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Endotoxin-like Reactions to Gentamicin Sulfate
JAMA. 1999;282:932.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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Since the start of 1998, FDA and CDC have received approximately 130 reports of endotoxin-like reactionscharacterized by fever, rigors, and/or hypotensionfollowing intravenous administration of two brands of gentamicin sulfate. About 70 of the reported cases were temporally associated with once-daily dosage of one product that was voluntarily withdrawn from the market in December. The other product, also voluntarily withdrawn, was associated with more than 60 endotoxin-like reactions reported this year. FDA is investigating these cases.
A number of injectable and parenteral drug products, including gentamicin and other aminoglycosides, contain endotoxin at levels that do not cause symptoms at the approved dosage. For gentamicin, this level is 1.7 endotoxin units per milligram. However, aminoglycosides often are administered in one 24-hour dose to minimize renal toxicity and simplify dosing instead of in the three doses described in the labeling. A published survey in 1995 indicated that once-daily was the preferred regimen for . . . [Full Text of this Article]
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