• Antiprotozoal, systemic

Meglumine antimoniate (MEG-loo-meen an-ti-MOE-nee-ate) 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 and is available in the following dosage form:

Parenteral
• Injection (France and Italy)

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 meglumine antimoniate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to meglumine antimoniate or sulfites. Also tell your health care provider if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether meglumine antimoniate passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are receiving this medicine and who wish to breast-feed should discuss this with their doctor.

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. When you are receiving meglumine antimoniate, it is especially important that your health care provider know if you are taking any of the following:

• Antiarrhythmics (medicines for heart rhythm problems [e.g., Cardioquin]) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Effects on the heart may be increased

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

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 meglumine antimoniate is based on the amount of pentavalent antimony it contains. The dose of meglumine antimoniate will be different for different patients. The following information includes only the average doses of meglumine antimoniate.

The amount of injection that you receive each day, the time allowed between doses, and the length of time you receive the medicine depend on the severity of the medical problem for which you are receiving meglumine antimoniate.

• 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.

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 .

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 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Drowsiness;  general feeling of discomfort ;  headache;  joint pain;  loss of appetite;  muscle pain;  stomach pain 
  
  

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