AMPHOTERICIN B LIPOSOMAL COMPLEX (Systemic)

Some commonly used brand names are:

In the U.S.—

• AmBisome

• Antifungal (systemic)
• antiprotozoal

Amphotericin B (am-foe-TER-i-sin) 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, in the following dosage form:

• Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For amphotericin B liposomal complex, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to amphotericin B liposomal complex. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Amphotericin B liposomal complex has not been reported to cause birth defects or other problems in humans. However, studies in animals have shown that amphotericin B liposomal complex causes the fetus to abort and other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether amphotericin B liposomal complex passes into breast milk. However, amphotericin B liposomal complex is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

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.

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 amphotericin B liposomal complex, it is especially important that your health care professional know if you are taking any of the following:

• Aminoglycosides (amikacin [e.g., Amikin], gentamicin [e.g., Garamycin], kanamycin [e.g., Kantrex], neomycin [e.g., Mycifradin], netilmicin [e.g., Netromycin], streptomycin, tobramycin [e.g., Nebcin]) or
• Cyclosporine (e.g., Sandimmune) or
• Pentamidine (e.g., NebuPent, Pentam 300) or
• Tacrolimus (e.g., Prograf)—Use of these medicines with amphotericin B liposomal complex may increase the risk of side effects affecting the kidneys

• Antineoplastic agents (cancer medicine)—Use of cancer medicines with amphotericin B liposomal complex may increase the risk of side effects affecting the blood, kidneys, and lungs

• Atracurium (e.g., Tracrium) or
• Gallamine (e.g., Flaxedil) or
• Metocurine (e.g., Metubine Iodide) or
• Pancuronium (e.g., Pavulon) or
• Tubocurarine or
• Vecuronium (e.g., Norcuron)—Use of these medicines with amphotericin B liposomal complex may increase the effects of these medicines

• Corticosteroids (cortisone-like medicine) or
• Corticotropin (ACTH) or
• Digitalis glycosides (heart medicine)—Use of amphotericin B liposomal complex with corticosteroids, corticotropin, or digitalis medicines (such as digoxin) may cause changes in the blood that may increase the chance of heart problems

Other medical problems—The presence of other medical problems may affect the use of amphotericin B liposomal complex. 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

Dosing—The dose of amphotericin B liposomal complex will be different for different patients. The following information includes only the average doses of amphotericin B liposomal complex.

• 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.

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)

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

Abdominal pain; cough; diarrhea; dizziness; nausea; vomiting

Less common

Skin rash

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

Developed: 03/26/1998
Revised: 11/22/2000

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