Generic Name and Formulations:
Miltefosine 50mg; hard gel caps.
Treatment of visceral, cutaneous, and mucosal leishmaniasis due to susceptible Leishmania species.
Not evaluated in treatment of other Leishmania species. Leishmania species studied in clinical trials were based on epidemiologic data; geographic variation in clinical response of the same Leishmania species may exist.
Swallow whole. Take with food. Treat for 28 consecutive days. ≥12yrs (30–44kg): 50mg twice daily (breakfast and dinner); (≥45kg): 50mg three times daily (breakfast, lunch, and dinner).
Pregnancy (Cat.D). Sjӧgren-Larsson-Syndrome.
Embryo-fetal toxicity; obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing; use effective contraception during therapy and for 5 months after completion; use additional non-hormonal or alternative methods of contraception if vomiting/diarrhea occur during therapy. Possibly reproductive effects (eg, impaired fertility). Monitor renal function weekly during therapy and for 4 weeks after completion. Monitor platelets (for visceral leishmaniasis), ALT, AST, and bilirubin during therapy. Maintain adequate hydration. Discontinue if exfoliative or bullous rash develops. Nursing mothers: not recommended (during and for 5 months after therapy).
Nausea, vomiting, diarrhea, decreased appetite, headache, motion sickness, dizziness, abdominal pain, pruritus, somnolence, elevated transaminases, elevated creatinine; thrombocytopenia, others.
Caps—28 (2 × 14 blister cards)
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