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Orlistat had no detectable mutagenic or genotoxic activity as determined by the Ames testa mammalian forward mutation assayV79/HPRTan in vitro clastogenesis assay in peripheral human lymphocytesan unscheduled DNA synthesis assayUDSin rat hepatocytes in cultureand an in vivo mouse micronucleus test.
It is unknown if this drug passes into breast milkConsult your doctor before breast-feeding.
In controlled clinical trials8.8of patients treated with XENICAL discontinued treatment due to adverse eventscompared with 5.0of placebo-treated patientsFor XENICALthe most common adverse events resulting in discontinuation of treatment were gastrointestinal.
Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotenesee DOSAGE AND ADMINISTRATIONand ADVERSE REACTIONSIn additionthe levels of vitamin D and beta-carotene may be low in obese patients compared with non-obese subjectsThe supplement should be taken once a day at least 2 hours before or after the administration of XENICALsuch as at bedtime.
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