ITRACONAZOLE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Alembic Pharmaceuticals Limited

INN (nume internaţional):

ITRACONAZOLE

Compoziție:

ITRACONAZOLE 100 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. Onychomyc

Rezumat produs:

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 46708-204-30        Bottle of    30 Capsules NDC 46708-204-90        Bottle of    90 Capsules NDC 46708-204-71        Bottle of    500 Capsules NDC 46708-204-10        Unit Dose Capsules of  100 (Blisters of 10) NDC 46708-204-04        7 Blister Packs x 4 Capsules Each (7 Day Treatment Pack) Store at controlled room temperature 15° to 25°C (59° to 77°F). Protect from light and moisture. Keep out of reach of children. Manufactured by: Alembic Pharmaceuticals Limited Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revised: 09/2019

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ITRACONAZOLE - ITRACONAZOLE CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
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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, ERGOT ALKALOIDS (SUCH AS
DIHYDROERGOTAMINE, ERGOMETRINE (ERGONOVINE), ERGOTAMINE,
METHYLERGOMETRINE (METHYLERGONOVINE)), IRINOTECAN, LURASIDONE, ORAL
MIDAZOLAM, PIMOZIDE, TRIAZOLAM, FELODIPINE, NISOLDIPINE, 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 Capsule is the generic name for itraconazole, an azo