Meronem - description of the drug, instructions for use, reviews

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Manufacturers: Sumitomo Pharmaceuticals Co. Ltd

Active ingredients

• Meropenem

Disease class

• Bacterial meningitis, not elsewhere classified
• Pneumonia without specifying the pathogen
• Peritonitis
• Local infection of skin and subcutaneous tissue, unspecified
• Detection of other specified substances not normally present in the blood
• Meningococcal infection
• 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

• Antibacterial

Pharmacological group

• Carbapenems

Lyophilisate for the preparation of solution for injection Meronem

Instructions for medical use of the drug

Description of pharmacological action

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 with D-alanine-D-alanine, inhibits transpeptidase and inhibits the formation of cross-links between peptidoglycan chains) and promotes the release of autolytic enzymes of the cell wall, which causes damage and death of bacteria.

Indications for use

Meronem is indicated for the treatment in children (over 3 months) and adults of the following infectious and inflammatory diseases caused by one or more pathogens sensitive to meropenem: - pneumonia, including nosocomial pneumonia; - urinary system infections; - abdominal infections; - infectious and inflammatory diseases of the pelvic organs, such as endometritis; — infections of the skin and its structures; - meningitis; - septicemia. Empirical treatment of adult patients with suspected infection and symptoms of febrile neutropenia, either alone or in combination with antiviral or antifungal drugs. The effectiveness of the drug Meronem has been proven both in monotherapy and in combination with other antimicrobial agents in the treatment of polymicrobial infections.

Release form

lyophilisate for preparing a solution for intravenous administration 0.5 g; bottle (bottle) cardboard pack 10; lyophilisate for preparing a solution for intravenous administration 1 g; bottle (bottle) cardboard pack 10;

Pharmacodynamics

The spectrum of antibacterial activity of meropenem includes the majority of clinically significant gram-positive and gram-negative aerobic and anaerobic strains of bacteria. Active (both in vitro and according to the results of clinical studies in the treatment of a number of infections) against most strains of the following microorganisms: aerobic and facultative gram-positive microorganisms - Enterococcus faecalis (except vancomycin-resistant strains), Staphylococcus aureus (beta-lactamase-producing and beta-lactamase-non-producing , methicillin-sensitive strains only), Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive strains only), Streptococcus pyogenes, Streptococcus viridans; aerobic and facultative gram-negative microorganisms - Escherichia coli, Haemophilus influenzae (including beta-lactamase-producing strains), Klebsiella pneumoniae, Neisseria meningitidis, Pseudomonas aeruginosa, Proteus mirabilis; anaerobic microorganisms - Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus spp. Meropenem is effective in vitro against the following microorganisms, but its clinical effectiveness against diseases caused by these pathogens has not been proven: aerobic and facultative gram-positive microorganisms - Staphylococcus epidermidis (including beta-lactamase-producing and non-producing, only methicillin-sensitive strains); aerobic and facultative gram-negative microorganisms - Acinetobacter spp., Aeromonas hydrophila, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Haemophilus influenzae (ampicillin-resistant, beta-lactamase-non-producing strains), Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (beta-lactamase producing and non-producing strains), 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 asaccharo lytica, Propionibacterium acnes.

Pharmacokinetics

After IV administration, depending on the dose (0.5 or 1 g) and method of application (bolus or drip), Cmax values ​​are 23 μg/ml, 45 μg/ml and 49 μg/ml, 112 μg/ml, respectively. . Binds to plasma proteins by 2%. Easily penetrates various tissues and fluids (including the spinal cord) of the body, bactericidal concentrations are created 0.5–1.5 hours after the start of the infusion. Subjects to minor biotransformation in the liver with the formation of a single metabolite (inactive). Terminal T1/2 is 1 hour. It is excreted mainly by the kidneys (more than 70% unchanged). In renal failure, clearance is directly proportional to the degree of decrease in creatinine clearance.

Use during pregnancy

Pregnancy The safety of Meronem in women during pregnancy has not been studied. Animal studies have not shown any adverse effects on the developing fetus. Meronem should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. In each case, the drug must be used under the strict supervision of a physician. Lactation Meropenem is detected in the breast milk of animals in very low concentrations. Meronem should not be used during breastfeeding, unless the potential benefit to the mother from the drug outweighs the possible risk to the baby. Having assessed the benefit for the mother, a decision should be made to stop breastfeeding or discontinue taking Meronem.

Contraindications for use

- history of hypersensitivity to meropenem or other drugs of the carbapenem group; - severe hypersensitivity (anaphylactic reactions, severe skin reactions) to any antibacterial agent having a beta-lactam structure (i.e. penicillins or cephalosporins); - children under 3 months. With caution: simultaneous use with potentially nephrotoxic drugs; patients with gastrointestinal complaints (diarrhea), especially those suffering from colitis.

Side effects

In general, meropenem is well tolerated. In rare cases, side effects led to discontinuation of therapy. Serious adverse reactions are rare. The frequency of adverse reactions is given below in the following gradation: very often (≥1/10); often (≥1/100, Hematopoietic system*: often - thrombocytosis; infrequently - eosinophilia, thrombocytopenia; rarely - leukopenia, neutropenia, agranulocytosis; very rarely - hemolytic anemia. Nervous system: infrequently - headache, paresthesia, fainting**, hallucinations **, depression**, anxiety**, increased excitability**, insomnia**; rarely - convulsions. Gastrointestinal tract: often - nausea, vomiting, diarrhea, increased activity of liver transaminases, alkaline phosphatase, LDH and bilirubin concentration in the blood serum; infrequently - constipation**, cholestatic hepatitis**; very rarely - pseudomembranous colitis. Skin and subcutaneous tissue: infrequently - rash, urticaria, pruritus; very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Immune system: very rarely - angioedema, manifestations of anaphylaxis. CVS: uncommon - heart failure**, cardiac arrest**, tachycardia**, bradycardia**, myocardial infarction**, decreased or increased blood pressure**, thromboembolism of the branches of the pulmonary artery**. Kidneys and urinary tract: uncommon - increased concentration of creatinine in the blood, increased concentration of urea in the blood. Respiratory tract: uncommon - dyspnea**. Other: often - local reactions (inflammation, thrombophlebitis, pain at the injection site); rarely - vaginal candidiasis and candidiasis of the oral mucosa. *Cases of positive direct or indirect Coombs test, as well as cases of decreased partial thromboplastin time, have been reported. **A cause-and-effect relationship with taking Meronem has not been established. Adverse effects were observed in a study of 2904 immunocompetent adult patients treated with Meronem (500 or 1000 mg every 8 hours) due to non-CNS infections. In 36 patients, therapy was discontinued due to adverse events. In 5 cases, a connection between the death and the therapy cannot be ruled out. Given the serious condition of the patients, numerous diseases and multiple concomitant therapy with other drugs, it was not possible to draw a conclusion about the connection of the side effect with therapy with Meronem.

Directions for use and doses

The method of application of Meronem (dosage and frequency of administration) is determined depending on the nature of the infection and the severity of the disease. In each specific case, this issue is resolved individually, but there are average standard dosages recommended for various nosologies: • Pneumonia (community-acquired), infections of the genitourinary system, infections of the skin and soft tissues - intravenous infusions of 0.5 g of Meronem three times a day, at regular intervals. . • Hospital-acquired pneumonia, sepsis, peritonitis, suspected infection, in patients with low immune status - intravenous infusions of 1 g of Meronem three times a day, at regular intervals. • Meningitis, cystic fibrosis, 2 g of Meronem three times a day, at regular intervals. Patients with renal pathology undergoing hemodialysis should receive an additional dose of Meronem after completion of the procedure; patients with renal failure require dose adjustment. For elderly patients and patients with liver failure, Meronem is administered in normal dosages. The dose for children is calculated depending on age and body weight. For children from the 3rd month of life to 12 years of age, the recommended dosage is from 30 to 60 mg per kg of body weight, the daily dose should be divided into 3 doses. If the child’s body weight is more than 50 kg, then Meronem, regardless of age, should be prescribed in the dosage recommended for adults. For some pathologies, children may be prescribed higher dosages. So, for meningitis, Meronem is used at a dose of 120 mg per kg of body weight, the daily dose should be divided into 3 doses. For the treatment of chronic respiratory diseases, with cystic fibrosis, the recommended dose is from 75 to 120 mg per kg of body weight, the daily dose should be divided into 3 doses. Meronem is administered intravenously using bolus injections (up to 5 minutes) or intravenous infusions (administration time up to half an hour). To prepare a solution for intravenous bolus injections, it is necessary to dilute Meronem with sterile water for injection, at the rate of 5 ml per 250 mg of Meronem, and shake the drug before administration. To prepare a solution for intravenous drip administration, you need to add 50-200 ml of 5% (10%) glucose solution or saline to Meronem. solution.

Overdose

Accidental overdose during treatment is possible, especially in patients with impaired renal function. Treatment: symptomatic. Normally, the drug is rapidly eliminated through the kidneys. In patients with impaired renal function, hemodialysis effectively removes meropenem and its metabolite.

Interactions with other drugs

The possibility of adverse effects should be considered when using Meronem concomitantly with potentially nephrotoxic drugs. Meropenem may significantly reduce valproic acid levels, which should be taken into account when using them together. Probenecid may affect the half-life of Meropenem, leading to increased concentrations.

Special instructions for use

There is no experience with the use of the drug in pediatric practice in patients with neutropenia or with primary or secondary immunodeficiency. As with other antibiotics, when meropenem is used as monotherapy in critically ill patients with known or suspected lower respiratory tract infection caused by Pseudomonas aeruginosa, regular susceptibility testing is recommended. In rare cases, when using the drug Meronem, as with the use of almost all antibiotics, the development of pseudomembranous colitis is observed, which can vary in severity from mild to life-threatening forms. It is important to remember the possibility of developing pseudomembranous colitis if diarrhea occurs while using the drug Meronem. There are clinical and laboratory signs of cross-allergic reactions between other carbapenems and beta-lactam antibiotics, penicillins and cephalosporins. There are rare reports of cases of hypersensitivity reactions (including fatal ones) when using the drug Meronem, as well as other beta-lactam antibiotics (see section “Side effects”). Before initiating meropenem therapy, the patient should be carefully interviewed, paying particular attention to any history of hypersensitivity reactions to beta-lactam antibiotics. Meronem should be used with caution in patients with a history of such phenomena. If an allergic reaction to meropenem occurs, it is necessary to stop administering the drug and take appropriate measures. The use of Meronem in patients with liver disease should be carried out under careful monitoring of transaminase activity and bilirubin concentration. As with other antibiotics, overgrowth of non-susceptible microorganisms is possible, and therefore constant monitoring of the patient is necessary. The prevalence of acquired antibiotic resistance of various pathogens may vary depending on the region and time, and it is desirable to have up-to-date information on the resistance of common pathogens in a particular region, especially when treating severe infections. If resistance is such that the effectiveness of the drug against at least some infections becomes doubtful, an expert should be consulted. It is not recommended to take Meronem and valproic acid together. The use of the drug for infections caused by methicillin-resistant staphylococcus is not recommended. Impact on the ability to drive a car and operate equipment. There have been no studies of the effect of Meronem on the ability to drive a car or use other equipment. However, it should be taken into account that headache, paresthesia and convulsions may occur when taking Meronem.

Storage conditions

List B.: At a temperature not exceeding 30 °C.

Best before date

48 months

ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01D Other beta-lactam antibiotics

J01DH Carbapenems

J01DH02 Meropenem

Meronem®

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 its effect on the synthesis of the bacterial cell wall. The potent bactericidal effect of meropenem against a wide range of aerobic and anaerobic bacteria is explained by its high ability to penetrate the bacterial cell wall, its high level of stability towards most β-lactamases and its significant affinity for penicillin binding proteins (PBPs). Minimum bactericidal concentrations (MBCs) are usually the same as minimum inhibitory concentrations (MICs). For 76% of the bacterial species tested, the MBC/MIC ratio was 2 or less.

Meropenem is stable in pathogen susceptibility tests. In vitro tests show that meropenem acts synergistically with various antibiotics. Meropenem has been shown in vitro and in vivo to have a post-antibiotic effect.

The only recommended criteria for sensitivity to meropenem are based on the pharmacokinetics of the drug and on the correlation of clinical and microbiological data - zone diameter and MIC determined for the relevant pathogens.

The spectrum of antibacterial activity of meropenem, determined in vitro, includes almost all clinically significant gram-positive and gram-negative aerobic and anaerobic microorganisms.

The drug is active against aerobic gram-positive bacteria:

Bacillus spp., Corynebacterium diphtheriae, Enterococcus liquifaciens, Enterococcus avium, Listeria monocytogenes, Lactobacillus spp., Nocardia asteroides, Staphylococcus aureus (strains producing and not producing penicillinase), coagulase-negative staphylococci, incl.
Staphylococcus saprophyticus, Staphylococcus capitis, Staphylococcus cohnii, Staphylococcus xylosus, Staphylococcus warneri, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus intermedius, Staphylococcus sciuri, Staphylococcus lugdenensis, Streptococcus pneumoniae (penicillin sensitive and resistant), Streptococcus agalact iae, Streptococcus pyogenes, Streptococcus equi, Streptococcus bovis, Streptococcus mitis, Streptococcus mitior, Streptococcus milleri, Streptococcus sanguis, Streptococcus viridans, Streptococcus salivarius, Streptococcus morbillorum, group G streptococci, group F, Rhodococcus equi; aerobic gram-negative bacteria:
Achromobacter xylosoxidans, Acinetobacter anitratus, Acinetobacter lwoffii, 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 β-lactamase-producing strains and ampicillin-resistant strains), Haemophilus parainfluenzae, Haemophilus ducreyi, Helicobacter pylori, Neisseria meningitidis, Neisseria gonorrhoeae (including strains that produce β-lactamases and are resistant to penicillin and spectinomycin), Hafnia alvei, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella ozaenae, Klebsiella oxytoca, Moraxella catarrhalis, Morganella morgannii, Proteus mirabilis, Proteus vulgaris, Proteus penneri, Providencia rettgeri, Providencia stuartii, Providencia alcalifaciens, Pasteurella multocida, Plesiomonas shigelloides, Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas alcaligenes, Pseudomonas cepacia, Pseudomonas fluorescens, Pseudomonas stutzeri, Pseudomonas pseudo mallei, Pseudomonas acidovorans, Salmonella spp., including Salmonella enteritidis, Salmonella 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, Bacteroides-Prevotella-Porphyromonas spp., Bacteroides fragilis, Bacteroides vulgatus, Bacteroides variabilis, Bacteroides pneumosintes, Bacteroides coagulans, Bacteroides uniformis, Bacteroides distasonis, Bacteroides ova tus, Bacteroides thetaiotaomicron, Bacteroides eggerthii, Bacteroides capsillosis, Prevotella buccalis, Prevotella corporis, Bacteroides gracilis, Prevotella melaninogenica, Prevotella intermedia, Prevotella bivia, Prevotella splanchnicus, Prevotella oralis, Prevotella disiens, Prevotella rumenicola, Prevotella ureolyticus, Prevotella oris, Prevotella buccae, Prevotella denticola , Prevotella levii, Porphyromonas asaccharolyticus, Bifidobacterium spp ., Bilophilia wadsworthia, Clostridium perfringens, Clostridium bifermentans, Clostridium ramosum, Clostridium sporogenes, Clostridium cadaveris, Clostridium sordellii, Clostridium butyricum, Clostridium clostridiiformis, Clostridium innocuum, Clostridium subterminale, Clostridium tertium, Eubacterium lentum, Eubacterium aerofaciens, Fusobacterium mortiferum, Fusobacterium necrophorum, Fusobacterium nucleatum, Fusobacterium varium, Mobiluncus curtisii, Mobiluncus mulieris, Peptostreptococcus anaerobius, Peptostreptococcus micros, Peptostreptococcus saccharolyticus, Peptococcus saccharolyticus, Peptococcus asaccharolyticus, Peptostreptococcus magnus, Peptostreptococcus prevot ii, Propionibacterium acnes, Propionibacterium avidium, Propionibacterium granulosum.

Resistant to the drug

Stenotrophomonas maltophilia, Enterococcus faecium and methicillin-resistant staphylococci.

Meronem has shown effectiveness as monotherapy or in combination with other antimicrobial agents in the treatment of polymicrobial infections.

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