MINT-ITRACONAZOLE

1 Dosing Considerations When MINT-ITRACONAZOLE therapy is indicated, the type of organism responsible for the infection should be isolated and identified; however, therapy may be initiated prior to obtaining these results when clinically warranted.

MINT-ITRACONAZOLE capsules are a different preparation than itraconazole oral solution and should not be used interchangeably. For maximal absorption, it is essential to administer MINT-ITRACONAZOLE immediately after a full meal (see 10 CLINICAL PHARMACOLOGY).

See 7 WARNINGS AND PRECAUTIONS for treatment of patients with decreased gastric acidity. Concomitant administration of MINT-ITRACONAZOLE with certain medications may require a dose adjustment for either MINT-ITRACONAZOLE or for the other medication (see 9 DRUG INTERACTIONS).

, aluminum hydroxide), these should be administered at least 1 hour before or 2 hours after the intake of MINT-ITRACONAZOLE. Special Populations Pediatrics (< 18 years of age) Health Canada has not authorized an indication for pediatric use.

1 Pediatrics). Geriatrics (> 65 years of age) Clinical data on the use of itraconazole capsules in elderly patients is limited. It is advised to use MINT-ITRACONAZOLE in these patients only if it is determined that the potential benefit outweighs the potential risks.

In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Patients with Hepatic Impairment Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic; 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).

Patients with Renal Impairment Limited data are available on the use of oral itraconazole in patients with renal impairment. The exposure of itraconazole may be lower in some patients with renal insufficiency. Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered (see 7 WARNINGS AND PRECAUTIONS, Renal; 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency).

). 1 Dosing Considerations When MINT-ITRACONAZOLE therapy is indicated, the type of organism responsible for the infection should be isolated and identified; however, therapy may be initiated prior to obtaining these results when clinically warranted.

MINT-ITRACONAZOLE capsules are a different preparation than itraconazole oral solution and should not be used interchangeably. For maximal absorption, it is essential to administer MINT-ITRACONAZOLE immediately after a full meal (see 10 CLINICAL PHARMACOLOGY).

See 7 WARNINGS AND PRECAUTIONS for treatment of patients with decreased gastric acidity. Concomitant administration of MINT-ITRACONAZOLE with certain medications may require a dose adjustment for either MINT-ITRACONAZOLE or for the other medication (see

5 Post-Market Adverse Reactions). • Coadministration with MINT-ITRACONAZOLE, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, causes increased plasma concentrations of drugs metabolized by this pathway which may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious situation may occur.

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. 4 Drug-Drug Interactions, Table 6).

Table 1:

Drugs that are contraindicated with MINT-ITRACONAZOLE Drug Class Drugs within Class that are Contraindicated with MINT-ITRACONAZOLE Analgesics methadone Anti-arrhythmics disopyramide, dronedarone, quinidine Anticoagulants and Antiplatelet Drugs ticagrelor, apixaban, rivaroxaban Antifungals isavuconazole Antimigraine Drugs ergot alkaloids, such as dihydroergotamine, ergometrine (ergonovine), ergotamine, eletriptan Antineoplastics irinotecan, venetoclax (for chronic lymphocytic leukemia/small lymphocytic lymphoma patients during initiation/titration/ramp-up phase).

Antipsychotics, Anxiolytics and Hypnotics lurasidone, pimozide, triazolam Antivirals asunaprevir (boosted) Calcium Channel Blockers felodipine Cardiovascular Drugs, ivabradine, ranolazine Diuretics eplerenone Gastrointestinal Drugs domperidone, naloxegol Lipid Regulating Drugs lomitapide, lovastatin, simvastatin Urologic Drugs fesoterodine, in subjects with moderate to severe renal impairment, or moderate to severe hepatic impairment solifenacin, in subjects with severe renal impairment or moderate to severe hepatic impairment.

Miscellaneous Drugs and Other Substances colchicine, in subjects with renal or hepatic impairment, eliglustat. • MINT-ITRACONAZOLE is contraindicated in patients with a known hypersensitivity to itraconazole or its excipients. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

• MINT-ITRACONAZOLE 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 Table 1, Calcium Channel Blockers;