ITRACONAZOLE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Eon Labs, Inc.

INN (International ime):

ITRACONAZOLE

Sastav:

ITRACONAZOLE 100 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ITRACONAZOLE- ITRACONAZOLE CAPSULE
EON LABS, INC.
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ITRACONAZOLE CAPSULES, 100 MG
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, ERGOT
ALKALOIDS [(SUCH AS
DIHYDROERGOTAMINE, ERGOMETRINE (ERGONOVINE), ERGOTAMINE,
METHYLERGOMETRINE
(METHYLERGONOVINE)], IRINOTECAN, LURASIDONE, ORAL MIDAZOLAM, PIMOZIDE,
TRIAZOLAM,
FELODIPINE, NISOLDIPINE, IVABRADINE, RANOLAZINE, EPLERENONE,
CISAPRIDE, LOVASTATIN,
SIMVASTATIN, TICAGRELOR AND, IN SUBJECTS WITH VARYING DEGREES OF RENAL
OR HEPATIC IMPAIRMENT,
COLCHICINE, FESOTERODINE, TELITHROMYCIN AND SOLIFENACIN. 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 INCLUDING OCCURRENCES OF _TORSADES DE POINTES_, A
POTENTIALLY FATAL ARRHYTHMIA.
SEE CONTRAINDICATIONS AND WARNINGS SECTIONS, AND PRECAUTIONS, DRUG
INTERACTIONS SECTION FOR SPECIFIC EXAMPLES.
DESCRIPTION
Itraconazole is an azole antifungal agent. Itraconazole is a 1: