For the treatment of complicated skin infections in adults, 500 mg to 2 grams should be administered intravenously every 8 hours. This medication is given by injection into a vein as directed by your doctor, usually every 8 hours. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. C. difficile, and surgical evaluation should be instituted as clinically indicated. Meropenem for injection is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Meropenem for injection should not be mixed with or physically added to solutions containing other drugs. To email a medicine you must sign up and log in. No information is available on the effects of meropenem on the breast-fed child or on milk production. 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. Meropenem should be stored at room temperature, 20 C to 25 C (68 F to 77 F). There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another β-lactam. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). 12 & 16 Chuangye Rd., Tainan City 74144, Taiwan, R.O.C. Adverse Reactions (6.1)]. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. 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. Staphylococcus epidermidis (MRSE). 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. Most of the dose is excreted unchanged in the urine within 12hours. Intentional overdosing of meropenem is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. Meropenem for injection should be given as intravenous infusion over 30 minutes. Meropenem 1 g: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. - Intravenous infusion is to be given over 30 minutes. Alert patients receiving meropenem on an outpatient basis regarding adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. [see [see 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. EUCAST clinical MIC breakpoints for meropenem (2013-02-11, v 3.1 ), Haemophilus influenzae1, 2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile. 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. ), 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. Meropenem for injection should be administered by intravenous infusion over approximately 15 minutes to 30 minutes. 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). Adverse Reactions(6.2)]. There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. Streptococcus pyogenes The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. 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. Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. Pseudomonas aeruginosa). 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. Dosage and Administration (2.3), 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. Dosage should be reduced in adult patients with renal impairment. 500 mg a 1 g, por administração intravenosa a cada 8 horas, dependendo do tipo e da gravidade da infecção, da suscetibilidade conhecida ou esperada do(s) patógeno(s) e das condições do paciente. However, when driving or operating machines, it should be taken into account that headache, paraesthesiae and convulsions have been reported for meropenem. Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding-protein (PBP) targets. Files, All Mapping 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. No accumulation of meropenem in plasma was observed with regimens using 500 mg administered every 8 hours or 1 gram administered every 6 hours in healthy volunteers with normal renal function. (8.6), Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). 1 may be used to estimate creatinine clearance. All reports received were consistent with events observed in the adult population. Enterococcus faecalis (vancomycin-susceptible isolates only), Table 1: Recommended Meropenem for Injection Dosage Schedule for Adult Patients with Renal Impairment. 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. Meropenem is cleared by haemodialysis and haemofiltration. Severe hypersensitivity (e.g anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. If administration of meropenem is necessary, then supplemental anti-convulsant therapy should be considered Meropenem injection is in a class of medications called antibiotics. The tables below provide general recommendations for dosing. Complicated intra-abdominal infections (adult and pediatric patients). 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. (, Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. 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. Know Meropenem 500 MG Injection uses, side-effects, composition, substitutes, drug interactions, precautions, dosage, warnings only on Lybrate.com 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.. 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. The trial was conducted in the United States, South Africa, Canada, and Brazil. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half- life and plasma concentration of meropenem. Mfd by Savior Lifetec Corp., Taiwan, R.O.C. In vitro tests show meropenem to act synergistically with aminoglycoside antibacterial drugs against some isolates of 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. Co-administration of probenecid with meropenem is not recommended. ), or very severe infections. 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. Warnings and Precautions (5.9), Presence in Breast Milk, Medline Plus, Consideration should be given to official guidance on the appropriate use of antibacterial agents. 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 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 MYLAN 1 g, poudre pour solution injectable/pour perfusion vous sera administré en injection ou en perfusion dans une grosse veine. The adverse reactions seen in these patients that were reported and their rates of occurrence are as follows: Adverse Laboratory Changes in Pediatric Patients: Laboratory changes seen in the pediatric studies, including the meningitis studies, were similar to those reported in the adult studies. There is one metabolite of meropenem that is microbiologically inactive. 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. Prior to Constitution: Store at 20 (. Sodium content is 45.1 mg (1.96 mEq). Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid. Until it is reasonably well established that meropenem is well tolerated, advise patients not to operate machinery or motorized vehicles Reference(s) National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Meropenem Injection 500MG Meropenem is used to treat severe infections of the skin or stomach. Single dose clear glass vials of meropenem for injection containing 500 mg or 1 gram (as the trihydrate blended with anhydrous sodium carbonate for re-constitution) of sterile meropenem powder. 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. Indications and Usage (1.3), 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). Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). After a single intravenous dose of Meropenem for injection (I.V. Meropenem for injection is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Staphylococcus aureus (methicillin-susceptible isolates only) Renal function - increase dose interval in renal failure. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent. There is inadequate information regarding the use of meropenem for injection in patients on hemodialysis or peritoneal dialysis. 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. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of Meropenem. Viridans group streptococci. Discard unused portion. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Dosage adjustment is necessary in patients with creatinine clearance 50 mL/min or less Its empirical formula is C The clinical efficacy rates by pathogen are provided in Table 8. Symptomatic treatments should be considered. 6.1). 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). They are for use only for organisms that do not have specific breakpoints. One trial of 47 patients with a mean age of 2 years (range, 4 days to 20 years) examined meropenem 20 mg/kg/dose (or up to 40 mg/kg/dose for CNS or critical infections) IV every 8 hours for a … Meropenem 500 MG Injection is used for Bacterial Meningitis, Skin And Structure Infection, Intra-Abdominal Infections etc. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. Until it is reasonably well established that meropenem for injection is well tolerated, patients should not operate machinery or motorized vehicles. 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. Dosage and Administration (2.2)]. 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. Sequelae were the most common reason patients were assessed as clinically not cured. 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Use under close clinical supervision after discussion with Starship ID service. Use under close clinical supervision after discussion with Starship ID service. Meropenem is not licensed for children <3 months of age. The pharmacokinetics of meropenem, in pediatric patients 2 years of age or older, are similar to those in adults. Clinical Trials, Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. The intravenous formulation was well tolerated in animal studies. Clinical Pharmacology (12.3)]. Know Meropenem 500 MG Injection uses, side-effects, composition, substitutes, drug interactions, precautions, dosage, warnings only on Lybrate.com Use normal dose every 12 hours if eGFR 26–50 mL/minute/1.73 m 2. • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. The easiest way to dilute meropenem is to do 2 vials at a time. Its structural formula is: Meropenem for injection is a white to pale yellow crystalline powder. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Events, (What Hypertoxin producing isolates of Warnings and Precautions (5.3), The values represent the number of patients clinically cured/number of clinically evaluable patients, with the percent cure in parentheses. 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. oC to 25 Urinary concentrations of meropenem in excess of 10 mcg/mL are maintained for up to 5 hours after a 500 mg dose. -- = Susceptibility testing not recommended as the species is a poor target for therapy with the drug. 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). (, Seizures and other adverse CNS experiences have been reported during treatment. (, 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. In the meropenem treated group, 12/15 patients with seizures had late onset seizures (defined as occurring on day 3 or later) versus 7/20 in the comparator arm. Clinical Pharmacology (12.3)]. Higher doses (40 mg/kg/dose IV every 8 hours) have been used in patients with severe infections. Meropenem is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (β)-lactams. Dosage and Administration (2.2), Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. Indications and Usage (1)]. In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %). See In subjects with normal renal function, the elimination half-life of meropenem is approximately 1 hour. Among these are included prior history of seizures or CNS abnormality and concomitant medications with seizure potential. The NOAEL value was considered to be 1000 mg/kg/day (approximately 3.2 times the MRHD based on body surface area comparisons). However, re-constituted solutions of meropenem for injection maintain satisfactory potency under the conditions described below. There are no or limited amount of data from the use of meropenem in pregnant women. & Articles, All Second generation offspring showed no meropenem-related effects. The pharmacokinetics of meropenem for injection I.V., in pediatric patients 2 years of age or older, are similar to those in adults. 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. 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). dosing Table 3 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. There was no evidence of mutagenic potential found in any of these tests. RxNorm, At least 90% of the following bacteria exhibit an No studies on the effect on the ability to drive and use machines have been performed. This target has not been established clinically. In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 µg/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 µg.h/ml. Using strict evaluability criteria and microbiologic eradication and clinical cures at follow-up which occurred 7 or more days after completion of therapy, the presumptive microbiologic eradication/clinical cure rates and statistical findings are provided in Table 9: Table 9: Presumptive Microbiologic Eradication and Clinical Cure Rates at Test-of-Cure Visit in the Evaluable Population with Complicated Intra-Abdominal Infection. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. injection or infusion Meronem 500 mg 1000 mg Active ingredient: Meropenem trihydrate 570 mg 1140 mg equivalent to anhydrous meropenem 500 mg 1000 mg Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. C. difficile produces toxins A and B which contribute to the development of CDAD. Adverse Reactions (6.1), angioedema, anaphylaxis (see sections 4.3 and 4.4), diarrhoea, vomiting, nausea, abdominal pain, antibiotic-associated colitis (see section 4.4). Meropenem for Injection Page 6 of 36 Meropenem for Injection, like all β-lactam antibiotics, has the potential to cause seizures. A pharmacokinetic study with meropenem in elderly patients has shown a reduction in the plasma clearance of meropenem that correlates with age-associated reduction in creatinine clearance 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. If administration of meropenem is necessary, consider supplemental anti-convulsant therapy 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. Meropenem is licensed for children over 3 months of age. 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. For the best effect, use this antibiotic at evenly spaced times. A further 28% is recovered as the microbiologically inactive metabolite. Freshly prepared solutions of meropenem for injection should be used. 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 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. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. No dose adjustment is necessary in patients with hepatic impairment (see section 4.4). Use in Specific Populations (8.5), This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. oF) [see USP Controlled Room Temperature]. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter-individual variability. However, the efficacy of meropenem in treating clinical infections caused by these bacteria have not been established in adequate and well-controlled clinical trials. However, bacteria may exhibit resistance to more than one class of antibacterials agents when the mechanism involved include impermeability and/or an efflux pump(s). Continue anti-convulsant therapy in patients with known seizure disorders. Two hundred and sixty one (261) patients randomized to meropenem and 287 patients randomized to imipenem-cilastatin were clinically evaluable. 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. Seizures and other adverse CNS experiences have been reported during treatment with meropenem. The half-life is approximately one hour. 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). 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 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. Diminished renal function and central nervous system lesions may increase the risk of seizures. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. Kawamura S, AW Russell, SJ Freeman, and RA Siddall, 1992, Reproductive and Developmental Toxicity of Meropenem in Rats, Chemotherapy, 40:S238-250. Pediatric 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. Meropenem for injection is indicated for the treatment of bacterial meningitis caused by At the end of a 30-minute intravenous infusion of a single dose of meropenem in healthy volunteers, mean peak plasma concentrations of meropenem are approximately 23 mcg/mL (range 14 to 26) for the 500 mg dose and 49 mcg/mL (range 39 to 58) for the 1 gram dose. 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. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. [see . Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for meropenem against isolates of similar genus or organism group.
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