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FDA.gov, Synercid Data Sheet.pdf

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Preview of FDA.gov, Synercid Data Sheet
🔗 Source: accessdata.fda.gov
📊 Size: 446 KB
📄 Pages: 16 pages
⬇️ Downloads: 62

Summary

Synercid is a streptogramin antibacterial agent for intravenous administration, approved for treating serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium bacteremia. Its approval is based on its ability to clear the bacterium from the bloodstream, considered a surrogate endpoint, although a study to verify its clinical benefit is ongoing. Synercid consists of quinupristin and dalfopristin, with a ratio of 30:70, and is converted to active metabolites in the body. Its pharmacokinetic parameters have been determined in healthy volunteers, showing moderate protein binding and penetration into noninflammatory blister fluid. Synercid can interfere with the metabolism of other drugs and is primarily eliminated through fecal excretion. Its pharmacokinetics are not significantly modified in elderly individuals or by gender, but may be affected in patients with renal or hepatic insufficiency, or obesity.

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Description

Synercid is a streptogramin antibacterial agent for intravenous administration, approved for treating serious or life-threatening infections associated with...

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  • File Format: PDF
  • File Size: 446 KB
  • Pages: 16
  • Language: EN
  • Total Downloads: 62
  • Last Updated: 1 month ago

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