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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Microbiology Doripenem belongs to the carbapenem class of antimicrobials. Reference Package Insert data. The following formula may be used to estimate CrCl. The magnitude of this value, coupled with the significant decrease in the elimination of doripenem with concomitant probenecid administration, suggests knsert doripenem undergoes both glomerular filtration and active tubular secretion.

Variations in color within this range do not affect the potency of the inseet. Facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa.

A local search option of this data can be found here. Mechanism of Action Doripenem is an antibacterial drug. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

Doripenem for Injection

When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. 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. Patients with Renal Impairment Table 2: Patients with seizure disorders controlled with valproic acid or sodium valproate will therefore be at an increased risk for breakthrough seizures.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. The mean plasma terminal elimination half-life of doripenem in healthy non-elderly adults is approximately 1 hour and mean SD plasma clearance is Facultative Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Serratia marcescens.

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Aseptic technique must be followed in preparation of the infusion solution. Interaction with Other Antimicrobials In vitro synergy tests with doripenem show doripenem has little potential to antagonize or be antagonized by other antibiotics e.

Doripenem is a carbapenem with in vitro antibacterial activity against aerobic and anaerobic Gram-positive and Gram-negative bacteria. Evaluate if diarrhea occurs.

Storage of Constituted Solutions Upon constitution with sterile water for injection or 0. 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 serum creatinine used in the formula should represent a steady state of renal function. Please review the latest applicable package insert for additional information and possible updates. Although cross-resistance may doriba, some isolates resistant to other carbapenems may be susceptible to doripenem. Mean SD renal clearance is Facultative Gram-positive microorganisms Streptococcus constellatus Streptococcus intermedius. Metabolism Metabolism of doripenem to a microbiologically inactive ring-opened metabolite doripenem-M1 occurs primarily via dehydropeptidase-I.

Doripenem inactivates multiple essential penicillin-binding proteins PBPs resulting in inhibition of cell wall synthesis inxert subsequent cell death.

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.

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. 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. 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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Anaerobic microorganisms Bacteroides caccae Bacteroides fragilis Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Peptostreptococcus micros. 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.

Doripenem for Injection, MG, 10 POWDER (VIAL)

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.

Doripenem has been shown to be active against most isolates of the following odribax, both in vitro and in clinical infections.

Reference s National Institutes of Health, U. Facultative Gram-positive microorganisms Staphylococcus aureus methicillin-susceptible isolates only Streptococcus agalactiae Streptococcus pyogenes.

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. The final infusion solution concentration is approximately 4. Excretion Doripenem is primarily eliminated unchanged by the kidneys. Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis.

The recommended dosage and administration by infection is packgae in Table 1: