Abelcet 5 mg/mL intravenous suspension

Generic name:
Amphotericin/lipid complex - injection

Pronunciation
(AM-foe-TER-i-sin/LIP-id)

Brand name(s)
Abelcet , Ambisome , Amphotec

This medication is used to treat a variety of serious fungal infections. It is often used in patients who cannot tolerate or who do not respond to the regular amphotericin treatment. It works by stopping the growth of fungi.

This medication is usually given by injection into a vein as directed by your doctor, usually once a day. It should be injected slowly over 2 hours. The dosage is based on your medical condition, weight, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications (including acetaminophen, diphenhydramine, corticosteroids such as hydrocortisone) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, shaking, chills, flushing, loss of appetite, dizziness, nausea, vomiting, headache, shortness of breath, or fast breathing. Your doctor may give you other medications to help with these side effects.

It may be necessary to continue this medication for several weeks to several months in order to treat certain infections. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

See also How to Use section.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• swelling/pain at injection site
• muscle/joint pain
• unusual tiredness
• weakness
• muscle cramping
• signs of kidney problems (such as change in the amount of urine, painful urination)
• numbness/tingling of arms/legs
• vision changes
• hearing changes (such as ringing in the ears)
• signs of liver problems (such as dark urine, stomach/abdominal pain, yellowing eyes/skin)
• swelling ankles/feet
• fast/slow/irregular heartbeat
• cold sweats
• blue lips
• easy bruising/bleeding
• other signs of infection (such as sore throat that doesn't go away, fever)
• mental/mood changes
• seizures
• black stools
• vomit that looks like coffee grounds

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using amphotericin/lipid complex, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• white blood cell (leukocyte) transfusions
• heart disease (such as irregular heartbeat, heart failure)
• liver disease
• kidney disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• anti-cancer drugs (such as mechlorethamine, nitrogen mustard)
• azole antifungals (such as ketoconazole, itraconazole)
• cidofovir
• digoxin
• flucytosine
• medications that affect the kidneys (including pentamidine, tacrolimus, aminoglycosides such as gentamicin)
• muscle relaxants (such as tubocurarine)
• zidovudine

This medication may interfere with certain lab tests (such as a phosphate levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as kidney/liver function, potassium/magnesium levels, complete blood counts) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.