Generic
Miltefosine
1 brands available in the market
At a glance
Miltefosine is an antibiotic drug used for the treatment of Kala-azar (Leishmaniasis).
Description
Miltefosine is a phospholipid derivative that kills Leishmania parasites by affecting apoptosis and lipid-dependent cell signalling pathways.
Indications
- Visceral Leishmaniasis (Kala-azar)
- Cutaneous Leishmaniasis
- Mucosal Leishmaniasis
Therapeutic class
Leishmaniacides
Pharmacological class
Antileishmanial Drug
Pharmacology
Miltefosine kills parasites by affecting apoptosis and lipid-dependent cell signalling pathways.
Mechanism of action
Kills parasites by disrupting cell membrane function.
Dosage
Adult Dose (Oral):
- 30-44 kg: 50 mg capsule twice daily (28 days)
- 45 kg or greater: 50 mg capsule three times daily (28 days)
Child Dose: 2.5 mg/kg/day (in 2 divided doses)
Adolescents (≥12 years): 30-44 kg: 100 mg/day; >45 kg: 150 mg/day
Administration
- Take with food (to reduce GI adverse reactions)
- Swallow capsule whole
- Take at the same time each day
- Complete full 28-day course
Missed dose
Not applicable (specific schedule)
Side effects
Common Side Effects (≥2%):
- Nausea and vomiting
- Diarrhea
- Headache
- Decreased appetite
- Dizziness
- Abdominal pain
- Pruritus
- Somnolence
- Elevated transaminases
- Elevated creatinine
Precautions & warnings
- Contraindicated in pregnancy - perform pregnancy test before treatment
- Use effective contraception during and for 5 months after treatment
- Monitor serum creatinine
- Monitor transaminases and bilirubin
- Encourage fluid intake
- Discontinue if Stevens-Johnson syndrome occurs
Contraindications
- Pregnancy
- Lactation
- Concurrent radiation therapy
Drug interactions
Miltefosine did not inhibit human cytochrome P450 enzymes in vitro. Did not induce cytochrome 3A activity in rats.
Food interactions
Information on alcohol interaction with Miltefosine is not available. Consult your doctor.
Use in pregnancy
Use in Pregnancy: Unsafe. Contraindicated during pregnancy. Perform pregnancy test before treatment.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Information not available. Discontinue drug or nursing. Avoid breastfeeding for 5 months after therapy.
Pediatric use
Dose established for patients ≥12 years weighing ≥30 kg.
Geriatric use
No specific dose adjustment for elderly.
Renal / hepatic impairment
Renal Impairment: Limited information available. Consult your doctor.
Hepatic Impairment: Limited information available. Consult your doctor.
Overdose effects
No overdose information available. Doses up to 8 mg/kg used in clinical trials.
Storage conditions
Keep below 30°C temperature away from light and moisture. Keep out of reach of children.
Chemical structure
Miltefosine