Overdose : מינון יתר

4.9     Overdose
No data are available in humans regarding overdose by accidental or deliberate ingestion.
Olopatadine has a low order of acute toxicity in animals. Accidental ingestion of the entire contents of a bottle of PATANOL would deliver a maximum systemic exposure of 5 mg olopatadine. This exposure would result in a final dose of 0.5 mg/kg in a 10 kg infant, assuming 100% absorption.

Prolongation of the QTc interval in dogs was observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. A 5 mg oral dose was administered twice-daily for 2.5 days to 102 young and elderly male and female healthy volunteers with no significant prolongation of QTc interval compared to placebo. The range of peak steady-state olopatadine plasma concentrations (35 to 127 ng/ml) seen in this study represents at least a 70-fold safety margin for topical olopatadine with respect to effects on cardiac repolarisation.



PAT API MAY21 V3                                                                             EU update In the case of overdose, appropriate monitoring and management of the patient should be implemented.