Sporanox Oral Solution (Itraconazole Oral Solution) Drug Information: Overdosage and Contraindications

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May 27, 2012

Sporanox Oral Solution

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Small amounts of the candida fungus are present in the mouth, digestive tract, and skin of most healthy people and are normally kept in check by other bacteria and microorganisms in the body. However, certain illnesses, stress, or medications can disturb the delicate balance, causing the fungus candida to grow out of control, causing thrush.

Medications that upset the balance of microorganisms in the mouth and may cause thrush include corticosteroids, antibiotics, and birth control pills. Illnesses or medical situations that make candida infection more likely to develop include uncontrolled diabetes, HIV infection, cancer, dry mouth, or pregnancy (caused by the hormonal changes that occur with pregnancy). People who smoke or wear dentures that don't fit properly also are at increased risk for thrush. In addition, babies can pass the infection to their mothers during breast-feeding.

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Sporanox Oral Solution

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OVERDOSE

Itraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures, including gastric lavage with sodium bicarbonate, should be employed.

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® Capsules, the adverse event profile was similar to that observed at recommended doses.

CONTRAINDICATIONS

Congestive Heart Failure

SPORANOX® (itraconazole) Oral Solution 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 WARNINGS, PRECAUTIONS: DRUG INTERACTIONS-Calcium Channel Blockers, ADVERSE REACTIONS: Post-marketing Experience, and CLINICAL PHARMACOLOGY: Special Populations.)

Drug Interactions

Concomitant administration of SPORANOX® (itraconazole) Capsules 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, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone and levacetylmethadol (levomethadyl) are contraindicated with SPORANOX®. HMG CoA-reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, are also contraindicated with SPORANOX®. 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® 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®to patients with hypersensitivity to other azoles.

Last reviewed on RxList: 4/12/2012
This monograph has been modified to include the generic and brand name in many instances.