Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6). 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. Pooled analysis from the two phase III TANGO 1 and TANGO 2 trials for meropenem/vaborbactam showed that mortality at 28 days was 25% in treatment-arm vs. 44% for best available therapy (43.7% reduction). For medical inquiries or to report an adverse event, other safety-related information, or product complaints for a company product, please contact Medical Information. 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. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Launch of Vaborem™ helps address the need for new products to combat multidrug-resistant Gram-negative bacteria. To view the changes to a medicine you must sign up and log in. Description: Meropenem (SM 7338) is an ultra-broad spectrum injectable antibiotic. Haemodialysis will remove meropenem and its metabolite. Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8). As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. A positive direct or indirect Coombs test may develop during treatment with meropenem. For ordering information, please click here. Meropenem is cleared by haemodialysis and haemofiltration. Burgess OS, Hall RG II. steven.edwards@kellogg.ox.ac.uk BACKGROUND: Treating patients admitted to critical care with severe pneumonia requires timely intervention with an effective antibiotic. ), or very severe infections. The threshold analysis showed that meropenem would be the dominant strategy until the cost of imipenem plus cilastatin was reduced to 4.08 or less (72 in the base-case), or until its daily cost was increased to 158.25 or more (85.25 in the base-case). Meropenem is already marketed in the UK; a 10 vial pack of 500mg powder for solution for injection costs £77. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated for 3 hours at up to 25°C or 12 hours under refrigerated conditions (2-8°C). Therefore, this study aimed to … • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. For the full list of excipients, see section 6.1. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). The medicinal product is supplied in pack sizes of 1 or 10 vials. Caution is required if probenecid is co-administered with 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. In individuals with normal renal function, rapid renal elimination will occur. 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. Use normal dose every 12 hours if estimated glomerular filtration rate 26–50 mL/minute/1.73 m 2.. Use half normal dose every 12 hours if estimated glomerular filtration rate 10–25 mL/minute/1.73 m 2.. Use half normal dose every 24 hours if estimated glomerular filtration rate less than 10 mL/minute/1.73 m 2. 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. All methicillin-resistant staphylococci are resistant to meropenem. Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above). -- = Susceptibility testing not recommended as the species is a poor target for therapy with the drug. Meronem 500 mg: anhydrous sodium carbonate. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. Meropenem is a clinically important antibacterial reserved for treatment of multi-resistant infections. There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. 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. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Isolates may be reported as R without prior testing. analysis, which revealed that in 99% of cases meropenem dominated imipenem plus cilastatin. No studies on the effect on the ability to drive and use machines have been performed. The Menarini Group Launches Vaborem™ (meropenem-vaborbactam) in the UK during World Antibiotic Awareness Week 2019. No specific medicinal product interaction studies other than probenecid were conducted. A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (e.g. The solution should be shaken before use. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. Interaction studies have only been performed in adults. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby. A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration of 50 mg/ml. Meropenem is generally well tolerated by the central nervous system. The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. The base case also predicts NHS resource savings valued at £6,091 in Year 1, increasing to £15,228 in Year 5. Concomitant use with valproic acid/sodium valproate/valpromide. 1. Animal studies indicate that meropenem is well tolerated by the kidney. However, bacteria may exhibit resistance to more than one class of antibacterial agents when the mechanism involved include impermeability and/or an efflux pump(s). † There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. steven.j.edwards@astrazeneca.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. These result from reduced cost of adverse events. All reports received were consistent with events observed in the adult population. The cost of Carbavance is not yet known. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Any unused product or waste material should be disposed of in accordance with local requirements. Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. 2004;49(1):41-46. 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. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. The intravenous formulation was well tolerated in animal studies. There is no dose adjustment necessary (see section 4.2). 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. 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. Prices are for cash paying customers only and are not valid with insurance plans. In the table below all adverse reactions are listed by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. By continuing to browse the site you are agreeing to our policy on the use of cookies. Thus, meropenem was the dominant strategy as it was both less expensive and more effective. The constituted solutions should not be frozen. 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). Do not freeze the reconstituted solution. To email a medicine you must sign up and log in. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with. Bloodstream Infections. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Meropenem was provided by Molekula (Gillingham, Dorset, UK), whereas amoxicillin and clavulanate were bought from Sigma-Aldrich (Poole, Dorset, UK). Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. 4.7 Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed. 9/2020  PP-VAB-US-0184. 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. Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. Meropenem is a carbapenem-type antibiotic that works by stopping the growth of bacteria. They are for use only for organisms that do not have specific breakpoints. Meropenem was FDA-approved in the United States in July of 1996 and is used today for a variety of infections including pneumonia, bacteremia, osteomyelitis, urinary tract infection, and meningitis. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. 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. To bookmark a medicine you must sign up and log in. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. Get PDF (494 KB) Cite . Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including meropenem, and may range in severity from mild to life threatening. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2 mEq of sodium (approximately 45 mg). Standard aseptic techniques should be used for solution preparation and administration. Continue typing to refine. Meropenem Prices. In meropenem-resistant bacteria of the family Enterobacteriales, NDM-1 is considerably more common than IMP-1, despite both metallo-β-lactamases (MBLs) hydrolysing meropenem with almost identical kinetics. In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 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. Direct antiglobulin test (Coombs test) seroconversion. 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25 mg/l (Susceptible) and 1 mg/l (Resistant). Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. 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%). Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem (see section 4.8). 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. Small amounts of meropenem have been reported to be excreted in human milk. The probabilistic analysis showed that meropenem was the dominant strategy in 94% of the simulations. 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). Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. Tuesday, November 19th 2019, London 07:30. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. The required dose should be administered after completion of the haemodialysis cycle. Meropenem-vaborbactam (Vabomere) Meropenem is a carbapenem antibiotic and vaborbactam is a beta-lactamase inhibitor. References: In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported. The cost for meropenem intravenous powder for injection 500 mg is around $41 for a supply of 10 powder for injection, depending on the pharmacy you visit. Continue, 2. The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea. Author information: (1)AstraZeneca UK Ltd, Luton, UK. Hypersensitivity to any other carbapenem antibacterial agent. The following table of pathogens listed is derived from clinical experience and therapeutic guidelines. 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. Meronem is indicated for the treatment of the following infections in adults and children aged 3 months and older (see sections 4.4 and 5.1): • Severe pneumonia, including hospital and ventilator-associated pneumonia. After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively. Vabomere® (meropenem and vaborbactam) is available for your patients and our wholesalers remain stocked with all of the products in our portfolio. There is no experience in children with renal impairment. 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. Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. Children from 3 months to 11 years of age and up to 50 kg body weight, Severe pneumonia including hospital and ventilator-associated pneumonia. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 μg/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 μg.h/ml. 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. As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of nonsusceptible organisms. Furthermore, the report also provides the qualitative results of diverse market … Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH02, Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. When suggestions are available use up and down arrows to review and ENTER to select. 5 Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. VABOMERE [package insert]: Melinta Therapeutics, Inc. 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 … Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Treatment with meropenem had an expected cost of £19,026 and QALYs were 4.768. Review appropriate cUTI patients for VABOMERE treatment, VABOMERE® has 32-fold more in vitro activity than meropenem alone1*, Meropenem and vaborbactam weredesigned to work together2,3. agranulocytosis, haemolytic anaemia, thrombocytopenia, neutropenia, leukopenia, eosinophilia, anaphylaxis (see sections 4.3 and 4.4), angioedema, diarrhoea, abdominal pain, vomiting, nausea, antibiotic-associated colitis (see section 4.4), transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme (see section 4.4), urticaria, drug reaction with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis (see section 4.4), blood creatinine increased, blood urea increased, General disorders and administration site conditions, thrombophlebitis, pain at the injection site. Global Meropenem Trihydrate Market Size, Status And Outlook 2020-2021. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Vaborbactam is an enzyme inhibitor (beta-lactamase inhibitor) that helps meropenem work better. Powder for solution for injection or infusion. 14. †In vitro activity does not necessarily correlate with clinical efficacy.

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