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Single doses of Xenical 800 mg and multiple doses of up to 400 mg 3 times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings. In addition, doses of 240 mg 3 times daily have been administered to obese patients for 6 months without significant increase of adverse findings.
Orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.
Should a significant overdose of Xenical occur, it is recommended that the patient be observed for 24 hrs. Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
