Itraconazole - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Itraconazole. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
BOXED WARNING Congestive Heart Failure, Cardiac Effects and Drug Interactions 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
WARNINGS Hepatic Effects: Itraconazole capsules 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 a serious underlying medical condition, and some of these cases developed within the first week of treatment.
If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed.
Continued itraconazole capsules use or reinstitution of treatment with itraconazole capsules are strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk. (See PRECAUTIONS : Information for Patients and ADVERSE REACTIONS .) Cardiac Dysrhythmias: Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using drugs such as cisapride, pimozide, methadone, or quinidine concomitantly with itraconazole capsules and/or other CYP3A4 inhibitors.
Concomitant administration of these drugs with itraconazole capsules are contraindicated. (See BOXED WARNING , CONTRAINDICATIONS , and PRECAUTIONS : Drug Interactions .) Cardiac Disease: 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.
Itraconazole capsules should not be used for other indications in patients with evidence of ventricular dysfunction unless the benefit clearly outweighs the risk.
For patients with risk factors for congestive heart failure, physicians should carefully review the risks and benefits of itraconazole capsules therapy.
These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders.
Such patients should be informed of the signs and symptoms of CHF, should be treated with caution, and should be monitored for signs and symptoms of CHF during treatment.
If signs or symptoms of CHF appear during administration of itraconazole capsules, discontinue administration.
Itraconazole has been shown to have a negative inotropic effect.
When itraconazole was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented.
In a healthy volunteer study of itraconazole intravenous infusion, transient, asymptomatic decreases in left ventricular ejection fraction were observed using gated SPECT imaging; these resolved before the next infusion, 12 hours later.
Itraconazole capsules has been associated with reports of congestive heart failure.
In postmarketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg although there were also cases reported among those receiving lower total daily doses.
Calcium channel blockers can have negative inotropic effects which may be additive to those of itraconazole.
In addition, itraconazole can inhibit the metabolism of calcium channel blockers.
Therefore, caution should be used when co-administering itraconazole and calcium channel blockers due to an increased risk of CHF.
Concomitant administration of itraconazole capsules and felodipine or nisoldipine is contraindicated.
Cases of CHF, peripheral edema, and pulmonary edema have been reported in the postmarketing period among patients being treated for onychomycosis and/or systemic fungal infections. (See CLINICAL PHARMACOLOGY : Special Populations , CONTRAINDICATIONS , PRECAUTIONS : Drug Interactions , and ADVERSE REACTIONS : Postmarketing Experience for more information.) Pseudoaldosteronism: Pseudoaldosteronism, manifested by the onset of hypertension or worsening of hypertension, and abnormal laboratory findings (hypokalemia, low serum renin and aldosterone, and elevated 11 deoxycortisol), has been reported with itraconazole use in the postmarketing setting.
Monitor blood pressure and potassium levels and manage as necessary.
Management of pseudoaldosteronism may include discontinuation of itraconazole capsules, substitution with an appropriate antifungal drug that is not associated with pseudoaldosteronism, or use of aldosterone receptor antagonists.
Interaction Potential: Itraconazole capsules has a potential for clinically important drug interactions.
Coadministration of specific drugs with itraconazole may result in changes in efficacy of itraconazole and/or the coadministered drug, life-threatening effects and/or sudden death.
Drugs that are contraindicated, not recommended or recommended for use with caution in combination with itraconazole are listed in PRECAUTIONS: Drug Interactions.
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