Treatment of infections in adults and children over 3 months: pneumonia, including community-acquired and nosocomial pneumonia; lung infections and bronchitis in the course of cystic fibrosis; complicated urinary tract infections; complicated abdominal infections; intestinal and postnatal infections; complicated skin and soft tissue infections; acute bacterial meningitis. It can be used to treat febrile neutropenic patients who are suspected of having a bacterial infection. The official guidelines for the correct use of antibacterial drugs should be taken into account.
Composition:
1 vial contains 500 mg meropenem as trihydrate and 104 mg sodium carbonate equivalent to 2 mEq sodium, ie 45 mg. 1 vial contains 1 g of meropenem as trihydrate and 208 mg of sodium carbonate equivalent to 4 mEq of sodium, i.e. 90 mg.
Action:
Β-lactam antibiotic from the carbapenem group. Meropenem works on Gram-positive bacteria (incl.Staphylococcus aureus (sensitive to methicillin),Staphylococcus spp.(sensitive to methicillin), inclS. epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae, groupStreptococcus milleri (S.anginosus, S.constellatus andS.intermedius), Streptococcus pyogenes, Enterococcus faecalis), Gram-negative bacteria (incl.Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morgani, Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) and anaerobic bacteria (incl.Clostridium perfringens, Peptoniphilus asaccharolyticus, Peptostreptococcus spp. includingP. micros, P. anaerobius, P. magnus, Bacteroides caccae, groupBacteroides fragilis, Prevotella bivia, Prevotella disiens). Species that may experience the problem of acquired resistance:Enterococcus faecium, Acinetobacter spp., Burkholderia cepacia, Pseudomonas aeruginosa. Organisms with congenital resistance: Stenotrophomonas maltophilia, Legionella spp., Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetii, Mycoplasma pneumoniae. Meropenem binds to approximately 2% of plasma proteins. The drug penetrates well into most tissues and body fluids (including inflamed cerebrospinal fluid), reaching therapeutic concentrations. It is partially metabolized in the liver to a microbiologically inactive metabolite. Approximately 70% of the dose is excreted in the urine in unchanged form within 12 hours, 2% of the dose is excreted via faeces. T0,5 in the blood is about 1 hour. T0,5 in children <6 months is 1.6 hours. Impaired renal function causes an increase in plasma AUC and an increase in the half-life of meropenem. The drug is removed by hemodialysis, and the clearance during hemodialysis is about 4 times higher than in anuric patients.
Contraindications:
Hypersensitivity to meropenem, other carbapenems or other ingredients of the preparation. Severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to β-lactam antibiotics (eg penicillin or cephalosporins).
Precautions:
If you experience a severe allergic reaction during treatment, stop taking the medicine and take appropriate measures. In any patient who has experienced diarrhea after antibiotic use, the possibility of pseudomembranous colitis should be considered - if the disease is diagnosed, the drugs that inhibit intestinal motility should not be administered. The preparation contains sodium - this should be taken into account in patients who control the sodium content of the diet.
Pregnancy and lactation:
Avoid taking the drug during pregnancy. Animal studies do not show direct or indirect harmful effects on reproduction. Small concentrations of meropenem in the milk of lactating animals were detected. You should decide to stop breast-feeding or stop treatment.
Side effects:
Common: thrombocytemia, headache, diarrhea, vomiting, nausea, abdominal pain, rash, pruritus, inflammation or pain at the injection site, elevation of transaminases, alkaline phosphatase, lactate dehydrogenase in the blood.Uncommon: oral and vaginal yeast, eosinophilia, thrombocytopenia, leukopenia, neutropenia, paresthesia, urticaria, increased bilirubin, creatinine and urea in the blood, venous thromboembolism. Rare: convulsions. In addition, agranulocytosis, haemolytic anemia, enteritis, angioneurotic edema, anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme were observed.
Dosage:
Intravenously.Adults and adolescents. Pneumonia, including community-acquired and nosocomial pneumonia; complicated urinary tract infections; complicated abdominal infections; intestinal and postnatal infections; complicated skin and soft tissue infections: 500 mg or 1 g every 8 hours. Cystic and bronchitis infections in cystic fibrosis; acute bacterial meningitis: 2 g every 8 h. Treatment of fever patients with neutropenia: 1 g every 8 h. Patients with impaired renal function, creatinine clearance 26-50 ml / min: 1 unit dose every 12 h; 10-25 ml / min: 1/2 unit dose every 12 hours; <10 ml / min: 1/2 unit dose every 24 hours. In patients undergoing hemodialysis, the appropriate dose should be administered after completion of the hemodialysis cycle. Dosing recommendations have not been established in patients undergoing peritoneal dialysis. In patients with hepatic and elderly dysfunction, no dosage adjustment is necessary.Children from 3 months to 11 years, about up to 50 kg. Pneumonia, including community-acquired and nosocomial pneumonia, complicated urinary tract infections, complicated abdominal infections, complicated skin and soft tissue infections: 10 or 20 mg / kg. every 8 hours. Cystic and bronchitis infections with cystic fibrosis, acute bacterial meningitis: 40 mg / kg every 8 hours. Treatment of febrile neutropenic patients: 20 mg / kg. every 8 hours. For children weighing> 50 kg, give the dose as for an adult. Efficacy and safety of meropenem in children under 3 months they have not been set or an optimal dosing schedule has been established for them. Limited pharmacokinetic data indicate that the appropriate dosing schedule may be 20 mg / kg meropenem. every 8 hours. The drug is usually administered as an intravenous infusion over approximately 15-30 minutes. Alternatively, doses up to 1 g in adults and adolescents or 20 mg / kg in children, it can be given by intravenous injection, lasting about 5 minutes. For the treatment of certain infections, such as nosocomial infections caused byPseudomonas aeruginosa orAcinetobacter spp., it may be particularly advisable to use a dose of 2 g 3 times daily in adults and adolescents, and a dose of up to 40 mg / kg. 3 times a day for children.