Detailed Drug Information:

DRUG CLASS AND MECHANISM: Ketoconazole is an antifungalmedication. Fungi are organisms normally found on the skin and in moistareas of the body. When the skin is injured or chronically moistened, ornormal bacteria flora of the body are altered due to prolonged antibiotictreatment, fungus can proliferate to cause inflammation of the skin ormoist body areas. Fungus organisms can also infect the lungs and otherbody tissues especially in patients with weakened immune systems.

PREPARATIONS: Tablets: 200 mg; Shampoo: 2%; Cream:2%.

STORAGE: Ketoconazole tablets: store at 59-86degrees F, protectfrom moisture. Ketaconazole shampoo: store at a temperature not above 77degrees F, protect from light.

PRESCRIBED FOR: Ketoconazole is used to treat a variety offungal infections. Examples of these fungal infections include candidainfections of the skin or mouth (thrush), blastomycosis, histoplasmosis,coccidiomycosis, and others. Ketoconazole is also used to treat fungalinfections that have not responded to griseofulvin, another antifungalmedication.

DOSING: Ketoconazole may be taken with or without food.Ketoconazole tablets need the acidity of the stomach to dissolve.Therefore, ketoconazole should be administered at least two hours beforetaking antacids or acid-inhibiting medications (such as Tagamet orZantac).

Ketoconazole should be avoided by patients with liver dysfunction. Signsof liver problems include unusual fatigue, loss of appetite, nausea andvomiting, yellowing of the skin (jaundice), dark urine, and pale stools. Developmentof these symptoms while taking ketoconazole should be reported to thephysician.

DRUG INTERACTIONS: Ketoconazole should not be administeredtogether with antihistamines terfenadine (Seldane) and astemizole (Hismanal), or with cisapride (Propulsid), because of increased risk ofserious heart side effects. Ketoconazole should not be taken with thesedative triazolam (Halcion), because of risk of excessive sedation.Digoxin (Lanoxin) and phenytoin (Dilantin) levels should be monitored whentaking ketoconazole. Tuberculosis medications INH and rifampin lower the blood levels of ketoconazole. Ketoconazole taken with alcohol can cause flushing, rash, swelling, headache, and nausea. Ketoconazole shampoo canirritate the eyes, and should be used with caution. Ketoconazole isavoided in children.

PREGNANCY: Ketoconazole is avoided during pregnancy.

NURSING MOTHERS: Ketoconazole is avoided in nursing mothers.

SIDE EFFECTS: Ketoconazole is generally well tolerated.Ketoconazole can cause rash, itching, nausea and/or vomiting, abdominalpain, headache, dizziness, fatigue, impotence, and blood countabnormalities. Rarely, ketoconazole has caused a reaction resulting inserious lowering of the blood pressure and shock (anaphylaxis). Alsorarely, ketoconazole has caused severe depression, hair loss, and tinglingsensations. Ketoconazole shampoo has been reported to result in loss ofcurl of permanently waved hair.