Pronunciation:

MEG-loo-meen an-ti-MOE-nee-ate

Uses of This Medicine:

Meglumine antimoniate belongs to the group of medicines called antiprotozoals. Meglumine antimoniate is used to treat an infection called leishmaniasis (Bay sore or chiclero ulcer, espundia, kala-azar or black sickness, Oriental sore, ulcera de Bejuco, uta), which is caused by protozoa (tiny, one-celled organisms).

Meglumine antimoniate should be administered by or under the supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Although there is no specific information comparing use of meglumine antimoniate in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of meglumine antimoniate in the elderly with use in other age groups.

Other 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.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Kidney disease or
• Liver disease or
• Pancreatic disease—Meglumine antimoniate may make these conditions worse

Proper Use of This Medicine:

To help clear up your infection completely, meglumine antimoniate is based on its amount of pentavalent antimony and must be given for the full time of treatment and on a regular schedule.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For leishmaniasis (Bay sore or chiclero ulcer, espundia, kala-azar or black sickness, Oriental sore, ulcera de Bejuco, uta):
    • Adults and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 milligrams (mg) of pentavalent antimony in meglumine antimoniate per kilogram (kg) (9.09 mg per pound) of body weight per day injected into a muscle for twenty to twenty-eight days. This treatment may be repeated or continued as needed. If your infection is not severe and involves only your skin, then your doctor may decide to just inject the medicine into the skin lesion. The dose will also be determined by your doctor.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This is to help make sure that the infection is cleared up completely.

If your symptoms become worse, check with your doctor .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Fever

irregular heartbeat

nausea

pain in the upper abdominal area and back

vomiting

Rare

Changes in skin color of the face

chills

cough or hoarseness

decreased amount and frequency of urination

difficulty in breathing, such as fast or irregular breathing, shortness of breath, tightness in chest, and/or wheezing

fainting or loss of consciousness

husky voice

puffiness or swelling of the eyelids or around the eyes

skin rash and/or itching

swelling of the face

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness

general feeling of discomfort

headache

joint pain

loss of appetite

muscle pain

stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.