Miltefosine

By Medically reviewed by hellodoktor

Generic Name: Miltefosine Brand Name(s): Miltefosine and Miltefosine.

Uses

What is Miltefosine used for?

Miltefosine is used to treat a certain infection called leishmaniasis. It works by stopping the growth of certain parasites.

How should I take Miltefosine?

Take this medication by mouth with food, as directed by your doctor, usually 2 or 3 times daily. The dosage is based on your medical condition, weight, and response to treatment.

Swallow the capsule whole. Do not chew, break, crush, or dissolve the capsule.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Take this drug at evenly spaced intervals.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

How do I store Miltefosine?

Miltefosine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Miltefosine in the bathroom or the freezer. There may be different brands of Miltefosine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Miltefosine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Miltefosine?

Before taking miltefosine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain genetic disorder (Sjogren-Larsson syndrome), kidney disease, liver disease.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor, for use during treatment and for 5 months after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

Vomiting or diarrhea can make birth control pills not work well. If you are using birth control pills and have vomiting or diarrhea, also use reliable forms of non-hormonal backup birth control (such as condoms, diaphragm with spermicide). Talk to your doctor for more information and about other options.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while you are using miltefosine and for 5 months after stopping treatment. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Miltefosine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Miltefosine. Miltefosine is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Miltefosine?

Nausea, vomiting, diarrhea, stomach/abdominal pain, joint pain, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Take this medication with food to help reduce stomach/intestinal side effects. Drink plenty of fluids to avoid dehydration and kidney problems if vomiting or diarrhea occur.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, bloody/black/tarry stool, signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine, testicular pain/swelling.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Miltefosine?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Miltefosine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Miltefosine?

Miltefosine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Miltefosine?

Miltefosine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Miltefosine.

What is the dose of Miltefosine for an adult?

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

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.

What is the dose of Miltefosine for a child?

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

Precautions

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

How is Miltefosine available?

Miltefosine is available in the following dosage forms and strengths:

  • Oral capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Miltefosine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 29, 2018 | Last Modified: September 12, 2019

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