Pharmacy and Therapeutics - January 2008 - (Page 19) InTrodUcIng dorIBax Clinical efficacy proven in complicated intra-abdominal infections* and complicated urinary tract infections, including pyelonephritis† Demonstrated safety and tolerability profiles—no seizures reported in 4 large Phase III clinical trials Break THroUgH carbapenem potency that breaks through today’s gram-negative pathogens‡1-3 Proven in vitro activity vs P aeruginosa, Enterobacteriaceae, and A baumannii1-3 ‡ In vitro activity does not necessarily correlate with clinical results. Please see brief summary of full Prescribing Information on following pages. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations cannot be maintained in the therapeutic range or seizures occur. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued. When doripenem has been used investigationally via inhalation, pneumonitis has occurred. DORIBAX should not be administered by this route. Safety and effectiveness in pediatric patients have not been established. The most common adverse reactions (≥5%) observed in clinical trials were headache, nausea, diarrhea, rash, and phlebitis. REFERENCES: 1. Evangelista AT, Yee C, Pillar CM, Aranza-Torres MK, Sahm DF, Thornsberry C. Surveillance profiling of doripenem activity against Pseudomonas aeruginosa isolated from inpatients and ICU patients: results of the TRUST surveillance initiative. Presented at the 45th Annual Meeting of the Infectious Diseases Society of America (IDSA); 2007: San Diego, CA. 2. Data on file, Ortho-McNeil, Inc. 3. Jones ME, Draghi DC, Brown NP, Aranza MK, Thornsberry C, Sahm DF, et al. Baseline surveillance profile of Doripenem (DOR) against key gram-negative pathogens encountered in the United States. Presented at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 2006:San Francisco, CA. for more information, visit us at www.doribax.com © Ortho-McNeil, Inc 2007 November 2007 02B039 http://www.doribax.com http://www.doribax.com
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.