Ceftobiprole: An Extended-Spectrum Anti–Methicillin-Resistant Staphylococcus aureus Cephalosporin

Shawn D Anderson, PharmD; John G Gums, PharmD, FCCP

Disclosures

The Annals of Pharmacotherapy. 2008;42(6):806-816. 

In This Article

Dosing and Administration

Based on pharmacokinetic and pharmacodynamic data, Monte Carlo simulations, and Phase 3 clinical trials, the predicted FDA-approved dose of ceftobiprole medocaril for suspected or documented gram-postive cSSSIs will be 500mg intravenously every 12 hours (1-h infusion) for 7–14 days. Predicted approved dosing if gram-negative pathogens are suspected or isolated, such as in a diabetic foot infection, may be 500mg intravenously every 8 hours (2-h infusion) for 7–14 days. The latter dose is predicted if current Phase 3 clinical trials show effectiveness of ceftobiprole in community-acquired pneumonia, hospital-acquired pneumonia, and chemotherapy-induced fever and neutropenia. As ceftobiprole is predominantly eliminated unchanged in the urine at a rate comparable to the normal glomerular filtration rate, reduced doses in renal impairment are required. Proposed renal dose adjustments are based on Cockcroft-Gault calculations of estimated Cl cr using actual body weight. All proposed dose adjustments are administered as 2-hour infusions: mild renal impairment (50–80mL/min) is 500mg every 8 hours, moderate (30–49mL/min) is 500mg every 12 hours, and severe (<30mL/min) is 250mg every 12 hours.[35] These recommendations have not been prospectively evaluated in clinical trials.

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