SPORANOX (Itraconazole)
SPORANOX (Itraconazole)
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SPORANOX (Itraconazole)

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What is this medication?

Itraconazole, Sporanox (US/CDN)/Onmel/Tolsura (US)
Antifungal, Azole Derivative

Itraconazole, Sporanox/Onmel/Tolsura is officially indicated for use in treating aspergillosis, blastomycosis, esophageal/oropharyngeal candidiasis, histoplasmosis, and onychomycosis.

“ALERT: US Boxed Warning

​Congestive heart failure:
Itraconazole can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously (IV) to dogs and healthy human volunteers, negative inotropic effects were seen. Do not administer itraconazole for the treatment of onychomycosis in patients with evidence of ventricular dysfunction, such as CHF or a history of CHF. If signs or symptoms of CHF occur during administration of itraconazole oral solution or capsule (65 mg [Tolsura]), reassess continued itraconazole use. If signs or symptoms of CHF occur during administration of itraconazole capsules (100 mg [Sporanox]) or tablets, discontinue administration.

​Drug interactions:
Coadministration of the following drugs is contraindicated with itraconazole: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (eg, dihydroergotamine, ergometrine [ergonovine], ergotamine, methylergometrine [methylergonovine]), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, and ticagrelor. In addition, coadministration with colchicine, fesoterodine, and solifenacin is contraindicated in patients with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in patients who are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors. 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.”

How does this medication work?

Itraconazole, Sporanox/Onmel/Tolsura inhibits ergosterol synthesis via action on cytochrome P450 activity, resulting in interfered fungal cell membrane formation.

How should I take this medication?

The dosages vary greatly with indication however 200mg one to four times daily is average depending on the infecting agent.  Some treatment regimens have varying number of days between each dosage.

How to Take: Administer capsule and tablet with a full meal. Oral solution should be taken on an empty stomach; when treating oropharyngeal and esophageal candidiasis, solution should be swished vigorously in mouth (10 mL at a time), then swallowed. Swallow capsule whole with food; do not crush, chew, or break. Formulations are not interchangeable; generally, oral solution is the preferred formulation because of improved absorption.

You Need to Avoid: This medication has many drug interactions so make sure to ask your physician or pharmacist before using any over the counter medications or herbal supplements.

What should I watch for while using this medication?

Before starting Itraconazole, Sporanox/Onmel/Tolsura make sure your physician is aware of any allergies or medications (QT prolonging agents/CYP 2D6 inhibitors) you currently take, if you have kidney disease, liver disease, cystic fibrosis, or are pregnant or breastfeeding.  Itraconazole use has been associated with rare but serious side effects such as CNS depression, hearing loss, exacerbation of heart failure

What if I miss a dose?

If you miss a dose of medication, try to take it as soon as possible.  However, if it is almost time for your next dose, take only that scheduled dose.  Do not take double or extra doses.

How should I store this medication?

Keep out of the reach of children at all times.  Store at room temperature, 59 to 86° F (15 to 30° C).  Protect from light.  Keep the container tightly closed.  Properly dispose of any unused medication after the expiration date.

What are the possible side effects of using this medication?

Diarrhea, nausea

Note this is not a complete list of side effects, only the most common ones.