Meropenem - Instructions For The Use Of An Antibiotic, Price, Analogues, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Meropenem

Meropenem: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Meropenem

ATX code: J01DH02

Active ingredient: meropenem (Meropenem)

Manufacturer: Elfa NPC (Russia); S. P. Incomed (SP Incomed) (India); Rafarma (Russia); Synthesis (Russia); Sandoz Private (India); Kraspharma (Russia); Galpha Laboratories (India); Khimfarm (Kazakhstan); M. J. Biopharm Pvt. Ltd. division of corporation M. J. Group (India)

Description and photo updated: 30.11.2018

Prices in pharmacies: from 301 rubles.

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Meropenem is an antibiotic carbapenem.

Release form and composition

Dosage form - powder for preparation of a solution for intravenous (i / v) administration: white or white with a yellowish tinge (0.5 g each in colorless glass vials of 10 or 20 ml, 1 g each in colorless glass vials of 30 ml); in a cardboard box 1 bottle and instructions for the use of Meropenem).

Powder composition in 1 bottle:

• active substance: meropenem (in the form of trihydrate) - 0.5 or 1 g;
• auxiliary component: sodium carbonate.

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug, meropenem, is an antibiotic from the carbapenem group, which has bactericidal activity (inhibits the synthesis of the bacterial cell wall).

Unlike imipenem, meropenem is not destroyed by dehydropeptidase-1 in the renal tubules, therefore, it does not require the simultaneous use of cilastatin, a specific inhibitor of dehydropeptidase-1. Due to this property, nephrotoxic decay products are not formed during treatment with the drug.

The drug is resistant to the action of most beta-lactamases. Its bacteriostatic and bactericidal concentrations are almost the same.

Meropenem has a high affinity for the proteins that bind penicillin. On the surface of the cytoplasmic membrane, it interacts with receptors, which are specific penicillin-binding proteins. Suppresses transpeptidase. Inhibits the synthesis of the peptidoglycan layer of the cell wall. Promotes the release of autolytic enzymes of the cell wall, due to which the bacterium is subsequently damaged and killed.

Meropenem has a broad spectrum of antibacterial activity against the following microorganisms:

• gram-negative aerobes: Pseudomonas aeruginosa, Escherichia coli, Neisseria meningitidis, Klebsiella pneumoniae, Proteus mirabilis, Haemophilus influenzae (penicillinase-producing and penicillinase-producing);
• gram-positive aerobes: Staphylococcus aureus [penicillinase-producing and penicillinase-producing (methicillin-sensitive)], Streptococcus spp. viridans group, Streptococcus pneumoniae (only penicillin-sensitive), Streptococcus agalactiae, Enterococcus faecalis (including vancomycin-resistant strains), Streptococcus pyogenes;
• anaerobic bacteria: Bacteroides thetaiotaomicron, Bacteroides fragilis, Peptostreptococcus spp.

In vitro, meropenem is also active against the following microorganisms, however, its clinical efficacy in diseases caused by these pathogens has not been proven:

• gram-negative aerobes: Haemophilus influenzae (ampicillin-resistant, penicillinase-non-producing strains), Campylobacter jejuni, Aeromonas hydrophila, Enterobacter cloacae, Citrobacter diversus, Acinetobacter spp., Serbs. vulgaris., Sh. oxytoca, Hafnia alvei, Citrobacter freundii, Salmonella spp., Moraxella catarrhalis (penicillinase non-producing and penicillinase producing);
• gram-positive aerobes: Staphylococcus epidermidis [penicillinase-non-producing and penicillinase-producing (methicillin-sensitive)];
• anaerobic bacteria: Clostridium difficile, Bacteroides ovatus, Prevotella bivia, Porphyromonas asaccharolytica, Bacteroides uniformis, Clostridium perfringens, Prevotella intermedia, Propionibacterium acnes, Bacteroides leemon distis, Bacteroides.

Pharmacokinetics

After i.v. 30-minute administration of meropenem at a dose of 250 mg, the maximum concentration (C _max) is 11 μg / ml, at a dose of 500 mg - 23 μg / ml, at a dose of 1000 mg - 49 μg / ml. There is no absolute pharmacokinetic proportional dependence of C _max and AUC (area under the concentration-time curve) on the administered dose. When the dose is increased from 250 to 2000 mg, the clearance decreases from 287 to 205 ml / min.

After a 5-minute intravenous bolus injection of meropenem at a dose of 500 mg, C _max is 52 μg / ml, at a dose of 1000 mg - 112 μg / ml.

About 2% of the dose binds to plasma proteins.

Meropenem penetrates well into most body fluids and tissues (including cerebrospinal fluid in patients with bacterial meningitis) and reaches higher concentrations than are required to suppress most bacteria (bactericidal concentrations are created 0.5-1.5 hours after the start of meropenem administration). In small quantities it passes into breast milk. Does not accumulate in the body.

Undergoes a slight metabolism in the liver with the formation of one pharmacologically inactive metabolite.

The half-life (T _½) is 1 hour, in children under 2 years of age - 1.5-2.3 hours.

In children and adults, when using the drug in the dose range from 10 to 40 mg / kg, there is a linear dependence of pharmacokinetic parameters.

Approximately 70% of the drug is excreted unchanged by the kidneys within 12 hours. The concentration of meropenem in urine above 10 μg / ml is determined within 5 hours after a dose of 500 mg.

In renal failure, meropenem clearance correlates with creatinine clearance (CC).

In elderly patients, a decrease in meropenem clearance correlates with an age-related decrease in CC. T _½ is 1.5 hours. The drug is excreted during hemodialysis.

Indications for use

Meropenem is prescribed for the treatment of the following infectious and inflammatory diseases caused by sensitive microorganisms (including several):

• bacterial meningitis;
• urinary tract infections (including pyelonephritis and pyelitis);
• lower respiratory tract infections (including pneumonia, including hospital);
• intra-abdominal infections (including peritonitis, pelvioperitonitis, and complicated appendicitis);
• infections of the pelvic organs (including endometritis);
• infections of the skin and soft tissues (including secondarily infected dermatoses, impetigo and erysipelas);
• septicemia;
• suspected infection in adults with febrile neutropenic episodes (empiric treatment).

Depending on the clinical situation, Meropenem can be used as a monopreparation or as part of a combination therapy in combination with other antibacterial, antifungal and antiviral agents.

Contraindications

Absolute:

• children's age up to 3 months;
• lactation period;
• severe hypersensitivity (severe skin reactions or anaphylactic reactions) to any antibiotic with a beta-lactam structure (for example, to penicillins, cephalosporins);
• hypersensitivity to any component of the drug or other agents of the carbapenem group.

With caution, after a thorough assessment of the benefits and risks, the antibiotic Meropenem is prescribed in the following cases:

• colitis;
• reduced threshold of convulsive readiness;
• simultaneous use of nephrotoxic drugs;
• pregnancy;
• a history of hypersensitivity reactions to beta-lactam antibiotics.

Meropenem, instructions for use: method and dosage

Meropenem is administered intravenously: as a bolus injection for at least 5 minutes or as an infusion for 15-30 minutes.

Before use, a solution is prepared from the powder. For bolus injection, the drug is dissolved with sterile injection water (250 mg - 5 ml), the concentration of the solution in this case is 50 mg / ml. For infusion, the drug is dissolved in 0.9% sodium chloride solution or 5% dextrose solution, the concentration of the solution in this case should be from 1 to 20 mg / ml.

The doctor sets the dose of Meropenem and the duration of treatment individually, depending on the patient's condition and the severity of the infectious process.

Recommended doses for adults:

• pneumonia, infections of the urinary tract, soft tissues and skin, infectious and inflammatory diseases of the pelvic organs: 500 mg every 8 hours;
• meningitis: 2000 mg every 8 hours;
• hospital pneumonia, peritonitis, septicemia, suspected bacterial infection in patients with neutropenia: 1000 mg every 8 hours.

The safety of using the drug as a bolus injection at a dose of 2000 mg in adults has not been studied enough.

Elderly people with normal renal function or CC> 50 ml / min do not need to adjust the treatment regimen.

With hepatic failure, there is no need to adjust the dosage regimen.

For patients with impaired renal function, the dose of Meropenem is adjusted depending on the CC. When CC is 26-50 ml / min, the usual dose is prescribed according to indications, but the administration is carried out at intervals of 12 hours. If CC is 10-25 ml / min, the standard dose is reduced by 2 times and injected at intervals of 12 hours. If CC is <10 ml / min. the usual dose is reduced by 2 times and the drug is administered at intervals of 24 hours. After a hemodialysis session, it is recommended to introduce an additional dose to restore the effective plasma concentration of the drug. There is no experience of using meropenem in patients undergoing peritoneal dialysis.

Children aged 3 months to 12 years (with a body weight of 50 kg are prescribed doses similar to those for adult patients.

For meningitis, the recommended dose for children is 40 mg / kg every 8 hours.

The safety of using the drug as a bolus injection at a dose of 40 mg / kg in children has not been studied enough.

Side effects

• from the digestive system: diarrhea, constipation, pain in the epigastric region, anorexia, nausea, vomiting, increased activity of hepatic transaminases, lactate dehydrogenase and alkaline phosphatase, jaundice, hyperbilirubinemia, cholestatic hepatitis; rarely - oral candidiasis, pseudomembranous colitis;
• from the nervous system: insomnia, drowsiness, impaired consciousness, agitation, dizziness, increased excitability, hallucinations, anxiety, paresthesia, headache, depression, convulsions, epileptiform seizures;
• on the part of the cardiovascular system: a decrease or increase in blood pressure, development or worsening of heart failure, bradycardia, tachycardia, fainting, thromboembolism of the branches of the pulmonary artery, myocardial infarction, cardiac arrest;
• on the part of the urinary system: edema, dysuria, hematuria, renal dysfunction (increased plasma urea concentration, hypercreatininemia);
• allergic reactions: urticaria, skin rash, itching of the skin, angioedema, exudative erythema multiforme, anaphylactic shock, malignant exudative erythema (Stevens-Johnson syndrome);
• local reactions: soreness at the injection site, phlebitis, inflammation, thrombophlebitis;
• laboratory parameters: leukopenia, neutropenia, eosinophilia; rarely - a decrease in partial thromboplastin time, reversible thrombocytopenia, hypokalemia, agranulocytosis, leukocytosis;
• others: dyspnea, hypervolemia, anemia, false positive direct / indirect Coombs' test, vaginal candidiasis.

Overdose

Overdose is mainly possible in patients with functional impairment of the kidneys.

Treatment is symptomatic. If necessary, hemodialysis is performed to remove the drug from the body.

special instructions

When monotherapy with a drug known or suspected severe lower respiratory tract infection caused by Pseudomonas aeruginosa, it is recommended to regularly determine the sensitivity of the pathogen to meropenem.

Patients with a history of hypersensitivity to penicillins, carbapenems, or other beta-lactam antibiotics may develop hypersensitivity to meropenem.

There is laboratory and clinical evidence of allergic cross-reactions between other carbapenems and beta-lactam antibiotics, penicillins and cephalosporins. Cases of severe hypersensitivity reactions, including fatal ones, have been reported in patients receiving meropenem. Before prescribing the drug, the doctor should carefully study the patient's history, paying special attention to the presence of hypersensitivity reactions to beta-lactam antibiotics. If there is a history of the disease, the antibiotic should be used with caution. If an allergic reaction develops during treatment with meropenem, the drug should be discontinued and appropriate therapy should be carried out.

The use of an antibiotic is not recommended for infections caused by methicillin-resistant staphylococcus.

Rare cases of seizures have been reported in patients treated with carbapenems, including meropenem. The drug should be used with caution in patients with a reduced seizure threshold.

When a patient has complaints from the digestive system, especially with colitis, it is necessary to take into account the likelihood of developing pseudomembranous colitis, the first symptom of which may be diarrhea. If the diagnosis is confirmed, the drug should be discontinued and appropriate therapy should be carried out.

During the period of use of Meropenem, it is forbidden to take drugs that inhibit intestinal peristalsis.

During antibiotic therapy, the development of resistant pathogens is possible, therefore, treatment should be accompanied by regular monitoring for the formation of resistant strains.

Influence on the ability to drive vehicles and complex mechanisms

Drivers of vehicles and persons employed in potentially hazardous industries that require speed of reactions and increased attention should be careful during therapy.

Application during pregnancy and lactation

For pregnant women, the antibiotic Meropenem can be prescribed only in cases where the expected benefit from therapy is clearly higher than the potential risks.

If treatment is necessary during lactation, it is recommended to consider stopping breastfeeding.

Pediatric use

Meropenem is contraindicated in children under 3 months of age.

There is no experience of using the drug in children with neutropenia, primary and secondary immunodeficiency. There is no experience of using the drug for the treatment of children with kidney and liver disorders.

With impaired renal function

Patients with functional impairment of the kidneys need dose adjustment depending on creatinine clearance.

For violations of liver function

If liver function is impaired, there is no need to adjust the dosage regimen. However, treatment should be carried out under close monitoring of hepatic transaminase activity and bilirubin concentration.

Use in the elderly

Elderly people with normal renal function or CC> 50 ml / min do not need to adjust the treatment regimen.

Drug interactions

Do not mix or add Meropenem to other medicines.

Meropenem reduces the concentration of valproic acid in plasma, which may lead to a decrease in the anticonvulsant effect. The simultaneous use of these drugs is not recommended.

Medicines that block tubular secretion increase the plasma concentration of meropenem and slow down its excretion.

Probenecid inhibits the renal excretion of meropenem (by competing for active tubular secretion), which causes an increase in its plasma concentration and an increase in the half-life. The effectiveness and duration of action of meropenem without probenecid are adequate, therefore, the simultaneous use of these drugs is not recommended.

Antibiotics can enhance the anticoagulant effect of simultaneously used indirect anticoagulants (including warfarin). Depending on the type of infection, the condition and age of the patient, the likelihood of this effect varies significantly, therefore it is difficult to assess the degree of influence of antibacterial agents on increasing the INR (International Normalized Ratio). It is recommended to constantly monitor the INR during the use of meropenem and for some time after its cancellation.

Analogs

Meropenem analogs are: Aquapenem, Grimipenem, Dzhenem, Doriprex, Invanz, Merexid, Meronoxol, Meronem, Meropenabol, Nerinam, Propinem, Penemera, Saironem, Tiepenem, Tienam, Tsilapenem, Tsilaspen and others.

Terms and conditions of storage

Store at a temperature not exceeding 30 ° C in a dry, dark place out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Meropenem

According to reviews, Meropenem is a powerful antibacterial agent that is effective in diseases caused by sensitive microorganisms.

Of the side effects, patients mention diarrhea, abdominal pain and oral candidiasis.

Price for Meropenem in pharmacies

Depending on the region of sale and the pharmacy network, the price for Meropenem may be: 1 bottle of 500 mg - 569-715 rubles, 1 bottle of 1000 mg - 575-920 rubles.

Meropenem: prices in online pharmacies

Drug name Price Pharmacy

Meropenem powder for prig. solution for intravenous injection. 500mg 301 RUB Buy

Meropenem 1 g powder for preparation of solution for intravenous administration 1 pc. RUB 514 Buy

Meropenem powder for prig solution for intravenous injection. 500mg 566 r Buy

Meropenem 0.5 g powder for preparation of solution for intravenous administration 1 pc. 566 r Buy

Meropenem 1 g powder for preparation of solution for intravenous administration 1 pc. 767 RUB Buy

Meropenem 1 g powder for preparation of solution for intravenous administration 1 pc. 873 r Buy

Meropenem powder for prig solution for intravenous injection. 1.0g fl 1186 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!