DORIBAX PACKAGE INSERT PDF

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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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The final infusion solution concentration is approximately 4.

Doripenem for Injection

Anaerobic microorganisms Bacteroides caccae Bacteroides fragilis Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Peptostreptococcus micros. Evaluate if diarrhea occurs. Doripenem has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections.

Mechanism of Action Doripenem is an antibacterial drug.

The mean plasma terminal elimination half-life of doripenem in healthy non-elderly adults is approximately 1 hour and mean SD plasma clearance is Although cross-resistance dotibax occur, some isolates resistant to other carbapenems packgae be pavkage to doripenem.

Facultative Gram-positive microorganisms Streptococcus constellatus Streptococcus intermedius. 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.

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.

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.

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. The following formula may be used to estimate CrCl. Facultative Gram-negative microorganisms Doribaxx freundii Enterobacter cloacae Enterobacter aerogenes Paackage oxytoca Morganella morganii Serratia marcescens.

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Aseptic technique must be followed in preparation of the infusion solution.

The authors make no claims of the accuracy of the information contained herein; and these insegt doses are not a substitute for clinical judgment. The serum creatinine used in the formula should represent a steady state of renal function.

Doripenem for Injection, MG, 10 POWDER (VIAL)

Reference s National Institutes of Health, U. Mean SD renal inssrt is The recommended dosage and administration by infection is described in Table 1: Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis. Excretion Doripenem is primarily eliminated unchanged by the kidneys. Reference Package Insert data. Please review the latest applicable package insert for additional information and possible updates.

Variations in color within this range do not affect the potency of the product. Doripenem is a carbapenem with in vitro antibacterial activity against aerobic and anaerobic Gram-positive and Gram-negative bacteria. Patients with seizure disorders controlled with valproic acid or sodium valproate will therefore be at an increased risk doribaz breakthrough seizures. Metabolism Metabolism of doripenem to a microbiologically inactive ring-opened metabolite doripenem-M1 occurs primarily via dehydropeptidase-I.

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. 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-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 dofibax 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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Storage of Constituted Solutions Upon constitution with sterile water for injection or 0. Mechanism s of Ddoribax Bacterial resistance mechanisms that affect doripenem include drug inactivation by carbapenem-hydrolyzing enzymes, mutant or acquired PBPs, decreased outer membrane permeability and active efflux.

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

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.

Interaction with Other Antimicrobials In vitro synergy tests with doripenem show doripenem has little potential to antagonize or be antagonized by other antibiotics e.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. Doripenem inactivates multiple essential penicillin-binding proteins PBPs resulting in inhibition of cell wall synthesis with subsequent cell death.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Microbiology Doripenem belongs to the carbapenem class of antimicrobials.

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. Patients with Renal Impairment Table 2: 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 pacckage.