Clinical Pharmacology (12.3), [see Meropenem binds to PBPs 2, 3 and 4 of Diminished renal function and central nervous system lesions may increase the risk of seizures. . A pharmacokinetic study with meropenem in elderly patients with renal impairment showed a reduction in plasma clearance of meropenem that correlates with age-associated reduction in creatinine clearance. Adverse Reactions (6.1), These highlights do not include all the information needed to use MEROPENEM FOR INJECTION safely and effectively. Withdraw 20 mL of 0.9% Sodium Chloride Injection from an infusion bag and constitute each vial. There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg. Use half normal dose every 24 hours if eGFR less than 10 mL/minute/1.73 m 2. Intentional overdosing of meropenem is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. 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. 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. If this occurs, patients should contact their physician as soon as possible, Counsel patients to inform their physician if they are taking valproic acid or divalproex sodium. Know Meropenem 500 MG Injection uses, side-effects, composition, substitutes, drug interactions, precautions, dosage, warnings only on Lybrate.com • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. 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 Skin reactions. 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. Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. Meropenem 500 MG Injection is used for Bacterial Meningitis, Skin And Structure Infection, Intra-Abdominal Infections etc. 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. • For pediatric patients weighing over 50 kg administer MERREM IV 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. 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%). As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. 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. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess. Indications and Usage (1)]. Continue typing to refine. At least 90% of the following bacteria exhibit an Files, All Mapping 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. Most of the dose is excreted unchanged in the urine within 12hours. Clinical Pharmacology (12.3)]. A pharmacokinetic study with meropenem in patients with hepatic impairment has shown no effects of liver disease on the pharmacokinetics of meropenem. Haemodialysis will remove meropenem and its metabolite. There is no experience in children with renal impairment. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. 1. The dog is stable and ready to be discharged from the hospital. Clinical Pharmacology (12.3)]. Counsel patients that antibacterial drugs including meropenem for injection should only be used to treat bacterial infections. 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). 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. Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding- protein (PBP) targets. Dosage and Administration (2.2)]. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. 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. Consider administration of antibacterial drugs other than carbapenems to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. 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. Clinical Pharmacology (12.3)]. At this dosage, no adverse pharmacological effects or increased safety risks have been observed. Pseudomonas aeruginosa). It allows continued monitoring of the benefit/risk balance of the medicinal product. 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. There is inadequate information regarding the use of meropenem for injection in patients on hemodialysis or peritoneal dialysis. European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below. Adverse Reactions(6.2)]. View NDC Code(s)NEW! There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. 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. 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 … In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval. Medicinal products that inhibit peristalsis should not be given. This meropenem injection is processed by optimum grade ingredients at vendor’s well equipped processing lab. Blood and Lymphatic System Disorders: agranulocytosis, neutropenia, and leukopenia; a positive direct or indirect Coombs test, and hemolytic anemia. Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. Drug Interactions (7.1)]. For a full list of excipients, see section 6.1. With respect to hearing loss, 263 of the 271 evaluable patients had at least one hearing test performed post-therapy. A population model developed from data in 79 patients with intra-abdominal infection or pneumonia, showed a dependence of the central volume on weight and the clearance on creatinine clearance and age. Gram-positive bacteria (5.9)], Respiratory: respiratory disorder, dyspnea, pleural effusion, asthma, cough increased, lung edema, Skin and Appendages: urticaria, sweating, skin ulcer, Urogenital System: dysuria, kidney failure, vaginal moniliasis, urinary incontinence. The dosage is based on your medical condition and response to treatment. Diminished renal function and central nervous system lesions may increase the risk of seizures. Table 10: Efficacy rates by Pathogen in the Clinically Evaluable Population with Bacterial Meningitis. Meropenem injection is used to treat skin and abdominal (stomach area) infections caused by bacteria and meningitis (infection of the membranes that surround the brain and spinal cord) in adults and children 3 months of age and older. Although the mechanism of this interaction is unknown, data from Meropenem is licensed for children over 3 months of age. Seizures and other adverse CNS experiences have been reported during treatment with meropenem. 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. Une dose est généralement administrée toutes les 8 heures. Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8). Vomiting and pseudomembranous colitis – consider alternate antibiotic. Viridans group streptococci. The pharmacokinetics of meropenem for injection I.V., in pediatric patients 2 years of age or older, are similar to those in adults. Meropenem Merrem ® - Renal dosing. Discard unused portion. - Intravenous infusion is to be given over 30 minutes. Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. Cockcroft DW, MH Gault, 1976, Prediction of creatinine clearance from serum creatinine, Nephron, 16:31-41. Pain at the site of injection. 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. Therapy, appropriate measures taken experienced severe hypersensitivity reactions to beta-lactam antibiotics may also be hypersensitive to meropenem and acid/sodium! 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