Instructions for use MEROPENEM-TF
Meropenem-TF is administered only intravenously.
The dosage regimen and duration of therapy are determined depending on the type and severity of the infection, the sensitivity of the pathogenic microorganism and the patient's condition.
When treating various types of infections, such as nosocomial infections caused by Acinetobacter spp. and Pseudomonas aeruginosa
- up to 2 g IV 3 times/day for
adults
and 40 mg/kg body weight IV 3 times/day for
children
.
For adults
The following daily doses are recommended.
In the treatment of pneumonia, complicated urinary tract infections, complicated abdominal infections, postpartum infections, skin and soft tissue infections
- 500 mg or 1 g IV every 8 hours.
In the treatment of hospital-acquired pneumonia, peritonitis, suspected bacterial infection in patients with neutropenia
- 1 g IV every 8 hours.
In the treatment of meningitis and bronchopulmonary infections in cystic fibrosis
- 2 g IV every 8 hours.
In patients with impaired renal function
The dose is adjusted depending on QC:
- with CC 26-50 ml/min - 500 mg-1 g 2 times/day;
- 10-25 ml/min - 250-500 mg 2 times/day;
- less than 10 ml/min - 250-500 mg 1 time/day.
Meropenem-TF is eliminated by hemodialysis and hemofiltration, therefore, if continued treatment is required, it is recommended that a unit dose (determined depending on the type and severity of infection) be administered at the end of the hemodialysis procedure to restore effective plasma concentrations. There is no experience with the use of Meropenem-TF in patients undergoing peritoneal dialysis.
In elderly patients
with normal renal function or CC more than 50 ml/min and with
liver failure
no dose adjustment is required.
For children aged 3 months to 12 years
The recommended dose for intravenous administration is 10-20 mg/kg every 8 hours, depending on the type and severity of the infection, the sensitivity of the pathogenic microorganism and the patient's condition.
For meningitis,
the recommended dose is 40 mg/kg every 8 hours.
In children weighing more than 50 kg
The same doses should be used as in adults.
Rules for preparing and administering the solution
Meropenem-TF should be administered as an IV bolus injection over 5 minutes, having previously dissolved the contents of the bottle at the rate of 5 ml of solvent for every 250 mg of the drug, or as a drip infusion over 15-30 minutes, having previously dissolved the contents of the bottle in 50 -250 ml of solvent. The solvent used is sterile water for injection or a compatible infusion fluid (0.9% sodium chloride solution, 5% or 10% glucose solution, 0.9% sodium chloride solution with 5% glucose solution, 2.5% or 10% mannitol solution). Meropenem-TF should not be mixed with solutions containing other drugs.
When diluting the drug Meropenem-TF, standard aseptic rules should be followed. The diluted solution must be shaken before use. Meropenem-TF solution should not be frozen.
Pharmacological properties of the drug Meropenem
β-lactam antibiotic of the carbapenem group for parenteral use. It has a bactericidal effect due to its effect on the synthesis of the bacterial cell membrane. It easily penetrates bacterial membranes, has a high level of resistance to the action of most β-lactamases and significant affinity for penicillin-binding proteins (PBSs), due to which it has a wide spectrum of action. Bactericidal concentrations of meropenem usually correspond to the MIC. The antibacterial spectrum of meropenem, determined in vitro , includes the majority of clinically significant gram-positive and gram-negative aerobic and anaerobic strains of bacteria, namely: Gram-positive aerobes Bacillus spp., Corynebacterium diphtheriae, Enterococcus liquifaciens, Enterococcus avium, Listeria monocytogenes, Lactobacillus spp., Nocardia asteroides , Staphylococcus aureus (penicillinase-negative and positive), staphylococcus (coagulase-negative), including Staphylococcus saprophyticus, Staphylococcus capitis, Staphylococcus cohnii, Staphylococcus xylosus, Staphylococcus warneri, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus intermedius, Staphylococcus sci uri, Staphylococcus lugdenensis, Staphylococcus pneumoniae (susceptible and resistant to penicillin), Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus equi, Streptococcus bovis, Streptococcus mitis, Streptococcus mitior, Streptococcus milleri, Streptococcus sanguis, Streptococcus viridans, Streptococcus salivarius, Streptococcus morbillor um, group G streptococci, group F streptococci, Rhodococcus equi. Gram-negative aerobes Achromobacter xylosoxidans, Acinetobacter anitratus, Acinetobacter lfwoffii, Acinetobacter baumannii, Aeromonas hydrophila, Aeromonas sorbria, Aeromonas caviae, Alcaligenes faecalis, Bordetella bronchiseptica, Brucella melitensis, Campylobacter coli, Campylobacter jejuni, Citrobacter freundii, Citrobacter diver sus, Citrobacter koseri, Citrobacter amalonaticus, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter sakazakii, Escherichia coli, Escherichia hermannii, Gardnerella vaginalis, Haemophilus influenzae (including beta-lactamase-positive and ampicillin-resistant strains), Haemophilus parainfiuenzae, Haemophilus ducreyi, Helicobacter pylori, Neisseria meningiti dis, Neisseria gonorrhoeae (including beta-lactamase-positive strains and resistant to penicillin and spectinomycin) Hafnia alvei, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella ozaenae, Klebsiella oxytoca, Moraxella (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Proteus penneri, Provide ncia rettgeri, Providencia stuartii, Providencia alcalifaciens, Pasteurella multocida, Plesiomonas shigelloides, Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas alcaligenes, Pseudomonas cepacia, Pseudomonas fluorescens, Pseudomonas stutzeri, Pseudomonas pseudomallei, Pseu domonas acidovorans, Salmonella spp. including S. enteritidis and S. typhi, Serratia marcescens, Serratia liquefaciens, Serratia rubidaea, Shigella sonnei, Shigella flexneri, Shigella boydii, Shigella dysenteriae, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica. Anaerobic bacteria Actinomyces odontolyticus, Actinomyces meyeri, Porphyromonas spp., Bacteroides fragilis, Bacteroides vulgatus, Bacteroides variabilis, Bacteroides pneumosintes, Bacteroides coagulans, Bacteroides uniformis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiota omicron, Bacteroides eggerthii, Bacteroides capsillosis, Bacteroides buccalis, Bacteroides corporis , Bacteroides gracilis, Prevotella melaninogenica, Prevotella intermedia, Prevotella bivi, Prevotella splanchnicus, Prevotella oralis, Prevotella disiens, Prevotella rumenicola, Prevotella urealyticus, Prevotella oris, Prevotella buccae, Prevotella denticolf, Prevotella levii, Porphyromonas asac charolyticus, Bifidobacterium spp., Bilophilia wadsworthia, Clostridium perfringens, Clostridium bitermentans, Clostridium ramosum, Clostridium sporogenes, Clostridium cadaveris, Clostridium sordellii, Clostridium butyricitum, Clostridium clostridiiformis, Clostridium innocuum, Clostridium subterminale, Clostridium tertium, Eubacterium lentum, Eubacterium aerofaciens, Fusobacterium mort iferum, Fusobacterium necrophorum, Fusobacterium nucleatum, Fusobacterium varium , Mobiluncus curtisii, Mobiluncus mulieris, Peptostreptococcus anaerobius, Peptostreptococcus micros, Peptostreptococcus saccharolyticus, Peptococcus saccharolyticus, Peptostreptococcus asaccharolyticus, Peptococcus magnus, Peptococcus prevotii, Propionibacterium acnes, Propionibacterium avidium , Propionibacterium granulosum, Xanthomonas maltophilia, Enterococcus faecium and methicillin-resistant staphylococci were resistant to meropenem . In patients with normal renal function, the half-life of meropenem with intravenous administration is about 60 minutes, with intramuscular administration it is 90 minutes. The bioavailability of meropenem with intramuscular administration is about 93.8%. Plasma protein binding - 2%. Approximately 70% of meropenem administered intravenously is excreted unchanged in the urine within 12 hours, after which further urinary excretion is negligible. The only metabolite of meropenem does not have antibacterial activity. Meropenem penetrates well into most tissues and body fluids, including the CSF of patients with bacterial meningitis, reaching concentrations exceeding the MIC for most bacteria. The pharmacokinetics of meropenem in children is the same as in adults. The half-life of meropenem in children under 2 years of age is approximately 1.5–2.3 hours, with linear pharmacokinetics observed over the dose range of 10–40 mg/kg. In elderly patients, the clearance of meropenem is reduced, and there is a correlation with the decrease in creatinine clearance associated with age. Meropenem clearance in patients with renal failure correlates with creatinine clearance. In such patients, dose adjustment is necessary. The pharmacokinetics of meropenem in patients with liver disease does not change.
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Indications for use of the drug Meropenem
Infections in children and adults caused by one or more pathogens sensitive to meropenem: IV: pneumonia, including hospital-acquired, urinary tract infections, abdominal infections, gynecological infections (endometritis) and pelvic infections, skin and soft tissue infections, meningitis, septicemia, empirical therapy for suspected bacterial infection in adult patients with episodes of fever associated with neutropenia. IM: chronic bronchitis of bacterial etiology in the acute phase, uncomplicated urinary tract infections. Meropenem is effective as monotherapy or in combination with antiviral or antifungal drugs in the treatment of polymicrobial infections. There is no experience of use in pediatric practice in patients with neutropenia, primary or secondary immunodeficiency.
Meropenem drug interactions
Meropenem is compatible with the following infusion media: 0.9% sodium chloride solution, 5% or 10% glucose solution, 5% glucose solution with 0.02% sodium bicarbonate, 0.9% sodium chloride solution with 5% glucose, 5% glucose solution with 0.225% sodium chloride, 5% glucose solution with 0.15% potassium chloride, manitol solution 2.5% and 10% for IV infusion. Meropenem should not be mixed with solutions containing other drugs. Caution should be exercised when meropenem is co-administered with potentially nephrotoxic drugs. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of the latter, increasing its half-life and plasma concentration. Given the high efficiency and sufficient duration of action of meropenem without the addition of probenecid, co-administration of probenecid with meropenem is not recommended. The possible effect of meropenem on the plasma protein binding of other drugs has not been studied. However, since the plasma protein binding of meropenem is low (about 2%), it can be assumed that there should be no clinically significant effect on the binding of other drugs.
Side effects of the drug Meropenem
Rash, urticaria, itching, abdominal pain, nausea, vomiting, diarrhea, reversible thrombocythemia, eosinophilia, thrombocytopenia and neutropenia, in some patients a positive direct or indirect Coombs test is possible, a reversible increase in bilirubin levels and transaminase activity, alkaline phosphatase and LDH in serum, headache, paresthesia, candidiasis of the oral cavity and vagina. With intravenous injection, thrombophlebitis, pain and inflammation at the injection site are possible; with IM - a feeling of discomfort, less often - pain and inflammation, as well as tissue damage at the injection site with a concomitant increase in CPK levels.