DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)Monitoring of hepatic functionMonitor liver function in all patients receiving treatment with ketoconazoletablets. Monitor liver function prior to treatment to rule out acute or chronicliver disease (see CONTRAINDICATIONS), after two weeks of treatment andthen on a monthly basis and at the first signs or symptoms of possible hepatictoxicity. When the liver function tests indicate liver injury, the treatment shouldbe stopped immediately.A risk and benefit evaluation should be made before oral ketoconazole is usedin cases of non-life threatening diseases requiring long treatment periods.In patients with elevated liver enzymes, or who have experienced liver toxicitywith other drugs, treatment should not be started unless the expected benefitexceeds the risk of hepatic injury. In such cases, close monitoring of the liverenzymes is necessary.UNDESIRABLE EFFECTSPost-marketing ExperienceHepato-biliary DisordersVery rare: serious hepatotoxicity, including hepatitis cholestatic, biopsyconfirmedhepatic necrosis, cirrhosis, hepatic failure including cases resultingin transplantation or death (see WARNINGS & PRECAUTIONS).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 384