国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)
Avera McKennan Hospital
Ketoconazole
Ketoconazole 200 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
KETOCONAZOLE- KETOCONAZOLE TABLET AVERA MCKENNAN HOSPITAL ---------- KETOCONAZOLE TABLETS USP, 200 MG RX ONLY WARNING Ketoconazole tablets USP, 200 mg 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. HEPATOTOXICITY Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGS section. QT PROLONGATION AND DRUG INTERACTIONS LEADING TO QT PROLONGATION Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions sections. DESCRIPTION Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1- ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula: Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44. CLINICAL PHARMACOLOGY PHARMACOKINETICS Absorption Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption. Mean peak plasma concentrations of approximately 3.5 μg/mL are reached within 1 to 2 hours, following o 完全なドキュメントを読む