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In humansDesyrel is well absorbed after oral administration without selective localization in any tissueWhen Desyrel is taken shortly after ingestion of foodthere may be an increase in the amount of drug absorbeda decrease in maximum concentration and a lengthening in the time to maximum concentrationPeak plasma levels occur approximately one hour after dosing when Desyrel is taken on an empty stomach or two hours after dosing when taken with food.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Desyrel.
Frequency not reportedCholestasis intrahepaticelevated liver enzymesfulminant hepatitishepatic failure with potentially fatal outcomehepatic function abnormalitieshepatitishepatocellular damagejaundicesevere hepatic disorders.
Safety and effectiveness in the pediatric population have not been establishedsee BOXED WARNING and WARNINGSClinical Worsening and Suicide Risk
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