethal dose in mice and rats were 1,490 mg/kg (approximately 1,200, 1,000 and 1,300 times the MRHD for adults, adolescents ≥12 years of age, and children 6-11 years of age, respectively, by intranasal administration on a mg/m² basis) and 3,870 mg/kg (approximately 6,600, 5,600 and 7,000 times the MRHD for adults, adolescents ≥12 years of age, and children 6-11 years of age, respectively, by intranasal administration on a mg/m² basis).
Mometasone Furoate: Because of low systemic bioavailability (estimated to be <1%) and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation. Treatment can be reinitiated at the usual recommended dose.
Intranasal administration of 1,600 micrograms (8 times the recommended daily dose of mometasone furoate from RYALTRIS) daily for 29 days in healthy human volunteers showed no increased incidence of adverse events. Single intranasal doses up to 4,000 micrograms and oral inhalation doses up to 8,000 micrograms have been studied in human volunteers, with no adverse effects reported. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism (see Precautions).