Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4)
Bryant Ranch Prepack
ITRACONAZOLE
ITRACONAZOLE 100 mg
PRESCRIPTION DRUG
New Drug Application
SPORANOX- ITRACONAZOLE CAPSULE BRYANT RANCH PREPACK ---------- SPORANOX (ITRACONAZOLE) CAPS ULES BOXED WARNING CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS SPORANOX (ITRACONAZOLE) CAPSULES SHOULD NOT BE ADMINISTERED FOR THE TREATMENT OF ONYCHOMYCOSIS IN PATIENTS WITH EVIDENCE OF VENTRICULAR DYSFUNCTION SUCH AS CONGESTIVE HEART FAILURE (CHF) OR A HISTORY OF CHF. If signs or symptoms of congestive heart failure occur during administration of SPORANOX Capsules, discontinue administration. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS. Drug Interactions, ADVERSE REACTIONS: Post-marketing Experience, and CLINICAL PHARMACOLOGY: Special Populations for more information.) DRUG INTERACTIONS COADMINISTRATION OF THE FOLLOWING DRUGS ARE CONTRAINDICATED WITH SPORANOX CAPSULES: METHADONE, DISOPYRAMIDE, DOFETILIDE, DRONEDARONE, QUINIDINE, ISAVUCONAZOLE, ERGOT ALKALOIDS (SUCH AS DIHYDROERGOTAMINE, ERGOMETRINE (ERGONOVINE), ERGOTAMINE, METHYLERGOMETRINE (METHYLERGONOVINE)), IRINOTECAN, LURASIDONE, ORAL MIDAZOLAM, PIMOZIDE, TRIAZOLAM, FELODIPINE, NISOLDIPINE, IVABRADINE, RANOLAZINE, EPLERENONE, CISAPRIDE, NALOXEGOL, LOMITAPIDE, LOVASTATIN, SIMVASTATIN, AVANAFIL, TICAGRELOR. IN ADDITION, COADMINISTRATION WITH COLCHICINE, FESOTERODINE AND SOLIFENACIN IS CONTRAINDICATED IN SUBJECTS WITH VARYING DEGREES OF RENAL OR HEPATIC IMPAIRMENT, AND COADMINISTRATION WITH ELIGLUSTAT IS CONTRAINDICATED IN SUBJECTS THAT ARE POOR OR INTERMEDIATE METABOLIZERS OF CYP2D6 AND IN SUBJECTS TAKING STRONG OR MODERATE CYP2D6 INHIBITORS. SEE PRECAUTIONS: DRUG INTERACTIONS SECTION FOR SPECIFIC EXAMPLES. COADMINISTRATION WITH ITRACONAZOLE CAN CAUSE ELEVATED PLASMA CONCENTRATIONS OF THESE DRUGS AND MAY INCREASE OR PROLONG BOTH THE PHARMACOLOGIC EFFECTS AND/OR ADVERSE REACTIONS TO THESE DRUGS. FOR EXAMPLE, INCREASED PLASMA CONCENTRATIONS OF SOME OF THESE DRUGS CAN LEAD TO QT PROLONGATION AND VENTRICULAR TACHYARRHYTHMIAS I Pročitajte cijeli dokument