Amphotec Side Effects
Generic Name: amphotericin b cholesteryl sulfate
Note: This page contains information about the side effects of amphotericin b cholesteryl sulfate. Some of the dosage forms included on this document may not apply to the brand name Amphotec.
For the Consumer
Applies to amphotericin b cholesteryl sulfate: intravenous powder for solution
In addition to its needed effects, some unwanted effects may be caused by amphotericin b cholesteryl sulfate (the active ingredient contained in Amphotec). In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking amphotericin b cholesteryl sulfate, check with your doctor or nurse as soon as possible:More common:
- Difficulty in breathing
- dizziness or fainting
- increased heartbeat
- unusual bleeding or bruising
- Difficulty in swallowing
- 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 of the side effects that can occur with amphotericin b cholesteryl sulfate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Less common:
For Healthcare Professionals
Applies to amphotericin b cholesteryl sulfate: intravenous powder for injection
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
Hematologic abnormalities associated with amphotericin B lipid complex therapy have occurred infrequently. Thrombocytopenia, anemia, coagulation defects, and altered leukocyte counts have been reported.[Ref]
Nervous system side effects including headache, insomnia, anxiety, and confusion, convulsions, coma, peripheral neuropathy, and somnolence have occurred.[Ref]
Hypersensitivity may present as bronchospasm, wheezing, or anaphylactoid reactions. Cell mediated immunological reactions have occurred.[Ref]
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.[Ref]
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.[Ref]
Dermatologic side effects have included alopecia, dry skin, skin discoloration, maculopapular rash, pruritus, sweating, flushing, and ulceration.[Ref]
Local inflammation at the injection site has been reported.[Ref]
Musculoskeletal side effects have included generalized bone, joint, or muscle pain.[Ref]
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.[Ref]
Rare genitourinary side effects have included hematuria and vaginal bleeding.[Ref]
Psychiatric side effects have included depression, hallucinations, and abnormal thought processes.[Ref]
1. "Product Information. Amphotec (amphotericin B cholesteryl sulfate)." Sequus Pharmaceuticals Inc, Menlo Park, CA.
2. Brogden RN, Goa KL, Coukell AJ "Amphotericin-B colloidal dispersion: A review of its use against systemic fungal infections and visceral leishmaniasis." Drugs 56 (1998): 365-83
3. Kauffman CA, Wiseman SW "Anaphylaxis upon switching lipid-containing amphotericin B formulations." Clin Infect Dis 26 (1998): 1237-8
Not all side effects for Amphotec may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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