SPORANOX itraconazole capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
11-05-2018

Aktivni sastojci:

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

Dostupno od:

Bryant Ranch Prepack

INN (International ime):

ITRACONAZOLE

Sastav:

ITRACONAZOLE 100 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application

Svojstava lijeka

                                SPORANOX- ITRACONAZOLE CAPSULE
BRYANT RANCH PREPACK
----------
SPORANOX
(ITRACONAZOLE)
CAPS ULES
BOXED WARNING
CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS
SPORANOX (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 SPORANOX 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
SPORANOX 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. 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
I
                                
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