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Ketoconazole has been shown to be teratogenicsyndactylia and oligodactyliain the rat when given orally in the diet at 80 mg/kg/daya dose 10 times the maximum recommended human oral doseHoweverthese effects may be related to maternal toxicitywhich was seen at this and higher dose levels.
General Disorders and Administration Site Conditionsastheniafatiguehot flushmalaiseedema peripheralpyrexiachills Investigationsplatelet count decreased.
Because severe hypoglycemia has been reported in patients concomitantly receiving oral miconazolean imidazoleand oral hypoglycemic agentssuch a potential interaction involving the latter agents when used concomitantly with ketoconazole tabletsan imidazolecannot be ruled out.
Rare cases of elevated plasma concentrations of digoxin have been reportedIt is not clear whether this was due to the combination of therapyIt isthereforeadvisable to monitor digoxin concentrations in patients receiving ketoconazole.
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