Use half normal dose every 24 hours if eGFR less than 10 mL/minute/1.73 m 2. (, Co-administration of meropenem with probenecid inhibits renal excretion of meropenem and is therefore not recommended. At follow-up, the clinical response rates were 96%, 89%, 93% and 96%, respectively. [see Staphylococcus aureus. Clinical Pharmacology (12.3)]. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. 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. 500 mg Injection Vial (NDC 72572-415-01) and packaged in cartons of 10 vials (NDC 72572-415-10). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Nausea and vomiting. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against Provided meropenem injection is used to treat infections such as bacterial meningitis. 1Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25 mg (Susceptible) and 1 mg/l (Resistant). In a peri-postnatal study in rats described in the published literature 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. Buy Meropenem 500 MG Injection Online. in vitro and in clinical infections 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. Meropenem Hospira Solution for Injection is used for complicated skin and soft tissue infection, complicated infections occurring within the stomach cavity, inflammation of the brain and spinal cord membranes (bacterial meningitis), or infection during or following childbirth (intra or post-partum infections). Discard unused portion. Events, (What 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. this version. [see MEROPENEM MYLAN 1 g, poudre pour solution injectable/pour perfusion vous sera administré en injection ou en perfusion dans une grosse veine. After infusion over 5 minutes Cmax values are 52 and 112 µg/ml after 500 and 1000 mg doses respectively. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. 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.. 5Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. angioedema, anaphylaxis (see sections 4.3 and 4.4), diarrhoea, vomiting, nausea, abdominal pain, antibiotic-associated colitis (see section 4.4). Streptococcus agalactiae 72572-416-01, Staphylococcus aureus (MRSA) or methicillin-resistant 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 in vitro data are available, but their clinical significance is unknown. When Meropenem for Injection is indicated in patients with these risk factors, caution is advised. 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. Use in Specific Populations (8.6)]. (, 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). Kawamura S, AW Russell, SJ Freeman, and RA Siddall, 1992, Reproductive and Developmental Toxicity of Meropenem in Rats, Chemotherapy, 40:S238-250. Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Table 4: Volume of Sterile Water for Injection for Reconstitution of Injection Vials. 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. Discard unused portion. A further 28% is recovered as the microbiologically inactive metabolite. eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis, haemolytic anaemia. Meropenem for injection, like all β-lactam antibiotics, has the potential to cause seizures. Meropenem injection is in a class of medications called antibiotics. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem. 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). The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Meropenem Equivalent, For Intravenous Use Only Sodium content is 45.1 mg (1.96 mEq). 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. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis. Hypertoxin producing isolates of Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6) Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. Dosage adjustment is necessary in patients with creatinine clearance 50 mL/min or less It allows continued monitoring of the benefit/risk balance of the medicinal product. They do not treat viral infections (e.g., the common cold). However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. (, Bacterial meningitis (pediatric patients 3 months of age and older only). DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. When only serum creatinine is available, the following formula (Cockcroft and Gault equation) There is no dose adjustment necessary (see section 4.2). ), 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. 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. Second generation offspring showed no meropenem-related effects. The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. Currently there is no additional information available to further interpret this observation. 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). The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. In repeat dose studies of up to 6 months' duration only minor effects were seen including a decrease in red cell parameters in dogs. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. ), 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 Les enfants pesant plus de 50 kg recevront la même dose qu'un adulte. What preparations of meropenem-injection are available? dosing Table 3 below. 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. 12 & 16, Chuangye Rd., Xinshi Dist, Tainan City, 74144, Taiwan, 500 mg per vial Meropenem is indicated for the treatment of the following infections in adults and children over 3 months of age (see sections 4.4 and 5.1): • Severe pneumonia, including hospital and ventilator-associated pneumonia. 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. View Labeling Archives, Four hundred forty-six patients (397 pediatric patients 3 months to less than 17 years of age) were enrolled in 4 separate clinical trials and randomized to treatment with meropenem (n=225) at a dose of 40 mg/kg every 8 hours or a comparator drug, i.e., cefotaxime (n=187) or ceftriaxone (n=34), at the approved dosing regimens. Meropenem Merrem ® - Renal dosing. [35489] [63245] 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. Carcinogenesis studies have not been performed. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. Biochemical Data Summary. Meropenem Injection is used for complicated skin and soft tissue infection, complicated infections occurring within the stomach cavity, inflammation of the brain and spinal cord membranes (bacterial meningitis), or infection during or following childbirth (intra or post-partum infections). Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. 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. Meropenem does not have Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. The dosage is based on your medical condition and response to treatment. Vial for I.V. 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. 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. [see Meropenem is cleared by haemodialysis and haemofiltration. transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased. Preparation of solution: Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection.Shake to dissolve and to obtain solution which is clear and colorless or pale yellow. There are no or limited amount of data from the use of meropenem in pregnant women. Gram-positive bacteria oF) [see USP Controlled Room Temperature]. Read the Patient Information Leaflet if available from your pharmacist before you start using meropenem and each time you get a refill. There are limited data to support the application of these dose adjustments for a unit dose of 2 g. Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above. The required dose should be administered after completion of the haemodialysis cycle. Includes dosages for Skin and Structure Infection, Intraabdominal Infection, Nosocomial Pneumonia and more; plus renal, liver and dialysis adjustments. Une dose est généralement administrée toutes les 8 heures. 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. See 17 for PATIENT COUNSELING INFORMATION. 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. The reconstituted solutions for intravenous injection or infusion should be used immediately. If superinfection does occur during therapy, appropriate measures should be taken. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. Hepatic function – at the beginning of treatment, and weekly thereafter. Meropenem - Injection. Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. 72572-415-10, The study included 510 patients randomized to meropenem and 527 patients randomized to imipenem-cilastatin. View NDC Code(s)NEW! 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. Withdraw 20 mL of 0.9% Sodium Chloride Injection from an infusion bag and constitute each vial. The content of the vial should be reconstituted in 10 ml of water for injection for meropenem 500 mg IV injection and in 20 ml water for injection for meropenem 1 gm. The appearance of Meropenem can differ based on the dosing. A five 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. Each vial contains meropenem equivalent to 1 g of meropenem activity. At follow-up, the clinical response rates were 96%, 89%, 93% and 96%, respectively. Meropenem may also be used for purposes not listed in this medication guide. 8 hours (maximum dose is 2 grams every 8 hours), depending on the type of infection (cSSSI, cIAI, intra-abdominal infection or meningitis). The elimination half-life for meropenem was approximately 1.5 hours in pediatric patients of age 3 months to 2 years. The dry powder should be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) [see USP]. 1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL) over 3 minutes to 5 minutes for adult patients. - There is no experience in pediatric patients with renal impairment. In fertility studies, intravenous meropenem was administered to male rats beginning 11 weeks before mating and throughout mating and to female rats from 2 weeks before mating through Gestation Day 7 at doses of 240, 500, and 1000 mg/kg/day. The solution varies from colorless to yellow depending on the concentration. Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) 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. dosing Table below.). C. difficile may need to be discontinued. Urinary concentrations of meropenem in excess of 10 mcg/mL are maintained for up to 5 hours after a 500 mg dose. Local adverse events that were reported with meropenem were as follows: Systemic adverse events that were reported with meropenem occurring in greater than 1.0% of the patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%). 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. The trial was conducted in the United States, South Africa, Canada, and Brazil. In individuals with normal renal function, rapid renal elimination will occur. 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. Blood and Lymphatic System Disorders: agranulocytosis, neutropenia, and leukopenia; a positive direct or indirect Coombs test, and hemolytic anemia. Medicinal products that inhibit peristalsis should not be given. [see 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. What is the dosage for meropenem injection? 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. Streptococcus pyogenes Use under close clinical supervision after discussion with Starship ID service. • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. 4F, No. The intravenous formulation was well tolerated in animal studies. For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: http://www.fda.gov/STIC. Until it is reasonably well established that meropenem for injection is well tolerated, patients should not operate machinery or motorized vehicles. 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). Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. No specific medicinal product interaction studies other than probenecid were conducted. 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. Until it is reasonably well established that meropenem is well tolerated, advise patients not to operate machinery or motorized vehicles Consider symptomatic treatments. Dosage and Administration (2.3), Labels, All Index Meropenem is also used to treat bacterial meningitis (infection of brain or spinal cord). Mfd by Savior Lifetec Corp., Taiwan, R.O.C, Report Adverse 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. See. At enrollment, approximately 37% of the patients had underlying diabetes, 12% had underlying peripheral vascular disease and 67% had a surgical intervention. This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. 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). Renal impairment results in higher plasma AUC and longer half-life for meropenem. Isolates may be reported as R without prior testing. All meropenem-treated patients with seizures had pre-existing contributing factors. [see How should I keep meropenem-injection stored? - Intravenous bolus injection (5 mL to 20 mL) is to be given over approximately 3 minutes to 5 minutes. Dosage should be reduced in patients with creatinine clearance of 50 mL/min or less. Mfd by Savior Lifetec Corp., Taiwan, R.O.C. Cockcroft DW, MH Gault, 1976, Prediction of creatinine clearance from serum creatinine, Nephron, 16:31-41. Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite. C. difficile produces toxins A and B which contribute to the development of CDAD. Meropenem administered intravenously to pregnant Cynomolgus monkeys during organogenesis from Day 20 to 50 after mating at doses of 120, 240, and 360 mg/kg/day did not produce maternal or fetal toxicity at the NOAEL dose of 360 mg/kg/day (approximately 2.3 times the MRHD based on body surface area comparison). (, Severe cutaneous adverse reactions have been reported in patients receiving meropenem. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of Meropenem. C. difficile, and surgical evaluation should be instituted as clinically indicated. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. 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). Dose usual. Microbiology (12.4)]. Before initiating therapy with meropenem, it is important to inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other β-lactams, and other allergens. When treating cSSSI caused by 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. Treonam 1000 mg Injection is commonly used to treat critically ill patients admitted to the hospital. Powder for Solution for injection or infusion. [see Drug Interactions (7.2)]. 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) Indications and Usage (1.3), 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. A further 28% is recovered as the microbiologically inactive metabolite. Table 10: Efficacy rates by Pathogen in the Clinically Evaluable Population with Bacterial Meningitis. Meropenem 1 g: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. 30 mg/kg and an equivalent dose of the drug-loaded nanoparticle dispersion; single intraperitoneal injection Application In septic rat model of Klebsiella pneumoniae, treatment with free meropenem exhibited 30% mortality, which was not statistically significant, as … There is one metabolite of meropenem that is microbiologically inactive. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. (, Renal Impairment: Dose adjustment is necessary, if creatinine clearance is 50 mL/min or less. Any unused product or waste material should be disposed of in accordance with local requirements. [see Meropenem is hemodialyzable. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Staphylococcus epidermidis (methicillin-susceptible isolates only). Adverse events with an incidence of greater than 1%, and not listed above, include: pharyngitis, accidental injury, gastrointestinal disorder, hypoglycemia, peripheral vascular disorder, and pneumonia. Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher than in anuric patients. Dosage and Administration (2.2), The tables below provide general recommendations for dosing. Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. Repeated evaluation of the patient is essential. However, re-constituted solutions of meropenem for injection maintain satisfactory potency under the conditions described below. This target has not been established clinically. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. 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. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. Clinical Pharmacology (12.3)]. Meropenem is licensed for children over 3 months of age. Its empirical formula is C 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). See full prescribing information for MEROPENEM FOR INJECTION, 72572-415-01, (8.6),  The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %). Table 6: Meropenem Pharmacokinetic Parameters in Patients Less Than 3 Months of Age

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