II. Indications

  1. Leishmaniasis
  2. Ameba Infection (off-label)
    1. Naegleria fowleri
    2. Balamuthia mandrillaris
    3. Acanthamoeba

III. Contraindications

  1. Pregnancy
  2. Lactation
  3. Age under 12 years old
  4. Sjogren-Larsson Syndrome

IV. Mechanism

  1. Alkyl-phosphocholine affects cellular membranes, interferes with cell mitosis and acts as an immunomodulator

V. Medications

  1. Capsules 50 mg in Blister packs

VI. Dosing: Adults and Children (age >12 years)

  1. General
    1. Take with food
  2. Leishmaniasis (Visceral, cutaneous or mucosal)
    1. Weight 30 to 44 kg: Miltefosine 50 mg orally twice daily for 28 days
    2. Weight >=45 kg: Miltefosine 50 mg orally three times daily for 28 days
  3. Ameba infections (Naegleria fowleri, Balamuthia mandrillaris, Acanthamoeba)
    1. See CDC and other references for dosing

VII. Adverse Effects

  1. Serum Creatinine Increase
    1. Monitor Serum Creatinine weekly for 4 weeks
  2. Increased Liver Function Tests
    1. Monitor transaminases and Serum Bilirubin
  3. Decreased Platelet Count (in Visceral Leishmaniasis)
    1. Monitor Platelet Count
  4. Common
    1. Vomiting and Diarrhea

VIII. Safety

  1. Avoid in Lactation for 5 months after last use
  2. Pregnancy Category D (avoid)
    1. Use reliable Contraception while taking Miltefosine and for 5 months after use

IX. Drug Interactions

  1. Oral Contraceptives
    1. Decreased absorption if Vomiting and Diarrhea occur

XI. References

  1. Hamilton (2020) Tarascon Pocket Pharmacopoeia

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