Multiple dose pharmacokinetics of an oral solution of itraconazole in patients receiving chemotherapy for acute myeloid leukaemia

J Antimicrob Chemother. 1995 Oct;36(4):657-63. doi: 10.1093/jac/36.4.657.

Abstract

The multiple dose pharmacokinetics of a solution of itraconazole given orally were measured in an open study of 20 patients undergoing remission induction chemotherapy for acute myeloid leukaemia. Patients were given itraconazole 5 mg/kg od, 2.5 mg/kg bd, 2.5 mg/kg od or 1.25 mg/kg bd. The mean daily dose of itraconazole was 407 mg for patients receiving 5 mg/kg/day and 148 mg in patients receiving 2.5 mg/kg/day. Mean concentrations of 493 and 495 micrograms/L were achieved on day 8 in patients who received 5 mg/kg/d od or 2.5 mg/kg bd itraconazole respectively. However, mean concentrations were significantly lower for those who received 2.5 mg/kg od itraconazole being 110 micrograms/L on day 8. Mean areas under the serum-concentration time curves were also markedly higher in patients receiving 5 mg/kg/day than in those receiving 2.5 mg/kg/day itraconazole and were 22,382 and 5615 micrograms.h/L on day 15 respectively. These findings suggest that the serum concentrations attained with an oral solution of 5 mg/kg itraconazole either once daily or in two divided doses are suitable for antifungal prophylaxis in patients receiving chemotherapy for acute myeloid leukaemia.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / adverse effects
  • Antifungal Agents / blood
  • Antifungal Agents / pharmacokinetics*
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Drug Administration Schedule
  • Drug Interactions
  • Female
  • Humans
  • Immunocompromised Host
  • Itraconazole / administration & dosage
  • Itraconazole / adverse effects
  • Itraconazole / blood
  • Itraconazole / pharmacokinetics*
  • Leukemia, Myelomonocytic, Acute / complications
  • Leukemia, Myelomonocytic, Acute / drug therapy
  • Leukemia, Myelomonocytic, Acute / metabolism*
  • Male
  • Middle Aged
  • Mycoses / prevention & control*

Substances

  • Antifungal Agents
  • Antineoplastic Agents
  • Itraconazole