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

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

Metabolism Metabolism of doripenem to a microbiologically inactive ring-opened metabolite doripenem-M1 occurs primarily via dehydropeptidase-I.

Doripenem for Injection, MG, 10 POWDER (VIAL)

Facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa.

Facultative Gram-positive microorganisms Streptococcus constellatus Streptococcus intermedius. 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 has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections. Interaction with Other Antimicrobials In vitro synergy tests with doripenem show doripenem has little potential to antagonize or be antagonized by other antibiotics e.

The final infusion solution concentration is approximately 4. Variations in color within this range do not affect the potency of the product.

Evaluate if diarrhea occurs. Facultative Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Serratia marcescens.

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.

Mechanism of Action Doripenem is an antibacterial drug. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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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Although cross-resistance may occur, some isolates resistant to other carbapenems may be susceptible to doripenem. The serum creatinine used in the formula should represent a steady state of renal function. Doripenem inactivates multiple essential penicillin-binding proteins PBPs resulting in inhibition of cell wall synthesis with subsequent cell death.

DORIBAX® (doripenem) powder – GlobalRPH

Reference s National Institutes of Health, Isnert. Doripenem is a carbapenem with in vitro antibacterial activity against aerobic and anaerobic Gram-positive and Gram-negative bacteria. The recommended dosage and administration by infection is described in Table 1: 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 dooribax 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. The magnitude of this value, coupled with the significant decrease in the elimination of doripenem with concomitant probenecid administration, dorkbax that doripenem undergoes both glomerular filtration and active tubular secretion.

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 indert equal to the susceptible breakpoint for doripenem of organisms of the same type shown in Table 6.

Doripenem for Injection

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

Excretion Doripenem is primarily eliminated unchanged by the kidneys. 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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In pooled human liver microsomes, no in vitro metabolism of doripenem could be detected, indicating that doripenem is not a substrate for dkribax CYP enzymes.

Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. Mean SD renal clearance is 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.

Reference Package Insert data.

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. Microbiology Doripenem belongs to the carbapenem class of antimicrobials.

Patients with Renal Impairment Table 2: Aseptic technique must be followed in preparation of the infusion solution. The following formula may be used to estimate CrCl. 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 authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. packaeg

Patients with seizure disorders controlled with valproic acid or sodium valproate will therefore be at an increased risk for breakthrough seizures. Storage of Constituted Solutions Upon constitution with sterile water for injection or 0.

A local inwert option of this data can be found here.