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New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria
Date:10/27/2008

cated 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, and

-- Complicated urinary tract infections, including pyelonephritis, 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 DORIBAX and other antibacterial drugs, DORIBAX 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

DORIBAX 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 DORIBAX 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 mon
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SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
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