Amphotericin b cholesteryl sulfate complex Intravenous

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 amphotericin b cholesteryl sulfate complex, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amphotericin b cholesteryl sulfate complex 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.

Pediatric

amphotericin b cholesteryl sulfate complex has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

amphotericin b cholesteryl sulfate complex has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

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.

Interactions with 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 amphotericin b cholesteryl sulfate complex, 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 amphotericin b cholesteryl sulfate complex 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

Interactions with Food/Tobacco/Alcohol

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 amphotericin B cholesteryl complex. Make sure you tell your doctor if you have any other medical problems.

Dosing

The dose of amphotericin b cholesteryl sulfate complex 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 amphotericin b cholesteryl sulfate complex. 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 injection dosage form:
  • For treatment of aspergillosis:
    • Adults and children—3 to 4 milligrams per kilogram (1.36 to 1.81 mg per pound) of body weight, injected slowly into a vein, once a day.

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:

• Chills
• fever
• headache
• nausea

• Difficulty in breathing
• dizziness or fainting
• increased heartbeat
• unusual bleeding or bruising

• 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:

• 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.

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 (e.g., irregular heartbeat, congestive heart failure), liver disease, kidney disease.

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 breast-feeding.

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 (e.g., mechlorethamine, nitrogen mustard), azole antifungals (e.g., ketoconazole, itraconazole), cidofovir, digoxin, flucytosine, medications that affect the kidneys (e.g., pentamidine, tacrolimus, aminoglycosides such as gentamicin), muscle relaxants (e.g., tubocurarine), zidovudine.

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

Applies to amphotericin b cholesteryl sulfate: intravenous powder for solution

Along with its needed effects, amphotericin b cholesteryl sulfate 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 while taking amphotericin b cholesteryl sulfate:

• Chills
• fever
• headache
• nausea

• Difficulty in breathing
• dizziness or fainting
• increased heartbeat
• unusual bleeding or bruising

• 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 of amphotericin b cholesteryl sulfate 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:

• Vomiting