Label: ITRACONAZOLE capsule
- NDC Code(s): 16571-245-03
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated January 29, 2025
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BOXED WARNING
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BOXED WARNING
Congestive Heart Failure, Cardiac Effects and Drug Interactions
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Congestive Heart Failure and Cardiac Effects:
• 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: Postmarketing Experience, and CLINICAL PHARMACOLOGY: Special Populations for more information.)
Drug Interactions:
• Coadministration of a number of CYP3A4 substrates are contraindicated with itraconazole capsules. Some examples of drugs that are contraindicated for coadministration with itraconazole capsules 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 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 Section for specific examples. -
DESCRIPTIONItraconazole is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by ...
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CLINICAL PHARMACOLOGYPharmacokinetics and Metabolism: General Pharmacokinetic Characteristics - Peak plasma concentrations of itraconazole are reached within 2 to 5 hours following oral administration. As a ...
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MICROBIOLOGYMechanism of Action: In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell ...
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INDICATIONS & USAGEItraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and ...
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CONTRAINDICATIONS(What is this?)Congestive Heart Failure: Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart ...
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WARNINGSHepatic Effects: Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor ...
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PRECAUTIONSGENERAL PRECAUTIONS - Itraconazole capsules should be administered after a full meal. (See CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism). Under fasted conditions, itraconazole ...
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ADVERSE REACTIONSBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials ...
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OVERDOSAGEItraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures should be employed. Contact a certified poison control center for the most up to date ...
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DOSAGE & ADMINISTRATIONItraconazole capsules should be taken with a full meal to ensure maximal absorption. Itraconazole capsules must be swallowed whole. Itraconazole capsules are a different preparation than ...
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HOW SUPPLIEDItraconazole capsules, 100 mg are available as size "0 el" hard gelatin white opaque capsules filled with off-white to cream colored pellets and imprinted with 'ITR' on cap and '100' on the body ...
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SPL PATIENT PACKAGE INSERTPATIENT INFORMATION Itraconazole Capsules - (it’’ra kon’ a zole) Read this Patient Information that comes with itraconazole capsules before you start taking it and each time ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL(What is this?)Rising® 16571-245-03 - Itraconazole capsules - 100mg - PHARMACIST: Dispense the patient information provided separately to each patient. 30 capsules
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INGREDIENTS AND APPEARANCEProduct Information