ITRACONAZOLE ORAL- itraconazole solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Natco Pharma USA LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.) 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 itraconazole. Plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergono

Ringkasan produk:

Itraconazole oral solution is supplied in 10mL amber HDPE unit dose medicine cups as follows: NDC: 69339-159-01          (1) UD cup NDC: 69339-159-17        (40) UD cups 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: DASH® PHARMACEUTICALS Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India DP-UD-PI-AT-XXXXXXX Rev 05/2021

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ITRACONAZOLE ORAL- ITRACONAZOLE SOLUTION
NATCO PHARMA USA LLC
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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. 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 SECTIO