ITRACONAZOLE capsule, coated pellets

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4)

Dostupné z:

Bryant Ranch Prepack

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Itraconazole Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. 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: 1. Onychomycosis of the toenail, with or without fingernail involvemen

Prehľad produktov:

NDC: 63629-8168-1: 30 Capsules in a BOTTLE

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ITRACONAZOLE- ITRACONAZOLE CAPSULE, COATED PELLETS
BRYANT RANCH PREPACK
----------
ITRACONAZOLE CAPSULES 100 MG
BOXED WARNINGS
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 TACHYARRH