Amphotec Side Effects

Generic name: amphotericin b cholesteryl sulfate

Note: This document contains side effect information about amphotericin b cholesteryl sulfate. Some of the dosage forms listed on this page may not apply to the brand name Amphotec.

Some side effects of Amphotec may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amphotericin b cholesteryl sulfate: intravenous powder for solution

Along with its needed effects, amphotericin b cholesteryl sulfate (the active ingredient contained in Amphotec) 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

For Healthcare Professionals

Applies to amphotericin b cholesteryl sulfate: intravenous powder for injection

General

General reactions such as fever and chills/rigors have been reported in 35% of patients. These symptoms usually begin within 1 to 3 hours of initiation of an amphotericin B cholesteryl sulfate infusion and diminish with subsequent infusions. Slowing the rate of infusion may control symptoms. Severe infusion-related side effects associated with conventional amphotericin B administration have been lessened by pretreatment/treatment with corticosteroids, acetaminophen, antihistamines, and meperidine.

Renal

Renal toxicity has been reported less frequently with amphotericin B cholesteryl sulfate than with conventional amphotericin B. Increased serum creatinine, BUN, and hypokalemia have occurred in patients receiving amphotericin B cholesteryl sulfate. Acute kidney failure, abnormal renal function including oliguria, albuminuria, dysuria, glycosuria, and urinary incontinence and retention have been reported.

Metabolic

Metabolic changes have occurred less frequently with amphotericin B cholesteryl sulfate than with conventional amphotericin B. Decreased serum concentrations of potassium, magnesium, sodium, and calcium often accompany amphotericin-induced nephrotoxicity and patients may require replacement therapy. Hyperglycemia, hypervolemia, and weight gain/loss have been reported.

Gastrointestinal

Common gastrointestinal side effects, including nausea, vomiting, and diarrhea have been reported. Gastrointestinal hemorrhage, abdominal pain, stomatitis, anorexia, dyspepsia, epigastric pain, cramping, malaise, and constipation have occurred less frequently.

Hematologic

Hematologic abnormalities associated with amphotericin B lipid complex therapy have occurred infrequently. Thrombocytopenia, anemia, coagulation defects, and altered leukocyte counts have been reported.

Nervous system

Nervous system side effects including headache, insomnia, anxiety, and confusion, convulsions, coma, peripheral neuropathy, and somnolence have occurred.

Hypersensitivity

Hypersensitivity may present as bronchospasm, wheezing, or anaphylactoid reactions. Cell mediated immunological reactions have occurred.

Cardiovascular

Cardiac side effects (primarily infusion-related) have occurred in approximately 9% of patients receiving amphotericin B cholesteryl sulfate. Side effects have included hypertension, hypotension, and tachycardia. Cardiac failure/arrest, chest pain, vasodilation, cardiomyopathy, and arrhythmias have been reported infrequently.

Respiratory

Infusion-related respiratory side effects have included dyspnea, and hypoxia. Increased cough, rhinitis, respiratory insufficiency/failure, hyperventilation, pneumonia, asthma, hemoptysis, and lung edema have been reported in treated patients.

Dermatologic

Dermatologic side effects have included alopecia, dry skin, skin discoloration, maculopapular rash, pruritus, sweating, flushing, and ulceration.

Local

Local inflammation at the injection site has been reported.

Musculoskeletal

Musculoskeletal side effects have included generalized bone, joint, or muscle pain.

Hepatic

Hepatic side effects associated with amphotericin B cholesteryl sulfate therapy have included elevated serum concentrations of alkaline phosphatase, ALT, AST, and bilirubin. Hepatocellular toxicity, hepatomegaly, and veno-occlusive liver disease have been reported.

Genitourinary

Rare genitourinary side effects have included hematuria and vaginal bleeding.

Psychiatric

Psychiatric side effects have included depression, hallucinations, and abnormal thought processes.

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