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Miltefosine Dosage

Applies to the following strength(s): 50 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Leishmaniasis

30 to 44 kg: 50 mg orally twice a day
45 kg or greater: 50 mg orally 3 times a day
Duration of therapy: 28 consecutive days

Uses: For the treatment of:
-Visceral leishmaniasis due to Leishmania donovani
-Cutaneous leishmaniasis due to L brasiliensis, L guyanensis, and L panamensis
-Mucosal leishmaniasis due to L braziliensis

Usual Pediatric Dose for Leishmaniasis

12 years or older:
30 to 44 kg: 50 mg orally twice a day
45 kg or greater: 50 mg orally 3 times a day
Duration of therapy: 28 consecutive days

Uses: For the treatment of:
-Visceral leishmaniasis due to L donovani
-Cutaneous leishmaniasis due to L brasiliensis, L guyanensis, and L panamensis
-Mucosal leishmaniasis due to L braziliensis

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:
-EMBRYOFETAL TOXICITY: This drug may cause fetal harm. Fetal death and teratogenicity occurred in animals administered doses lower than those recommended in humans. This drug should not be administered to pregnant women. A serum or urine pregnancy test should be obtained in females of reproductive potential before prescribing this drug. Females of reproductive potential should be advised to use effective contraception during and for 5 months after therapy.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer with food to diminish gastrointestinal side effects. Administer twice-daily regimen with breakfast and dinner; administer thrice-daily regimen with breakfast, lunch, and dinner.
-Swallow capsule whole; do not crush, split, or chew.

Storage requirements:
-Protect from moisture.

General:
Limitations of use:
-Leishmania species studied in trials evaluating this drug were based on epidemiologic data.
-There may be geographic variation in clinical response of the same Leishmania species to this drug.
-Efficacy has not been evaluated in the treatment of other Leishmania species.

Patient advice:
-Read the US FDA-approved Medication Guide.

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