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Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reportedThere have been reports of hepatic failure observed with the use of XENICAL in postmarketing surveillancewith some of these cases resulting in liver transplant or deathsee WARNINGS AND PRECAUTIONSRare cases of hypersensitivity have been reported with the use of XENICALSigns and symptoms have included pruritusrashurticariaangioedemabronchospasm and anaphylaxisVery rare cases of bullous eruption have been reportedRare cases of leukocytoclastic vasculitis have been reportedClinical signs include palpablepurpuramaculopapular lesionsor bullous eruptionAcute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal diseasesee WARNINGS AND PRECAUTIONSPancreatitis has been reported with the use of XENICAL in postmarketing surveillanceNo causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively establishedLower gastrointestinal bleeding has been reported in patients treated with XENICALMost reports are nonserioussevere or persistent cases should be investigated further.

Orlistat is a white to off-white crystalline powderOrlistat is practically insoluble in waterfreely soluble in chloroformand very soluble in methanol and ethanolOrlistat has no pK within the physiological pH range.

The dose-response relationship for orlistat in human volunteers is shown in Figure 1The effect is the percentage of ingested fat excretedreferred to as fecal fat excretion percentageBoth individual dataopen circlesand the curve predicted for the population with the maximum-effect modelcontinuous lineare shown in Figure 1.

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