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Manufacturers: Sanjivani Parenteral
Active ingredients
- Meropenem
Disease class
- Pneumonia without specifying the pathogen
- Impetigo
- Peritonitis
- Local infection of skin and subcutaneous tissue, unspecified
- Infectious dermatitis
- Soft tissue disease, unspecified
- Septicemia, unspecified
- Bacterial infection of unspecified localization
- Urinary tract infection without established localization
- Inflammatory disease of the uterus, other than the cervix
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Broad spectrum antibacterial action
- Bactericidal
Pharmacological group
- Carbapenems
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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.
Meropenem por d/ra fl 1g N1 (Pharmguide)
Pharmacodynamics. An antibiotic from the carbapenem group, intended for parenteral use. It has a bactericidal effect by inhibiting the synthesis of bacterial cell walls. The bactericidal effect of meropenem against a wide range of aerobic and anaerobic bacteria is explained by the high ability of meropenem to penetrate the bacterial cell wall, its high level of stability towards most beta-lactamases and its significant affinity for penicillin-binding proteins. Interacts with receptors - specific penicillin-binding proteins on the surface of the cytoplasmic membrane, inhibits the synthesis of the peptidoglycan layer of the cell wall (due to structural similarity), inhibits transpeptidase, promotes the release of autolytic enzymes of the cell wall, which ultimately causes its damage and death of bacteria. Bactericidal and bacteriostatic concentrations are practically the same. Spectrum of activity. Gram-positive aerobes. Enterococcus faecalis (including vancomycin-resistant strains), Staphylococcus aureus (penicillinase-non-producing and penicillinase-producing [methicillin-sensitive]); Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive only); Streptococcus pyogenes, Streptococcus spp. viridans group. Gram-negative aerobes. Escherichia coli, Haemophilus influenzae (non-penicillinase-producing and penicillinase-producing), Klebsiella pneumoniae, Neisseria meningitidis, Pseudomonas aeruginosa, Proteus mirabilis. Anaerobic bacteria. Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus spp. Meropenem is effective against the following microorganisms in vitro, but its clinical effectiveness against diseases caused by these pathogens has not been proven: Gram-positive aerobes. Staphylococcus epidermidis (penicillinase-non-producing and penicillinase-producing [methicillin-sensitive]). Gram-negative aerobes. Acinetobacter spp., Aeromonas hydrophila, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Haemophilus influenzae (ampicillin-resistant, penicillinase-non-producing strains), Hafiiia alvei, Klebsiella oxytoca, Moraxella catarrhalis (penicillinase-non-producing and penicillinase-producing strains) citating), Morganella morganii, Pasteurella multocida, Proteus vulgaris, Salmonella spp., Serratia marcescens, Shigella spp., Yersinia enterocolitica. Anaerobic bacteria. Bacteroides distasonis, Bacteroides ovatus, Bacteroides uniformis, Bacteroides ureolyticus, Bacteroides vulgatus, Clostridium difficile, Clostridium perfringens, Eubacterium lentum, Fusobacterium spp., Prevotella bivia, Prevotella intermedia, Prevotella melaninogenica, Porphyromonas asaccharolytica, Propionibacter ium acnes. Pharmacokinetics. With intravenous administration of 250 mg over 30 minutes, the maximum concentration (Cmax) is 11 μg/ml, for a dose of 500 mg - 23 μg/ml, for a dose of 1 g - 49 μg/ml. When the dose is increased from 250 mg to 2 g, the clearance of meropenem decreases from 287 to 205 ml/min. When administered intravenously as a bolus over 5 minutes, 500 mg of meropenem Cmax is 52 μg/ml, 1 g -112 μg/ml. Communication with blood plasma proteins - 2%. Penetrates well into most tissues and body fluids, incl. into the cerebrospinal fluid of patients with bacterial meningitis, reaching concentrations exceeding those required to suppress most bacteria (bactericidal concentrations are created 0.5-1.5 hours after the start of the infusion). Passes into breast milk in small quantities. Subjects to minor metabolism in the liver with the formation of a single microbiologically inactive metabolite. The half-life is 1 hour, in children under 2 years of age - 1.5 - 2.3 hours. The pharmacokinetics of meropenem in children and adults is similar; in the dose range of 10-40 mg/kg, a linear dependence of the pharmacokinetic parameters is observed. Does not accumulate. Excreted by the kidneys - 70% unchanged within 12 hours. The concentration of meropenem in the urine exceeding 10 mcg/ml is maintained for 5 hours after administration of 500 mg. In patients with renal failure, meropenem clearance correlates with creatinine clearance. In such patients, dose adjustment is necessary. In elderly patients, the decrease in meropenem clearance correlates with an age-related decrease in creatinine clearance. The half-life is 1.5 hours. Meropenem is eliminated by hemodialysis.
MEROPENEM
Pharmacokinetics
After an intravenous (IV) 30-minute infusion in doses of 0.5 g and 1 g, maximum serum concentrations (Cmax) are reached at the end of administration and are 23 μg/ml and 49 μg/ml, respectively (absolute pharmacokinetic proportional to the administered dose for Cmax and area under the concentration-time curve (AUC) no).
When the dose is increased from 0.25 g to 2 g, plasma clearance decreases from 287 to 205 ml/min. When administered intravenously as a bolus over 5 minutes, 0.5 g and 1 g Cmax are 52 mcg/ml and 112 mcg/ml, respectively. Already 6 hours after intravenous administration of 0.5 g, the concentration of meronem in the blood plasma decreases to values of 1 μg/ml and below. Plasma protein binding is approximately 2%.
Extended (up to 3 hours) infusion of carbapenems (including meropenem) can lead to optimization of their pharmacokinetic and pharmacodynamic parameters. In a standard 30-minute infusion into healthy volunteers of two doses of 0.5 g and 2 g every 8 hours, the %T>MIC value (the ratio between the period of time when the drug concentration exceeds the minimum inhibitory concentration for susceptible microorganisms (MIC) and the dosing interval; for The MIC (accepted value of 4 µg/ml) was 30% and 58%, respectively. When the same doses were administered by 5-hour infusion every 8 hours, the %T>MIC increased to 43% and 73%, respectively, for 0.5 g and 2 g. The average plasma concentration in healthy volunteers after an intravenous bolus of 1 g of meropenem in within 10 minutes exceeded the MIC = 4 μg/ml for 42% of the dosing interval, but compared with 59% for a 3-hour infusion of the same dose of the drug.
Meropenem penetrates well into most tissues and body fluids, incl. into the cerebrospinal fluid of patients with bacterial meningitis, reaching concentrations higher than those required to inhibit most susceptible bacteria. With repeated administration of meropenem at intervals of 8 hours to patients with normal renal function, no accumulation of the drug is observed. In patients with normal renal function, the half-life is approximately 1 hour.
About 70% of the administered dose is excreted unchanged by the kidneys within 12 hours, after which insignificant renal excretion is determined. Meropenem concentrations in urine exceeding 10 mcg/ml are maintained for 5 hours after administration of 0.5 g of the drug. With administration regimens of 0.5 g every 8 hours or 1 g every 6 hours, no accumulation of meropenem in the blood plasma or urine was observed in volunteers with normal liver function.
The only metabolite of meropenem is microbiologically inactive.
Studies have shown that the pharmacokinetics of meropenem in children and adults are similar. The half-life of meropenem in children under 2 years of age is approximately 1.5-2.3 hours, with a linear relationship observed in the dose range of 10-40 mg/kg.
Kidney failure.
In patients with renal insufficiency, meropenem clearance correlates with creatinine clearance (CC), therefore dose adjustment and dosage interval are necessary.
In older people
a decrease in meropenem clearance correlates with an age-related decrease in creatinine clearance. Meropenem is eliminated by hemodialysis.
Liver failure.
Liver disease does not affect the pharmacokinetics of meropenem.
Meropenem
Antibiotic for parenteral use from the carabapenem group. It has a bactericidal effect (inhibits the synthesis of the bacterial cell wall), easily penetrates the bacterial cell wall, and is resistant to the action of most beta-lactamases.
Unlike imipenem, it is practically not destroyed in the renal tubules by dehydropeptidase-1 (does not need to be combined with cilastatin, a specific inhibitor of dehydropeptidase-1) and, accordingly, no nephrotoxic breakdown products are formed, and has a high affinity for penicillin-binding proteins.
Bactericidal and bacteriostatic concentrations are practically the same.
Interacts with receptors - specific penicillin-binding proteins on the surface of the cytoplasmic membrane, inhibits the synthesis of the peptidoglycan layer of the cell wall, inhibits transpeptidase, promotes the release of autolytic enzymes of the cell wall, which ultimately causes its damage and death of bacteria.
The spectrum of antibacterial activity of meropenem includes the majority of clinically significant gram-positive and gram-negative aerobic and anaerobic strains of bacteria:
Gram-positive aerobes:
Enterococcus faecalis (including vancomycin-resistant strains); Staphylococcus aureus (penicillinase-non-producing and penicillinase-producing [methicillin-sensitive]): Streptococcus agalactiae; Streptococcus pneumoniae (penicillin-sensitive only); Streptococcus pyogenes; Streptococcus spp. viridans group.
Gram-negative aerobes:
Escherichia coli; Haemophilus influenza (penicillinase-non-producing and penicillinase-producing); Klebsiella pneumoniae; Neisseria meningitidis; Pseudomonas aeruginosa; Proteus mirabilis.
Anaerobic bacteria:
Bacteroides fragilis; Bacteroides thetaiotaomicron; Peptostreptococcus spp.
Meropenem is effective in vitro against the following microorganisms, however, its clinical effectiveness against diseases caused by these pathogens has not been proven:
Gram-positive aerobes:
Staphylococcus epidermidis (penicillinase-non-producing and penicillinase-producing | methicillin-sensitive]).
Gram-negative aerobes:
Acinetobacter spp.; Aeromonas hydrophila; Campylobacter jejuni; Citrobacter diversus; Citrobacter freundii; Enterobacter cloacae; Haemophilus influenzae (ampicillin-resistant, penicillinzone-non-producing strains); Hafnia alvei; Klebsiella oxytoca; Moraxella catarrhalis (penicillinase-non-producing and penicillinase-producing); Morganella morganii; Pasteurella multocida; Proteus vulgaris; Salmonella spp.; Serratia marcescens; Shigella spp.; Yersinia enterocolitica.
Anaerobic bacteria:
Bacteroides distasonis; Bacteroides ovatus; Bacteroides uniformis; Bacteroides ureolyticus; Bacteroides vulgatus; Clostridium difficile; Clostridium perfringens; Eubacterium lentum; Fusobacterium spp.; Prevotella bivia; Prevotella intermedia; Prevotella melaninogenica; Porphyromonas asaccharolytica; Propionibacterium acnes.
