Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Itraconazole (UNII: 304NUG5GF4) (Itraconazole - UNII:304NUG5GF4)
Vensun Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: - Blastomycosis, pulmonary and extrapulmonary - Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and - Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: - Onychomycosis of the toenail, with or without fingernail involvement
Itraconazole capsules are available containing 100 mg of itraconazole, with a light blue opaque cap/light blue transparent body capsules with "P" printed on the cap and "214" printed on the body, containing white to off-white beads. The capsules are supplied as follows: NDC 42543-113-33: Unit dose blister pack of 30 capsules (3 blister units of 10 capsules each) NDC 42543-113-30: Bottles of 30 capsules NDC 42543-113-01: Bottles of 100 capsules Store at controlled room temperature 15° to 25°C (59° to 77°F); [see USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children . Rx Only Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Rev. 00, June 2019
Abbreviated New Drug Application
ITRACONAZOLE- ITRACONAZOLE CAPSULE VENSUN PHARMACEUTICALS, INC. ---------- ITRACONAZOLE CAPSULES BOXED WARNING CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS: 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 itraconazole 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 ITRACONAZOLE 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 IN Olvassa el a teljes dokumentumot