ITRACONAZOLE capsule, coated pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

INN (International Name):

ITRACONAZOLE

Composition:

ITRACONAZOLE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 involveme

Product summary:

Itraconazole capsules are available containing 100 mg of itraconazole USP, with a blue opaque cap and pink transparent body hard gelatin capsule imprinted with "ITR" on cap and "100" on body in white ink. The capsules are supplied in unit-dose blister packs of 3 × 10 capsules (NDC 67877-454-84), bottles of 30 capsules (NDC 67877-454-30),bottle of 90 capsules (NDC 67877-454-90), bottle of 500 capsules (NDC 67877-454-05). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children. Manufactured by: Alkem Laboratories Ltd., INDIA.   Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: January, 2023 PT2268-08

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ITRACONAZOLE - ITRACONAZOLE CAPSULE, COATED PELLETS
ASCEND LABORATORIES, LLC
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ITRACONAZOLE CAPSULES 100 MG
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