CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. 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. There are numerous reports of seizure activity associated with imipenem-cilastatin, with seizure rates ranging from 3-33%. Ertapenem is a 1-beta methyl-carbapenem which is chemically similar to beta lactams. The following adverse reactions have been identified during post-approval use of Meropenem. 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. However, as their use increases and expands into new patient populations, the rate of seizures with these agents may increase. Proteus mirabilis Following administration of probenecid with Meropenem, the mean systemic exposure increased 56% and the mean elimination half-life increased 38% [see Drug Interactions (7.1)]. The trial was conducted in the United States, South Africa, Canada, and Brazil. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. This is not a list of all drugs or health problems that interact with meropenem. See dosing Table 3 below. [1] It is more resistant to breakdown by β-lactamase producing bacteria. The bactericidal activity of Meropenem results from the inhibition of cell wall synthesis. Mechanism of Action: Meropenem is a structural analog of impipenem that is resistant to cleavage by renal dehydropeptidase I. In 2016, a synthetic peptide-conjugated PMO (PPMO) was found to inhibit the expression of New Delhi metallo-beta-lactamase, an enzyme that many drug-resistant bacteria use to destroy carbapenems. If you are taking probenecid. Mechanism of Action. 12.4 Microbiology. The overall spectrum is similar to that of imipenem, although meropenem is more active against Enterobacteriaceae and less active against Gram-positive bacteria. If administration of Meropenem is necessary, consider supplemental anti-convulsant therapy [see Drug Interactions (7.2)]. The bactericidal activity of meropenem results from the inhibition of cell wall synthesis. In individuals with normal renal function, rapid renal elimination takes place. Genetic toxicity studies were performed with Meropenem using the bacterial reverse mutation test, the Chinese hamster ovary HGPRT assay, cultured human lymphocytes cytogenic assay, and the mouse micronucleus test. The pH of freshly constituted solutions is between 7.3 and 8.3. In contrast to other beta-lactams, it is highly resistant to degradation by β-lactamases or cephalosporinases. Propionibacterium acnes. Approximately 70% (50% - 75%) of the dose is excreted unchanged within 12 hours. Viridans group streptococci, Gram-negative bacteria From: Side Effects of … With respect to hearing loss, 263 of the 271 evaluable patients had at least one hearing test performed post-therapy. [6], Meropenem is administered intravenously as a white crystalline powder to be dissolved in 5% monobasic potassium phosphate solution. Cross-resistance is sometimes observed with isolates resistant to other carbapenems. [1] It is in the carbapenem family of medications. Pasteurella multocida However, there is no information on the usefulness of hemodialysis to treat overdosage [see Overdosage (10)]. [8] For ß-lactams, including meropenem, prolonged intravenous administration is associated with lower mortality than bolus intravenous infusion in persons with whose infections are severe, or caused by bacteria that are less sensitive to meropenem, such as Pseudomonas aeruginosa.[8][9]. Five patients were found to be bacteriologically not cured, 3 in the comparator group (1 relapse and 2 patients with cerebral abscesses) and 2 in the Meropenem group (1 relapse and 1 with continued growth of Pseudomonas aeruginosa). Mechanism of Action. 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. 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. One controlled clinical study of complicated intra-abdominal infection was performed in the United States where Meropenem was compared with clindamycin/tobramycin. The walls are necessary to protect bacteria from their environment and to keep the contents of the bacterial cell together. However, the efficacy of Meropenem in treating clinical infections caused by these bacteria have not been established in adequate and well-controlled clinical trials. The success rates for the clinically evaluable population are provided in Table 7. Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. 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. 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). The success rates in the clinically evaluable patients at the follow-up visit were 86% (225/261) in the Meropenem arm and 83% (238/287) in imipenem-cilastatin arm. In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported [see Dosage and Administration (2.2), Adverse Reactions (6.1), Use In Specific Populations (8.5), (8.6), Clinical Pharmacology (12.3)]. Medically reviewed by Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. A 55-year-old, 102kg Caucasian male, with a history of seizures andmultiple sclerosis, complicated by quadriplegia and dysphagia, wastransferred to Veteran Affairs Medical Centre in Long Beach,California, for the treatment of urosepsis, Clostridium difficile colitis and aspiration pneumonia (sputum samples had tested positive for Klebsiella spp and Pseudomonas spp). The safety and effectiveness of Meropenem have been established for pediatric patients 3 months of age and older with complicated skin and skin structure infections and bacterial meningitis, and for pediatric patients of all ages with complicated intra-abdominal infections. Mechanism of Action. 1. The clinical efficacy rates by pathogen are provided in Table 8. Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding-protein (PBP) targets. If you are allergic to meropenem; any part of meropenem; or any other drugs, foods, or substances. Chemistry and Mechanism of Action Meropenem. Meropenem Meropenem reduces plasma valproate concentrations, affording two mechanisms for an increased risk of seizures in patients with epilepsy, epileptogenic effect of meropenem, and loss of antiepileptic action of valproate [46A,47A,48A,49A,50A,51A,52c]. The solution varies from colorless to yellow depending on the concentration. ... -Meningitis - meropenem-If Pseudomonas is known or suspected - NOT ertapenem. 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. Following intravenous doses of 500 mg, mean plasma concentrations of Meropenem usually decline to approximately 1 mcg/mL at 6 hours after administration. Second generation offspring showed no Meropenem-related effects. 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). Prevotella intermedia When treating complicated skin and skin structure infections caused by P.aeruginosa, a dose of 1 gram every 8 hours is recommended. Doripenem has high affinity for PBP2 and PBP3 in Pseudomonas aeruginosa and PBP2 in Escherichia coli [9]. 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). Streptococcus pyogenes The elimination half-life for Meropenem was approximately 1.5 hours in pediatric patients of age 3 months to 2 years. 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. Carcinogenesis studies have not been performed. This condition frequently occurs in patients with hematological malignancies and cancer patients receiving anticancer drugs that suppress bone marrow formation. It is approved for complicated skin and skin structure infections, complicated intra-abdominal infections and bacterial meningitis. Meropenem for injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, and Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae. Meropenem prevents bacteria from forming the walls that surround them. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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). BluePoint Laboratories, For Intravenous Use Only Imipenem and meropenem are useful in cases in which P. aeruginosa is a suspected pathogen. Re-constitute injection vials (500 mg and 1 gram) with sterile Water for Injection (see Table 4 below). [11][12] Meropenem has a reduced potential for seizures in comparison with imipenem. Meropenem has a niche in its spectrum of coverage. Meropenem is bactericidal except against Listeria monocytogenes, where it is bacteriostatic. The pharmacokinetics of Meropenem, in pediatric patients 2 years of age or older, are similar to those in adults. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving Meropenem [see Adverse Reactions (6.2) ]. Before initiating therapy with Meropenem, it is important to inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other β-lactams, and other allergens. The recommended dose of Meropenem for injection is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. DrugBank Meropenem Anhydrous is the anhydrous form of meropenem, a broad-spectrum carbapenem with antibacterial properties, synthetic Meropenem inhibits cell wall synthesis in gram-positive and gram-negative bacteria. Review the mechanism of action of ZERBAXA® (ceftolozane and tazobactam), which demonstrated in vitro activity in the presence of certain mechanisms of resistance. Consider symptomatic treatments. Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. For meropenem, doripenem, and ertapenem, the seizure rate for each agent is reported as less than 1%. A similar trend was also seen in the cUTI trial. [1] It is on the World Health Organization's List of Essential Medicines. The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with Meropenem. The most common adverse effects are diarrhea (4.8%), nausea and vomiting (3.6%), injection-site inflammation (2.4%), headache (2.3%), rash (1.9%) and thrombophlebitis (0.9%). 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. However, re-constituted solutions of Meropenem for injection maintain satisfactory potency under the conditions described below. Additional systemic adverse events that were reported with Meropenem and occurring in less than or equal to 1.0% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency: Bleeding events were seen as follows: gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%). To compare and contrast imipenem and meropenem in terms of in vitro activity, pharmacokinetics, clinical efficacy and adverse effects. Over time, however, problems such as resistance development and selection of resistant organisms have become apparent. [1], Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. Meropenem binds to PBPs 2, 3 and 4 of Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of Staphylococcus aureus. Meropenem is a substrate of OAT1 and OAT3 transporters in the proximal tubule of the kidney, and probenecid is an inhibitor of these drug transporters. [5] Meropenem is frequently given in the treatment of febrile neutropenia. 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. At the end of a 30-minute intravenous infusion of a single dose of Meropenem for injection 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 39-58) for the 1 gram dose. 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. The medical need for compounds with broad-spectrum activity, rapid bactericidal action, limited resistance-promoting properties and good tolerability has been met with carbapenem compounds. The types of systemic and local adverse events seen in these patients are similar to the adults, with the most common adverse reactions reported as possibly, probably, or definitely related to Meropenem and their rates of occurrence as follows: In the meningitis studies, the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received Meropenem and those who received comparator agents (either cefotaxime or ceftriaxone). It inhibits cell wall synthesis by binding to several penicillin-binding proteins, resulting in defective cell walls & osmotically unstable organisms susceptible to cell lysis. During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with Meropenem (500 mg or 1 gram every 8 hours). Freshly prepared solutions of Meropenem for injection should be used. Mechanism of Action Meropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death. Unlike imipenem, it is stable to dehydropeptidase-1, so can be giv… Table 5: Meropenem Concentrations in Selected Tissues (Highest Concentrations Reported). Savior Lifetec Corporation Prevotella melaninogenica 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. Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding-protein (PBP) targets. Parabacteroides distasonis Meropenem is an injectable carbapenem antibiotic. The pharmacokinetics of Meropenem in patients less than 3 months of age receiving combination antibacterial drug therapy are given below. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Bacteroides uniformis Serratia marcescens, Bacteroides ovatus 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) [see Dosage and Administration (2.2), Warnings and Precautions (5.9), Use in Specific Populations (8.5), (8.6), Clinical Pharmacology (12.3)]. Meropenem is primarily excreted unchanged by the kidneys. For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: Its molecular formula is C22H24N3O7SNa and MW is 497.50.The chemical structure is: Compatibility of Meropenem for injection with other drugs has not been established. The background risk of major birth defects and miscarriage for the indicated population is unknown. Continue anti-convulsant therapy in patients with known seizure disorders. Among these are included prior history of seizures or CNS abnormality and concomitant medications with seizure potential. Gram-positive bacteria Use of Meropenem in pediatric patients 3 months of age and older with bacterial meningitis is supported by evidence from adequate and well-controlled studies in the pediatric population [see Indications and Usage (1.3), Dosage and Administration (2.3), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.3)]. 12 & 16, Chuangye Rd., Xinshi Dist., Tainan City 74144, Taiwan for
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