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Indications & Uses
Miltefos is a leishmaniacide used in adults and adolescents aged 12 and older who weigh at least 30 kg (66 lbs). It is prescribed to treat visceral leishmaniasis caused by *Leishmania donovani*; cutaneous leishmaniasis caused by *Leishmania braziliensis*, *Leishmania guyanensis*, or *Leishmania panamensis*; and mucosal leishmaniasis caused by *Leishmania braziliensis*.
Pharmacology
Miltefosine is active against Leishmania parasites and against neoplastic cells, mainly because of its effects on apoptosis and its disturbance of lipid-dependent cell signalling pathways. Several ways in which it might kill Leishmania have been proposed, but none has been identified with certainty. Inside the mitochondria, miltefosine inhibits cytochrome-c oxidase, which leads to mitochondrial dysfunction and apoptosis-like cell death.
Its antineoplastic actions are linked to the same targets that matter in leishmaniasis. They include inhibition of phosphatidylcholine biosynthesis and inhibition of Akt (also called protein kinase B). Akt is an important protein in the PI3K/Akt/mTOR intracellular signalling pathway, which helps regulate the cell cycle.
Animal studies also suggest that miltefosine may work against Trypanosome cruzi (the organism that causes Chagas' disease) and against metronidazole-resistant strains of Trichonomas vaginalis. It may also have broad-spectrum anti-fungal activity.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Administer with food to help reduce stomach upset. For patients weighing 30 to 44 kg, take one 50 mg capsule twice a day for 28 days in a row. For patients weighing 45 kg or more, take one 50 mg capsule three times a day for 28 days in a row.
Side Effects
Adverse effects reported in at least 2% of patients receiving miltefosine include nausea, vomiting, diarrhea, and headache, along with reduced appetite, dizziness, and abdominal pain. Itching and drowsiness have also been noted, as well as rises in liver enzyme (transaminase) and creatinine levels on blood tests.
Cautions & Contraindications
Warnings & Precautions
Embryo-Fetal Toxicity. Do not use Miltefos in pregnant women. Get a urine or serum pregnancy test before starting therapy, and advise women of reproductive potential to use effective contraception. Reproductive Effects. Miltefos caused testicular atrophy and impaired fertility in male rats and impaired fertility in female rats. Patients should be told of these reproductive toxicities seen in animal studies and that its potential effects on human fertility have not been adequately evaluated. Renal Effects. Monitor serum creatinine during therapy and for 4 weeks after therapy ends. Hepatic Effects. Monitor transaminases and bilirubin during therapy. Gastrointestinal Effects. Encourage the patient to drink plenty of fluids. Thrombocytopenia. Monitor platelet count during therapy for visceral leishmaniasis. Absorption of Oral Contraceptives. If vomiting and/or diarrhea occur, advise the patient to use an alternative method of contraception. Stevens-Johnson Syndrome. Discontinue Miltefos if this occurs.
Pregnancy & Breastfeeding
Pregnancy: Miltefosine should not be used during pregnancy. A urine or serum pregnancy test should be obtained in females of reproductive potential before prescribing.
Nursing Mothers: Depending on how important the drug is to the mother, either the drug or nursing should be discontinued. Breastfeeding should be avoided for 5 months after finishing Miltefosine therapy.
Females and Males of Reproductive Potential: Females should be advised to use effective contraception during therapy and for 5 months afterward. Patients should also be advised of the reproductive toxicities seen in animals, and that the potential for impaired fertility in humans has not been adequately evaluated.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store Miltefosine below 30°C, away from light and moisture. Keep it out of the reach of children.
Common questions about Miltefos 50 mg
What is Miltefos 50 mg Capsule?
Miltefos 50 mg Capsule is a medicine that contains Miltefosine. It is made by Popular Pharmaceuticals PLC. It belongs to the Leishmaniacides group of medicines.
What is Miltefos used for?
Miltefos is a leishmaniacide used in adults and adolescents aged 12 and older who weigh at least 30 kg (66 lbs). It is prescribed to treat visceral leishmaniasis caused by *Leishmania donovani*; cutaneous leishmaniasis caused by *Leishmania braziliensis*, *Leishmania guyanensis*, or *Leishmania panamensis*; and mucosal leishmaniasis caused by *Leishmania braziliensis*.
What are the side effects of Miltefos?
Adverse effects reported in at least 2% of patients receiving miltefosine include nausea, vomiting, diarrhea, and headache, along with reduced appetite, dizziness, and abdominal pain. Itching and drowsiness have also been noted, as well as rises in liver enzyme (transaminase) and creatinine levels on blood tests.
Can I take Miltefos during pregnancy or while breastfeeding?
Pregnancy: Miltefosine should not be used during pregnancy. A urine or serum pregnancy test should be obtained in females of reproductive potential before prescribing. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Miltefos?
Store Miltefosine below 30°C, away from light and moisture. Keep it out of the reach of children.
Is there a cheaper medicine with the same ingredient?
Miltefos is already among the lowest-priced brands of Miltefosine at this strength.
Do I need a prescription for Miltefos?
Miltefos is a prescription (Rx) medicine. Take it as your doctor advises.