Miltefosine may cause fetal harm, including fetal death in animals; do not administer to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing miltefosine. Females of reproductive potential should be advised to use effective contraception during miltefosine therapy and for 5 months after therapy .
Medically reviewed by Drugs.com. Last updated on Nov 2, 2019.
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Anti-Infective Agent
Uses for miltefosine
Miltefosine is used to treat certain types of leishmaniasis, such as visceral leishmaniasis (affects the internal organs), cutaneous leishmaniasis (affects the skin), or mucosal leishmaniasis (affects the nose, mouth, or throat).
Miltefosine is available only with your doctor's prescription.
Before using miltefosine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For miltefosine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to miltefosine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of miltefosine in children younger than 12 years of age. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of miltefosine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with food/tobacco/alcohol
Other medical problems
The presence of other medical problems may affect the use of miltefosine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diarrhea or
- Kidney disease or
- Liver disease—Use with caution. May make these conditions worse.
- Sjögren-Larsson-Syndrome (a rare disease)—Should not be used in patients with this condition.
Proper use of miltefosine
Take miltefosine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Miltefosine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole. Do not crush, break, or chew it.
Take miltefosine with food to help prevent stomach problems.
Keep using miltefosine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
The dose of miltefosine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of miltefosine. If your dose is different, do not change it unless your doctor tells you to do so.
- For oral dosage form (capsules):
- For leishmaniasis:
- Adults and children 12 years of age and older weighing 45 kg or more—50 mg three times a day, with food (breakfast, lunch, and dinner), taken for 28 days.
- Adults and children 12 years of age and older weighing 30 to 44 kilograms (kg)—50 milligrams (mg) two times a day, with food (breakfast and dinner), taken for 28 days.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For leishmaniasis:
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 go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions while using miltefosine
It is very important that your doctor check your or your child's progress at regular visits. This will allow your to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.
Using miltefosine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 5 months after the last dose of miltefosine. If you think you have become pregnant while using miltefosine, tell your doctor right away.
You must have a negative urine or blood pregnancy test before you will be allowed to take miltefosine. If you miss a period while you are using miltefosine, tell your doctor right away.
Vomiting or diarrhea may occur while taking miltefosine. These side effects may prevent birth control pills from working properly. You may use other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
Serious skin reactions can occur with miltefosine. Check with your doctor right away if you or your child have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using miltefosine.
Miltefosine side effects
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Abdominal or stomach pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody, black, or tarry stools
- chills or fever
- itching or rash
- pain in the scrotum
- pinpoint red spots on the skin
- smaller amount of semen ejaculated than usual
- severe diarrhea or vomiting
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
- Decreased appetite
- lack or loss of strength
- General feeling of discomfort or illness
- itching skin
- sleepiness or unusual drowsiness
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