DORIBAX PACKAGE INSERT PDF

Based on reported adverse drug reactions, it is not anticipated that Doribax will affect the ability to .. PACKAGE LEAFLET: INFORMATION FOR THE USER. Based on reported adverse drug reactions, it is not anticipated that Doribax will affect the ability to drive and Package leaflet: Information for the user. Doribax . Doripenem is an antibacterial drug. Bacterial resistance mechanisms that affect doripenem include drug inactivation . Package Insert data.

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Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis. Reference s National Institutes of Health, U.

Facultative Gram-positive microorganisms Staphylococcus aureus methicillin-susceptible isolates only Streptococcus agalactiae Streptococcus pyogenes Facultative Gram-negative microorganisms Packave freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Serratia marcescens Pharmacodynamics———————————— Similar to other beta-lactam antimicrobial agents, the time that unbound plasma concentration of doripenem exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in animal models of infection.

Variations in color within this range do not affect the potency of the product. Evaluate if diarrhea occurs. Interaction with Other Antimicrobials In vitro synergy tests with doripenem show doripenem has little potential to antagonize or soribax antagonized by other antibiotics e.

The following formula may be used to estimate CrCl.

Doripenem for Injection, MG, 10 POWDER (VIAL)

The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Facultative Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Serratia marcescens. Mechanism s of Resistance Bacterial resistance mechanisms that affect doripenem include drug inactivation by carbapenem-hydrolyzing enzymes, mutant or acquired PBPs, decreased outer membrane permeability and active efflux.

Please review the latest applicable package insert for additional information and possible updates.

Doripenem for Injection

At least 90 percent of the following microorganisms exhibit an in vitro minimal inhibitory concentration MIC less than or equal to the susceptible breakpoint for doripenem of organisms of the same type shown in Table 6. Facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Facultative Gram-positive microorganisms Streptococcus constellatus Streptococcus intermedius Anaerobic microorganisms Bacteroides caccae Bacteroides fragilis Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Peptostreptococcus micros At least 90 percent of the following microorganisms exhibit an in vitro minimal inhibitory concentration MIC less than or equal to the susceptible breakpoint for doripenem of organisms of the same type shown in Table 6.

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Doripenem is a carbapenem with in vitro antibacterial activity against aerobic and anaerobic Gram-positive and Gram-negative bacteria. In pooled human liver microsomes, no in vitro metabolism of doripenem could be detected, indicating that doripenem is not a substrate for hepatic CYP enzymes. Patients with seizure disorders controlled with valproic acid or sodium valproate will therefore be at an increased risk for breakthrough seizures.

Mean SD renal clearance is Mechanism of Action Doripenem is an antibacterial drug. Pharmacodynamics———————————— Similar to other beta-lactam antimicrobial agents, the time that unbound plasma concentration of doripenem exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in animal models of infection.

Facultative Gram-positive microorganisms Staphylococcus aureus methicillin-susceptible isolates only Streptococcus agalactiae Streptococcus pyogenes. Facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa.

The safety and efficacy of doripenem in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. Aseptic technique must be followed in preparation of the infusion solution. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy.

A local search option of this data can be found here. Although cross-resistance may occur, some isolates resistant to other carbapenems may be susceptible to doripenem. Patients with Renal Impairment Table 2: Metabolism Metabolism of doripenem to a microbiologically inactive ring-opened metabolite doripenem-M1 occurs primarily via dehydropeptidase-I. The serum creatinine used in the formula should represent a steady state of renal function.

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In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Disclaimer The authors make no claims of the inwert of the information contained herein; and these suggested packaeg are not doirbax substitute for clinical judgment.

Anaerobic microorganisms Bacteroides caccae Bacteroides fragilis Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Peptostreptococcus micros. The recommended dosage and administration by infection is described in Table 1: The mean plasma terminal elimination half-life of doripenem in healthy non-elderly adults is approximately 1 hour and mean SD plasma clearance is Doripenem inactivates multiple essential penicillin-binding proteins PBPs resulting in inhibition of cell wall synthesis with subsequent cell death.

Storage of Constituted Solutions Upon constitution with sterile water for injection or 0. Doripenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by Gram-positive and Gram-negative bacteria, with the exception of carbapenem hydrolyzing beta-lactamases.

DORIBAX® (doripenem) powder – GlobalRPH

Facultative Gram-positive microorganisms Streptococcus constellatus Streptococcus intermedius. Doripenem has been shown to be active against most insfrt of the following microorganisms, both in vitro and in clinical infections.

The final infusion solution concentration is approximately 4. Microbiology Doripenem belongs to the carbapenem class of antimicrobials. Excretion Doripenem is primarily eliminated unchanged by the kidneys.

The magnitude of this value, coupled with the significant decrease in the elimination of doripenem with concomitant probenecid administration, suggests that doripenem undergoes both glomerular filtration and active tubular secretion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. Reference Package Insert data.