מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)
Bryant Ranch Prepack
KETOCONAZOLE
KETOCONAZOLE 200 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
KETOCONAZOLE- KETOCONAZOLE TABLET BRYANT RANCH PREPACK ---------- KETOCONAZOLE TABLETS USP, 200 MG 0900 WARNING When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGS and PRECAUTIONS sections. Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and torsades de pointes have been observed in patients taking ketoconazole tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections. Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections. Coadministration of cisapride with ketoconazole is contraindicated. Serious cardiovascular adverse events including ventricular tachycardia, ventricular fibrillation and torsades de pointes have occurred in patients taking ketoconazole concomitantly with cisapride. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections. DESCRIPTION Ketoconazole is a synthetic broad-spectrum antifungal agent. Each tablet, for oral administration, contains 200 mg ketoconazole base. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is (±)_cis_-1-Acetyl-4-[_p_-[[2-(2,4-dichlorophenyl)-2-(imidazol-1- ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-piperazine and has the following structural formula: C H Cl N O M.W. 531.44 Ketoconazole is a white to slig קרא את המסמך השלם