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Pregnancy Category CKetoconazole has been shown to be teratogenicsyndactylia and oligodactyliain the rat when given in the diet at 80 mg/kg/day2 times the maximum recommended human dosebased on body surface area comparisonsHoweverthese effects may be related to maternal toxicityevidence of which also was seen at this and higher dose levels.

Co-administration of the following drugs with ketoconazole is contraindicateddofetilidequinidinepimozidecisaprideKetoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervalssometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointesSee CONTRAINDICATIONSWARNINGSand PRECAUTIONSDRUG INTERACTIONS sections.

In the event of acute accidental overdosetreatment consists of supportive and symptomatic measuresWithin the first hour after ingestionactivated charcoal may be administered.

Ketoconazole has also been found to be embryotoxic in the rat when given in the diet at doses higher than 80 mg/kg during the first trimester of gestation.

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