ITRACONAZOLE- itraconazole solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Camber Pharmaceuticals, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experience for more information.) Congestive Heart Failure: Itraconazole oral solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatening or other serious infections. (See BOXED WARNING, WARNINGS, PRECAUTIONS: Drug Interactions-Calcium Channel Blockers, ADVERSE REACTIONS: Post-marketing Experience, and CLINICAL PHARMACOLOGY: Special Populations.) Drug Interactions: Coadministration of a number of CYP3A4 substrates are contraindicated with itraconazole. Plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), met

Descriptif du produit:

Itraconazole Oral Solution is available in 150 mL amber glass bottles (NDC 31722-006-31) containing 10 mg of itraconazole per mL. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India. Revised: 02/2023

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ITRACONAZOLE - ITRACONAZOLE SOLUTION
CAMBER PHARMACEUTICALS, INC.
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ITRACONAZOLE ORAL SOLUTION
BOXED WARNING
CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS: If
signs
or symptoms of congestive heart failure occur during administration of
itraconazole oral solution, continued itraconazole use should be
reassessed. 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 ORAL SOLUTION: 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. COADMINISTRATION WITH VENETOCLAX
IS CONTRAINDICATED IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
(CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL) DURING THE DOSE INITIATION AND
RAMP-UP PHASE OF VENETOCLAX. 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 PROLONGAT