ITRACONAZOLE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

ITRACONAZOLE

Composition:

ITRACONAZOLE 10 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ). Co-administration of a number of CYP3A4 substrates are contraindicated with itraconazole. 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, co-administration with colchicine, fesoterodine, and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and co-administration 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). This increase in drug concentrations caused by co-administration 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. Co-administration 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. Itraconazole oral solution 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 itraconazole to patients with hypersensitivity to other azoles.

Product summary:

Itraconazole Oral Solution, 10 mg/mL, is available in 150 mL amber glass bottles (NDC 65162-087-74) containing 10 mg of itraconazole, USP per mL. It is also available as: 10 mL unit dose cup                                                               NDC 65162-087-13 10 unit dose cups in a tray                                                      NDC 65162-087-34 Store at or below 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of the reach of children. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2024-08

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ITRACONAZOLE- ITRACONAZOLE SOLUTION
AMNEAL PHARMACEUTICALS LLC
----------
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 ITRACONAZOLE ORAL SOLUTION, 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: POST-MARKETING EXPERIENCE, AND CLINICAL
PHARMACOLOGY: SPECIAL POPULATIONS FOR MORE INFORMATION).
DRUG INTERACTIONS:
CO-ADMINISTRATION OF A NUMBER OF CYP3A4 SUBSTRATES ARE
CONTRAINDICATED WITH ITRACONAZOLE ORAL SOLUTION. SOME EXAMPLES OF
DRUGS THAT ARE CONTRAINDICATED FOR CO-ADMINISTRATION WITH ITRACONAZOLE
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.
CO-ADMINISTRATION WITH COLCHICINE, FESOTERODINE AND SOLIFENACIN IS
CONTRAINDICATED IN SUBJECTS WITH VARYING DEGREES OF RENAL OR HEPATIC
IMPAIRMENT.
CO-ADMINISTRATION WITH ELIGLUSTAT IS CONTRAINDICATED IN SUBJECTS THAT
ARE POOR OR INTERMEDIATE METABOLIZERS OF CYP2D6 AND IN SUBJECTS
TAKING STRONG OR MODERATE CYP2D6 INHIBITORS.
CO-ADMINISTRATION 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).
CO-ADMINISTRATION WITH ITRACONAZOLE CAN CAUSE ELEVATED PLASMA
CONCENTRATIONS OF THESE DRUGS AND MAY INCREASE OR PROLONG BOTH THE
PHARM