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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.
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.
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.
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