With respect to hearing loss, 263 of the 271 evaluable patients had at least one hearing test performed post-therapy. Treonam 1000 mg Injection is commonly used to treat critically ill patients admitted to the hospital. Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. Streptococcus pyogenes There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. 5Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. Pharmacokinetic studies with meropenem in patients with renal impairment have shown that the plasma clearance of meropenem correlates with creatinine clearance. Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. However, re-constituted solutions of meropenem for injection maintain satisfactory potency under the conditions described below. Withdraw 20 mL of 0.9% Sodium Chloride Injection from an infusion bag and constitute each vial. Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 –75 %) of the dose is excreted unchanged within 12 hours. Data). 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. resistant to other antibiotics. 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 AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment. Similar to other beta-lactam antibacterial agents, the time that meropenem concentrations exceed the MIC (T>MIC) has been shown to best correlate with efficacy. Meropenem injection is in a class of medications called antibiotics. Comparison showed consistent pharmacokinetics between the doses and half-lives similar to those observed in adults in all but the youngest subjects (<6 months t1/2 1.6 hours). If you are a consumer or patient please visit The dosage is based on your medical condition and response to treatment. Vomiting and pseudomembranous colitis – consider alternate antibiotic. The appearance of Meropenem can differ based on the dosing. Dosage and Administration (2.3), It should be used with caution in patients with central nervous system disorders. Meropenem for injection should not be mixed with or physically added to solutions containing other drugs. 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. If administration of meropenem is necessary, consider supplemental anti-convulsant therapy Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. 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. 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. Meropenem Updated September 2016 $48.50 for 500mg $63.50 for 1g Example A 30kg dog has a resistant urinary tract infection that is sensitive to meropenem. Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Vial for I.V. When only serum creatinine is available, the following formula (Cockcroft and Gault equation) 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. Fecal elimination represents only approximately 2% of the dose. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. Intentional overdosing of meropenem is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. 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). & Articles, All Enterococcus faecalis (vancomycin-susceptible isolates only) The NOAEL value was considered to be 1000 mg/kg/day (approximately 3.2 times the MRHD based on body surface area comparisons). 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 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. 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. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. P. aeruginosa. 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). 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. Use under close clinical supervision after discussion with Starship ID service. At enrollment, approximately 37% of the patients had underlying diabetes, 12% had underlying peripheral vascular disease and 67% had a surgical intervention. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis. Warnings and Precautions (5.4)]. The tables below provide general recommendations for dosing. The study compared the clinical response between treatment groups in the clinically evaluable population at the follow-up visit (test-of-cure). 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). 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. Adverse Reactions (6.1), [see Complicated intra-abdominal infections (adult and pediatric patients). 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). The pharmacokinetics of meropenem for injection I.V., in pediatric patients 2 years of age or older, are similar to those in adults. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Meropenem - Injection. [see Its structural formula is: Meropenem for injection is a white to pale yellow crystalline powder. 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. 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. Pharmacotherapeutic group: antibacterials for systemic use, carbapenems. The mean meropenem clearance values were 5.8 ml/min/kg (6-12 years), 6.2 ml/min/kg (2-5 years), 5.3 ml/min/kg (6- 23 months) and 4.3 ml/min/kg (2-5 months). Bactericidal concentrations (defined as a 3 log 25N 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. The offered meropenem injection 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). Hepatic function – at the beginning of treatment, and weekly thereafter. Currently there is no additional information available to further interpret this observation. Clinical Pharmacology (12.3), Distributed by Civica, Inc., Lehi, Utah 84043, Manufactured by Savior Lifetec Corporation, 4F, No. 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%). One controlled clinical study of complicated intra-abdominal infection was performed in the United States where meropenem was compared with clindamycin/tobramycin. Small amounts of meropenem have been reported to be excreted in human milk. Meropenem is also used to treat bacterial meningitis (infection of brain or spinal cord). 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). 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. To report SUSPECTED ADVERSE REACTIONS, contact Savior Lifetec Corporation at 886-6-505-1200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis. in vitro and in clinical infections Presence in Breast Milk, Medline Plus, 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. 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. Meropenem for injection vials re-constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of meropenem for injection) 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). Hepatic function – at the beginning of treatment, and weekly thereafter. 1 gram Injection Vial (NDC 72572-416-01) and packaged in cartons of 10 vials (NDC 72572-416-10). Continue anti-convulsant therapy in patients with known seizure disorders. Episódios de febre em pacientes neutropênicos – a dose deve ser de 1 … Adverse Reactions (6.1)]. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). 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 MEROPENEM (injection, powder, for solution) comes in different strengths and amounts. 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. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. No specific medicinal product interaction studies other than probenecid were conducted. When suggestions are available use up and down arrows to review and ENTER to select. Indication : • Wide spectrum antibiotic used to treat both Gram-positive and Gram-negative infections including pseudomonas spp. Sodium content is 45.1 mg (1.96 mEq). A 5-minute intravenous bolus injection of meropenem in healthy volunteers results in mean peak plasma concentrations of approximately 45 mcg/mL (range 18 to 65) for the 500 mg dose and 112 mcg/mL (range 83 to 140) for the 1 gram dose. (, 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. Meropenem for injection should be given as intravenous infusion over 30 minutes. In children, the dosage is also based on age and weight. 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. See full prescribing information for MEROPENEM FOR INJECTION, 72572-415-01, The clinical efficacy rates by pathogen are provided in Table 8. - Intravenous infusion is to be given over 30 minutes. Faecal elimination represents only approximately 2% of the dose. If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken. Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. Skin reactions. Meropenem 500 MG Injection is used for Bacterial Meningitis, Skin And Structure Infection, Intra-Abdominal Infections etc. Meropenem is also used to treat bacterial meningitis (infection of brain or spinal cord). Table 3: Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-abdominal Infections and Normal Renal Function, Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.. Use normal dose every 12 hours if eGFR 26–50 mL/minute/1.73 m 2. Start typing to retrieve search suggestions. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. There were AUC increases of 2.4 fold in patients with moderate impairment (CrCL 33-74 ml/min), 5 fold in severe impairment (CrCL 4-23 ml/min) and 10 fold in haemodialysis patients (CrCL <2 ml/min) when compared to healthy subjects (CrCL >80 ml/min). Dosage and Administration (2.2), 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. Until it is reasonably well established that meropenem for injection is well tolerated, patients should not operate machinery or motorized vehicles. How to use Meropenem Vial. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter-individual variability. No studies on the effect on the ability to drive and use machines have been performed. A pharmacokinetic study with meropenem in patients with hepatic impairment has shown no effects of liver disease on the pharmacokinetics of meropenem. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). After infusion over 5 minutes Cmax values are 52 and 112 µg/ml after 500 and 1000 mg doses respectively. 72572-415-10, In vitro meropenem shows reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem and there is no requirement to co-administer a DHP-I inhibitor. varies across the European Union. 12 & 16, Chuangye Rd., Xinshi Dist, Tainan City, 74144, Taiwan, 500 mg per vial 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. There is no experience in pediatric patients with renal impairment. The pharmacokinetics of meropenem in neonates requiring anti-infective treatment showed greater clearance in neonates with higher chronological or gestational age with an overall average half-life of 2.9 hours. Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8). After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. Dosage should be reduced in adult patients with renal impairment. transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased. (current), meropenem (as meropenem trihydrate) 500 MG Injection, meropenem (as meropenem trihydrate) 1000 MG 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. Glanders and melioidosis: Use of meropenem in humans is based on in vitro B.mallei and B. pseudomallei susceptibility data and on limited human data. 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. Severe pneumonia including hospital and ventilator-associated pneumonia.