ITRACONAZOLE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Itraconazole (UNII: 304NUG5GF4) (Itraconazole - UNII:304NUG5GF4)

Disponible depuis:

Vensun Pharmaceuticals, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

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

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ITRACONAZOLE- ITRACONAZOLE CAPSULE
VENSUN PHARMACEUTICALS, INC.
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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