Miltefosine
میلتفوسین
🪱 Antiparasitic Products, Insecticides And RepellentsOral antileishmanial
Market / country: 🇺🇸 USA
Impavido (US)
🧮 Dose calculator
Cutaneous leishmaniasis · Regimen source: FDA Impavido · 2, Table 1
- • With food. Label-approved species for cutaneous disease: L. braziliensis, L. guyanensis, L. panamensis; the species common in Iran (L. major, L. tropica) are not in the label. FDA Impavido · 2, Table 1FDA Impavido · 1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy — contraindicated (fetal death and malformation). FDA Impavido · 4
- ⛔ Sjögren-Larsson syndrome. FDA Impavido · 4
- ⛔ Hypersensitivity to miltefosine. FDA Impavido · 4
Warnings
- • Boxed warning: embryo-fetal toxicity. Pregnancy test before starting; effective contraception during treatment and for 5 months after. FDA Impavido · Boxed Warning
Formulations
- 50 mg capsule — capsule 🇺🇸 USA FDA Impavido · 3
👥 Special populations
- 🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Impavido · 4
“IMPAVIDO is contraindicated in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Impavido · 8.3
“Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from IMPAVIDO, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Impavido · 8.4
“Safety and effectiveness in pediatric patients < 12 years have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Impavido · 8.5
“Clinical studies of IMPAVIDO did not include sufficient numbers of subjects 65 years of age and over to determine if they respond differently than younger subjects.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Impavido · 8.8
“Contraception IMPAVIDO may cause fetal harm when used during pregnancy.”
🔗 Reference links
- FDA (approval record)NDA204684
- DailyMed (FDA label)FDA Impavido
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDP01CX04
- Darooyab (Iran)Miltefosine
🇮🇷 Registered in Iran Darooyab · G-1029/Miltefosine
Dosage forms with Iranian generic codes, per Darooyab.
- 18499 · MILTEFOSIN 50MG CAP. · کپسول میلتفوسین ۵۰ میلیگرم .
- 51441 · MILTEFOSINE CAPSULE ORAL 50 mg · کپسول میلتفوسین ۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Impavido · 3FDA Impavido · 2, Table 1FDA Impavido · 1FDA Impavido · 4FDA Impavido · Boxed WarningFDA Impavido · 8.3FDA Impavido · 8.4FDA Impavido · 8.5FDA Impavido · 8.8FDA Impavido · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1029/Miltefosine
- Clinical review⚠ Unverified