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.

Author: Grokasa Tejora
Country: Iceland
Language: English (Spanish)
Genre: Travel
Published (Last): 2 April 2004
Pages: 396
PDF File Size: 19.7 Mb
ePub File Size: 9.53 Mb
ISBN: 426-9-67243-119-3
Downloads: 44270
Price: Free* [*Free Regsitration Required]
Uploader: Yozshumuro

The mean plasma terminal elimination half-life of doripenem in healthy non-elderly adults is approximately 1 hour and mean SD plasma clearance is 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.

Doripenem is a carbapenem with in vitro antibacterial activity against aerobic and packae Gram-positive and Gram-negative bacteria. Facultative Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Serratia marcescens.

Microbiology Doripenem belongs to the carbapenem class of antimicrobials. Anaerobic microorganisms Bacteroides caccae Bacteroides fragilis Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Peptostreptococcus micros. 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. Variations in color within this range do not affect the potency of the product. 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.

Most 10 Related  LA FUERZA DEL SHECCID PDF

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

Mean SD renal clearance is 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 serum creatinine used in the formula should represent dlribax steady state of renal function.

Doripenem has been shown to be active against most isolates of dofibax following microorganisms, both in vitro and in clinical infections. Please review the latest applicable package insert for additional information and possible updates.

Mechanism of Action Doripenem is an antibacterial drug. 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. 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 pacakge in Table 6.

Reference s National Institutes of Health, U. At least 90 percent of the following ijsert exhibit an in vitro minimal inhibitory concentration MIC less than or equal to the susceptible paciage for doripenem of organisms of the same type shown in Table 6. The final infusion solution concentration is approximately 4.

DORIBAX® (doripenem) powder – GlobalRPH

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. Facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa. Interaction with Other Antimicrobials In vitro synergy tests with doripenem show doripenem has little potential to antagonize or be antagonized by other antibiotics e.

Most 10 Related  JACQUES STOTZEM WITH OR WITHOUT YOU PDF

Facultative Gram-positive microorganisms Streptococcus constellatus Streptococcus intermedius. A local search option of this data can be found here.

Doripenem for Injection

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 dorbiax. The following formula may be used to estimate CrCl. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

Patients with Renal Impairment Table 2: Although cross-resistance may occur, some isolates resistant to other carbapenems may be susceptible to doripenem. Patients with seizure disorders controlled with valproic acid or sodium valproate will therefore be at an increased risk for breakthrough seizures.

Doripenem for Injection, MG, 10 POWDER (VIAL)

Excretion Doripenem is primarily eliminated unchanged by the kidneys. 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. Evaluate if diarrhea occurs. Inser Gram-positive microorganisms Staphylococcus aureus methicillin-susceptible isolates only Streptococcus agalactiae Streptococcus pyogenes.