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Meropenem-sanita

Meropenem-sanita

International Nonproprietary Name:

Meropenem

Pharmaceutical form:

Powder for injection solution
  • Properties

    An antibiotic from the carbapenem group for parenteral use, resistant to human dehydropeptidase-1 (DHP-1), does not require additional administration of a DHP-1 inhibitor. Meropenem has a bactericidal effect due to the effect on the synthesis of the bacterial cell wall. The powerful bactericidal effect of meropenem against a wide range of aerobic and anaerobic bacteria is explained by the high penetration ability of bacteria across the cell wall, a high level of resistance to most β-lactamases, and a significant affinity for penicillin-binding proteins (TFD). The minimum bactericidal concentrations (MMC) are usually the same as the minimum inhibitory concentrations (MICs). For 76% of the tested bacterial species, the ratio of MMC / MIC was 2 or less. The spectrum of antibacterial activity of meropenem, determined in vitro, includes virtually all clinically relevant Gram-positive and Gram-negative, aerobic and anaerobic microorganisms.

    Gram-positive aerobic bacteria: Bacillus spp., Corynebacterium diphtheriae, Enterococcus faecalis, Lactobacillus spp., Staphylococcus aureus (strains producing and not producing penicillinase), coagulase-negative staphylococci, incl. Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus intermedius, Streptococcus pneumoniae (sensitive and resistant to penicillin), Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus bovis, Streptococcus viridansi.

    Gram-negative aerobic bacteria: Acinetobacter baumannii, Campylobacter coli, Campylobacter jejuni, Citrobacter freundii, Citrobacter diversus, Enterobacter aerobes, Escherichia coli, Haemophilus influenzae (including strains producing β-lactamases and ampicillin-resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Neisseria gonorrhoeae (including strains , Producing β-lactamases, and resistant to penicillin and spectinomycin), Klebsiella pneumoniae, Klebsiella aerogenes, Moraxella catarrhalis, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Salmonella spp. Vibrio cholerae

    Anaerobic bacteria:  Bacteroides fragilis, Bacteroides coagulans, Bacteroides uniformis, Clostridium perfringens, Clostridium sporogenes, Clostridium innocuum, Fusobacter ium mor tiferum, Fusobacterium varium, Peptostreptococcus anaerobius, Peptostreptococcus micros, Peptococcus saccharolyticus, Propionibacterium acnes, Propionibacterium avidum.

    Stenotrophomonas maltophilia, Enterococcus faecium and methicillin-resistant staphylococci are stable to the drug.

     

    Pharmacokinetics

    Intravenous administration of 30 mg of a single dose of meropenem to healthy volunteers leads to a peak of plasma concentration of approximately 23 μg / ml for a dose of 500 mg and 49 μg / ml for a dose of 1 g.

    After 6 hours after intravenous administration of 500 mg, the level of meropenem in the blood plasma is reduced to 1 μg / ml or less. With repeated administration of meropenem with an interval of 8 hours, accumulation of the drug does not observe in patients with normal renal function.  Patients with normal renal function, the elimination half-life is approximately 1 hour. Binding with plasma proteins approximately 2% meropenem penetrates well into most tissues and body fluids. Including the cerebrospinal fluid of bacterial meningitis patients, reaching concentrations exceeding those required for the suppression of most bacteria. Studies of children have shown that the pharmacokinetics of meropenem are similar between children and adults. The half-life of meropenem in children from 3 months to 2 years is approximately 1.5 hours, a linear dependence is observed in the dose range of 10-40 mg / kg.

    In patients with impaired kidney function, clearance of meropenem correlates with creatinine clearance. For such patients, dose adjustment is necessary. As for elderly patients, the decrease of the clearance of meropenem correlates with the age-related decrease in creatinine clearance.

    Researches of pharmacokinetics in patients with hepatic disorders have shown that these pathological changes do not affect the pharmacokinetics of meropenem.   

  • Indications

    Meropenem is indicated for the treatment of adults and children, with the following infections caused by one or more pathogens that are sensitive to meropenem.

    • Sepsis;

    • Intra-abdominal infections (including complicated appendicitis, peritonitis, pelvioperitonitis);

    • Gynecological infections (including endometritis);

    • Infections of the skin and soft tissues (including erysipelas, impetigo, secondarily infected dermatoses);

    • Bacterial meningitis;

    • Infections of the lower respiratory tract (including pneumonia, including hospital ones);

    • Infections of the urinoexcretory system (including pyelonephritis, pyelitis);

    • Empirical treatment (in the form of monotherapy or in combination with antiviral or antifungal drugs) with suspected infection in adult patients with febrile neutropenia.

    Meropenem is used as a monotherapy or in combination with other antimicrobial medicines in the treatment of polymicrobial infections.    Intravenous use Meropenem in the form of monotherapy or in combination with other antibacterial agents effectively acts on patients with cystic fibrosis and chronic infections of the lower respiratory tract. 

  • Contraindications
    Hypersensitivity to meropenem and other beta-lactam antibiotics.
  • Dosage and Administration

    Adults: Dosage and duration of therapy are determined depending on the type, severity of the infection and the condition of the patient. The recommended daily dose is:

    Treatment of pneumonia, including nosocomial - 500 mg every 8 hours intravenously.

    Treatment of patients with septicemia - 500 mg every 8 hours intravenously.

    Treatment of gynecological infections, such as endometritis - 500 mg every 8 hours intravenously.

    Treatment of skin and soft tissue infections - 500 mg every 8 hours intravenously.

    Treatment of urinoexcretory infections - 1 g every 8 hours intravenously.

    When treating suspected infections in patients with neutropenia - 1 g every 8 hours intravenously.

    In cystic fibrosis, the recommended dose is 2 g every 8 hours intravenously.

    For bacterial meningitis, the recommended dose is 2 g every 8 hours intravenously.

    Dosage for adult patients with impaired renal function:

    In patients with a creatinine clearance below 51 ml / min, the dose should be reduced as follows:

     


    Creatinine clearance (ml / min)

    The dose (based on a unit dose of 500 mg, 1 g, 2 g)

    Frequency of use

     

    26-50

    One dose unit

    Every 12 hours

    10-25

    Half dose Unit

    Every 12 hours

    < 10

    Half dose Unit

    Every 24 hours


     

    Meropenem is excreted with hemodialysis; If prolonged treatment is needed, it is recommended to administer a dose unit (depending on the type and severity of the infection) after completion of the hemodialysis procedure to restore therapeutically effective plasma concentrations.

    There is no experience in using of meropenem in patients on peritoneal dialysis.

    Patients with impaired kidney function dose Correction of the dose is not required.

    Elder patients:  For elder patients with normal renal function or creatinine clearance above 50 ml / min, dose adjustment is not required.

    Children: For children aged 3 months to 12 years, the recommended dose is 10-20 mg / kg every 8 hours, depending on the type and severity of the infection, the sensitivity of the pathogen and the patient's condition Children with a body weight of more than 50 kg should use adults dose. For children aged 4 to 18 years with cystic fibrosis, as well as for the treatment of exacerbation of chronic lower respiratory infections, doses ranging from 25-40 mg / kg every 8 hours are used. With meningitis, the recommended dose is 40 mg / kg every 8 hours. Using meropenem in children with renal insufficiency is not experienced.

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  • Drug form

    Powder for injection solution.