ANTIPROTOZOAL EFFECTS Miltefosine is the first orally available therapy for leishmaniasis. It is safe and effective treatment for visceral leishmaniasis and has also shown >95% efficacy against cutaneous leishmaniasis. In Leishmania, the drug may alter ether-lipid metabolism, cell signaling, or glycosylphosphatidylinosital anchor biosynthesis. Mutations in a P-type ATPase of the aminophospholipid translocase subfamily apparently decrease drug uptake and thereby confer resistance.
ABSORPTION, FATE, AND EXCRETION
Miltefosine is well absorbed orally and distributed throughout the body. Plasma concentrations are proportional to the dose.
THERAPEUTIC USES Oral miltefosine is registered in India for use in the treatment of visceral leishmaniasis in adults at a dose of 100 mg/kg daily (for patients weighing more than 25 kg) for 28 days. A similar dosing schedule has shown efficacy against cutaneous disease. Children should be given 2.5 mg/kg/day. The compound cannot be given intravenously because of hemolysis.
TOXICITY AND SIDE EFFECTS Vomiting and diarrhea have been reported in up to 60% of patients. Elevations in hepatic transaminases and serum creatinine also have been reported. These are typically mild and resolve quickly once the drug is withdrawn. The drug is contraindi-cated in pregnant women. Women should receive a negative pregnancy test prior to treatment, and birth control is required during and for at least 2 months after treatment.
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