ITRACONAZOLE capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Patriot Pharmaceuticals

INN:

ITRACONAZOLE

composition:

ITRACONAZOLE 100 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 invol

leaflet_short:

Itraconazole Capsules are available containing 100 mg of itraconazole, with a blue opaque cap and pink transparent body, imprinted with "PP 100." The capsules are supplied in bottles of 30 capsules (NDC 10147-1700-3). Store at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.

authorization_status:

New Drug Application

SPC

ITRACONAZOLE- ITRACONAZOLE CAPSULE
PATRIOT PHARMACEUTICALS
----------
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
POPULATIONSFOR 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, FINERENONE, VOCLOSPORIN. 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
INTERACTIONSSECTION FOR SPECIFIC EXAMPLES. COADMINISTRATION WITH
ITRACONAZOLE CAN CAUSE ELEVATED PLASMA CONCENTRATIONS OF THESE DRUGS
AND MAY INCREASE O