Meropenem, vial, 1g

Composition

1 bottle contains 1 g of meropenem.

Auxiliary substances:

sodium carbonate anhydrous 208 mg

Pharmacological action

An antibiotic from the carbapenem group, intended for parenteral use. It has a bactericidal effect by suppressing the synthesis of the bacterial cell wall. The bactericidal effect of meropenem against a wide range of aerobic and anaerobic bacteria is explained by the high ability of meropenem to penetrate the bacterial cell wall, a high level of stability to most beta-lactamases, and a significant affinity for penicillin-binding proteins.

It 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), suppresses transpeptidase, promotes the release of autolytic enzymes of the cell wall, which ultimately causes its damage and bacterial death.

Bactericidal and bacteriostatic concentrations practically do not differ.

Activity spectrum

Gram-positive aerobes: Enterococcus faecalis (including vancomycin-resistant strains), Staphylococcus aureus (penicillinazone-producing and penicillinase-producing [methicillin-sensitive]); Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive only); Streptococcus pyogenes, Streptococcus spp. groups viridans.

Gram-negative aerobes: Escherichia coli, Haemophilus influenzae (penicillinase-producing and penicillinase-producing), Klebsiella pneumoniae, Neisseria meningitidis, Pseudomonas aeruginosa, Proteus mirabilis.

Anaerobic bacteria: Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus spp. For the following microorganisms, meropenem is effective in vitro, but clinically its effectiveness in diseases caused by these pathogens has not been proven:

Gram-positive aerobes: Staphylococcus epidermidis (penicillinazone-producing and penicillinase-producing [methicillin-sensitive]).

Gram-negative aerobes: Acinetobacter spp., Aeromonas hydrophila, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Haemophilus influenzae (ampicillin-resistant, penicillinaseproducing strains), Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (penicillinaseproducing and penicillinaseproducing), Morganella morganii, Pasteurella multocida, Proteus vulgaris, Salmonella spp., Serratia marcescens, Shigella spp., Yersinia enterocolitica.

Anaerobic bacteria: Bacteroides distasonis, Bacteroides ovatus, Bacteroides uniformis, Bacteroides ureolyticus, Bacteroides vulgatus, Clostridium difficile, Clostridium perfringens, Eubacterium lentum, Fusobacterium spp., Prevotella bivia, Prevotella intermedia, Prevotella melaninogenica, Porphyromonas asaccharolytica, Propionibacterium acnes.

Indications

Infectious and inflammatory diseases (monotherapy or in combination with other antimicrobial drugs) caused by pathogens sensitive to meropenem:

• infections of the lower respiratory tract (including pneumonia, including hospital);
• the abdominal infections (complicated appendicitis, peritonitis, pelvioperitonit);
• infections of the urinary tract (pyelonephritis, pyelitis);
• infections of skin and soft tissue (including erysipelas, impetigo, secondarily infected dermatoses);
• infection of the pelvic organs (including endometritis);
• bacterial meningitis;
• septicaemia;
• empirical treatment (monotherapy or in combination with antiviral or antifungal drugs) if you suspect an infection in adult patients with febrile neutropenia.

Contraindications

History of hypersensitivity to meropenem or other beta-lactam antibiotics, children under 3 months of age.

With cautionConcomitant use with potentially nephrotoxic drugs.

Persons with complaints from the gastrointestinal tract (including colitis).

Side effects

From the digestive system: epigastric pain, nausea, vomiting, diarrhea, constipation, anorexia, jaundice, cholestatic hepatitis, hyperbilirubinemia, increased activity of “hepatic” transaminases, alkaline phosphatase, lactate dehydrogenase; rarely – candidiasis of the oral mucosa, pseudomembranous colitis.

From the cardiovascular system: development or aggravation of heart failure, cardiac arrest, tachy – or bradycardia, lowering or increasing blood pressure, syncope, myocardial infarction, thromboembolism of the branches of the pulmonary artery.

From the urinary system: dysuria, edema, impaired renal function (hypercreatininemia, increased urea concentration in plasma), hematuria. Allergic reactions: skin pruritus, skin rash, urticaria, erythema multiforme (Stevens-Johnson syndrome), angioedema, anaphylactic shock.

Nervous system disorders: headache, dizziness, paresthesia, insomnia, drowsiness, increased excitability, agitation, anxiety, depression, impaired consciousness, hallucinations, epileptiform seizures, convulsions.

Laboratory parameters: eosinophilia, neutropenia, leukopenia, rarely-agranulocytosis, hypokalemia, leukocytosis, reversible thrombocytopenia, reduced partial thromboplastin time, anemia.

Local reactions: inflammation, phlebitis, thrombophlebitis, soreness at the injection site.

Other services: positive direct or indirect Coombs test, hypervolemia, shortness of breath, vaginal candidiasis.

Interaction

Probenecid competes with meropenem for active tubular secretion and, thus, inhibits renal excretion of meropenem, causing an increase in its half-life and plasma concentration (concomitant use is not recommended).

Use of the drug Meropenem only as prescribed by a doctor, instructions are given for reference!

How to take, course of use and dosage

IV for adults, a single dose varies from 500 mg to 2 g, the frequency of use and duration of treatment are set individually, depending on the indications and severity of the disease.

Children with a body weight of less than 50 kg – 10-12 mg / kg every 8 hours; in children with a body weight of more than 50 kg, doses intended for adults are used.

In / m adults-500 mg every 8 hours, elderly patients-500 mg every 12 hours

Overdose

Overdose may occur during treatment, especially in patients with impaired renal function.

Treatment: conduct symptomatic therapy.

Normally, rapid elimination of the drug through the kidneys occurs.

In patients with impaired renal function, hemodialysis effectively removes meropenem and its metabolite.

Special instructions

Treatment of patients with liver diseases should be carried out under careful control of the activity of “hepatic” transaminases and bilirubin concentration. In the course of treatment, pathogen resistance may develop, and therefore long-term treatment is carried out under constant control of the spread of resistant strains.

In individuals with gastrointestinal diseases, especially colitis, it is necessary to consider the possibility of developing pseudomembranous colitis (the toxin produced by Clostridium difficile is one of the main causes of colitis associated with antibiotics), the first symptom of which may be the development of diarrhea during treatment.

When using meropenem as monotherapy in critically ill patients with a detected or suspected lower respiratory tract infection caused by Pseudomonas aeruginosa, regular testing for the sensitivity of the pathogen to meropenem is recommended.

There is no experience of using the drug in children with neutropenia, with primary or secondary immunodeficiency.

Form of production

Powder for preparing a solution for intravenous use is white or white with a yellowish tinge.

Storage conditions

 In a dark place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Meropenem

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Urinary Tract Infections, Pneumonia, Intestinal Infections, Skin Infections, Infectious Diseases, Respiratory Tract Infections