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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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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.

Microbiology Doripenem belongs to the carbapenem class of antimicrobials. 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.

Doripenem is a carbapenem with in vitro antibacterial activity against aerobic and anaerobic Gram-positive and Gram-negative bacteria. Metabolism Metabolism of doripenem to a microbiologically inactive ring-opened metabolite doripenem-M1 occurs packqge via dehydropeptidase-I.

Excretion Doripenem is primarily eliminated unchanged by the packag. 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.

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. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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Doripenem for Injection, MG, 10 POWDER (VIAL)

Mechanism s of Resistance Bacterial resistance mechanisms that affect foribax include drug inactivation by carbapenem-hydrolyzing enzymes, mutant or acquired PBPs, decreased outer membrane permeability and active efflux. Anaerobic microorganisms Bacteroides caccae Bacteroides fragilis Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Peptostreptococcus micros.

Evaluate if diarrhea occurs. Reference s National Institutes of Health, U.

The mean plasma terminal elimination half-life of doripenem in healthy non-elderly adults is approximately 1 hour doribzx mean SD plasma clearance is Interaction with Other Antimicrobials In vitro synergy tests with doripenem show doripenem has little potential to antagonize or be inserg by other antibiotics e.

The final infusion solution concentration is approximately 4. Doripenem has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections.

Patients with seizure disorders controlled with valproic acid or sodium valproate will therefore be at an increased risk for breakthrough seizures. Aseptic technique must be followed in preparation of the infusion solution. Facultative Gram-positive microorganisms Staphylococcus aureus methicillin-susceptible isolates only Streptococcus agalactiae Streptococcus pyogenes.

Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. The recommended dosage and administration by infection is described in Table 1: 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.

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.

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

A local search option of this data can be found here. Facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa.

DORIBAX® (doripenem) powder – GlobalRPH

Facultative Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Serratia marcescens. Mean SD renal clearance is Facultative Gram-positive microorganisms Streptococcus constellatus Streptococcus intermedius.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy.

Doripenem for Injection

The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Please review the latest applicable package insert for additional information and possible updates. Facultative Gram-positive microorganisms Staphylococcus aureus methicillin-susceptible isolates only Streptococcus agalactiae Streptococcus pyogenes Facultative Gram-negative microorganisms Citrobacter 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.