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When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Use with caution in patients with impaired hepatic function. Liver function tests (such as alkaline phosphatase, ALT, AST and bilirubin) should be measured before starting treatment and at frequent intervals during treatment. Patients receiving ketoconazole concurrently with other potentially hepatotoxic drugs should be carefully monitored, particularly those patients requiring prolonged therapy or those who have had a history of liver disease.
Ketoconazole requires acidity for dissolution. If concomitant antacids, anticholinergics, and H2-blockers are needed, they should be given at least 2 hours after administration of ketoconazole.
Effects on ability to drive and use machines: No effects have been observed. However, patients should not take ketoconazole with antacids; this may cause dizziness and effect the ability to drive and use machines.
Use in Children: Ketoconazole has not been systematically studied in children of any age, and essentially no information is available on children younger than 2 years. Therefore, it should not be used in pediatric patients unless the potential benefit outweighs the risks.
