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Sporanox Injection

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Sporanox Injection

Overdosage
Contraindications

OVERDOSE

Itraconazole is not removed by dialysis.

There are limited data on the outcomes of patients ingesting high doses of itraconazole. In patients taking either 1000 mg of SPORANOX® (itraconazole) Oral Solution or up to 3000 mg of SPORANOX® (itraconazole injection) Capsules, or b.i.d. dosing for four days with SPORANOX® (itraconazole injection) Injection, the adverse event profile was similar to that observed at recommended doses.

CONTRAINDICATIONS

Drug Interactions

Concomitant administration of SPORANOX® (itraconazole) Capsules, Injection, or Oral Solution and certain drugs metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) may result in increased plasma concentrations of those drugs, leading to potentially serious and/or life-threatening adverse events. Cisapride, oral midazolam, nisoldipine, pimozide, quinidine, dofetilide, triazolam and levacetylmethadol (levomethadyl) are contraindicated with SPORANOX® (itraconazole injection) . HMG CoA-reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, are also contraindicated with SPORANOX® (itraconazole injection) . Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) are contraindicated with SPORANOX®. (See BOX WARNING, and PRECAUTIONS: DRUG INTERACTIONS.)

SPORANOX® (itraconazole injection) is contraindicated for patients who have shown hypersensitivity to itraconazole or its excipients. There is no information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used when prescribing SPORANOX® (itraconazole injection) to patients with hypersensitivity to other azoles.

SPORANOX IV cannot be used when administration of Sodium Chloride Injection is contraindicated.

The excipient hydroxypropyl-β-cyclodextrin is eliminated through glomerular filtration. Therefore, SPORANOX IV is contraindicated in patients with severe renal impairment (defined as creatinine clearance below 30 mL/min). (See CLINICAL PHARMACOLOGY: Special Populations, PRECAUTIONS, and DOSAGE AND ADMINISTRATION.)

Last reviewed on RxList: 5/18/2009
This monograph has been modified to include the generic and brand name in many instances.

Overdosage
Contraindications
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