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Indications:

Ketoconazole Tablets are indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid. Ketoconazole Tablets are also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin. Topical treatment of tinea corporis, tinea cruris, tinea pedis, pityriasis versicolor & cutaneous candidiasis. Treatment & prevention of relapse of fungal skin infections eg dandruff, seborrhoeic dermatitis & pityriasis versicolor.

Contraindications:

Coadministration of terfenadine or astemizole with Ketoconazole Tablets is contraindicated. Concomitant administration of Ketoconazole Tablets with cisapride, with oral triazolam is contraindicated. Ketoconazole is contraindicated in patients who have shown hypersensitivity to the drug.

Adverse reactions:

In rare cases, anaphylaxis has been reported after the first dose. However, the most frequent adverse reactions were nausea and/or vomiting in approximately 3%, abdominal pain in 1.2%, pruritus in 1.5%, and the following in less than 1% of the patients: headache, dizziness, somnolence, fever and chills, photophobia, diarrhea, gynecomastia, impotence, thrombocytopenia, leukopenia, hemolytic anemia, and bulging fontanelles. In contrast, the rare occurrences of hepatic dysfunction require special attention. Skin irritation-burning sensation, pruritus, dermatitis Rarely, local burning sensation, itch, irritation, oily/dry hair & scalp, increased hair loss, abnormal hair texture, scalp pustules.

Interactions:

Ketoconazole is a potent inhibitor of the cytochrome P450 3A4 enzyme system. Coadministration of Ketoconazole Tablets and drugs primarily metabolized by the cytochrome P450 3A4 enzyme system may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic and adverse effects. Ketoconazole Tablets inhibit the metabolism of terfenadine, resulting in an increased plasma concentration of terfenadine. Ketoconazole inhibits the metabolism of astemizole.Ketoconazole potently inhibits the metabolism of cisapride resulting in a mean eight-fold increase in AUC of cisapride. Ketoconazole Tablets may alter the metabolism of cyclosporine, tacrolimus, and methylprednisolone, resulting in elevated plasma concentrations of the latter drugs. Coadministration of Ketoconazole Tablets with midazolam or triazolam has resulted in elevated plasma concentrations of the latter two drugs. It is, therefore, advisable to monitor digoxin concentrations in patients receiving Ketoconazole. When taken orally, imidazole compounds like Ketoconazole may enhance the anticoagulant effect of coumarin-like drugs. a potential interaction involving the latter agents when used concomitantly with Ketoconazole Tablets (an imidazole) can not be ruled out. Concomitant administration of Ketoconazole Tablets with phenytoin may alter the metabolism of one or both of the drugs. Concomitant administration of rifampin with Ketoconazole Tablets reduces the blood levels of the latter. INH (isoniazid) is also reported to affect Ketoconazole concentrations adversely.

Warnings:

General: Ketoconazole Tablets have been demonstrated to lower serum testosterone. Ketoconazole Tablets also decrease ACTH induced corticosteroid serum levels at similar high doses. Ketoconazole Tablets require acidity for dissolution. If concomitant antacids, anticholinergics, and H 2 -blockers are needed, they should be given at least two hours after administration of Ketoconazole Tablets. Pregnancy: Pregnancy Category C Nursing Mothers: Since Ketoconazole is probably excreted in the milk, mothers who are under treatment should not breast feed. Nursing Mothers: Since Ketoconazole is probably excreted in the milk, mothers who are under treatment should not breast feed.

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