ITRACONAZOLE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Mylan Pharmaceuticals Inc.

INN (Internationale Bezeichnung):

ITRACONAZOLE

Zusammensetzung:

ITRACONAZOLE 100 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 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: Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experience for more information.) Analyses were cond

Produktbesonderheiten:

Itraconazole Capsules, USP are available containing 100 mg of itraconazole, USP. The 100 mg capsules are hard-shell gelatin capsules with a dark blue opaque cap and caramel opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 5100 in white ink on both the cap and the body. They are available as follows: NDC 0378-5100-93 bottles of 30 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ITRACONAZOLE- ITRACONAZOLE CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
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. 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 _