Amphotericin b cholesteryl sulfate Side Effects
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]
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]
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]
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
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