Pronunciation:

am-foe-TER-i-sin B LYE-poh-some

Brand Names:

• Ambisome

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antifungal

Chemical—

Polyene

Uses of This Medicine:

Amphotericin B liposomal complex is an antifungal and an antiprotozoal medicine. It is used to help the body overcome serious infections caused by fungus or protozoa.

This medicine is available only with your doctor's prescription.

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—

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of amphotericin B liposomal complex in children.

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. Although there is no specific information comparing use of amphotericin B liposomal complex in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast-feeding—

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.

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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine

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:

• Blood transfusion—Amphotericin B liposomal complex may cause side effects affecting the lungs

• Kidney disease—Amphotericin B liposomal complex may make your kidney problems worse

Proper Use of This Medicine:

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 the treatment of infection caused by fungus or protozoa
  • For injection dosage form:
    • Adults and children: 3 to 6 milligrams (mg) per kilogram (1.36 to 2.73 mg per pound) of body weight once a day, injected slowly into a vein. The number of days that you receive this treatment depends on the medical problem for which you are receiving amphotericin B liposomal complex.

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

Chills

fever

irregular heartbeat

muscle cramps or pain

unusual tiredness or weakness

Less common

Back pain

chest pain

dark urine

difficulty in breathing

headache

yellowing of eyes or skin

Rare

Difficulty in swallowing

hives

itching, especially of feet or hands

reddening of skin, especially around ears

swelling of eyes, face, or inside of nose

unusual tiredness or weakness (sudden and severe)

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

Abdominal pain

cough

diarrhea

dizziness

nausea

vomiting

Less common

Skin rash

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.