Finished product reference
Miltefosine
Capsule · Oral · 50 mg
- List code
- 51441
- Pharmacologic class
- Antiprotozoal (alkylphosphocholine antileishmanial agent)
What it is and how it works
Miltefosine is an oral alkylphosphocholine analogue that disrupts parasite membrane phospholipid and sterol metabolism, cell signalling and mitochondrial function, leading to apoptosis-like death of Leishmania.
Indications
Visceral leishmaniasis and cutaneous or mucosal leishmaniasis caused by susceptible Leishmania species.
Dosage and administration (summary)
Oral, with food, usually for 28 days: 50 mg twice daily in patients weighing 45 kg or more, or 50 mg once daily in those weighing 30–44 kg (higher-weight schedules per protocol).
Contraindications
Pregnancy, breast-feeding, Sjögren-Larsson syndrome and hypersensitivity to miltefosine.
Warnings and precautions
Teratogenic: pregnancy must be excluded before treatment and effective contraception used during treatment and for 5 months afterwards. Vomiting and diarrhoea are common and may cause dehydration and renal impairment; monitor renal and hepatic function. Thrombocytopenia and Stevens-Johnson syndrome have been reported.
Pregnancy
Contraindicated because of embryo-fetal toxicity.
Storage and supply
Store below 25–30 °C in the original package.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.