Amphotericin B warnings and precautions

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Amphotericin B
ABELCET® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]

Warnings

Anaphylaxis has been reported with amphotericin B desoxycholate and other amphotericin B-containing drugs. Anaphylaxis has been reported with ABELCET® with an incidence rate of <0.1%. If severe respiratory distress occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of ABELCET®.

Precautions

  • General:

As with any amphotericin B-containing product, during the initial dosing of ABELCET®, the drug should be administered under close clinical observation by medically trained personnel.

Acute reactions including fever and chills may occur 1 to 2 hours after starting an intravenous infusion of ABELCET®. These reactions are usually more common with the first few doses of ABELCET® and generally diminish with subsequent doses. Infusion has been rarely associated with hypotension, bronchospasm, arrhythmias, and shock.

  • Laboratory Tests:

Serum creatinine should be monitored frequently during ABELCET® therapy (see ADVERSE REACTIONS). It is also advisable to regularly monitor liver function, serum electrolytes (particularly magnesium and potassium), and complete blood counts.[1]

References

  1. "ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]".

Adapted from the FDA Package Insert.