Meglumine antimoniate (Intravenous, Injection)

Meglumine antimoniate is part of a group of medicines known as antiprotozoals. It 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 given by or under the supervision of your doctor.

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

If your symptoms become worse, check with your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know 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.

Pediatric

There is no specific information comparing the use of meglumine antimoniate in children to its use in other age groups. This medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work 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 the use of meglumine antimoniate in the elderly to its use in other age groups.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Heart disease or
• Kidney disease or
• Liver disease or
• Pancreatic disease—Meglumine antimoniate may worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

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

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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen in some patients. If you notice any other effects, check with your health care professional.

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

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.