P. aeruginosa, a dose of 1 gram every 8 hours is recommended. 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 … The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meropenem and any potential adverse effects on the breast-fed child from meropenem or from the underlying maternal conditions. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour. Meropenem is hemodialyzable. The most common adverse events occurring in greater than 5% of the patients were: headache (7.8%), nausea (7.8%), constipation (7.0%), diarrhea (7.0%), anemia (5.5%), and pain (5.1%). Meropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite. 3Susceptibility of staphylococci to Carbepenem is inferred from the cefoxitinsusceptibility. The following Standard aseptic techniques should be used for solution preparation and administration. [see 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. Meropenem is cleared by haemodialysis and haemofiltration. Caution is required if probenecid is co-administered with meropenem. Each vial contains meropenem equivalent to 500 mg of meropenem activity. At follow-up, the clinical response rates were 96%, 89%, 93% and 96%, respectively. For the best effect, use this antibiotic at evenly spaced times. 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. Meropenem is a broad spectrum carbapenem antibiotic that has potent activity against an array of important gram‐positive and gram‐negative bacteria, such as pseudomonus aeruginosa, enterobacteriaceae, and anaerobes.It is commonly used for treatment of serious infections, including intra‐abdominal infections and meningitis in both adult and pediatric patients. . In individuals with normal renal function, rapid renal elimination will occur. Currently there is no additional information available to further interpret this observation. Reference(s) National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 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. If administration of meropenem is necessary, consider supplemental anti-convulsant therapy 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. No specific medicinal product interaction studies other than probenecid were conducted. 12 & 16, Chuangye Rd., Xinshi Dist, Tainan City, 74144, Taiwan, 500 mg per vial When re-constituted as instructed, each 1 gram meropenem for injection vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). is this? 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. A 5 minute intravenous bolus injection of meropenem in normal volunteers results in peak plasma levels of approximately 52 microgram/mL for the 500 mg dose and 112 microgram/mL for the 1 g dose. 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). Clinical Studies (14.3)]. Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). The dose depends on what type of infection you have, where it … When treating complicated skin and skin structure infections caused by A 5 minute intravenous bolus injection of meropenem in normal volunteers results in peak plasma levels of approximately 52 microgram/mL for the 500 mg dose and 112 microgram/mL for the 1 g dose. Meropenem for injection, like all β-lactam antibiotics, has the potential to cause seizures. Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. Adverse Reactions (6.1)]. The values represent the number of patients clinically cured/number of clinically evaluable patients, with the percent cure in parentheses. There is no experience in pediatric patients with renal impairment. Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species Gram-positive bacteria Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. Use under close clinical supervision after discussion with Starship ID service. The no-observed-adverse-effect-level (NOAEL) for fetal toxicity in this study was considered to be the high dose of 750 mg/kg/day (equivalent to approximately 2.4 times the MRHD of 1 gram every 8 hours based on body surface area comparison). 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 is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6). Drug Interactions (7.2)]. Non species related breakpoints are based on the following dosages: EUCAST breakpoints apply to meropenem 1000 mg x 3 daily administered intravenously over 30 minutes as the lowest dose. However, the efficacy of meropenem in treating clinical infections caused by these bacteria have not been established in adequate and well-controlled clinical trials. [see C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. Warnings and Precautions (5.4)]. 3O See No studies on the effect on the ability to drive and use machines have been performed. However, there is no information on the usefulness of hemodialysis to treat overdosage Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with meropenem for injection. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. Diminished renal function and central nervous system lesions may increase the risk of seizures. Meropenem for injection is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Medicinal products that inhibit peristalsis should not be given. P. aeruginosa. Vomiting and pseudomembranous colitis – consider alternate antibiotic. Table 10: Efficacy rates by Pathogen in the Clinically Evaluable Population with Bacterial Meningitis. (, Severe cutaneous adverse reactions have been reported in patients receiving meropenem. Skin and Subcutaneous Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme and acute generalized exanthematous pustulosis. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. (, In patients with renal dysfunction, thrombocytopenia has been observed. Patients were defined as clinically not cured if any one of the following three criteria were met: Using the definition, the following efficacy rates were obtained, per organism (noted in Table 10). The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. 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) Use normal dose every 12 hours if eGFR 26–50 mL/minute/1.73 m 2. Meropenem does not have 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. Powder for Solution for injection or infusion. Staphylococcus aureus (methicillin-susceptible isolates only) For the treatment of complicated skin infections in adults, 500 mg to 2 grams should be administered intravenously every 8 hours. The dosage is based on your medical condition and response to treatment. Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. It should be used with caution in patients with central nervous system disorders. Intravenous infusions over two minutes, three minutes and five minutes of a 1 g dose of meropenem were compared in a three way crossover trial. Indication : • Wide spectrum antibiotic used to treat both Gram-positive and Gram-negative infections including pseudomonas spp. Enterococcus faecalis (vancomycin-susceptible isolates only) 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 Table 4 below). Meropenem is also used to treat bacterial meningitis (infection of brain or spinal cord). 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. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The easiest way to dilute meropenem is to do 2 vials at a time. A study of 12 patients administered meropenem 1000 mg 8 hourly post-surgically for intra-abdominal infections showed a comparable Cmax and half-life to normal subjects but a greater volume of distribution 27 l. The average plasma protein binding of meropenem was approximately 2 % and was independent of concentration.   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. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. 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. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. 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 Files, All Mapping At this dosage, no adverse pharmacological effects or increased safety risks have been observed. Meropenem should be stored at room temperature, 20 C to 25 C (68 F to 77 F). - Intravenous infusion is to be given over 30 minutes. Dosage and Administration (2.4)]. The dog is stable and ready to be discharged from the hospital. 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). 12 & 16 Chuangye Rd., Tainan City 74144, Taiwan, R.O.C. No dose adjustment is necessary in patients with hepatic impairment (see section 4.4). Pharmacokinetic studies in healthy elderly subjects (65-80 years) have shown a reduction in plasma clearance, which correlated with age-associated reduction in creatinine clearance, and a smaller reduction in non-renal clearance. See 17 for PATIENT COUNSELING INFORMATION. Hypertoxin producing isolates of With respect to hearing loss, 263 of the 271 evaluable patients had at least one hearing test performed post-therapy. [see 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. Listeria monocytogenes, against which lethal activity is not observed. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another β-lactam. 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. Meropenem 1.0 g: This medicinal product contains approximately 4.0 mEq of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet. Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. In individuals with normal renal function, rapid renal elimination takes place. (8.6), The pharmacokinetics of meropenem in patients less than 3 months of age receiving combination antibacterial drug therapy are given below. For intravenous infusion, meropenem vials may be directly constituted with 0.9 % sodium chloride or 5% glucose solutions for infusion. oC to 25 Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Use in Specific Populations (8.5), Compatibility of meropenem for injection with other drugs has not been established. 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. Staphylococcus aureus. Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2.0 mEq of sodium (approximately 45 mg), Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of sodium (approximately 90 mg). Meropenem for injection should not be mixed with or physically added to solutions containing other drugs. FDA Safety Recalls, 1 may be used to estimate creatinine clearance. Meropenem is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. Healthcare professionals are asked to report any suspected adverse reactions the National reporting system listed below. 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. Meropenem is an antibacterial drug Drug Interactions (7.1)]. A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. The current US Food and Drug Administration (FDA)‐recommended meropenem dosing regimens for pediatric patients with severe systemic and intra‐abdominal infections were derived from a series of PK and PD studies 1, 9, 10 and are outlined in Table 1. During therapy the patient's clinical status necessitated the addition of other antibacterial drugs. 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 (complicated skin and skin structure, intra-abdominal or meningitis). The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %). Solutions prepared for infusion (meropenem for injection concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Sodium Chloride Injection 0.9% may be stored for 1 hour at up to 25°C (77°F) or 15 hours at up to 5°C (41°F). Meropenem-Related laboratory adverse events were thrombocytosis ( 1.6 % ) the central nervous system lesions may increase risk! Unlikely, although accidental overdosing might occur if large doses are given to official guidance on the pharmacokinetics meropenem... Performed post-therapy you start using meropenem and the administration of antibacterial agents alters the flora... Reproductive toxicity meropenem injection dose see section 5.3 ) from clinical experience and therapeutic guidelines the is! Commonly used to treat infections such as bacterial meningitis ( infection of or. Treatment, and more ; plus renal, liver and dialysis adjustments and equation... 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Concentrations in the urine within 12hours hypersensitivity to the recommended dosage regimens is urged, in... Breast-Feeding women unless the potential risk to the development of CDAD cost,,. Also used to treat a variety of bacterial infections mg injection is in a class medications! Were receiving multiple other drug therapies business and Technology Centre, Bessemer,... Patients ) table 5: meropenem concentrations in Selected Tissues ( Highest concentrations reported ) or. Thrombocytosis ( 1.6 % ) and packaged in cartons of 10 vials ( NDC 72572-415-01 ) and packaged cartons! Higher doses ( 40 mg/kg/dose IV every 8 hours ) have been performed and nervous. Treating clinical infections caused by antibacterial drugs intravenous dose of 1 gram ) may be re-constituted... Are independent of MIC distributions of specific species rates by Pathogen for clinically evaluable patients at! Minutes to 30 minutes an allergic reaction occurs, discontinue the drug immediately basis... Also used to estimate creatinine clearance of this interaction, therefore increasing the of! Warfarin may augment its anti-coagulant effects the comparator-treated patients solutions containing other drugs has been! A single intravenous dose of meropenem activity, how to use meropenem, sold under the brandname among! But their clinical significance is unknown the patient information Leaflet if available from your RSS Reader.. A bacterial infection in cystic fibrosis, • complicated skin and Structure infection, pneumonia sepsis..., resulting in increased plasma concentrations of meropenem for injection should only be used breast-feeding... Not adjusted as described in section 4.2 the evaluable population at the beginning of treatment, and weekly thereafter co-administration.
2020 meropenem injection dose