Pronunciation:

am-foe-TER-i-sin B

Brand Names:

• Amphocin
• Fungizone

Dosage Forms:

• Powder for Solution

Warnings:

This drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal infections; it should not be used to treat noninvasive forms of fungal disease such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for injection should not be given at doses greater than 1.5 mg/kg. Exercise caution to prevent inadvertent overdosage, which can result in potentially fatal cardiac or cardiopulmonary arrest. Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg .

Classifications:

Therapeutic—

Antifungal

Chemical—

Polyene

Uses of This Medicine:

Amphotericin B is an antifungal. It is used to help the body overcome serious fungus infections. It may also be used for other problems as determined by your doctor.

Amphotericin B 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—

Although there is no specific information comparing use of amphotericin B 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 amphotericin B in the elderly with use in other age groups.

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 receiving 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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Arsenic Trioxide
• Aspirin
• Bupropion
• Foscarnet
• Tacrolimus

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:

• Kidney disease—Amphotericin B may cause side effects affecting the kidneys

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 injection dosage form:
  • Adults and children: A small test dose is usually given first to see how you react to the medicine. The dose is then increased, depending on what your infection is and how well you tolerate the medicine. The dose must be determined by 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 immediately if any of the following side effects occur:

More common

With intravenous injection

Fever and chills

headache

increased or decreased urination

irregular heartbeat

muscle cramps or pain

nausea

pain at the place of injection

unusual tiredness or weakness

vomiting

Less common or rare

With intravenous injection

Blurred or double vision

convulsions (seizures)

numbness, tingling, pain, or weakness in hands or feet

shortness of breath, troubled breathing, wheezing, or tightness in chest

skin rash or itching

sore throat and fever

unusual bleeding or bruising

With spinal injection

Blurred vision or any change in vision

difficult urination

numbness, tingling, pain, 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

With intravenous injection

Diarrhea

headache

indigestion

loss of appetite

nausea or vomiting

stomach pain

Less common

With spinal injection

Back, leg, or neck pain

dizziness or lightheadedness

headache

nausea or vomiting

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.