Interaction studies have only been performed in adults. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. Meronem 500 mg: This medicinal product contains 45 mg sodium per 500 mg vial, equivalent to 2.25% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Meropenem was provided by Molekula (Gillingham, Dorset, UK), whereas amoxicillin and clavulanate were bought from Sigma-Aldrich (Poole, Dorset, UK).
VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs. The acquisition cost of meropenem alone is £17.78 (excluding VAT) for 1 vial containing 1 g of powder for solution for injection (Drug Tariff, October 2019). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8). A solution for infusion is prepared by dissolving the drug product in either 0.9% sodium chloride solution for infusion or 5% dextrose solution for infusion to a final concentration of 1 to 20 mg/ml. 2. Medicinal products that inhibit peristalsis should not be given. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory. Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction. Burgess OS, Hall RG II. 14. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). Haemodialysis will remove meropenem and its metabolite. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration and above and in monkeys at 500 mg/kg in a 7-day study.
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
This information is intended for use by health professionals. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. Background: The rising incidence of resistance to currently available antibiotics among pathogens, particularly Gram-negative pathogens, in complicated intra-abdominal infections (cIAIs) has become a challenge for clinicians. The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. penicillins or cephalosporins). Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Species for which acquired resistance may be a problem, $ Species that show natural intermediate susceptibility, £ Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. The Meropenem Trihydrate Market report is a collection of useful information, quantitative and qualitative estimation by industry experts, the contribution from industry connoisseurs and industry accomplices across the value chain. It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. Standard aseptic techniques should be used for solution preparation and administration. Symptomatic treatments should be considered. Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 3 hours at up to 25°C or 24 hours under refrigerated conditions (2-8°C). Tuesday, November 19th 2019, London 07:30. Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above). ), or very severe infections. Consideration should be given to official guidance on the appropriate use of antibacterial agents. The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). A positive direct or indirect Coombs test may develop during treatment with meropenem. Pharmacoeconomic analyses of meropenem from a health payer perspective in the UK, US and Russia predicted that meropenem is a cost-effective therapy relative to other antibacterials, including imipenem/cilastatin or conventional combination antibacterial treatments in the treatment of serious bacterial infections in intensive care units. Due to the rapid onset and the extent of the decrease, co-administration of valproic acid/sodium valproate/valpromide with carbapenem agents is not considered to be manageable and therefore should be avoided (see section 4.4). Intravenous bolus injection administration. This site is intended for US Healthcare Professionals. email@example.com This study compared the cost-effectiveness of meropenem with that of imipenem plus cilastatin in the treatment of severe infections in hospital intensive care in the UK. Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). 9/2020 PP-VAB-US-0184. The constituted solutions should not be frozen. The cost of 1 day's treatment with 2 g (2 vials) every 8 hours is £106.68. Isolates may be reported as R without prior testing. Cost-minimization analysis of imipenem/cilastatin versus meropenem in moderate to severe infections at a tertiary care hospital in Saudi Arabia . In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. Case reports in the literature have shown that. meropenem: [ mer″o-pen´em ] a broad-spectrum β-lactam antibiotic effective against a wide variety of gram-positive and gram-negative organisms; used in treatment of … Further, prolonged storage of reconstituted meropenem in elastomeric infusion devices may be required in rural or remote administration sites where several days’ supply may be needed. There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals. There is no experience in children with renal impairment. Introduction. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Any unused product or waste material should be disposed of in accordance with local requirements. Monte Carlo simulation based on a population PK model showed that a dose regimen of 20 mg/kg 8 hourly achieved 60%T>MIC for P. aeruginosa in 95% of pre-term and 91% of full term neonates. Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days. VabomereÂ® (meropenem and vaborbactam) is available for your patients and our wholesalers remain stocked with all of the products in our portfolio. When suggestions are available use up and down arrows to review and ENTER to select. Use normal dose every 12 hours if eGFR 26–50 mL/minute/1.73 m 2.. Use half normal dose every 12 hours if eGFR 10–25 mL/minute/1.73 m 2.. Use half normal dose every 24 hours if eGFR less than 10 mL/minute/1.73 m 2. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. EUCAST clinical MIC breakpoints for meropenem (2013-02-11, v 3.1), Haemophilus influenzae1, 2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile. Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria. Meropenem is a broad-spectrum carbapenem antibiotic with clinical utility in a wide range of multidrug-resistant Gram-negative infections.1 Outpatient parenteral antimicrobial therapy (OPAT) is becoming an increasingly important model for managing infections both in the UK and worldwide. All methicillin-resistant staphylococci are resistant to meropenem. The tables below provide general recommendations for dosing. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Continue, 2. As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of nonsusceptible organisms. In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3%), rash (1.4%), nausea/vomiting (1.4%) and injection site inflammation (1.1%).
Meropenem is generally well tolerated by the central nervous system. Currently, there is a lack of stability data on meropenem at various concentrations in elastomeric infusion devices for use in outpatient parenteral antimicrobial therapy (OPAT). A 2015 meta analysis concluded that the anti-pseudomonal penicillin-beta lactamase inhibitor combination piperacillin-tazobactam gives results equivalent to treatment with a carbapenem in patients with sepsis. Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. To email a medicine you must sign up and log in. resistance. Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2 mEq of sodium (approximately 45 mg). Furthermore, the report also provides the qualitative results of diverse market … Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Diagn Microbiol Infect Dis. Meronem 500 mg: anhydrous sodium carbonate. Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. Hypersensitivity to any other carbapenem antibacterial agent. VABOMERE [package insert]: Melinta Therapeutics, Inc.
meropenem/vaborbactam would lead to an overall cost of [commercial in confidence figure removed] in Year 1, increasing to [commercial in confidence figure removed] in Year 5. To view the changes to a medicine you must sign up and log in. analysis, which revealed that in 99% of cases meropenem dominated imipenem plus cilastatin.
Imipenem and meropenem are useful in cases in which P. aeruginosa is a suspected pathogen. The intravenous formulation was well tolerated in animal studies.
Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. †In vitro activity does not necessarily correlate with clinical efficacy. The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. To bookmark a medicine you must sign up and log in. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Average Wholesale Prices (AWP) for Commonly-Used Intravenous Antibiotics, by dose, per day (source: Bartlett, J. et al, Johns Hopkins Antibiotic Guide, 2005) Meropenem is cleared by haemodialysis and haemofiltration.