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Abelcet Side Effects

Generic Name: amphotericin b lipid complex

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

For the Consumer

Applies to amphotericin b lipid complex: powder for solution, suspension

Along with its needed effects, amphotericin b lipid complex (the active ingredient contained in Abelcet) 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 lipid complex:

More common
  • Chills and fever
  • headache
  • nausea and vomiting
Less common
  • Difficulty in breathing
  • sore throat and fever
  • unusual bleeding or bruising
  • unusual tiredness and weakness
Rare
  • Increased or decreased urination

Some side effects of amphotericin b lipid complex 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:

More common
  • Diarrhea
  • loss of appetite
  • stomach pain

For Healthcare Professionals

Applies to amphotericin b lipid complex: intravenous suspension

General

General side effects during infusions have included fever (15%), chills (15%), and shivering. These symptoms usually begin 1 to 2 hours after the beginning of an amphotericin B lipid complex infusion, and are more common with the first few doses administered.

Severe infusion-related side effects have been associated with conventional amphotericin B administration, and may be lessened by treatment with corticosteroids, acetaminophen, antihistamines, and meperidine.[Ref]

Renal

Renal side effects have been reported less frequently with amphotericin B lipid complex than with conventional amphotericin B, and often included increased serum creatinine and BUN. Renal failure occurred in about 5% of treated patients. Decreased renal function, including oliguria, anuria, and renal tubular acidosis have also been reported.[Ref]

Metabolic

Metabolic side effects have occurred less frequently with amphotericin B lipid complex than with conventional amphotericin B. Hypokalemia and hypomagnesemia often accompany amphotericin-induced nephrotoxicity. Hypocalcemia has also been reported in treated patients.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects, including nausea, vomiting, or diarrhea in 5% to 8% of patients, have been associated with amphotericin B lipid complex infusions. GI hemorrhage, abdominal pain, anorexia, dyspepsia, epigastric pain, cramping, malaise, and weight loss have occurred less frequently.[Ref]

Hematologic

Hematologic side effects have included thrombocytopenia, leukopenia, anemia, and less frequently, coagulation defects, blood dyscrasias, and leukocytosis.[Ref]

Nervous system

Nervous system side effects have been reported rarely, except for headache, which occurred in about 4% of treated patients. Less frequently, convulsions, peripheral neuropathy visual impairment, including diplopia, hearing loss, tinnitus, and transient vertigo have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported. These may present as bronchospasm, wheezing, or anaphylactoid reactions. Erythema multiforme has also been reported.[Ref]

Cardiovascular

Cardiovascular side effects including cardiac arrest and hypotension have been reported in 6% to 8% of treated patients. Hypertension, cardiac failure, cardiomyopathy, arrhythmias, and ventricular fibrillation have been uncommonly reported.[Ref]

Respiratory

Respiratory side effects including respiratory failure, dyspnea, pneumonia, or other respiratory disorders have been reported in treated patients.[Ref]

Dermatologic

Dermatologic side effects have included maculopapular rash, pruritus, and exfoliative dermatitis. Exanthema has been reported in a patient who was treated concomitantly with amphotericin B lipid complex and imipenem-cilastatin. The exact cause is unknown.[Ref]

Local

Local side effects including thrombophlebitis and inflammation at the injection site have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including generalized bone, joint, or muscle pain have been reported.[Ref]

Hepatic

Hepatic side effects have been uncommonly reported. These have included liver failure, jaundice, hepatitis, and increased AST, ALT, and alkaline phosphatase levels.[Ref]

Genitourinary

Genitourinary side effects have rarely included impotence.[Ref]

References

1. Kline S, Larsen TA, Fieber L, Fishbach R, Greenwood M, Harris R, Kline MW, Tennican PO, Janoff EN "Limited toxicity of prolonged therapy with high doses of amphotericin b lipid complex." Clin Infect Dis 21 (1995): 1154-8

2. Rapp RP, Gubbins PO, Evans ME "Amphotericin B lipid complex." Ann Pharmacother 31 (1997): 1174-86

3. Sharkey PK, Graybill JR, Johnson ES, Hausrath SG, Pollard RB, Kolokathis A, Mildvan D, Fanhavard P, Eng RHK, Patterson TF, "Amphotericin b lipid complex compared with amphotericin b in the treatment of cryptococcal meningitis in patients with AIDS." Clin Infect Dis 22 (1996): 315-21

4. Oravcova E, Mistrik M, Sakalova A, Drgona L, Kollar T, Helpianska L, Ilavska I, Sorkovska D, Spanik S, Kukuckova E, Krcmery V "Amphotericin b lipid complex to treat invasive fungal infections in cancer patients: report of efficacy and safety in 20 patients." Chemotherapy 41 (1995): 473-6

5. Sundar S, Murray HW "Cure of antimony-unresponsive indian visceral leishmaniasis with amphotericin b lipid complex." J Infect Dis 173 (1996): 762-5

6. Lopez-Velez R, Videla S, Marquez M, et al. "Amphotericin B lipid complex versus no treatment in the secondary prophylaxis of visceral leishmaniasis in HIV-infected patients." J Antimicrob Chemother 53 (2004): 540-3

7. "Product Information. Abelcet (amphotericin B)." Liposome Company Inc, The, Princeton, NJ.

8. Gales MA, Gales BJ "Acute renal failure with amphotericin B in lipid emulsion." Ann Pharmacother 30 (1996): 1036

9. Sorkin P, Nagar H, Weinbroum A, Setton A, Israitel E, Scarlatt A, Silbiger A, Rudick V, Kluger Y, Halpern P "Administration of amphotericin b in lipid emulsion decreases nephrotoxicity: results of a prospective, randomized, controlled study in critically ill patients." Crit Care Med 24 (1996): 1311-5

10. Rowles DM, Fraser SL "Amphotericin B lipid complex (ABLC)-associated hypertension: Case report and review." Clin Infect Dis 29 (1999): 1564-5

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

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