Symptomatic treatments should be considered. Its empirical formula is C (5.9)], Respiratory: respiratory disorder, dyspnea, pleural effusion, asthma, cough increased, lung edema, Skin and Appendages: urticaria, sweating, skin ulcer, Urogenital System: dysuria, kidney failure, vaginal moniliasis, urinary incontinence. Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). Table 7: Success Rates at Test-of-Cure Visit for Clinically Evaluable Population with Complicated Skin and Skin Structure Infections. See full prescribing information for MEROPENEM FOR INJECTION, 72572-415-01, [see Solutions prepared for infusion (meropenem for injection concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Dextrose Injection 5% should be used immediately. When Meropenem for Injection is indicated in patients with these risk factors, caution is advised. 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. ), More about getting RSS News & Updates from DailyMed, Complicated skin and skin structure infections, 30 mL in 1 VIAL; Type 0: Not a Combination Product, 20 mL in 1 VIAL; Type 0: Not a Combination Product, 2 A pharmacokinetic study with meropenem in elderly patients with renal impairment showed a reduction in plasma clearance of meropenem that correlates with age-associated reduction in creatinine clearance. Meropenem is also used to treat bacterial meningitis (infection of brain or spinal cord). 25N Meropenem binds to PBPs 2, 3 and 4 of If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against Clinical Pharmacology (12.3)]. 12 & 16, Chuangye Rd., Xinshi Dist, Tainan City, 74144, Taiwan, 500 mg per vial Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage. Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients, Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6). Pediatric Patients with Serious Bacterial Infections (excluding Bacterial Meningitis): Meropenem was studied in 515 pediatric patients (3 months to less than 13 years of age) with serious bacterial infections (excluding meningitis, see next section) at dosages of 10 mg/kg to 20 mg/kg every 8 hours. [see Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. Cross-resistance is sometimes observed with isolates resistant to other carbapenems. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. See. Overdosage (10)]. Standard aseptic techniques should be used for solution preparation and administration. in vitro activity against methicillin-resistant Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. To email a medicine you must sign up and log in. Une dose est généralement administrée toutes les 8 heures. The types of systemic and local adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably, or definitely related to Meropenem and their rates of occurrence as follows: Pediatric Patients with Bacterial Meningitis: Meropenem was studied in 321 pediatric patients (3 months to less than 17 years of age) with meningitis at a dosage of 40 mg/kg every 8 hours. Indications and Usage (1)]. RxNorm, Files, All Mapping The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response. The values represent the number of patients clinically cured/number of clinically evaluable patients, with the percent cure in parentheses. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Nausea and vomiting. The meropenem group had a statistically higher number of patients with transient elevation of liver enzymes. The following dosing Table below.). Pediatric Patients (Neonates and Infants less than 3 months of Age): Meropenem was studied in 200 neonates and infants less than 3 months of age. (, Seizures and other adverse CNS experiences have been reported during treatment. 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. Healthcare professionals are asked to report any suspected adverse reactions the National reporting system listed below. How to use Meropenem Vial. Second generation offspring showed no meropenem-related effects. Hypersensitivity to any other carbapenem antibacterial agent. Meropenem has been shown to penetrate well into several body fluids and tissues: including lung, bronchial secretions, bile, cerebrospinal fluid, gynaecological tissues, skin, fascia, muscle, and peritoneal exudates. For patients with varying degrees of renal impairment, the incidence of heart failure, kidney failure, seizure and shock reported with meropenem, increased in patients with moderately severe renal impairment (creatinine clearance 10 to 26 mL/min) Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with meropenem for injection. Seizures and other adverse CNS experiences have been reported during treatment with meropenem. In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported Meropenem Equivalent, For Intravenous Use Only To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of Meropenem. 3O Indications and Usage (1.3), The background risk of major birth defects and miscarriage for the indicated population is unknown. To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection and other antibacterial drugs, meropenem for injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1 may be used to estimate creatinine clearance. Meropenem for injection is a penem antibacterial indicated for the treatment of: To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection and other antibacterial drugs, meropenem for injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. [see 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. Among these are included prior history of seizures or CNS abnormality and concomitant medications with seizure potential. Clinical Pharmacology (12.3), When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. Adverse Reactions (6.1), The patients in the intermittent bolus group (n = 5) were given a 1500 mg meropenem first dose (in 10 mL of water-for-injection infused by central line over 5 min) and then 1000 mg (in 10 mL of water-for-injection infused by central line over 3 min) every 8 h. The dose for both groups on day 1 was 3500 mg and 3000 mg/day thereafter. Higher doses (40 mg/kg/dose IV every 8 hours) have been used in patients with severe infections. Five patients were found to be bacteriologically not cured, 3 in the comparator group (1 relapse and 2 patients with cerebral abscesses) and 2 in the meropenem group (1 relapse and 1 with continued growth of GA: gestational age and PNA: postnatal age, Most common adverse reactions (2% or less) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash. At follow-up, the clinical response rates were 96%, 89%, 93% and 96%, respectively. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Dosage and Administration (2.2)]. in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for meropenem against isolates of similar genus or organism group. Use of meropenem in pediatric patients 3 months of age and older with complicated skin and skin structure infections is supported by evidence from an adequate and well-controlled study in adults and additional data from pediatric pharmacokinetics studies Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. 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. Staphylococcus epidermidis (MRSE). When suggestions are available use up and down arrows to review and ENTER to select. The study evaluated meropenem at doses of 500 mg administered intravenously every 8 hours and imipenem-cilastatin at doses of 500 mg administered intravenously every 8 hours. Alternatively, an injection vial may be re-constituted, then the resulting solution added to an intravenous container and further diluted with an appropriate infusion fluid. After a single intravenous dose of Meropenem for injection (I.V. All meropenem-treated patients with seizures had pre-existing contributing factors. No dose adjustment is required in elderly patients, except in cases of moderate to severe renal impairment (see section 4.2). Meropenem injection is used to treat skin and abdominal (stomach area) infections caused by bacteria and meningitis (infection of the membranes that surround the brain and spinal cord) in adults and children 3 months of age and older. The values represent the number of patients clinically cured/number of clinically evaluable patients at the post-treatment follow-up visit, with the percent cure in parentheses (Fully Evaluable analysis set). 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). It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. 2O with a molecular weight of 437.52. Detailed Meropenem dosage information for adults and children. Complicated intra-abdominal infections (adult and pediatric patients). What preparations of meropenem-injection are available? Adverse Reactions (6.1)]. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. Prescribing meropenem in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Clinical Trials, Meropenem for injection, like all β-lactam antibiotics, has the potential to cause seizures. 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. A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. 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. A comparable number of patients were found to be clinically evaluable (ranging from 61-68%) and with a similar distribution of pathogens isolated on initial CSF culture. 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.   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 variety of infections. Dosage adjustment is recommended in patients with advanced age and/or adult patients with creatinine clearance of 50 mL/min or less There were no adverse effects in the dams and no adverse effects in the first generation offspring (including developmental, behavioral, and functional assessments and reproductive parameters) except that female offspring exhibited lowered body weights which continued during gestation and nursing of the second generation offspring. The pharmacokinetics in infants and children with infection at doses of 10, 20 and 40 mg/kg showed Cmax values approximating to those in adults following 500, 1000 and 2000 mg doses, respectively. Presence in Breast Milk, Medline Plus, 10 reduction in cell counts within 12 hours to 24 hours) are typically 1 to 2 times the bacteriostatic concentrations of meropenem, with the exception of Consider symptomatic treatments. Worldwide post-marketing adverse reactions not otherwise listed in the Adverse Reactions from Clinical Trials section of this prescribing information and reported as possibly, probably, or definitely drug related are listed within each body system in order of decreasing severity. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. Dosage and Administration (2.3), Pseudomonas aeruginosa). Two hundred and sixty one (261) patients randomized to meropenem and 287 patients randomized to imipenem-cilastatin were clinically evaluable. For pediatric patients weighing over 50 kg administer meropenem for injection at a dose of 500 mg every 8 hours for cSSSI, 1 gram every 8 hours for cIAI and 2 grams every 8 hours for meningitis. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. 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. Genetic toxicity studies were performed with meropenem using the bacterial reverse mutation test, the Chinese hamster ovary HGPRT assay, cultured human lymphocytes cytogenic assay, and the mouse micronucleus test. With respect to hearing loss, 263 of the 271 evaluable patients had at least one hearing test performed post-therapy. If administration of meropenem is necessary, then supplemental anti-convulsant therapy should be considered Updated If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. 1. In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with meropenem. Indications and Usage (1.3), The dry powder should be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) [see USP]. Les enfants pesant plus de 50 kg recevront la même dose qu'un adulte. However, there is no information on the usefulness of hemodialysis to treat overdosage C. difficile may need to be discontinued. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. If administration of meropenem is necessary, consider supplemental anti-convulsant therapy Meropenem 500 MG Injection is used for Bacterial Meningitis, Skin And Structure Infection, Intra-Abdominal Infections etc. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. After a single intravenous dose of meropenem, 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. 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%). Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite. Pronunciation: MER-oh-PEN-em. Use of meropenem in pediatric patients 3 months of age and older with intra-abdominal infections is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetics studies and controlled clinical trials in pediatric patients. Learn how to use Meropenem Hospira, and it's dosage, warnings, side-effects, and more. Approximately 70% (50% - 75%) of the dose is excreted unchanged within 12 hours. 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. Treonam 1000 mg Injection is commonly used to treat critically ill patients admitted to the hospital. The bactericidal activity of meropenem results from the inhibition of cell wall synthesis. It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. The solution varies from colorless to yellow depending on the concentration. When only serum creatinine is available, the following formula (Cockcroft and Gault equation) Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. For IV Preparation: Dilute with approved diluent and prepare as specified in the package insert. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another β-lactam. Discard unused portion. This information is intended for use by health professionals, Meropenem 500 mg powder for solution for injection or infusion, Meropenem 1 g powder for solution for injection or infusion. During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with meropenem (500 mg or 1 gram every 8 hours). Compatibility of meropenem for injection with other drugs has not been established. 72572-415-10, [see Dosage and Administration (2.2), Each vial contains meropenem equivalent to 500 mg of meropenem activity. [see Warnings and Precautions (5.4)]. Table 4 below). Meropenem after reconstitution and dilution in aqueous solution was unstable, with ~56% degradation loss recorded for low concentrations prepared in 5% w/v citrate buffered saline pH 6 after 24 hours at 32°C. If treatment with meropenem for injection is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed, Patients receiving meropenem for injection on an outpatient basis must be alerted of adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. See dosing table 2 below. Page 1 of 3 King Edward Memorial Hospital & Perth Children’s Hospital Neonatology Meropenem - Neonatal NEONATAL MEROPENEM This document should be read in conjunction with this DISCLAIMER Restricted: Requires Microbiologist review within 24 hours of initiation Presentation Vial: 500mg Classification Bactericidal carbapenem antibiotic. Reference(s) National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Dosage and Administration (2.3), They do not treat viral infections (e.g., the common cold). (, 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. [see Continue anti-convulsant therapy in patients with known seizure disorders. See When treating infections caused by, 1 gram every 8 hours by intravenous infusion over 15 minutes to 30 minutes for intra-abdominal infections for adult patients. No overall differences in safety or effectiveness were observed between these subjects and younger subjects; spontaneous reports and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 5-minute intravenous bolus injection of Meropenem in normal volunteers results mean peak plasma concentrations of approximately 45 µg/mL (range 18-65) for the 500 mg dose and 112 µg/mL (range 83-140) for the 1 g dose. Withdraw 20 mL of 0.9% Sodium Chloride Injection from an infusion bag and constitute each vial. This meropenem injection is processed by optimum grade ingredients at vendor’s well equipped processing lab. Clinical Pharmacology (12.3)]. This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. For 4 g (2 g meropenem and 2 g vaborbactam) dose, use an infusion bag with a volume of 250, 500, or 1,000 mL. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. This medication is given by injection into a vein as directed by your doctor, usually every 8 hours. These experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) or with bacterial meningitis and/or compromised renal function Biochemical Data Summary. 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 … Carcinogenesis studies have not been performed. Copy the URL below and paste it into your RSS Reader application. One controlled clinical study of complicated intra-abdominal infection was performed in the United States where meropenem was compared with clindamycin/tobramycin. Meronem IV injection contains 208 mg sodium carbonate for each gram of meropenem (anhydrous potency). Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. Acts by interfering with bacterial cell wall synthesis. The following Use under close clinical supervision after discussion with Starship ID service. Pediatric Patients Less Than 3 Months of Age. The study included 510 patients randomized to meropenem and 527 patients randomized to imipenem-cilastatin. Either during or post-therapy, the patient developed a large subdural effusion needing surgical drainage, or a cerebral abscess, or a bacteriologic relapse. Intravenous powder for solution: 500 mg/vial and 1 gram/vial. Adverse Reactions (6.1), Intravenous infusions over 2 minutes, 3 minutes and 5 minutes of a 1 g dose of meropenem were compared in a three way crossover trial. Meropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite. - Intravenous infusion is to be given over approximately 15 minutes to 30 minutes. Use under close clinical supervision after discussion with Starship ID service. Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae. There is no dose adjustment necessary (see section 4.2). Dosage and Administration (2.4)]. Get Label RSS Feed, In rats administered intravenous meropenem in late pregnancy and during the lactation period, there were no adverse effects on offspring at doses equivalent to approximately 3.2 times the MRHD based on body surface area comparison (see Urinary concentrations of meropenem in excess of 10 mcg/mL are maintained for up to 5 hours after a 500 mg dose. 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. How should I keep meropenem-injection stored? Viridans group streptococci. Haemophilus influenzae, Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. Sequelae were the most common reason patients were assessed as clinically not cured. For 2 g (1 g meropenem and 1 g vaborbactam) dose, use an … Use of meropenem in pediatric patients less than 3 months of age with intra-abdominal infections is supported by evidence from adequate and well-controlled studies in adults with additional data from a pediatric pharmacokinetic and safety study The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Meropenem injection is in a class of medications called antibiotics. It allows continued monitoring of the benefit/risk balance of the medicinal product. Meropenem Injection 500MG Meropenem is used to treat severe infections of the skin or stomach. Provided meropenem injection is used to treat infections such as bacterial meningitis. Mfd by Savior Lifetec Corp., Taiwan, R.O.C, Report Adverse At this dosage, no adverse pharmacological effects or increased safety risks have been observed. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). When treating complicated skin and skin structure infections caused by P. aeruginosa, a dose of 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended. Deaths in 5 patients were assessed as possibly related to meropenem; 36 (1.2%) patients had meropenem discontinued because of adverse events. 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 … Table 8: Clinical Efficacy Rates by Pathogen for Clinically Evaluable Population. See 17 for PATIENT COUNSELING INFORMATION. Staphylococcus aureus. Prior to Constitution: Store at 20 Until it is reasonably well established that meropenem for injection is well tolerated, patients should not operate machinery or motorized vehicles. (, Severe cutaneous adverse reactions have been reported in patients receiving meropenem. Dosage adjustments are necessary in subjects with renal impairment (creatinine clearance 50 mL/min or less) 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).
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