ITRACONAZOLE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Par Pharmaceutical, Inc.

INN (Tên quốc tế):

ITRACONAZOLE

Thành phần:

ITRACONAZOLE 100 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 involve

Tóm tắt sản phẩm:

Itraconazole capsules are available containing 100 mg of itraconazole, with a white opaque cap and body, imprinted with “par” and “239.” The capsules are supplied in bottles of 30 capsules (NDC 49884-239-11). Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from light and moisture. Keep out of reach of children. Manufactured for: Par Pharmaceutical Chestnut Ridge, NY 10977 Made in India Revised: 01/2023

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

ITRACONAZOLE- ITRACONAZOLE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
ITRACONAZOLE CAPSULES
RX ONLY
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. COADMINISTRATION WITH VENETOCLAX
IS CONTRAINDICATED IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
(CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL) DURING THE DOSE INITIATION AND
RAMP-UP PHASE OF VENETOCLAX. SEE PRECAUTIONS: DRUG
INTERACTIONS SECTION FOR SPECIFIC EXAMPLES. COADMINISTRATION WITH
ITRACONAZOLE CAN CAUSE ELEVATED PLASMA CONCENTRATIONS OF THESE DRUGS
AND MAY INCREASE OR PROLONG BO