ITRACONAZOLE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

REMEDYREPACK INC.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. Onyc

Toote kokkuvõte:

Itraconazole capsules are supplied as follows: 100 mg: Blue opaque cap/pink transparent body size “0” hard gelatin capsules having imprinting “A” on cap with black ink and “175” on body with black ink filled with white to off-white pellets. NDC: 70518-3264-00 PACKAGING: 14 in 1 BOTTLE PLASTIC Store between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

ITRACONAZOLE- ITRACONAZOLE CAPSULE
REMEDYREPACK 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 BOTH TH