(quinupristin/dalfopristin, Rhone-Poulenc Rorer)
A streptogramin antibiotic for infections caused by vancomycin-resistant Enterococcus faecinm (VREF) bacteria, when no alternative is available. Also for complicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes. Available since 1993 through the FDA's compassionate use program.
* Recommended Dosage: 7.5 mg/kg IV every 8 hours (no oral formulation).
* Special Considerations: Should not be used with drugs that can prolong the Q-Tc interval; must be used cautiously with P450 3A4 substrates like terfenadine.
* Comment: Because Synercid was approved under the FDA's accelerated approval program--applied to products that are used to treat serious or life-threatening conditions and that provide a "meaningful therapeutic" benefit over existing treatments--approval was based on trials using the surrogate end point of effectiveness, which in this case was clearance of VREF bacteremia.
A study evaluating clinical benefit with more traditional end points like resolution of the specific infection site is underway.
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