Phytoral Tablets (Ketoconazole )

• Composition :
  Each tablet contains Ketoconazole 200mg.
• Indications :
  Indicated in the treatment of systemic fungal infections, candidiasis, chronic mucocutaneous candidiasis, vaginal candidiasis, oral rush candiduria.
• Pharmacodynamics :
  Ketoconazole is a steroidogenesis inhibitor. Ketoconazole is an imidazole derivative that is a potent inhibitor of cortisol synthesis resulting from its ability to inhibit several cytochrome P450 enzymes in the adrenal glands. Ketoconazole inhibits primarily the activity of 17α-hydroxylase, but it also inhibits 11-hydroxylation steps, and at higher doses the cholesterol side-chain cleavage enzyme. Therefore, ketoconazole is an inhibitor of cortisol and aldosterone synthesis.
• Dosage and administration :
  The recommended dose at initiation in adults and adolescents is 400-600 mg/day taken orally in two or three divided doses and this dose can be increased rapidly to 800-1200 mg/day in two or three divided doses.
• Contraindications :
  Contraindicated in patients who have shown hypersensitivity to the drug. Contraindicated in patients with acute or chronic liver disease.
• Precautions and warnings :
  Should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored.Ketoconazole can prolong the QT interval.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Ketoconazole tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during lactation. Safety and efficacy in pediatric patients have not been established.
• Drug interactions :
  Ketoconazole may decrease the elimination of drugs metabolized by CYP3A4, thereby increasing their plasma concentrations. Hence, co-administration is contraindicated. Co-administration drugs which have to the potential to cause QT prolongation (dofetilide, quinidine, pimozide, and cisapride) with ketoconazole is contraindicated.
• Adverse reactions :
  The most frequent adverse reactions are nausea, vomiting, abdominal pain, diarrhoea, pruritus, rash and elevation in hepatic enzymes.
• Therapy Area :
  Anti-Fungals