国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4)
Camber Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
ITRACONAZOLE - ITRACONAZOLE SOLUTION CAMBER PHARMACEUTICALS, INC. ---------- 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 完全なドキュメントを読む