The study included 510 patients randomized to meropenem and 527 patients randomized to imipenem-cilastatin. Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher than in anuric patients. 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). Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding- protein (PBP) targets. FDA Safety Recalls, Adverse Reactions (6.1), Meropenem administered to pregnant rats during organogenesis (Gestation Day 6 to Gestation Day 17) in intravenous doses of 240, 500, and 750 mg/kg/day was associated with mild maternal weight loss at all doses, but did not produce malformations or fetal toxicity. Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. Shake to dissolve and let stand until clear. Dosage should be reduced in adult patients with renal impairment. Caution is required if probenecid is co-administered with meropenem. The offered meropenem injection In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. P. aeruginosa, a dose of 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended. 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. this version. The pH of freshly constituted solutions is between 7.3 and 8.3. Animal studies indicate that meropenem is well tolerated by the kidney. The recommended dose regimens are shown in the table below: Broncho-pulnonary infections in cystic fibrosis. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Powder for Solution for injection or infusion. Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. Solutions of intravenous meropenem for injection should not be frozen. The appearance of Meropenem can differ based on the dosing. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Presence in Breast Milk, Medline Plus, Provided meropenem injection is used to treat infections such as bacterial meningitis. Table 1: Recommended Meropenem for Injection Dosage Schedule for Adult Patients with Renal Impairment. Meropenem - Injection. 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. C. difficile produces toxins A and B which contribute to the development of CDAD. Its structural formula is: Meropenem for injection is a white to pale yellow crystalline powder. (See Meropenem is licensed for children over 3 months of age. 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). Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including meropenem, and may range in severity from mild diarrhea to fatal colitis. The pharmacokinetics of meropenem for injection I.V., in pediatric patients 2 years of age or older, are similar to those in adults. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). A positive direct or indirect Coombs test may develop during treatment with meropenem. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=b0075b72-c3cc-f844-e053-2a95a90a417f, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. • 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. oF) [see USP Controlled Room Temperature]. 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, Streptococcus agalactiae, viridans group streptococci, This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. [see DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. 6.1). If an allergic reaction to meropenem occurs, discontinue the drug immediately. Clinical Pharmacology (12.3), 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. 8 hours (maximum dose is 2 grams every 8 hours), depending on the type of infection (cSSSI, cIAI, intra-abdominal infection or meningitis). There was no evidence of mutagenic potential found in any of these tests. & Articles, All Dosage and Administration (2.2), The solution varies from colorless to yellow depending on the concentration. 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 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). Listeria monocytogenes, against which lethal activity is not observed. <10 one-half unit dose every 24 hours Meropenem is cleared by haemodialysis. [see injection or infusion Meronem 500 mg 1000 mg Active ingredient: Meropenem trihydrate 570 mg 1140 mg equivalent to anhydrous meropenem 500 mg 1000 mg 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). View Labeling Archives, Table 10: Efficacy rates by Pathogen in the Clinically Evaluable Population with Bacterial Meningitis. Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. Administer meropenem for injection as an intravenous infusion over approximately 15 minutes to 30 minutes or as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes. 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. Meropenem Injection 500MG Meropenem is used to treat severe infections of the skin or stomach. 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. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. 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). Symptomatic treatments should be considered. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. 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). 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. oC to 25 (. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. Co-administration of probenecid with meropenem is not recommended. Meropenem is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. The meropenem group had a statistically higher number of patients with transient elevation of liver enzymes. Meropenem has been shown to be active against most isolates of the following microorganisms, both The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. 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. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8). 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 content and pH values before and after storage at 32°C for 24 hours in different buffered diluents are shown in table 1. (2.3), Pediatric patients less than 3 months of age, Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-Abdominal Infections and Normal Renal Function (2.3), Infants less than 32 weeks GA and PNA less than 2 weeks, Infants less than 32 weeks GA and PNA 2 weeks and older, Infants 32 weeks and older GA and PNA less than 2 weeks, Infants 32 weeks and older GA and PNA 2 weeks and older. Glanders and melioidosis: Use of meropenem in humans is based on in vitro B.mallei and B. pseudomallei susceptibility data and on limited human data. The following 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. (, Known hypersensitivity to product components or anaphylactic reactions to β-lactams. [see 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. Clinical Pharmacology (12.3), 1. [see 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. (8.6), Dosage adjustment is necessary in patients with creatinine clearance 50 mL/min or less Doses of 1 gram may also be administered as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes. 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. 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. Vomiting and pseudomembranous colitis – consider alternate antibiotic. o to 77 Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby. 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. 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. 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. Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. RxNorm, After infusion over 5 minutes Cmax values are 52 and 112 µg/ml after 500 and 1000 mg doses respectively. The following These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. 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. Streptococcus pneumoniae (penicillin-susceptible isolates only) Withdraw 20 mL of 0.9% Sodium Chloride Injection from an infusion bag and constitute each vial. Detailed Meropenem dosage information for adults and children. - There is no experience in pediatric patients with renal impairment. 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. In children, the dosage is also based on age and weight. What is the dosage for meropenem injection? MEROPENEM (injection, powder, for solution) comes in different strengths and amounts. Use half normal dose every 24 hours if eGFR less than 10 mL/minute/1.73 m 2. Healthcare professionals are asked to report any suspected adverse reactions the National reporting system listed below. 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. Distributed by Civica, Inc., Lehi, Utah 84043, Manufactured by Savior Lifetec Corporation, 4F, No. Table 6: Meropenem Pharmacokinetic Parameters in Patients Less Than 3 Months of Age, Escherichia coli and Pseudomonas aeruginosa, All Drug 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. Freshly prepared solutions of meropenem for injection should be used. 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 not be mixed with or physically added to solutions containing other drugs. - Intravenous infusion is to be given over 30 minutes. 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. They are for use only for organisms that do not have specific breakpoints. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. Continue typing to refine. Severe hypersensitivity (e.g anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. 1 may be used to estimate creatinine clearance. Patients who are hypersensitive to penicillins may also be hypersensitive to meropenem. Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of 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. Diminished renal function and central nervous system lesions may increase the risk of seizures. 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 %). Bacterial resistance to meropenem may result from: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins) (2) reduced affinity of the target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyse carbapenems. Each vial contains meropenem equivalent to 500 mg of meropenem activity. [see Meropenem binds to PBPs 2, 3 and 4 of Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding-protein (PBP) targets. Vial for I.V. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. Indications and Usage (1.2), Reconstitution procedure. Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients, Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6).
2020 meropenem injection dose