Find out what health conditions may be a health risk when taken with meropenem intravenous. Meropenem side effects, dosage, interactions drugs. Although there are limited data documenting the optimal dose and tolerance of meropenem in neonates gramnegative bacillary meningitis. Meropenem was stable for the longest time in sterile water for injection and in 0. However, the pharmacokinetic parameters, such as steadystate concentration, must be considered, and how these compare to the infecting pathogens mic. Meropenems stability was examined at two temperatures 22c and 33c to mimic average and high temperature in hospital wards. The kinetic model for firstorder degradation process was confirmed. Stability of meropenem after reconstitution for administration by. Meropenem reconstitution instructions 500 mg vial your pet was prescribed meropenem, a liquid intravenous antibiotic for infections.
In conclusion, we obtained stability data for cefepime, meropenem. However, the stability of meropenem reconstituted in solution is influenced by the storage temperature. Antimicrobial susceptibility testing ast methods in conjunction with reliable, easytouse thermo scientific oxoid meropenem antimicrobial susceptibility. Currently, there is a lack of stability data on meropenem at various. Until now we have had no data to evaluate the stability of this drug during continuous. The stability of these medicines after reconstitution as reported on a data sheet report is 6 hours for merrem and 1 hour for generics. Continuous infusions of meropenem in ambulatory care. Meropenem is recommended for treatment of infections caused by most mdr enteric organisms. Jun 16, 2006 similar kinetic data was obtained for meropenem powder for injection. Data suggest that meropenem is less stable in phosphate buffer, even when the ph is maintained at 6. What still needs a solution is the lack of chemical stability of. Full text an investigation of the stability of meropenem in.
Currently, no data on chemical stability of generic bioequivalent versions of meropenem over time are available. Features and benefits this compound was developed by astrazeneca. Meropenem trihydrate is an ultrabroad spectrum betalactam antibiotic active against both grampositive and gramnegative bacteria. In the absence of such data, local epidemiology and susceptibility. Pdf stability of meropenem in normal saline solution after.
Generally, the stability of a drug in a mixed infusion can be predicted from the ph profile and arrhenius equation of the degradation rate constants, if the temperature and ph of the test solution are known. Meropenem for injection is not recommended for use in infants under the age of 3 months. Data from previously published studies reveal that this infusion strategy can. These stability data allow for enhanced flexibility in the preparation, storage, wastage, and administration of meropenem and vaborbactam in the hospital and outpatient setting. Some of these include meningitis, intraabdominal infection, pneumonia, sepsis, and anthrax. Meropenem degradation analysis data from reference 10 was digitized using unscanit software silk scienti. The meropenem mics for penicillinresistant streptococcus pneumoniae were higher than for the penicillin. Meropenem was subsequently assayed using highperformance liquid chromatography hplc.
Triplicate samples of 5 mgml solutions of a generic meropenem formulation, hospira, were evaluated for chemical stability at increasing temperatures 25c, 30c, 35c, and 40c by means of a highperformance liquid. What still needs a solution is the lack of chemical stability of meropenem, a problem which may be addressed by finding control methods ensuring therapeutic safety and effectiveness 10,11. Identification of the substancemixture and the companyundertaking product identifier material name. Triplicate samples of 5 mgml solutions of a generic meropenem formulation, hospira, were. A maximum infusion time of 8 h was chosen based on the available meropenem stability data 27 and a stability study performed in our laboratory to confirm the previous results data not shown. Stability was also influenced by storage temperature. Pdf stability of meropenem in normal saline solution. Meropenem 20 mgml required immediate administration following preparation under ambient temperatures, whilst meropenem 25 mgml did not remain stable following 24 hrs storage at.
Solidstate stability study of meropenem solutions based on. Meropenem 20 mgml required immediate administration following preparation under ambient temperatures, whilst meropenem 25 mgml did not remain stable following 24 hrs storage at ambient temperatures. Meropenem meropenem this product information is intended only for residents of the united states. Use of meropenem for injection in pediatric patients less than 3 months of age with intraabdominal infections is supported by evidence from adequate and wellcontrolled studies in adults. Frozen meropenem solutions displayed good stability in all concentrations but were physically unstable due to the formation of a precipitate. Tdmmonograph meropenem october 2015, concept version page 4 of 5 meropenem 500 mg every 8 hours, or 1 gram every 6 hours in patients with normal renal function. The method was developed and validated in compliance with international council for.
Center for drug evaluation and research approval package for. Carbapenem antibiotic relevant identified uses of the substance or mixture and uses advised against. Meropenem s stability was examined at two temperatures 22c and 33c to mimic average and high temperature in hospital wards. Manually determine the antibiotic susceptibility of microorganisms using antimicrobial susceptibility testing ast methods in conjunction with reliable, easytouse thermo scientific oxoid meropenem. The method was developed and validated in compliance with international council for harmonisation ich guidelines. Meropenem is a carbapenem antibiotic with broad spectrum of activity that is administered intravenously and used for severe bacterial infections due to sensitive agents. Meropenem is a recently developed carbapenem antibiotic, similar to imipenem, with a wide spectrum of activity against grampositive and gramnegative bacteria. To browse the list of other pharmadeveloped compounds and approved drugsdrug candidates, click here.
At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration mic less than or equal to the susceptible breakpoints for meropenem. Here, we reexamine the stability of meropenem in dilute solutions at both 25 and 37c to better guide its potential clinical use by continuous infusion. Meropenem is used to treat a wide variety of bacterial infections. An investigation of the stability of meropenem in elastomeric. Full text an investigation of the stability of meropenem. Meropenem for injection product monograph page 8 of 39 pediatrics.
Meropenem, sold under the brandname merrem among others, is a broadspectrum antibiotic used to treat a variety of bacterial infections. Nov 09, 2018 meropenem is an antibiotic that fights bacteria. Meropenem is a common cause of mild transient aminotransferase elevations and can rarely result in clinically apparent, cholestatic liver injury. Iv meropenem for injection, for intravenous use initial u. Nosocomial pneumonia, bacterial meningitis, febrile neutropenia, bacteremia associated with intravascular line due to susceptible gram. Cerner multum provides the data within some of the basics, side effects, interactions, and dosage tabs. Numerous recent studies have assessed the clinical benefits of.
Meropenem is metabolised by hydrolysis of the betalactam ring generating a microbiologically inactive metabolite. Dailymed meropenem injection, powder, for solution. Stability and degradation kinetics of meropenem in powder for. Meropenem has significant stability to hydrolysis by betalactamases, both penicillinases and cephalosporinases produced by grampositive and gramnegative bacteria. Meropenem compatibility reconstitution and stability wikidoc. Quantification of cefepime, meropenem, piperacillin, and. However, studies to date have shown that carbapenems and in particular, meropenem, are relatively unstable in solution. Assessment of meropenem and vaborbactam room temperature and. At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration mic less than or equal. Meropenem has been shown to penetrate well into several body fluids and tissues.
Solidstate stability study of meropenem solutions based. Investigation of meropenem stability after reconstitution. Stability in plastic syringes, tubing and intravenous infusion sets. In light of data demonstrating a lack of stability of meropenem and variability in clinical ci use, we performed a study with two components. Stability of meropenem after reconstitution for administration by prolonged infusion authors sarah fawaza, stephen bartona, laura whitneyb, julian swindena and shereen nabhanigebaraa a faculty. View detailed import data, price, monthly trends, major importing countries, major ports of meropenem. Stability of meropenem after reconstitution for administration by prolonged infusion authors sarah fawaza, stephen bartona, laura whitneyb, julian swindena and shereen nabhanigebaraa a faculty of science, engineering and computing, kingston university, penrhyn rd, kingston upon thames, london, kt1 2ee. Meropenem for injection, usp is a sterile, pyrogenfree, synthetic, carbapenem antibacterial for intravenous administration.
This prior approval labeling supplement provides for revisions to section 2, dosage and administration. An investigation of the stability of meropenem in elastomeric infusion. Nov 12, 2019 use of meropenem for injection in pediatric patients less than 3 months of age with intraabdominal infections is supported by evidence from adequate and wellcontrolled studies in adults with additional data from a pediatric pharmacokinetic and safety study see indications and usage 1. Stability and degradation kinetics of meropenem in powder.
Stability of meropenem in polyvinyl chloride bags and an. Fortunately, king guide, the oldest continuously published reference on parenteral drug stability and compatibility, is designed to provide practitioners with the timely information they need in this era of drug shortages. In vitro stability evaluation of different pharmaceutical products. Meropenem and vaborbactam in pvc bags 4, 8, and 16 mgml and elastomeric pumps 11. Dec 23, 2019 meropenem has been shown to penetrate well into several body fluids and tissues. Single dose minibags can be infused over 1530 minutes. Data on the stability of meropenem for extended periods would make this type of preparation feasible for most home infusion providers. Stability of generic meropenem solutions for administration.
Meropenem does not have invitro activity against methicillinresistant staphylococcus aureus mrsa or methicillinresistant staphylococcus epidermidis mrse. Pdf stability of meropenem in normal saline solution after storage. Meropenem for injection product monograph page 4 of 39 gynecologic gynecologic infections caused by staphylococcus aureus methicillinsusceptible strains only, staphylococcus epidermidis. Manually determine the antibiotic susceptibility of microorganisms using antimicrobial susceptibility testing ast methods in conjunction with reliable, easytouse thermo scientific oxoid meropenem antimicrobial susceptibility disks. Meropenem stability has been shown to be influenced by temperature,7 ph10 11 and. The correlation coefficients r observed for storage at 70, 80 and 90 c were 0. The first year of a home infusion program can offer many lessons for. The dry powder should be stored at controlled room temperature 2025c 6877f see usp. Prediction of the stability of meropenem in intravenous. This medication is known as a carbapenemtype antibiotic. Meropenem has been shown to inhibit penicillinasenegative, positive and methicillinsusceptible staphylococci 1. Apr 02, 20 stability in baxter minibag plus manufactured by baxter, inc. Monographs for commonly administered intravenous medications in home and community care 2 p a g e meropenem administration2,4,5 can be dispensed as single doses and administered by gravity or pole pump with each nursing visit.
Provides stability and compatibility data using 11 different infusion fluids. Manufacturer states data insufficient to make dosage recommendations in patients undergoing hemodialysis or peritoneal dialysis. This medication is good for only 5 days after mixing when stored. Meropenem is a carbapenem analog in which the introduction of a methyl group at c4 solved the problem of enzymatic instability figure 1. The following in vitro data are available, but their clinical significance is unknown. Although there are limited data documenting the optimal dose and tolerance of meropenem in.
Features and benefits this compound was developed by. By continuing to browse this site you are agreeing to our use of cookies. However, extended stability data for the meropenem. Stability of meropenem and doripenem solutions for. Apr 12, 2019 meropenem 20 mgml required immediate administration following preparation under ambient temperatures, whilst meropenem 25 mgml did not remain stable following 24 hrs storage at ambient temperatures. The prediction of the stability of a drug in an intravenous admixture mixed infusion is important for accurate and safe drug administration. The instrument control and data processing software analyst 1. Fawaz, sarah, barton, stephen, whitney, laura, swinden. We also analyse meropenem degradation using 1 h nmr spectroscopy, and extend our studies to doripenem, a recently registered carbapenem sharing many of the properties of meropenem and. Some of these include meningitis, intraabdominal infection. Webmd provides common contraindications for meropenem intravenous.
Meronem iv 500mg summary of product characteristics. Feb 15, 1997 stability was also influenced by storage temperature. Generally, the stability of a drug in a mixed infusion can be. Solutions of meropenem for injection meropenem concentrations ranging from 2. At a low meropenem concentration of 6 mgml, the data showed promising stability over a sevenday period when stored at 6. Monographs for commonly administered intravenous medications. Keywords drug stability, meropenem, continuous infusion. Similar kinetic data was obtained for meropenem powder for injection. Meropenem fda prescribing information, side effects and uses. Merrem iv is supplied in 20 ml and 30 ml injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. Monographs for commonly administered intravenous medications in home and community care 1 p a g e meropenem 1drug class antibiotic carbapenem spectrum1,2 refer to product monograph for.