SPORANOX- itraconazole solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Janssen Pharmaceuticals, Inc.

INN (Alþjóðlegt nafn):

itraconazole

Samsetning:

itraconazole 10 mg in 1 mL

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

SPORANOX ® (itraconazole) Oral Solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experiencefor more information.) SPORANOX ® (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.) Coadministration of a number of CYP3A4 substrates are contraindicated with SPORANOX ® . Some examples of drugs for which plasma concentrations increase are: 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, finerenone, voclosporin. 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 InteractionsSection for specific examples.) This increase in drug concentrations caused by coadministration with itraconazole 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 torsade de pointes, a potentially fatal arrhythmia. Some specific examples are listed in PRECAUTIONS: Drug Interactions. Coadministration with venetoclax is contraindicated in patients with CLL/SLL during the dose initiation and ramp-up phase of venetoclax due to the potential for an increased risk of tumor lysis syndrome. SPORANOX ® is contraindicated for patients who have shown hypersensitivity to itraconazole. There is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used when prescribing SPORANOX ® to patients with hypersensitivity to other azoles.

Vörulýsing:

SPORANOX ® (itraconazole) Oral Solution is available in 150 mL amber glass bottles (NDC 50458-295-15) containing 10 mg of itraconazole per mL. Store at or below 25°C (77°F). Do not freeze.

Leyfisstaða:

New Drug Application

Vara einkenni

SPORANOX- ITRACONAZOLE SOLUTION
JANSSEN PHARMACEUTICALS, INC.
----------
SPORANOX
(ITRACONAZOLE)
ORAL SOLUTION
®
BOXED WARNING
CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS
Congestive Heart Failure and Cardiac Effects
IF SIGNS OR SYMPTOMS OF CONGESTIVE HEART FAILURE OCCUR DURING
ADMINISTRATION OF SPORANOX
(ITRACONAZOLE) ORAL SOLUTION, CONTINUED
SPORANOX
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 POPULATIONSFOR MORE INFORMATION.)
Drug Interactions
COADMINISTRATION OF A NUMBER OF CYP3A4 SUBSTRATES ARE
CONTRAINDICATED WITH SPORANOX
. SOME EXAMPLES OF DRUGS THAT ARE
CONTRAINDICATED FOR COADMINISTRATION WITH SPORANOX
ORAL SOLUTION
ARE: 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, FINERENONE, VOCLOSPORIN.
COADMINISTRATION WITH COLCHICINE, FESOTERODINE AND SOLIFENACIN IS
CONTRAINDICATED IN SUBJECTS WITH VARYING DEGREES OF RENAL OR HEPATIC
IMPAIRMENT.
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 INTERACTIONSSECTION FOR SPECIFIC EXAMPLES.
COADMINISTRATION WITH ITRACONAZOLE CAN CAUSE ELEVATED PLASMA
CONCENTRATIONS OF THESE DRUGS AND MAY INCREASE OR PROLONG BOTH