ITRACONAZOLE capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Zydus Pharmaceuticals USA Inc.

Designació comuna internacional (DCI):

ITRACONAZOLE

Composición:

ITRACONAZOLE 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 involv

Resumen del producto:

Itraconazole  Capsules, 100 mg are white to off-white free flowing pellets filled in size '0el' hard gelatin capsules with blue-colored cap printed with "ZA 65" in white ink & transparent body printed with "100 mg" in white ink and are supplied as follows: NDC 68382-697-06 in bottle of 30 capsules NDC 68382-697-01 in bottle of 100 capsules NDC 68382-697-10 in bottle of 1000 capsules NDC 68382-697-77 in unit-dose blister cartons of 100 (10x10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep out of reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ITRACONAZOLE - ITRACONAZOLE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
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ITRACONAZOLE CAPSULES, USP
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 TACHYARRHYT