Until it is reasonably well established that meropenem for injection is well tolerated, patients should not operate machinery or motorized vehicles. Additional systemic adverse events that were reported with meropenem and occurring in less than or equal to 1.0% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency: Bleeding events were seen as follows: gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%). Warnings and Precautions (5.3), Enterococcus faecalis (vancomycin-susceptible isolates only) Until it is reasonably well established that meropenem is well tolerated, advise patients not to operate machinery or motorized vehicles The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (MRHD) based on body surface area comparison, respectively. One trial of 47 patients with a mean age of 2 years (range, 4 days to 20 years) examined meropenem 20 mg/kg/dose (or up to 40 mg/kg/dose for CNS or critical infections) IV every 8 hours for a … Meropenem 500 MG Injection is used for Bacterial Meningitis, Skin And Structure Infection, Intra-Abdominal Infections etc. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. injection or infusion Meronem 500 mg 1000 mg Active ingredient: Meropenem trihydrate 570 mg 1140 mg equivalent to anhydrous meropenem 500 mg 1000 mg If continued treatment with MEROPENEM RANBAXY for Injection is necessary, the unit dose (based on the type and severity of infection) is recommended at the completion of the haemodialysis procedure to … Adverse laboratory changes that were reported and occurring in greater than 0.2% of the patients were as follows: Hepatic: increased alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, lactate dehydrogenase (LDH), and bilirubin, Hematologic: increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased white blood cell (WBC), shortened prothrombin time and shortened partial thromboplastin time, leukocytosis, hypokalemia, Renal: increased creatinine and increased blood urea nitrogen (BUN), Complicated Skin and Skin Structure Infections. The intravenous formulation was well tolerated in animal studies. Continue anti-convulsant therapy in patients with known seizure disorders. ( Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 –75 %) of the dose is excreted unchanged within 12 hours. Powder for Solution for injection or infusion. Meropenem injection is in a class of medications called antibiotics. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2), Children from 3 months to 11 years of age and up to 50 kg body weight. Dose usual. The following are discussed in greater detail in other sections of labeling: Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. - There is no experience in pediatric patients with renal impairment. Meropenem 500 MG Injection is a broad spectrum antibiotic used to treat a variety of conditions caused by bacteria such as infections of stomach, brain, and lungs. The safety and effectiveness of meropenem have been established for pediatric patients 3 months of age and older with complicated skin and skin structure infections and bacterial meningitis, and for pediatric patients of all ages with complicated intra-abdominal infections. Clinical Studies (14.1)]. Meropenem administered to pregnant rats during organogenesis (Gestation Day 6 to Gestation Day 17) in intravenous doses of 240, 500, and 750 mg/kg/day was associated with mild maternal weight loss at all doses, but did not produce malformations or fetal toxicity. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. Of the total number of subjects in clinical studies of meropenem, approximately 1100 (30%) were 65 years of age and older, while 400 (11%) were 75 years and older. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Pediatric 2, intravenous meropenem was administered to dams from Gestation Day 17 until Lactation Day 21 at doses of 240, 500, and 1000 mg/kg/day. Files, Presentations Pediatric Patients Less Than 3 Months of Age. Carcinogenesis studies have not been performed. Seizures and other adverse CNS experiences have been reported during treatment with meropenem. Includes dosages for Skin and Structure Infection, Intraabdominal Infection, Nosocomial Pneumonia and more; plus renal, liver and dialysis adjustments. 1. Two hundred and sixty one (261) patients randomized to meropenem and 287 patients randomized to imipenem-cilastatin were clinically evaluable. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. It should be used with caution in patients with central nervous system disorders. The study was open-label, uncontrolled, 98% of the infants received concomitant medications, and the majority of adverse events were reported in neonates less than 32 weeks gestational age and critically ill at baseline, making it difficult to assess the relationship of the adverse events to meropenem. For pediatric patients 3 months of age and older, the meropenem for injection dose is 10 mg/kg, 20 mg/kg or 40 mg/kg every 8 hours (maximum dose is 2 grams every 8 hours), depending on the type of infection (cSSSI, cIAI, intra-abdominal infection or meningitis). Viridans group streptococci. Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter-individual variability. Counsel patients that antibacterial drugs including meropenem for injection should only be used to treat bacterial infections. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Vial for I.V. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against Discard unused portion. Concomitant use with valproic acid/sodium valproate/valpromide. A solution for bolus injection is prepared by dissolving the drug product meropenem in sterile water for injection to a final concentration of 50 mg/ml. However, re-constituted solutions of meropenem for injection maintain satisfactory potency under the conditions described below. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Compatibility of meropenem for injection with other drugs has not been established. Use normal dose every 12 hours if eGFR 26–50 mL/minute/1.73 m 2. Staphylococcus aureus (MRSA) or methicillin-resistant Meropenem 500 mg: This medicinal product contains approximately 2.0 mEq of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet. See full prescribing information for MEROPENEM FOR INJECTION, 72572-415-01, Learn how to use Meropenem, and it's dosage, warnings, side-effects, and more. Vomiting and pseudomembranous colitis – consider alternate antibiotic. dose Every 24 hours Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of Meropenem. 72572-416-10, Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal Renal Function, Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-Abdominal Infections and Normal Renal Function, Streptococcus pyogenes, Streptococcus agalactiae, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus. This meropenem injection is processed by optimum grade ingredients at vendor’s well equipped processing lab. The clinical response rate in LRTI at end of therapy was 93% for meropenem 500 mg tds, compared with 92% for ceftazidime 1 g tds; for meropenem 500 mg bd the clinical response rate was 96%, compared with 91% for imipenem/cilastatin 500 mg bd (P = 0.054). When suggestions are available use up and down arrows to review and ENTER to select. MERREM IV injection vials re-constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of MERREM IV) may be stored for up to 3 hours at up to 25°C (77°F) or for 13 hours at up to 5°C (41°F). 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). (, Seizures and other adverse CNS experiences have been reported during treatment. Meropenem may also be used for purposes not listed in this medication guide. [see Meropenem is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (β)-lactams. Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species Following intravenous doses of 500 mg, mean plasma concentrations of meropenem usually decline to approximately 1 mcg/mL at 6 hours after administration. No accumulation of meropenem in plasma was observed with regimens using 500 mg administered every 8 hours or 1 gram administered every 6 hours in healthy volunteers with normal renal function. Adverse Reactions (6.1)]. Meropenem is given intravenously by infusion or slow injection every 8 hours. dose Every 24 hours Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of Meropenem. oC to 25 There was no evidence of mutagenic potential found in any of these tests. Dosage and Administration (2.4)]. †Resistance rate ≥ 50% in one or more EU countries. The percentage of time of a dosing interval that unbound plasma concentration of meropenem exceeds the meropenem minimum inhibitory concentration (MIC) against the infecting organism has been shown to best correlate with efficacy in animal and in vitro models of infection. A 5-minute intravenous bolus injection of MERREM IV in healthy volunteers results in mean peak plasma concentrations of approximately 45 mcg/mL (range 18-65) for the 500 mg dose and 112 mcg/mL (range 83-140) for the 1 gram dose. There was no evidence of impaired fertility at doses up to 1000 mg/kg/day (on the basis of body surface area comparison, approximately 3.2 times to the MRHD of 1 gram every 8 hours). varies across the European Union. The dog is stable and ready to be discharged from the hospital. 2O with a molecular weight of 437.52. The proportion of patients who discontinued study treatment due to an adverse event was similar for both treatment groups (meropenem, 2.5% and imipenem-cilastatin, 2.7%). 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. Meropenem 1 g: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. Doses of 1 gram may also be administered as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes. If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken. Date of first authorisation/renewal of the authorisation. Repeated evaluation of the patient is essential. However, there is no information on the usefulness of hemodialysis to treat overdosage Meropenem Injection 500MG Meropenem is used to treat severe infections of the skin or stomach. To view the changes to a medicine you must sign up and log in. in vitro and animal studies suggest that carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid. The types of systemic and local adverse events seen in these patients are similar to the adults, with the most common adverse reactions reported as possibly, probably, or definitely related to Meropenem and their rates of occurrence as follows: In the meningitis studies, the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem and those who received comparator agents (either cefotaxime or ceftriaxone). It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. (, Co-administration of meropenem with probenecid inhibits renal excretion of meropenem and is therefore not recommended. [see Fecal elimination represents only approximately 2% of the dose. Body as a Whole: pain, abdominal pain, chest pain, fever, back pain, abdominal enlargement, chills, pelvic pain, Cardiovascular: heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension, syncope, Digestive System: oral moniliasis, anorexia, cholestatic jaundice/jaundice, flatulence, ileus, hepatic failure, dyspepsia, intestinal obstruction, Hemic/Lymphatic: anemia, hypochromic anemia, hypervolemia, Metabolic/Nutritional: peripheral edema, hypoxia, Nervous System: insomnia, agitation, delirium, confusion, dizziness, seizure, nervousness, paresthesia, hallucinations, somnolence, anxiety, depression, asthenia For a full list of excipients, see section 6.1. Continue, 2. Dosage and Administration (2.2), The clinical efficacy rates by pathogen are provided in Table 8. A solution for bolus injection is prepared by dissolving the drug product meropenem in sterile water for injection to a final concentration of 50 mg/ml. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. Meropenem does not have & Articles, All 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. Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding- protein (PBP) targets. Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). EUCAST clinical MIC breakpoints for meropenem (2013-02-11, v 3.1 ), Haemophilus influenzae1, 2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile. In children, the dosage is also based on age and weight. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of meropenem. The clinical response rate in LRTI at end of therapy was 93% for meropenem 500 mg tds, compared with 92% for ceftazidime 1 g tds; for meropenem 500 mg bd the clinical response rate was 96%, compared with 91% for imipenem/cilastatin 500 mg bd (P = 0.054). eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis, haemolytic anaemia. However, the efficacy of meropenem in treating clinical infections caused by these bacteria have not been established in adequate and well-controlled clinical trials. The offered meropenem injection If superinfection does occur during therapy, appropriate measures should be taken. GA: gestational age and PNA: postnatal age, Most common adverse reactions (2% or less) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash. At this dosage, no adverse pharmacological effects or increased safety risks have been observed. ), the highest mean concentrations of meropenem were found in tissues and fluids at 1 hour (0.5 hours to 1.5 hours) after the start of infusion, except where indicated in the tissues and fluids listed in Table 5 below. At the 5 to 7 week post-completion of therapy visit, the patient had any one of the following: moderate to severe motor, behavior or development deficits, hearing loss of greater than 60 decibels in one or both ears, or blindness. Warnings and Precautions (5.9), 1 may be used to estimate creatinine clearance. Table 11: Hearing Loss at Post-Therapy in the Evaluable Population Treated with Meropenem. [see Reporting suspected adverse reactions after authorisation of the medicinal product is important. Mfd by Savior Lifetec Corp., Taiwan, R.O.C. Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. No dose adjustment is required in elderly patients, except in cases of moderate to severe renal impairment (see section 4.2). For 2 g (1 g meropenem and 1 g vaborbactam) dose, use an … Clinical Pharmacology (12.3), See dosing table 2 below. PubMed, Gram-positive bacteria Meropenem is cleared by haemodialysis and haemofiltration. Provided meropenem injection is used to treat infections such as bacterial meningitis. The adverse reactions seen in these patients that were reported and their rates of occurrence are as follows: Adverse Laboratory Changes in Pediatric Patients: Laboratory changes seen in the pediatric studies, including the meningitis studies, were similar to those reported in the adult studies. Injection vials (500 mg and 1 gram) may be directly re-constituted with a compatible infusion fluid. Additionally, in a study of 511 patients with complicated skin and skin structure infections, 93 (18%) were 65 years of age and older, while 38 (7%) were 75 years and older. The finding that meropenem was not statistically equivalent to cefotaxime/metronidazole may have been due to uneven assignment of more seriously ill patients to the meropenem arm. Following administration of probenecid with meropenem, the mean systemic exposure increased 56% and the mean elimination half-life increased 38% [see [see The study included 510 patients randomized to meropenem and 527 patients randomized to imipenem-cilastatin. Abdominal pain. In mice and rats, large intravenous doses of meropenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities. Data).  Haemophilus influenzae, There are several mechanisms of resistance to carbapenems: 1) decreased permeability of the outer membrane of gram-negative bacteria (due to diminished production of porins) causing reduced bacterial uptake, 2) reduced affinity of the target PBPs, 3) increased expression of efflux pump components, and 4) production of antibacterial drug-destroying enzymes (carbapenemases, metallo-β-lactamases). Updated [see There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with meropenem in pregnant women. Any unused product or waste material should be disposed of in accordance with local requirements. Use of meropenem in pediatric patients 3 months of age and older with bacterial meningitis is supported by evidence from adequate and well-controlled studies in the pediatric population Copy the URL below and paste it into your RSS Reader application. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess. Table 4 below). this version. Intentional overdosing of meropenem is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval. There are no or limited amount of data from the use of meropenem in pregnant women. They are for use only for organisms that do not have specific breakpoints. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Dosage and Administration (2.2), Les enfants pesant plus de 50 kg recevront la même dose qu'un adulte. Sequelae were the most common reason patients were assessed as clinically not cured. Staphylococcus aureus (methicillin-susceptible isolates only), The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of Detailed Meropenem dosage information for adults and children. 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 generalized exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem Indication : • Wide spectrum antibiotic used to treat both Gram-positive and Gram-negative infections including pseudomonas spp. IXZA® 500/IXZA® (Meropenem Injection IP) is a sterile, pyrogen-free, synthetic, Alert patients receiving meropenem on an outpatient basis regarding adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Pseudomonas aeruginosa. Shake to dissolve and let stand until clear. Meropenem is generally well tolerated by the central nervous system.
2020 meropenem injection dose