Nizoral (Ketoconazole) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames Salmonella microsomal activator assay was also negative. A long term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity.

Pregnancy

Teratogenic effects

Pregnancy Category C

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given in the diet at 80 mg/kg/day (10 times the maximum recommended human dose). However, these effects may be related to maternal toxicity, evidence of which also was seen at this and higher dose levels.

There are no adequate and well controlled studies in pregnant women. NIZORAL^® Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

OVERDOSAGE

In the event of accidental overdosage, supportive measures, including gastric lavage with sodium bicarbonate, should be employed.

CONTRAINDICATIONS

Coadministration of terfenadine or astemizole with ketoconazole tablets is contraindicated. (See BOX WARNING, WARNINGS, and PRECAUTIONS sections.)

Concomitant administration of NIZORAL^® Tablets with cisapride is contraindicated. (See BOX WARNING, WARNINGS, and PRECAUTIONS sections.)

Concomitant administration of NIZORAL^® Tablets with oral triazolam is contraindicated. (See PRECAUTIONS section.)

NIZORAL^® is contraindicated in patients who have shown hypersensitivity to the drug.