Dosage form"type="checkbox">
Dosage form
Lyophilisate for preparing a solution for intravenous administration
Compound
One bottle contains
active substance - meropenem trihydrate 570 mg and 1140 mg (equivalent to meropenem anhydrous 500 mg and 1000 mg)
excipient – sodium carbonate anhydrous 104 mg and 208 mg respectively.
Description
Powder from white to light yellow, free from visible mechanical inclusions.
Pharmacotherapeutic group
Antimicrobials for systemic use. Other betalactam antibacterial drugs. Carbapinemas. Meropenem.
ATX code J01DH02
Pharmacological properties"type="checkbox">
Pharmacological properties
Pharmacokinetics
In healthy individuals, the average half-life is approximately 1 hour; the mean volume of distribution is about 0.25 L/kg (11-27 L), and the mean clearance is 239 ml/min at a dose of 500 mg and decreases to 205 ml/min at a dose of 2 g. Doses of 500, 1000 and 2000 mg, administered over 30 min, lead to mean Cmax values of about 23, 49 and 115 μg/ml, respectively, corresponding to AUC values of 39.3; 62.3 and 153 mcg*h/ml. After infusion of 500 and 1000 mg doses over 5 minutes, Cmax values were 52 and 112 mcg/ml, respectively. When multiple doses are administered at 8-hour intervals to patients with normal function Meropenem does not accumulate in the kidneys.
A study of 12 patients who were given meropenem 1000 mg every 8 hours after surgical operation for the treatment of intra-abdominal infections, showed that in these patients Cmax and half-life values were comparable to those in healthy subjects, but the volume of distribution was 27 L.
Distribution
The average binding of meropenem to plasma proteins is approximately 2% and is independent of its concentration. Meropenem penetrates well into some body fluids and tissues: including the lungs, bronchial secretions, bile, cerebrospinal fluid, genital tissue, skin, fascia, muscle, and peritoneal exudate.
Metabolism
Meropenem is metabolized by hydrolysis of the β-lactam ring to form microbiologically inactive metabolite. Unlike imipenem, meropenem in conditions in vitro demonstrates low sensitivity to hydrolysis by human dehydropeptidase-1 (DHP-1) and does not require additional administration of a DHP-1 inhibitor
Removal
Meropenem is excreted primarily unchanged by the kidneys, with approximately 70% (50-75%) of the dose excreted unchanged within 12 hours. Another 28% is excreted as an inactive metabolite. Excretion in feces is only about 2% of the dose. Measurements of renal clearance and the effect of probenecid indicate that meropenem undergoes both filtration and tubular secretion.
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.
Pharmacokinetic studies in patients with renal failure showed that meropenem clearance correlates with creatinine clearance. In such patients, dose adjustment is necessary.
Pharmacokinetic studies in elderly subjects revealed a decrease in meropenem clearance, which correlated with an age-related decrease in creatinine clearance.
A study of patients with alcoholic cirrhosis showed that this liver disease did not affect the pharmacokinetics of meropenem when administered multiple times.
Pharmacodynamics
Meronem is an antibiotic of the carbapenem class, intended for parenteral use, relatively resistant to human dehydropeptidase-1 (DHP-1), and does not require additional administration of a DHP-1 inhibitor.
Meronem has a bactericidal effect due to its effect on the synthesis of the bacterial cell wall. The bactericidal effect of Meronem against wide range aerobic and anaerobic bacteria is explained by the high ability of Meronem to penetrate the cell wall of bacteria, high level resistance to most b-lactamases and 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.
Meroneme is stable in pathogen sensitivity tests. Meronem acts synergistically with various antibiotics. Meronem also has a post-antibiotic effect.
Spectrum of antibacterial activity of Meronem based on clinical experience and therapeutic recommendations includes the following types:
Gram-positive aerobes:
Enterococcusfaecalis(E. faecalis may be intermediate in nature) Staphylococcus aureus(methicillin-sensitive strains only: methicillin-resistant staphylococci, including MRSA, are resistant to meropenem) , species of the genus Staphylococcus, including Staphylococcus epidermidis(only methicillin-sensitive strains: methicillin-resistant staphylococci, including MRSE, show resistance to meropenem), Streptococcus agalactiae(group B streptococci), group Streptococcus milleri(WITH.anginosus, S . constellatus, WITH.intermedius), Streptococcus pneumoniae,Streptococcus pyogenes(group A streptococci)
Gram-negative aerobes:
Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Serratiamarcescens.
Anaerobic gram-positive bacteria:
Clostridium perfringens, Peptoniphilus asaccharolyticus, Peptostreptococcus species(including P. micros, P. anaerobius, P. magnus).
Anaerobic gram-negative bacteria
Bacteroides caccae, Bacteroides fragilis, Prevotella bivia, Prevotella disiens
Species for which acquired resistance may be a problem:
Gram-positive aerobes
Enterococcusfaecium
Gram-negative aerobes
Acinetobacterspp,BurkholderiacepaciaPseudomonasaeruginosa
Initially resistant microorganisms
Gram-negative aerobes
StenotrophomonasmaltophiliaLegionellaspp.
Other intrinsically resistant microorganisms
Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetii, Mycoplasma Pneumoniae
The prevalence of acquired resistance may vary geographically and temporally among individual species, so local information on resistance is desirable, especially when treating severe infections.
Indications for use
Meronem for intravenous administration is indicated for the treatment of the following infections in children and adults caused by one or more pathogens susceptible to meropenem:
Pneumonia, including hospital-acquired
Infections urinary system
Infections abdominal cavity
Gynecological infections such as endometritis and inflammatory
diseases of the pelvic organs
Skin and soft tissue infections
Meningitis
Septicemia
Empirical treatment as monotherapy or combination with
antiviral or antifungal agents if you suspect
adult patients for infection with symptoms of febrile neutropenia.
Meronem has shown effectiveness as monotherapy or in combination with other antimicrobial agents in the treatment of polymicrobial infections.
Meronem for intravenous administration is effectively used in patients with cystic fibrosis(cystic fibrosis) and chronic infections of the lower respiratory tract as monotherapy or in combination with other antibacterial agents.
Experience of using the drug in pediatric practice in patients with neutropenia or primary or secondary immunodeficiency No.
Directions for use and doses
The dosage and duration of therapy should be based on the type and severity of the infection and the patient's condition.
500 mg IV every 8 hours for the treatment of pneumonia, infections urinary tract, gynecological infections such as endometritis, skin and soft tissue infections.
1 g intravenously every 8 hours for the treatment of hospital-acquired pneumonia, peritonitis, suspected bacterial infection in patients with symptoms of neutropenia, as well as septicemia.
For infection caused by Pseudomonas aeruginosa, the recommended dose is at least 1 g every 8 hours for adults (maximum permissible dose is 6 g per day, divided into 3 doses), and at least 20 mg/kg every 8 hours for children (maximum permissible dose is 120 mg/kg per day, divided into 3 doses).
Dosage in adult patients with impaired renal function
In patients with creatinine clearance less than 50 ml/min, the dose should be reduced as follows:
Creatinine clearance Dose Frequency of administration
(ml/min) (based on unit doses of 500 mg, 1 g, 2 g)
26 - 50 one dose unit every 12 hours
10 - 25 0.5 dose units every 12 hours
< 10 0,5 единицы дозы каждые 24 часа
Meronem is excreted by hemodialysis and hemofiltration. If long-term treatment with Meronem is required, it is recommended that a unit dose (based on the type and severity of infection) be administered at the end of the hemodialysis procedure to restore effective concentration in blood plasma.
Dosage in adult patients with impaired liver function
There is no need for dose adjustment in patients with liver failure.
Elderly patients
In elderly patients with normal renal function or creatinine clearance more than 50 ml/min, no dose adjustment is required.
Children
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 infection, the sensitivity of the pathogen and the patient's condition.
In children weighing more than 50 kg, dosages recommended for adults should be used.
In children aged 4 to 18 years suffering from cystic fibrosis (cystic fibrosis), in the period of exacerbation chronic infections lower respiratory tract, dosages of 25 to 40 mg/kg are used every 8 hours.
There is no experience with the use of the drug in children with impaired renal function.
Method of administration
Meronem for intravenous use can be administered as an intravenous bolus injection over at least 5 minutes, or as an intravenous infusion over 15 to 30 minutes, using appropriate infusion fluids for dilution.
Meronem for intravenous bolus injections should be diluted sterile water for injection (10 ml per 500 mg of meropenem), with a drug concentration of about 50 mg/ml. The resulting solution is a clear, colorless or light yellow liquid.
There is limited data to support the safety of bolus administration of the drug at a dose of 2g in adults and 40mg/kg in children.
Meronem for intravenous infusion can be diluted with a compatible infusion fluid equal to 50 mg/ml.
Meronem should not be mixed or added to other drugs.
Meronem is compatible with the following infusion solutions:
0.9% sodium chloride solution
5% or 10% glucose solution (dectrose).
When diluting Meronem, the standard antiseptic regimen should be followed. Shake the diluted solution before use.
All bottles are for single use only.
Meronem solution should not be frozen.
Side effects"type="checkbox">
Side effects
Often
Thrombocythemia
Headache
Nausea, vomiting, diarrhea
Increased concentrations of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase and γ-glutamyltransferase in blood serum
Rash, itching
Inflammation and pain at the injection site
Infrequently
Oral candidiasis and vaginal candidiasis
Eosinophilia, thrombocytopenia, leukopenia, neutropenia
Paresthesia
Increased serum bilirubin concentration
Hives
Thrombophlebitis
Convulsions
Agranulocytosis
Very rarely
Hemolytic anemia
Quincke's edema, manifestations of anaphylaxis
Pseudomembranous colitis
Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Anorexia
Increased excitability, agitation, restlessness, depression, hallucinations, anxiety, insomnia
Peripheral edema, dysuria, hematuria, renal dysfunction
Reversible thrombocytosis, eosinophilia, thrombocytopenia, leukopenia
Quincke's edema
Convulsions
Epileptiform seizures
Cholestatic hepatitis, hyperbilirubinemia, jaundice
Cardiac arrest, heart failure, tachycardia, bradycardia, shortness of breath, decreased or increased blood pressure, myocardial infarction, thromboembolism pulmonary artery
Contraindications
History of hypersensitivity to meropenem and other components of the drug, including other beta-lactam antibacterial agents
Pregnancy and lactation
Children up to 3 months of age (efficacy and safety for this
patient groups were not studied).
Carefully:
simultaneous administration of Meronem with potentially nephrotoxic drugs. Persons with gastrointestinal diseases, especially those suffering from colitis.
Drug interactions
Probenecid competes with Meronem for active tubular secretion, inhibiting renal excretion and causing an increase in the half-life and plasma concentration of Meronem. Because the efficacy and duration of action of Meronem administered without probenecid are adequate, coadministration of probenecid with Meronem is not recommended.
The possible effects of Meronem on protein binding or metabolism of other drugs have not been studied. Meronem's protein binding is low (about 2%), and it is assumed that there should be no interaction with other drugs based on displacement from plasma proteins.
Meronem may reduce serum levels of valproic acid. Concomitant use of valproic acid/sodium valproate with Meronem is not recommended.
The use of Meronem while taking other drugs was not accompanied by the development of adverse pharmacological interactions. However, specific data on possible drug interactions(with the exception of probenecid) no.
special instructions"type="checkbox">
special instructions
When using Meronem as monotherapy, as with the use of other antibiotics, in patients in critical condition with identified lower respiratory tract infection caused by Pseudomonas aeruginosa or if it is suspected, regular sensitivity testing to this antibiotic and caution in use are recommended.
In rare cases, when using 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. Therefore, patients with gastrointestinal diseases, especially colitis, should be prescribed antibiotics with extreme caution. It is important to keep in mind the diagnosis of “pseudomembranous colitis” if diarrhea develops while taking Meronem. Although research has shown that the toxin produced Clostridium difficile, is one of the main causes of colitis associated with the use of antibiotics, however, it is necessary to keep in mind other causes.
There is evidence of partial cross-allergenicity between other carbapenems and beta-lactam antibiotics, penicillins and cephalosporins. Before starting therapy with Meronem, the patient should be carefully interviewed, paying special attention to a 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 Meronem 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 and bilirubin levels.
As with other antibiotics, predominant growth of insensitive microorganisms is possible, and therefore constant monitoring of the patient is necessary.
The use of the drug for infections caused by methicillin-resistant staphylococcus is not recommended.
Pregnancy and lactation
The safety of Meronem in women during pregnancy has not been studied. Meronem should not be used during pregnancy unless the potential benefit of its use is justified. possible risk for the fetus. In each case, the drug must be used under the direct supervision of a physician.
Meronem should not be used in breastfeeding women unless the potential benefit justifies the possible risk to the baby. If it is necessary to use the drug during lactation, you should consider stopping breastfeeding.
Use in pediatrics
The effectiveness and tolerability of the drug in children under 3 months of age has not been assessed, and therefore the use of the drug in children under this age is not recommended. There is no experience with the use of the drug in children with impaired liver and kidney function, in patients with neutropenia, or with primary and secondary immunodeficiency.
Features of influence medicine on the ability to drive a vehicle or potentially dangerous machinery
Special studies of the effect of Meronem on the ability to drive a car and other equipment have not been conducted, however, the possibility of developing headaches, convulsions and paresthesia when using Meronem should be taken into account.
Overdose
Accidental overdose during treatment is possible, especially when treating patients with impaired renal function.
Symptoms: gain side effects drug.
Treatment: symptomatic. In patients with normal renal function, the drug is rapidly excreted in the urine. In patients with renal disorders hemodialysis is effective.
Release form and packaging
The drug with a dosage of 0.5 g is placed in clear glass vials with the AstraZeneca logo with a capacity of 20 ml or with a dosage of 1 g in clear glass vials with the AstraZeneca logo with a capacity of 30 ml, sealed with rubber stoppers and crimped with aluminum caps with a blue plastic cap (for a dosage of 0.5 g ) or garnet color (for a dosage of 1 g).
10 bottles each, along with instructions for use in the state and Russian languages, are placed in a cardboard pack.
Storage conditions
Store at temperatures below 30°C.
Keep out of the reach of children!
Compound
active substance: meropenem;
1 bottle contains: meropenem trihydrate 570 mg (equivalent to 500 mg meropenem anhydrous) or meropenem trihydrate 1140 mg (equivalent to 1000 mg meropenem anhydrous)
Excipients: sodium carbonate anhydrous.
Dosage form
Powder for the preparation of solution for injection.
Pharmacological group"type="checkbox">
Pharmacological group
Antimicrobials for systemic use. Carbapenems. ATC code J01D H02.
Indications
Meronem is indicated for the treatment of the following infections in adults and children over 3 months of age:
- pneumonia, including community-acquired and hospital-acquired pneumonia,
- bronchopulmonary infections in cystic fibrosis;
- complicated urinary tract infections
- complicated intra-abdominal infections;
- infections during childbirth and postpartum infections;
- complicated infections of the skin and soft tissues;
- acute bacterial meningitis.
Meronem can be used to treat patients with neutropenia and fever when a bacterial infection is suspected.
Consideration should be given to providing formal advice regarding the appropriate use of antibacterial drugs.
Contraindications
Hypersensitivity to the active substance or to any of the excipients of the drug.
Hypersensitivity to any other antibacterial agent of the carbapenem group.
Severe hypersensitivity (eg. anaphylactic reactions, severe skin reactions) before any other type of beta-lactam antibacterial agent (for example, penicillin or cephalosporins).
Directions for use and doses
The dose of meropenem and the duration of treatment depend on the type of pathogen, the severity of the disease and the individual sensitivity of the patient.
Meronem, when used at doses up to 2 g three times daily in adults and children weighing more than 50 kg and at doses up to 40 mg/kg three times daily in children, may be particularly suitable for the treatment of certain types of infections, such as hospital infections caused by Pseudomonas aeruginosa or Acinetobacter spp.
Meronem should usually be given as an infusion over 15 to 30 minutes.
Alternatively, doses up to 1 g can be administered as a bolus injection over 5 minutes. There are limited safety data supporting administration of the 2 g bolus injection in adults.
Renal dysfunction
Data supporting the use of the drug doses indicated in Table 2, adjusted per 2 g dose unit, are limited.
Meropenem is eliminated by hemodialysis and hemofiltration, so required dose The drug should be administered after completion of the hemodialysis procedure.
Liver dysfunction
For patients with impaired liver function, no dose adjustment is required.
Dosing in elderly patients
For elderly patients with normal renal function or with creatinine clearance values of 50 ml/min, no dose adjustment is required.
There is no experience with the use of the drug in children with impaired renal function.
Meronem should usually be given as an infusion over 15 to 30 minutes. Alternatively, doses of meropenem up to 20 mg/kg can be administered as a bolus injection over 5 minutes. Safety data supporting administration of the drug at a dose of 40 mg/kg by bolus injection to children is limited.
Children weighing more than 50 kg
The dose should be used as for adult patients.
Performing a bolus injection
The solution for bolus injection should be prepared by dissolving the drug Meronem in water for injection to obtain a concentration of 50 mg/ml.
The chemical and physical stability of the prepared solution for bolus injection was maintained for 3:00 at room temperature (15-25 °C).
From a microbiological point of view, the drug must be used immediately.
If the medicine is not used immediately, the doctor is responsible for the period and conditions of its storage after preparation.
Carrying out intravenous infusion
An infusion solution should be prepared by dissolving the drug Meronem in 0.9% sodium chloride injection or 5% glucose (dextrose) injection to obtain a concentration of 1-20 mg/ml.
The chemical and physical stability of the prepared solution for infusion using 0.9% sodium chloride solution was maintained for 6:00 at room temperature (15-25 °C) or for 24 hours at a temperature of 2-8 °C. The prepared solution, if It has been refrigerated and should be used within 2:00 after being refrigerated. From a microbiological point of view, the drug must be used immediately. If the medicine is not used immediately, the doctor is responsible for the period and conditions of its storage after preparation.
Meronem solution prepared with 5% glucose (dextrose) solution should be used immediately, that is, within 1:00 after preparation.
Adverse reactions
In a review of data from 4872 of 5026 patients on the effects of meropenem treatment, common adverse reactions associated with meropenem use were diarrhea (2.3%), rash (1.4%), nausea/vomiting (1.4%), and inflammation in injection site (1.1%). Common meropenem-related laboratory events reported were thrombocytosis (1.6%) and elevated liver enzymes (1.5-4.3%).
In 2367 patients who were enrolled in pre-approved clinical studies of intravenous and intramuscular meropenem, unwanted reactions, indicated in the table with a frequency of “frequency unknown”, were not observed, but were recorded during post-marketing use of the drug.
In the table below, all adverse reactions are indicated by organ system class and frequency: very often (≥ 1/10); often (from ≥ 1/100 to<1/10); нечасто (от ≥ 1/1000 до <1/100); редко (от ≥ 1/10000 до <1/1000); очень редко (<1/10000); частота неизвестна (нельзя оценить на основе имеющихся данных). В рамках каждой группы частот побочные реакции указаны в порядке уменьшения серьезности.
|
Organ systems |
Adverse reaction |
|
|
Infections and infestations |
Oral and vaginal candidiasis. |
|
|
From the blood and lymphatic system |
Frequency unknown |
Thrombocythemia. Eosinophilia, thrombocytopenia, leukopenia, neutropenia. Agranulocytosis, hemolytic anemia. |
|
From the immune system |
Frequency unknown |
Angioedema, anaphylactic reactions. |
|
From the nervous system |
Headache. Paresthesia. Cramps. |
|
|
From the gastrointestinal tract |
Frequency unknown |
Diarrhea, nausea, vomiting, abdominal pain. Colitis associated with antibiotic use. |
|
From the liver and biliary tract |
Increased levels of transaminases, increased levels of alkaline phosphatase in the blood, increased levels of lactate dehydrogenase in the blood. Increased level of bilirubin in the blood. |
|
|
From the skin and subcutaneous tissue |
Frequency unknown |
Rash, itching. Hives. Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme. |
|
From the kidneys and urinary tract |
Increased level of creatinine in the blood, increased level of urea in the blood. |
|
|
General disorders and conditions at the injection site |
Frequency unknown |
Inflammation, pain. Thrombophlebitis. Pain at the injection site. |
Overdose
Relative overdose is possible in patients with impaired renal function if the dose is not adjusted. Limited post-marketing experience with the drug indicates that if adverse reactions occur after an overdose, they are consistent with the profile of the indicated adverse reactions, and, as a rule, are mild in severity and resolve after discontinuation of the drug or dose reduction. The need for symptomatic treatment should be considered.
In persons with normal renal function, the drug is rapidly excreted by the kidneys.
Hemodialysis removes meropenem and its metabolites from the body.
Use during pregnancy or breastfeeding
There are no or limited data on the use of meropenem in pregnant women.
Animal studies have not revealed direct or indirect effects of reproductive toxicity. As a precautionary measure, it is advisable to avoid the use of meropenem during pregnancy.
It is unknown whether meropenem passes into breast milk. Meropenem appears in very low concentrations in animal breast milk. Given the benefit of therapy to women, a decision must be made regarding whether to discontinue breastfeeding or discontinue treatment with meropenem.
Children.
The drug should be used in children aged 3 months and older.
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Features of application.
When choosing meropenem as a treatment, the appropriateness of using a carbapenem antibacterial should be taken into account, taking into account factors such as the severity of the infection, the prevalence of resistance to other relevant antibacterial agents, and the risk of choosing the drug against carbapenem-resistant bacteria.
As with other beta-lactam antibiotics, serious and sometimes fatal hypersensitivity reactions have been reported.
Patients with a history of hypersensitivity to carbapenems, penicillins, or other beta-lactam antibiotics may also have hypersensitivity to meropenem. Before initiating meropenem therapy, careful questioning regarding previous hypersensitivity reactions to beta-lactam antibiotics should be performed.
If a severe allergic reaction occurs, use of the drug should be discontinued and appropriate measures taken.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial drugs, including meropenem, and can range in severity from mild to life-threatening. It is therefore important to consider the possibility of such a diagnosis in patients who experience diarrhea during or after use of meropenem. Consideration should be given to discontinuation of meropenem treatment and the use of specific treatment directed against Clostridium difficile. You should not prescribe medications that suppress intestinal motility.
Assaults have been reported rarely during treatment with carbapenems, including meropenem.
Due to the risk of liver toxicity (impaired liver function with cholestasis and cytolysis), liver function should be carefully monitored during treatment with meropenem.
Use of the drug in patients with liver disease During treatment with meropenem in patients with pre-existing liver disease, liver function should be carefully monitored. No dose adjustment is required.
Treatment with meropenem may cause the development of a positive direct or indirect Coombs test.
Concomitant use of meropenem and valproic acid/sodium valproate is not recommended.
Meronem contains approximately 2.0 mEq or 4.0 mEq of sodium per 500 mg or 1 g dose, respectively, which should be considered when prescribing the drug to patients on a sodium-controlled diet.
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The ability to influence the reaction rate when driving a vehicle or working with other mechanisms.
Study of the effect of the drug on the ability to drive vehicles and did not work with the mechanisms.
Interaction with other drugs and other types of interactions
Studies on the interaction of the drug with individual drugs other than probenecid have not been conducted.
Probenecid competes with meropenem for active tubular elimination and thus inhibits the renal secretion of meropenem, resulting in an increase in the half-life and increased plasma concentrations of meropenem. Caution should be exercised when probenecid is used concomitantly with meropenem.
The potential effects of Meronem on protein binding of other drugs or metabolism have not been studied. However, protein binding is so slight that interactions with other compounds cannot be expected based on this mechanism.
When used concomitantly with carbapenems, a decrease in valproic acid blood levels has been reported, resulting in a 60-100% reduction in valproic acid levels in approximately two days. Due to the rapid onset of action and degree of reduction, concomitant use of valproic acid and carbapenems is considered unmanageable and such interactions should be avoided.
Concomitant use of antibiotics with warfarin may increase its anticoagulant effect. There have been many reports of an increase in the anticoagulant effect of oral anticoagulant drugs, including warfarin, in patients receiving concomitant antibacterial drugs. Risk may vary depending on underlying infections, age, and general condition patient, thus the contribution of antibacterial drugs to increasing the level of INR (international normalized ratio) is difficult to assess. Frequent monitoring of INR levels is recommended during and shortly after concomitant use of antibiotics with an oral anticoagulant.
Pharmacological properties
Pharmacological.
Meropenem exerts its bactericidal effect by inhibiting bacterial cell wall synthesis in gram-positive and gram-negative bacteria by binding to penicillin binding proteins (PBPs).
As with other beta-lactam antibacterial agents, the time at which meropenem concentrations exceeded minimum inhibitory concentrations (MICs) (T > MIC) indicated a high correlation with efficacy. In preclinical models, meropenem has demonstrated activity at plasma concentrations above the MIC for infecting organisms by approximately 40% of the dosing interval. This target value has not been established clinically.
Bacterial resistance to meropenem may result from: (1) decreased permeability outer membrane gram-negative bacteria (due to decreased production of Plunge), (2) decreased affinity for target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyze carbapenems.
Cases have been reported in the European Union infectious diseases caused by bacteria resistant to carbapenems.
There is no cross-resistance between meropenem and drugs belonging to the classes of quinolones, aminoglycosides, macrolides and tetracyclines, taking into account the target microorganisms. However, bacteria can exhibit resistance to more than one class of antibacterial drug when the mechanism involved involves cell membrane permeability and/or the presence of efflux pump(s).
The MIS limit values that were determined during clinical trials European Committee on Antimicrobial Susceptibility Testing (EUCAST) are given below.
|
Microorganism |
Sensitive (S), (mg/l) |
Resistant (R), (mg/l) |
|
Enterobacteriaceae |
||
|
Streptococcus, groups A, B, C, G |
||
|
Streptococcus pneumoniae 1 |
||
|
Other streptococci |
||
|
Staphylococcus 2 |
Note 3 |
Note 3 |
|
Haemophilus influenzae 1 and Moraxella catarrhalis |
||
|
Neisseria meningitidis 2.4 |
||
|
Gram-positive anaerobes |
||
|
Gram-negative anaerobes |
||
|
Limit values not related to microorganism species 5 |
1 Limit values for meropenem for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25/L mg/L.
2 Microorganism strains with MIS values above the S/I limit values are very rare or have not been reported at this time. Identification and antimicrobial susceptibility testing for any such isolate must be repeated, and if the result is confirmed, the isolate is sent to a reference laboratory. By the time the clinical response data of verified MIS isolates is above the current resistance cutoff values (indicated in italics), the isolates should be reported as resistant.
3 The sensitivity of staphylococci to meropenem is predicted based on sensitivity data to methicillin.
4 Limit values for meropenem Neisseria meningitidis apply only to meningitis.
5 Species-neutral limit values were determined primarily from PK/PD data and are independent of the MIS distribution of individual species. They are intended for use with species not listed in the table and footnotes.
"-" Susceptibility testing is not recommended because the species is a poor target for drug treatment.
The prevalence of acquired resistance may vary geographically and over time for individual species, so it is advisable to rely on local information on microbial resistance, especially when treating severe infections. If necessary, when the prevalence of microbial resistance at the local level is such that the benefit of the drug, at least in relation to some types of infections, is doubtful, expert advice should be sought.
The following table lists pathogenic microorganisms based on clinical experience and therapeutic protocols for treating diseases.
Usually sensitive species
gram-positive aerobes
Enterococcus faecalis 6
Staphylococcus aureus (methicillin sensitive) 7
Staphylococcus species (methicillin sensitive), including Staphylococcus epidermidis
Streptococcus agalactiae (group B)
Streptococcus milleri group (S. anginosus, S. constellatus and S. intermedius)
Streptococcus pneumoniae
Streptococcus pyogenes (group A)
gram-negative aerobes
Citrobacter freudii
Citrobacter koseri
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Morganella morganii
Neisseria meningitides
Proteus mirabilis
Proteus vulgaris
Serratia marcescens
gram-positive anaerobes
Clostridium perfringens
Peptoniphilus asaccharolyticus
Peptostreptococcus species (including P. micros, P. anaerobius, P. magnus)
gram-negative anaerobes
Bacteroides caccae
Group Bacteroides fragilis
Prevotella bivia
Prevotella disiens
Species for which acquired resistance may be a problem
gram-positive aerobes
Enterococcus faecium 6,8
gram-negative aerobes
Acinetobacter species
Burkholderia cepacia
Pseudomonas aeruginosa
Inherently resistant microorganisms
gram-negative aerobes
Stenotrophomonas maltophilia
Legionella species
other microorganisms
Chlamydophila pneumoniae
Chlamydophila psittaci
Coxiella burnetii
Mycoplasma pneumoniae
6 Species found to have a natural intermediate sensitivity.
7 All methicillin-resistant staphylococci are resistant to meropenem.
8 Resistance rate >50% in one or more EU countries.
Pharmacokinetics.
In healthy individuals, the plasma half-life is approximately 1:00; average volume of distribution is approximately 0.25 L/kg (11-27 L); the average clearance is 287 ml/min when using the drug at a dose of 250 mg, with a decrease in clearance to 205 ml/min when using the drug at a dose of 2 g. When using the drug in doses of 500, 1000 and 2000 mg, administered as an infusion over 30 minutes, mean Cmax values were respectively approximately 23, 49 and 115 µg/ml; corresponding AUC values were 39.3, 62.3 and 153 µg x h/ml. After an infusion for 5 minutes, the Cmax value is 52 and 112 mcg/ml when the drug is administered in doses of 500 and 1000 mg, respectively. When multiple doses of the drug were administered every 8:00 to patients with normal renal function, no accumulation of meropenem was observed.
A study of 12 patients administered meropenem 1000 mg every 8 hours following surgery for intra-abdominal infections found Cmax and half-life values consistent with healthy controls, but a larger volume of distribution (27 l).
distribution
The average binding of meropenem to plasma proteins was approximately 2% and was independent of drug concentration. After rapid administration of the drug (5 minutes or less), the pharmacokinetics are biexponential, but this is much less obvious after a 30-minute infusion. Meropenem has been found to penetrate well into several body fluids and tissues, including the lungs, bronchial secretions, bile, cerebrospinal fluid, female genital tissue, skin, fascia, muscle, and peritoneal exudates.
metabolism
Meropenem is metabolized by hydrolysis of the beta-lactam ring, forming a microbiologically inactive metabolite. In conditions in vitro Meropenem exhibits reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem and there is no need for concomitant use of a DHP-I inhibitor.
conclusion
Meropenem is primarily excreted unchanged by the kidneys; about 70% (50-75%) of the drug dose is excreted unchanged within 12:00. Another 28% is excreted as a microbiologically inactive metabolite. Fecal excretion represents only about 2% of the dose. Measured renal clearance and the effect of probenecid indicate that meropenem undergoes both filtration and tubular secretion.
renal failure
Impaired renal function leads to high plasma AUC levels and a long half-life of meropenem. There was an increase in AUC values by 2.4 times in patients with moderate renal impairment (creatinine clearance (CR) 33-74 ml/min), by 5 times in patients with severe renal impairment (CC 4-23 ml/min) and 10 times - in patients on hemodialysis (HD<2 мл / мин) по сравнению со здоровыми лицами (КК>80 ml/min). AUC values of the microbiologically inactive ring-opened metabolite were also significantly increased in patients with renal impairment. Dose adjustment of the drug is recommended for patients with moderate to severe renal impairment.
Meropenem is eliminated by hemodialysis with a clearance that was approximately 4 times higher during hemodialysis than in anuric patients.
liver failure
A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses of the drug.
adult patients
Pharmacokinetic studies conducted in patients did not reveal significant pharmacokinetic differences compared to healthy individuals with similar renal function. A population-based model based on data from 79 patients with intra-abdominal infection or pneumonia showed a relationship between basal volume and body weight, creatinine clearance and age.
children
Pharmacokinetic studies in infants and children with infection using the drug at doses of 10, 20 and 40 mg / kg demonstrated Cmax values that approach the values identified in adults after using the drug at doses of 500, 1000 and 2000 mg, respectively. The comparison revealed pharmacokinetic characteristics between drug doses and half-lives that were similar to those observed in all but the youngest adult patients (<6 месяцев t1 / 2 1,6 часов). Средние значения клиренса меропенема составляли 5,8 мл / мин / кг (6-12 лет), 6,2 мл / мин / кг (2-5 лет), 5,3 мл / мин / кг (6-23 месяца) и 4,3 мл / мин / кг (2-5 месяцев). Примерно 60% дозы выводится с мочой в течение 12:00 в виде меропенема и еще 12% - в виде метаболита. Концентрации меропенема в спинномозговой жидкости у детей с менингитом составляют примерно 20% от одновременно выявленных уровней препарата в плазме крови, хотя имеет место значительная межиндивидуальная вариабельность показателей.
The pharmacokinetics of meropenem in neonates receiving antibacterial treatment demonstrated high clearance in neonates of advanced chronological or gestational age, with an overall mean half-life of 2.9 hours. Monte Carlo simulation of the process taking into account the population PK model showed that with a dosing regimen of 20 mg/kg every 8:00 a T>MIC of 60% was achieved relative to P. aeruginosa in 95% of newborns born prematurely and in 91% of full-term newborns.
Elderly patients
Pharmacokinetic studies in healthy elderly subjects (65-80 years) showed a decrease in plasma clearance, correlated with an age-related decrease in creatinine clearance, as well as a slight decrease in non-renal clearance. Dose adjustment of the drug is not required in elderly patients, except in cases of moderate and severe violation kidney function.
Best before date
On prescription.
Manufacturer
AstraZeneca UK Limited, UK
The description is valid on 13.03.2015- Latin name: Meronem
- ATX code: J01DH02
- Active substance: Meropenem
- Manufacturer: Astra Zeneca UK Ltd. (UK), ACSDobfar (Italy), Dainippon Sumitomo Pharmaceuticals Company (Japan)
Compound
In 1 bottle meropenem trihydrate 570 mg or 1140 mg, which corresponds to 500 mg or 1000 mg anhydrous meropenem .
Anhydrous sodium carbonate as an excipient.
Release form
Powder in bottles of 0.5 and 1 g.
pharmachologic effect
Antibacterial.
Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Meronem - , having a wide spectrum of action. Its bactericidal effect is due to its effect on the synthesis of the bacterial cell membrane. Has a high ability to penetrate bacterial cells, is stable to β-lactamases and has an affinity for proteins that bind penicillin . It is these features that explain the powerful bactericidal effect.
The following are sensitive to the drug: gram-positive And gram-negative aerobes , gram-positive and gram-negative anaerobes , pathogens with natural resistance and other pathogens ( chlamydia pneumoniae And psittaci, Mycoplasma pneumoniae, Coxiella burnetii). In studies outside a living organism, it has been revealed that meropenem acts synergistically with other antibiotics. Clinical trials have shown that the drug has post-antibiotic action .
Pharmacokinetics
Meronem penetrates into the tissues and fluids of the body (also cerebrospinal fluid) and is found in them in concentrations that exceed those necessary to suppress bacteria. Metabolized in the liver. The half-life is 1.5 hours, and within 12 hours it can still be detected in the urine. About 70% of the drug is excreted by the kidneys. When 500 mg is prescribed after 8 hours, no accumulation is observed. Elderly persons require dose adjustment. At liver failure used in normal dosages.
The pharmacokinetics of the drug in children and adults is similar.
Indications for use
Meronem is used for diseases:
- septicemia;
- pneumonia ;
- abdominal infections (complicated , pelvioperitonitis );
- diseases of the urinary system ( , pyelitis );
- pelvic infections;
- skin infections;
Contraindications
- increased hypersensitivity to group antibiotics carbapenems ;
- pregnancy ;
- lactation;
- to beta-lactam antibiotics ( or cephalosporins );
- age up to 3 months.
Meronem should be used with caution concomitantly with .
Side effects
It is well tolerated by patients, and serious adverse reactions are rare.
Possible:
- local reactions (, inflammation at the injection site);
- headache, paresthesia, depression, anxiety, excitability, ;
- thrombocytosis , thrombocytopenia , leukopenia , ;
- nausea, loose stool, rarely - pseudomembranous .
- rash, itchy skin;
- decreased or increased blood pressure, heart failure, or bradycardia ;
- dyspnea ;
- level up creatinine in blood.
Meronem, instructions for use (Method and dosage)
Administered intravenously: bolus (at least 5 minutes), infusion (20–30 minutes). For intravenous injections the drug is diluted with water for injection in a ratio of 10 ml per 500 mg meropenem and 20 ml per 1000 mg.
The following infusion fluids are used for infusions: dextrose , sodium chloride + dextrose , dextrose + , mannitol . For IV infusions and injections, only freshly prepared solution is used.
Adults are given 500 mg IV every 8 hours for moderate infections, and 1 g IV every 8 hours for peritonitis
, heavy nosocomial pneumonia
, septicemia
. At meningitis
2 g every 8 hours.
Children from 3 months. up to 12 years - 10 -20 mg per kg of weight after 8 hours. bacterial meningitis
40 mg per kg of weight after 8 hours. For weights over 50 kg, doses for adults are prescribed.
Instructions for use Meronem contains detailed information about drug dosages in patients with renal failure. B in this case, depending on ground clearance creatinine , the dose and frequency of administration are reduced.
Overdose
Overdose is possible in patients with impaired renal function. In such cases, it is carried out hemodialysis .
Interaction
Uricosuric drug suppresses the excretion of meropenem and increases its half-life.
At joint reception With there is a risk of developing seizures.
Agents that block tubular secretion (NSAIDs, Probenecid) will slow down the elimination of this drug and increase its plasma concentration.
Use cautiously with nephrotoxic antibiotics (Ristomycin , Florimycin , cephalosporins I generation).
Incompatible with . Acts antagonistically with beta-lactam antibiotics .
Terms of sale
On prescription.
Storage conditions
In a dry place. Storage temperature should not exceed 30°C.
Best before date
Meronem's analogs
Level 4 ATX code matches:, Meropenabol , Meropenem-Vexta , Meropenem Spencer , Meropenem Jodas , Meropenem Vial , Meropenem-Vero , Let's propine , Cyronem . These analogs have the same release form and dosage.
Reviews
According to reviews from most patients, this is effective drug, which was used in them for severe diseases (community-acquired infections, pyelonephritis with development urosepsis , purulent meningitis , peritonitis , surgical sepsis ). It has a very broad spectrum of action, high bioavailability, minimal microbial resistance and minimal side effects. That is why Meronem is very often used in the intensive care unit.
Thus, the experience of using Meronem in severe cases is described bacterial meningitis in newborns , when carried out earlier antibacterial therapy(III generation cephalosporins, fluoroquinolones And aminoglycosides ) turned out to be ineffective. It was not recorded in children toxic effects .
Many patients are not satisfied with its cost. But, if you calculate the exchange rate cost of treatment with this drug, it is significantly lower than therapy Thienam .
Meronem price, where to buy
You can buy it in pharmacies in Moscow and other cities. The price of Meronem depends on the dose. The cost of the drug 1 g in bottle No. 10 ranges from 12,880 rubles. up to 15,560 rubles, and 0.5 g in bottle No. 10 from 8,022 rubles. up to 8845 rub.
Meronem is a medicine belonging to the group of antibiotics. It effectively copes with harmful bacteria of aerobic and anaerobic nature. The active substance of this drug penetrates the cells of microorganisms and blocks their synthesis. The result is complete elimination of the infection. This medicine should only be used after consulting a doctor. Otherwise, there is a high probability of harm to health.
Composition and release form
The main indicator of the admissibility of taking a drug is its presence in the register of medicines (RLS). Meronem can be purchased in pharmacies in any city. To do this, you will need not only a large amount, but also a doctor’s prescription. Without it, you will not be able to legally buy medicine.
The price of the antibiotic Meronem (INN Meropenem) directly depends on the quantity active substance contained in the drug. It is produced in glass bottles with a capacity of 10, 20 or 30 milliliters. They are tightly closed with a rubber stopper and crimped with an aluminum ring. There is a plastic cover on top. The bottles are packaged in carton boxes 10 pieces each.
Meronem consists of the following components:
- Meropenem trihydrate. This chemical compound acts as an active substance. In one bottle its content ranges from 570 to 1140 mg (corresponding to 500 mg of anhydrous meropenem). The volume depends on the size of the container and the concentration of the drug.
- Anhydrous sodium carbonate. It is added to Meronem as an excipient. Its amount can vary from 104 to 208 mg.
The medicine is available only in powder form, which may be white or light yellow. The prepared drug is packaged in bottles of 0.5 or 1 gram. This powder is intended for self-cooking solution that is administered intravenously.
Indications for use
This medicine can be used for both adults and children. The only difference in application will be the dosage.
This drug is prescribed for the following diseases and states:
- pneumonia and any other respiratory problems;
- inflammation in the pelvis;
- endometritis;
- diseases genitourinary system;
- gynecological complications after childbirth;
- bacterial meningitis;
- peritonitis, appendicitis and other inflammations in the abdominal cavity;
- blood poisoning;
- various infectious diseases skin and soft tissues (impetigo, erysipelas, dermatosis);
- neuropenia (decrease in the number of neutrophils in the blood).
Contraindications
Meronem is like any other medicinal product, has several contraindications. They must be taken into account before taking them, since carelessness can lead to an exacerbation of the disease, as well as a severe deterioration in health.
It is prohibited to use the medicine in the following cases:
- individual intolerance to the active substance (meropenem trihydrate);
- hypersensitivity to sodium carbonate;
- During pregnancy and breastfeeding;
- anaphylactic reactions to certain antibiotics (cephalosporin, penicillin);
- infancy up to 3 months;
- simultaneously with nephrotoxic antibiotics;
- colitis, diarrhea and other problems with gastrointestinal tract(You can take it, but with extreme caution).
Instructions for use
Meronem can only be used after consultation with your doctor. Only a specialist can determine the optimal schedule for taking the medication and select the most effective dosages. All these characteristics are selected based on current state the patient's health and the severity of the disease.
For adults
Patients over 18 years of age tolerate this antibiotic much better than minors and children. Therefore, the duration of the course and the dosage of the medicine are large for them.
- At gynecological diseases, pathologies of the urinary tract, pneumonia, and skin infections. Intravenous injections should be given (up to 500 mg per injection). Such procedures should be performed no more than three times a day. The frequency of injections and their number are determined by the attending physician.
- For the treatment of peritonitis, nosocomial pneumonia, bacterial diseases(in people suffering from symptoms of neutropenia and septicemia). 1 gram of medicine per procedure. Injections should be given every 8 hours for 5-10 days.
- For meningitis at any stage of the disease. The standard dose should be increased to 2 g. The frequency of intravenous injections is selected based on the stage of the disease and can vary from 1 to 3 times a day.
- For people with impaired kidney function. For such diseases, it is recommended to reduce not only the dosage of the medicine, but also the frequency of injections. These two parameters depend on the creatinine clearance rate. If it is less than 51 ml/min, you should switch to one-time injections of Meronem 500 mg. The drug is eliminated from the body during hemodialysis, so a new dose should be administered only after this procedure is completed.
- For liver diseases. People with liver failure can use Meronem in the same way as others. In this case, no restrictions are provided.
Children and elderly patients
Otherwise, Meronem should be used for children and the elderly. They require special dosages and the right approach to the choice of the number of injections.
Dosages:
- Children from 3 months to 12 years. The dose for intravenous administration should be reduced to 10−20 mg/kg and calculated based on the child’s weight. If your body weight exceeds 50 kg, you can do “adult” injections. The frequency of injections is selected depending on the type of disease, stage, sensitivity of bacteria and the patient’s condition.
- From 12 to 18 years. Most often, a full dose of medication is administered. The only exception is adolescents weighing up to 50 kg. For them, a special amount of the drug is determined.
- Aged people. The amount of medicine can be reduced only in case of problems with the kidneys and urinary system.
Pregnant and lactating women
It is especially important to correctly determine the dosage and duration of treatment with Meronem during pregnancy. A doctor's mistake can lead to the most serious problems with health expectant mother and a child. To prevent this from happening, the following rules must be taken into account:
- The medicine can be administered intravenously only under the supervision of a specialist.
- It is prohibited to use even minimal dosages if you are individually intolerant to the drug.
- Injections should not be given if the positive effect of the medicine on the mother outweighs the potential risk to the child.
During breastfeeding Meronem should be discontinued. If this is not done, there is a high probability that the medicine will enter the baby’s body. In extreme cases, when antibiotic treatment is vital, the mother should avoid breastfeeding.
Side effects
If the medicine is taken incorrectly, some side effects may occur. However, serious pathologies are extremely rare.
The main ones:
- Circulatory system. Patients often present with platelet count and eosinophilia. In rare cases, leukopenia, agranulocytosis, and anemia may occur.
- Nervous system. In addition to headaches, rare hallucinations or fainting may occur. Meronem can increase anxiety, excitability or provoke depression. In rare cases, such disorders lead to insomnia.
- Gastrointestinal tract. If the drug is used incorrectly, nausea, vomiting, diarrhea, and colitis may occur. Infrequent manifestations are constipation, cholestatic hepatitis.
- Skin. A rash, hives, and sensations may appear on the surface of the skin. severe itching. Erythema multiforme and epidermal necrolysis sometimes occur.
- The immune system. Meronem has virtually no effect, but can sometimes cause anaphylaxis and angioedema.
- The cardiovascular system. The consequence of taking the medicine may be mild tachycardia or bradycardia. In the most extreme cases, heart failure, myocardial infarction, and cardiac arrest are possible.
In addition to all of the listed side effects, thrombophlebitis, pain at the injection sites and minor inflammation may occur.
Interaction with other drugs
While taking Meronem, you should pay attention to its interactions with other drugs. Some combinations may cause side effects and significantly worsen your health.
- Do not take Meronem with heparin.
- Concomitant use of an antibiotic with nephrotoxic agents increases the likelihood of dangerous complications.
- Combination with valproic acid can reduce the effectiveness of combating pathogens.
- Taking Meronem and probenecids contribute to the rapid removal of the antibiotic from the body and increases its concentration in the circulatory system.
Analogs
Drug manufacturers have developed several dozen analogues of Meronem. They all have a similar effect and differ only in cost. The price of the drug in Moscow can vary from 8 to 15 thousand rubles, depending on the size of the bottle.
Analogues of the product are more affordable for most patients and can cost around 2,000 rubles. Price for Meronem in St. Petersburg and others major cities Russia is practically no different from Moscow.
The most popular analogues:
- Medopenem. The medicine is produced in the form of a soluble powder for injection. Its main advantage is low price, and the disadvantage is the presence of a large number of contraindications.
- Invas. This drug works well against most harmful bacteria. It can be used when diabetes mellitus, but should not be taken if you are hypersensitive to lidocaine.
- Merogram. Available in powder form for making a solution. The drug is much better tolerated than Meronem and has fewer side effects. Its only drawback is its relatively high price.
Meronem - high quality and effective medicine, helping to cope with many harmful bacteria. At correct use and following all the recommendations of doctors, you can not be afraid of any side effects and recover as quickly as possible.
Latin name: Meronem
ATX code: J01DH02
Active substance:
Meropronem trihydrate
Manufacturer: AstraZeneca UK Limited,
Great Britain
Conditions for dispensing from a pharmacy: On prescription
Price: from 6300 to 12000 rub.
“Meronem” is an antibiotic that acts against infections bacterial origin anaerobic and aerobic in nature. Belongs to the class of carbapenems. The effect of using the drug is achieved thanks to the active substance, which easily penetrates bacterial cells and blocks the synthesis processes in microorganisms.
Indications for use
The antibiotic “Meronem” is used in the treatment of various diseases and conditions in both adults and children:
- Pneumonia and other respiratory diseases
- Infections of the genitourinary system
- Inflammation in the pelvis, endometritis, gynecological complications after childbirth
- Meningitis of bacterial origin
- Inflammatory processes in the peritoneum (peritonitis, appendicitis)
- Infections of soft tissues and skin (dermatosis, erysipelas, impetigo)
- Blood poisoning (sepsis)
- Neuropenia (simultaneously with antifungal and antiviral drugs).
Polymicrobial infections are effectively treated if the drug Meronem is combined with other antibacterial drugs.
Compound
The main substance is meropronem trihydrate, equivalent to meroneme anhydrous. Additional Ingredients: Anhydrous sodium carbonate.
Medicinal properties
Once in the body, the product inhibits the work in the cells of various bacteria:
- Pseudomonas aeruginosa
- Streptococci and staphylococci
- Fusobacterium
- Prevotell
- Cyclobacter
- Klebsiella rods.
This leads to their damage and death. Infectious processes stop progressing. The highest concentration of the drug “Meronem” is observed in the blood plasma 40 minutes after intravenous administration. The drug easily enters all body systems. About 75% of the drug is excreted through the human kidneys if not taken for 11–12 hours, provided the organs are functioning normally.
Average price from 6,300 to 12,000 rubles.
Release forms
The antibiotic “Meronem” is available as a yellowish or white, intended for the production of a solution for intravenous injection. The drug is available in bottles of 10, 20 and 30 ml. Glass bottles can contain a dose of 500 mg and 1000 mg (30 ml capacity). Each bottle is closed with a rubber stopper, topped with an aluminum ring and a plastic cap. Bottles are packed in 10 pcs. in cardboard packs.
Mode of application
The drug “Meronem” is administered intravenously in two ways:
- As a bolus injection over 5–6 minutes
- As an infusion (in the form of a dropper) over 20–25 minutes.
To use bolus injections, the antibiotic is diluted with sterile water intended for the procedure at the rate of 5 ml of water per 250 mg of medication.
For droppers, make a solution from Meronem powder and any of the liquids listed below:
- Dextrose solution 10%
- Mannitol solution 10%
- A mixture of a solution of dextrose 5% and potassium chloride 0.15%
- A mixture of dextrose 5% and sodium chloride 0.9%.
The prepared solution can only be used once. You must adhere to the rules for diluting medications, and do not forget to shake the bottle immediately before starting the procedure.
The specific dosage and course of treatment with the drug are determined individually, it depends on the general health of the patient and the severity of the disease. The standard treatment regimen consists of a course of 5 to 15 days.
- For urinary tract and respiratory infections, inflammatory processes gynecological direction - intravenously 500 mg with step-by-step intervals of 8–9 hours
- In the presence of sepsis, pneumonia, peritonitis - 1000 mg every 8 hours
- For meningitis - 2000 mg, repeated every 9 hours regularly.
For adults whose kidney function is impaired, the frequency of repeating the dose of “Meronem” is from 11 to 23 hours, depending on the rate of blood movement through renal pelvis(creatinine clearance).
- From 3 months to 12 years - the medicine is administered intravenously every 8 hours cyclically 10 or 20 mg, based on the type of infection and the severity of the child’s condition
- If the weight of children is more than 51 kg, then doses aimed at adults are prescribed
- To treat meningococcal infection, the dose of antibiotic should be at least 40 mg per kilogram of weight, repeated after 7–8 hours
- There is no data on whether the drug was used among children with disorders of the genitourinary system and liver.
Do not mix Meronem solution with other medications.
During pregnancy and breastfeeding
The antibiotic has not been studied to determine whether it is dangerous for pregnant women or nursing mothers. Experiments have shown that if the dose recommended for an adult was exceeded 12 times, then the amount spontaneous abortions increased.
Since “Meronem” carries a risk to the fetus, the use of the drug in pregnant women, as well as during lactation, is strictly not recommended. Exceptions are cases when the risk is justified, and we are talking about saving the life of the mother and child.
Contraindications
The drug “Meronem” is not used in the presence of the following factors:
- The child has not reached the age of three months
- The body's sensitivity to antibacterial drugs cephalosporin or penicillin series
- Individual intolerance to meropenem
- Stomach ailments and colitis (prescribe with caution)
- During pregnancy and lactation.
Precautionary measures
When using the broad-spectrum antibiotic “Meronem” for the treatment of infectious diseases of the lower respiratory tract caused by bacteria Pseudomonas aeruginosa, you need to systematically test for sensitivity to this microbe.
If the patient experiences an allergic reaction to the drug, its use should be discontinued.
In the presence of liver disease, it is necessary to monitor the level of bilirubin in patients.
When the infection is caused by a methicillin-resistant staphylococcus, it is not recommended to use Meronem for therapy.
You should refrain from taking the drug before driving a car or operating mechanical processes, as convulsions, severe headache and numbness in parts of the body may occur after administration of the drug.
Cross-drug interactions
The following factors need to be taken into account:
- Cannot be used with heparin
- The combined use of Meronem and nephrotoxic drugs increases the risk of developing dangerous health complications
- Valproic acid in combination with meroprenem reduces the effect on bacterial pathogens
- Complex therapy of substances to reduce urea in the blood (probenecids) and the antibiotic “Meronem” increases the rate of elimination of the latter and increases its amount in the circulatory system.
Side effects
Undesirable consequences from taking the drug are rare. There is information about the following consequences:
- Stool upset, abdominal pain, vomiting – in the digestive tract system
- Rashes, urticaria, itching – dermatological reactions
- Leukopenia, anemia, reversible thrombocytosis – circulatory system
- Elevated levels of urea and creatinine – urinary system
- Headache, convulsions, possible paresthesia – nervous system
- Tachycardia, heart failure, hypertension
- Allergic edema and anaphylactic shock
- Inflammatory processes, pain or thrombophlebitis at the injection sites
- Occasionally, thrush (candidiasis) both in the mouth and vaginal
- Insomnia, hallucinations, depressive state- You can find out more about depression in the article:.
Overdose
During use of the drug, there is a possibility of accidental overdose. This applies in most cases to patients who have impaired renal function. Assign symptomatic treatment and hemodialysis procedure.
Conditions and shelf life
“Meronem” is stored in a dry place without access to children. Maximum temperature– 28 °C.
An antibiotic is considered suitable for use if stored under appropriate conditions for no more than four years.
Analogs
IN pharmaceutical industry There are more than 30 analogues that contain the active ingredient meropenem. In addition, there are about 100 drugs that contain different ingredients, but they can be used to treat similar diseases.
Medokemi Ltd., Cyprus
Price from 340 to 620 rub. for 1 bottle
The main substance is meropenem. It is produced in the form of a crystalline powder prepared for solution used for injection.
pros
- Affordable price
