Ketoconazole

Dosing

Limited data on efficacy and toxicity in neonates

Oral Candidiasis Unresponsive to Nystatin SuspensionCutaneous Candidiasis (Unresponsive to Nystatin Cream/Ointment)5 mg/kg/24H PO divided Q12H-24H

Continue treatment for 2 days after lesions clear, (usual course of therapy 2-3 weeks). Discontinue therapy if no improvement observed after 1 weekApply topical cream BID-TID

Has been associated with hepatotoxicity; use with caution in patients with impaired hepatic function

General Information

Neonatal: Perform periodic liver function tests and monitor patient for evidence of adrenal insufficiency

Neonatal:

  • Hepatotoxicity

  • Nausea/vomiting

  • Adrenal cortical insufficiency (reported with high doses in adults)

Neonatal:

  • Increases serum levels of the following drugs:

    • Phenytoin
    • Theophylline
    • Cyclosporine
    • Warfarin
  • Decreases serum levels of the following drugs:

    • Rifampin
    • Isoniazid
  • Decreased GI absorption when administered with H₂ blocker or antacid

Neonatal:

Topical: 2% topical cream PO: 20 mg/mL compounded oral suspension

  • Tablets require adequate gastric acidity for dissolution

    • In patients receiving H₂-antagonists (e.g. ranitidine) or proton pump inhibitors (e.g. omeprazole) administer ketoconazole with a cola beverage
  • Do not administer with antacids (space doses by 2 hrs)

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