amphotericin B

Amphotericin B is a prescription medication used to treat potentially life-threatening fungal infections.

Amphotericin B belongs to a group of drugs called systemic antifungals. These work by killing the fungi that cause infections.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of amphotericin B include fever, weight loss, decreased blood pressure, rapid breathing, nausea, vomiting, and diarrhea.

Amphotericin B is a prescription medication used to treat potentially life-threatening fungal infections including

• aspergillosis
• cryptococcosis (torulosis)
• North American blastomycosis
• systemic candidiasis
• coccidioido-mycosis
• histoplasmosis
• zygomycosis including mucormycosis

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

amphotericin B may be found in some form under the following brand names:

• Abelcet

• Ambisome

• Amphocin

• Amphotec

• Fungizone

• Fungizone Cream

Serious side effects have been reported with amphotericin B. See the “Amphotericin B Precautions” section.

Common side effects of amphotericin B include the following:

• fever
• chills
• fast breathing
• headache
• changes in heart beat
• dizziness
• fainting
• blurred vision
• nausea
• vomiting
• loss of appetite

This is not a complete list of amphotericin B side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Nes-RX, Neo-Fradin), paramomycin (Humatin), streptomycin, and tobramycin (Tobi, Nebcin)
• certain antifungals such as clotrimazole, fluconazole, itraconazole (Sporanox), ketoconazole, and miconazole
• corticotropin (ACTH, H.P., Acthar Gel)
• cyclosporine (Neoral, Sandimmune)
• digoxin (Digitek, Lanoxicaps, Lanoxin)
• flucytosine (Ancobon)
• medications for the treatment of cancer, such as nitrogen mustard
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• pentamidine (NebuPent, Pentam 300)

This is not a complete list of amphotericin B drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with amphotericin B.

Tell your health care provider if any of these symptoms are severe or do not go away:

• pale skin
• flushing
• tiredness
• diarrhea
• stomach cramping
• heartburn
• muscle or joint pain
• weight loss
• ringing in the ears
• hearing loss
• pain, burning, numbness, or tingling in the hands or feet

If you experience any of the following symptoms, call your health care provider immediately:

• rash
• itching
• hives
• difficulty breathing or swallowing
• wheezing
• confusion
• loss of responsiveness or consciousness
• seizures
• decreased urination
• change in heartbeat
• pain in the upper right part of the stomach
• extreme tiredness
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit
• vomiting material that looks like coffee grounds
• lack of energy
• yellowing of the skin or eyes
• changes in vision
• flu-like symptoms
• sore throat, chills, cough, and other signs of infection

Do not take amphotericin B if you are allergic to amphotericin B or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of amphotericin B, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking amphotericin B, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to amphotericin B or to any of its ingredients
• are receiving blood transfusions or radiation treatments
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Amphotericin B falls into category B. In animal studies, pregnant animals were given amphotericin B and some babies had problems. But in human studies, pregnant women were given this medication and their babies did not have any problems related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if amphotericin B crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using amphotericin B.

Take amphotericin B exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

The dose of amphotericin B varies depending on the type and location of infection and the patient’s overall health status. The total daily dose should not exceed 1.5 mg/kg.

If you take too much amphotericin B, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If amphotericin B is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store amphotericin B under refrigeration (2˚ to 8˚C (36˚to 46˚F)).
• Protect from exposure to light.

BOXED WARNING

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 in doses greater than 1.5 mg/kg.

EXERCISE CAUTION to prevent inadvertent overdosage, which may result in potentially fatal cardiac or cardiopulmonary arrest. Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.