Miltefosine

میلتفوسین

⚠ Unverified

🪱 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

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🛡️ Safety & information

Contraindications

Warnings

  • • Boxed warning: embryo-fetal toxicity. Pregnancy test before starting; effective contraception during treatment and for 5 months after. FDA Impavido · Boxed Warning

Formulations

👥 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.”

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