ITRACONAZOLE- itraconazole capsules capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Itraconazole (UNII: 304NUG5GF4) (Itraconazole - UNII:304NUG5GF4)

Available from:

Jubilant Cadista Pharmaceuticals Inc.

INN (International Name):

Itraconazole

Composition:

Itraconazole 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: - Blastomycosis, pulmonary and extrapulmonary - Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and - 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: - Onychomycosis of the toenail, with or without fingernail involvement

Product summary:

Itraconazole Capsules are available containing 100 mg of itraconazole USP, with a blue colored opaque cap and pink colored transparent body, size '0' hard gelatin capsules, printed in white ink with 'C282' on cap and body containing cream colored beads. Bottle pack of 30’s count:                                      NDC 59746-282-30 Carton of 7x4’s (7-Day Treatment Pack):             NDC 59746-282-22   Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].   Protect from light and moisture.   Keep out of the reach of children.    Manufacured by:      Jubilant Generics Limited Roorkee - 247661, India Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA           Revised: 03/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ITRACONAZOLE - ITRACONAZOLE CAPSULES CAPSULE
JUBILANT CADISTA PHARMACEUTICALS INC.
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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,
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 VENT