Pharmacy & Therapeutics - October 2008 - (Page 563)

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 UNLEASH THE POTENCY 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. * DORIBAXTM is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by susceptible strains of E coli, K pneumoniae, P aeruginosa, B caccae, B fragilis, B thetaiotaomicron, B uniformis, B vulgatus, S intermedius, S constellatus, or P micros. † DORIBAXTM is indicated as a single agent for the treatment of complicated urinary tract infections caused by susceptible strains of E coli, including cases with concurrent bacteremia, K pneumoniae, P mirabilis, P aeruginosa, or A baumannii. To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAXTM and other antibacterial drugs, DORIBAXTM should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Important Safety Information DORIBAXTM is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems, or in patients who have demonstrated anaphylactic reactions to beta lactams. Serious and occasionally fatal hypersensitivity (anaphylactic) and serious skin reactions have been reported in patients receiving beta-lactam antibiotics. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. If an allergic reaction to DORIBAXTM occurs, discontinue the drug. Serious acute anaphylactic reactions require emergency treatment with epinephrine and other emergency measures, including oxygen, IV ﬂuids, IV antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Carbapenems may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. 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. DORIBAXTM 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-Janssen Pharmaceuticals, 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-Janssen Pharmaceuticals, Inc. 2008 June 2008 02B07140R3 http://www.doribax.com http://www.doribax.com

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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