Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Reconstitution procedure. Dosage and Administration (2.2), [see Meropenem for injection, like all β-lactam antibiotics, has the potential to cause seizures. The dosage is based on your medical condition and response to treatment. Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of (, Seizures and other adverse CNS experiences have been reported during treatment. The pharmacokinetics of meropenem for injection I.V., in pediatric patients 2 years of age or older, are similar to those in adults. Includes dosages for Skin and Structure Infection, Intraabdominal Infection, Nosocomial Pneumonia and more; plus renal, liver and dialysis adjustments. 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. View NDC Code(s)NEW! Dosage should be reduced in adult patients with renal impairment. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Citations, 1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only), 1.2 Complicated Intra-abdominal Infections (Adult and Pediatric Patients), 1.3 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only), 2.2 Use in Adult Patients with Renal Impairment, 2.4 Preparation and Administration of Meropenem for Injection, 5.4 Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid, 5.5 Clostridium difficile-associated Diarrhea, 5.6 Development of Drug-Resistant Bacteria, 5.7 Overgrowth of Nonsusceptible Organisms, 6.1 Adverse Reactions from Clinical Trials, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility, 14.1 Complicated Skin and Skin Structure Infections, 14.2 Complicated Intra-Abdominal Infections, PRINCIPAL DISPLAY PANEL - 500 mg Vial Carton, PRINCIPAL DISPLAY PANEL - 1 gram Vial Carton, PRINCIPAL DISPLAY PANEL - 500 mg Vial Label, PRINCIPAL DISPLAY PANEL - 1 gram Vial Label, Report Adverse (, In patients with renal dysfunction, thrombocytopenia has been observed. 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. Treonam 1000 mg Injection is commonly used to treat critically ill patients admitted to the hospital. Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding-protein (PBP) targets. The half-life is approximately one hour. injection or infusion Meronem 500 mg 1000 mg Active ingredient: Meropenem trihydrate 570 mg 1140 mg equivalent to anhydrous meropenem 500 mg 1000 mg It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. (, Bacterial meningitis (pediatric patients 3 months of age and older only). Dose usual. Meropenem content and pH values before and after storage at 32°C for 24 hours in different buffered diluents are shown in table 1. Meropenem binds to PBPs 2, 3 and 4 of [see Get Label RSS Feed, There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 grams) bolus dose. Drug Interactions (7.2)]. GA: gestational age and PNA: postnatal age, Most common adverse reactions (2% or less) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species Clinical Trials, Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. 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. The dose depends on what type of infection you have, where it … 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. eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis, haemolytic anaemia. If an allergic reaction to meropenem occurs, discontinue the drug immediately. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. ), or very severe infections. [see This meropenem injection is processed by optimum grade ingredients at vendor’s well equipped processing lab. 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). The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Table 4 below). 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 %). DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Table 8: Clinical Efficacy Rates by Pathogen for Clinically Evaluable Population. In mice and rats, large intravenous doses of meropenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities. 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. MEROPENEM (injection, powder, for solution) comes in different strengths and amounts. Listeria monocytogenes, against which lethal activity is not observed. Clinical Pharmacology (12.3), What is the dosage for meropenem injection? For the best effect, use this antibiotic at evenly spaced times. Reference(s) National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Diminished renal function and central nervous system lesions may increase the risk of seizures. Provided meropenem injection is used to treat infections such as bacterial meningitis. Clinical Studies (14.2)]. Discard unused portion. These highlights do not include all the information needed to use MEROPENEM FOR INJECTION safely and effectively. [see This medication is given by injection into a vein as directed by your doctor, usually every 8 hours. [see No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (MRHD) based on body surface area comparison, respectively. 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. 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. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2), Children from 3 months to 11 years of age and up to 50 kg body weight. 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). There is no experience in children with renal impairment. 1 may be used to estimate creatinine clearance. 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. Urinary concentrations of meropenem in excess of 10 mcg/mL are maintained for up to 5 hours after a 500 mg dose. Each vial contains meropenem equivalent to 1 g of meropenem activity. Seizures and other adverse CNS experiences have been reported during treatment with meropenem. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. [see 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. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The pharmacokinetics of meropenem for injection I.V., in pediatric patients 2 years of age or older, are similar to those in adults. 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 (complicated skin and skin structure, intra-abdominal or meningitis). Clinical Pharmacology (12.3)]. There is inadequate information regarding the use of meropenem for injection in patients on hemodialysis or peritoneal dialysis. 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. 12 & 16, Chuangye Rd., Xinshi Dist, Tainan City, 74144, Taiwan, 500 mg per vial [see Common Brand Name(s): Merrem. 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). No specific medicinal product interaction studies other than probenecid were conducted. transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. P. aeruginosa. 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).