Welcome to the Official DORIBAX (doripenem for injection) Web site-Information on DORIBAX

DORIBAX is indicated for adults in the treatment of complicated intra-abdominal infections^* and complicated urinary tract infections, including pyelonephritis^†

Excellent gram-positive and gram-negative and anaerobic coverage
Demonstrated safety and tolerability profiles—no seizures reported in 4 large Phase III clinical trials

Carbapenem potency that breaks through today's gram-negative pathogens^‡1-3

Proven in vitro activity vs P aeruginosa, Enterobacteriaceae, and Acinetobacter^1-3
Low propensity to select for in vitro resistance in P aeruginosa^4,5
The molecular structure of DORIBAX may confer a high level of in vitro activity vs a wide range of pathogens⁶

^*Caused by susceptible strains of E coli, K pneumoniae, P aeruginosa, B caccae, B fragilis, B thetaiotamicron, B uniformis, B vulgatus, S intermedius, S constellatus, or P micros.

^†Caused by susceptible strains of E coli, including cases with concurrent bacteremia, K pneumoniae, P mirabilis, P aeruginosa, or A baumannii.

^‡In vitro activity does not necessarily correlate with clinical results.

Please see Important Safety Information Below

REFERENCES

INDICATIONS

DORIBAX 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; and for the 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 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 use of 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.

Challenging Gram-Negative Pathogens

About DORIBAX

Interactive Prescribing Information

Break Through With DORIBAX

Important Safety Information

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This page was last modified on: Jun 16 2008 at 15:46:05 EDT

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