DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)77. KETOCONAZOLEThe following statement shall be included in the package inserts of productscontaining ketoconazole:CONTRAINDICATIONSIn patients with acute or chronic liver disease.WARNINGS & PRECAUTIONSBecause of the risk for serious hepatotoxicity, [BRAND NAME] should beused only when the potential benefits are considered to outweigh thepotential risks, taking into consideration the availability of other effectiveantifungal therapy.Assess liver function, prior to treatment to rule out acute or chronic liverdisease, and monitor at frequent and regular intervals during treatment,and at the first signs or symptoms of possible hepatotoxicity.HepatotoxicityVery rare cases of serious hepatotoxicity, including cases with a fatal outcomeor requiring liver transplantation have occurred with the use of oralketoconazole. Some patients had no obvious risk factors for liver disease.Cases have been reported that occurred within the first month of treatment,including some within the first week.The cumulative dose of the treatment is a risk factor for serious hepatotoxicity.Factors which may increase the risk of hepatitis are prolonged treatment withketoconazole tablets, females over 50 years of age, previous treatment withgriseofulvin, a history of liver disease, known drug intolerance and concurrentuse of medication which compromises liver function. A period of one monthshould be allowed between cessation of griseofulvin treatment andcommencement treatment with ketoconazole tablets because of an apparentassociation between recent griseofulvin therapy and hepatic reactions toketoconazole tablets.Monitor liver function in all patients receiving treatment with ketoconazoletablets (see Monitoring of hepatic function).Patients should be instructed to promptly report to their physician signs andsymptoms suggestive of hepatitis such as anorexia, nausea, vomiting, fatigue,jaundice, abdominal pain or dark urine. In these patients, treatment should bestopped immediately and liver function should be conducted.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 392
Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 393
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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