Meropenem-LEXVM powder for solution for iv. enter 1 g bottle 30 ml 1 pc. pack (Meropenem)

Release form

Powder for solution for iv. enter

Packaging

1 g - bottles (1) 30 ml - packs of cardboard.

Pharmacological action

Meropenem-LEXVM - parenteral antibiotic from the group of carabapenems, has a bactericidal effect (inhibits the synthesis of the bacterial cell wall), easily penetrates the bacterial cell wall, and is resistant to most beta-lactamases. In contrast to imipenem, it is practically not destroyed in the renal tubules by dehydropeptidase-1 (it does not need to be combined with cilastatin, a specific inhibitor of dehydropeptidase-1) and, accordingly, nephrotoxic decomposition products are not formed, and has high affinity for penicillin binding proteins. Bactericidal and bacteriostatic concentrations practically do not differ. It interacts with receptors - specific penicillin-binding proteins on the surface of the cytoplasmic membrane, inhibits the synthesis of the pentidoglycan layer of the cell wall, inhibits transpeptidase, promotes the release of autolytic enzymes of the cell wall, which ultimately causes its damage and the death of bacteria.

The spectrum of antibacterial activity of meropenem includes the majority of clinically significant gram-positive and gram-negative aerobic and anaerobic strains of bacteria: Gram-positive aerobes: Enterococcus faecalis (including vancomycin-resistant strains), Staphylococcus aureus [penicillin-resistant-sensitive] penicillin-binding-resistant receptors Streptococcus pneumoniae (penicillin-sensitive only) Streptococcus pyogenes, Streptococcus spp. viridans groups.

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

Anaerobic bacteria: Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus spp.

Meropenem is effective in vitro against the following microorganisms, however, its clinical efficacy in diseases caused by these pathogens has not been proven: Gram-positive aerobes: Staphylococcus epidermidis (penicillin-non-producing and penicillin-producing [methylillin-sensitive]).

Gram-negative aerobes: Acinetobacter spp., Aeromonas hydrophila, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Haemophilus influenzae (ampicillin-resistant, penicillinase-non-producing strains), Hafnia alvei, Klebsiella oxytocene, penilephenella, penis, penisphenella Serratia marcesccns, Shigella spp., Yersinia enterocolitica.

Anaerobic bacteria: Bacteroides distasonis, Bacteroides ovatus, Bacteroides uniformis, Bacteroides ureolyticus, Bacteroides vulgatus, Clostridium difficile, Clostridium peifringens, Eubacterium lentum, Previvionella bibella pella, Previvioella bella, Previvella bella

Pharmacokinetics: With an iv injection of 250 mg for 30 min, the Cmax of the active substance in the blood plasma reaches 11 μg / ml, for a dose of 500 mg - 23 μg / ml, 1 g - 49 μg / ml (absolute pharmacokinetic proportional to the dose administered for Cmax and AUC. With an increase in dose from 0.25 to 2 g, clearance decreases from 287 to 205 ml / min, with an iv bolus injection of 5 mg 500 mg Cmax - 52 μg / ml, 1 g - 112 μg / ml for 5 minutes. plasma proteins - 2%.

It penetrates well into most tissues and body fluids, including the cerebrospinal fluid (CSF) of patients with bacterial meningitis, reaching a concentration of and exceeding those required to suppress most bacteria (bactericidal concentrations are created 0.5-1.5 hours after the start of the infusion) .In small quantities, pass into breast milk.

It undergoes a slight metabolism in the liver with the formation of a single inactive metabolite. T1 / 2 - 1 hour, in children under 2 years of age - 1.5-2.3 hours. In the dose range of 10-40 mg / kg in adults and children, a linear dependence of pharmacokinetic parameters is observed. Does not cumulate.

It is excreted by the kidneys - 70% unchanged for 12 hours. The concentration of meropenem in urine in excess of 10 μg / ml is maintained for 5 hours after administration of 500 mg. In patients with renal failure, clearance correlates with creatinine clearance. In elderly patients, a decrease in clearance of meropenem correlates with a decrease in age-related creatinine clearance. T1 / 2 - 1.5 hours. It is excreted during hemodialysis.

Indications

Infectious and inflammatory diseases caused by meropenem-sensitive microorganisms, including polymicrobial infections (as monotherapy or in combination with other antibacterial, antiviral and antifungal drugs):

- lower respiratory tract infections (including pneumonia, including hospital)

- urinary tract infections (including pyelonephritis, pyelitis)

- infections of the skin and soft tissues (including erysipelas, impetigo, secondarily infected dermatoses)

- intraabdominal infections (complicated appendicitis, peritonitis, pelvic peritonitis)

- septicemia

- organs of the scarlet pelvis (including endometritis)

- bacterial meningitis

- suspected bacterial infection in adults with febrile neutropenia (empirical treatment as monotherapy or in combination with antiviral or antifungal agents).

Use during pregnancy and lactation

Use of the drug during pregnancy is possible only in those cases when the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Composition

Powder Meropenem-LEXVM for solution for intravenous administration of

1 vial: meropenem 1 g.

Dosage and administration of

IV.

IV bolus: diluted with sterile water for injection 15 ml per 1000 mg for at least 5 minutes.

IV infusion: for 15-30 minutes, diluted to 50-200 ml with a compatible infusion fluid.

Meropenem is compatible with the following fluids:

- 0.9% sodium chloride solution 5-10% dextrose (glucose) solution

- 5% dextrose (glucose) solution with 0.02%

sodium bicarbonate - 5% dextrose (glucose) solution with 0.225%

sodium chloride solution - 5% dextrose (glucose) solution with 0.15%

potassium chloride solution - 2.5 and 10% mannitol solution.

Meropenem should not be mixed or added to other medicines.

Dose and duration of therapy are determined depending on the severity of the infection and the condition of the patient. The following doses are recommended:

Adults:

For pneumonia, urinary tract infections, pelvic infections, infections of the skin and soft tissues - iv 500 mg every 8 hours

With hospital pneumonia, peritonitis, septicemia, suspected bacterial infection in patients with neutropenia - iv, 1000 mg 3 times a day

With meningitis - 2000 mg every 8 hours

In case of impaired function the dose is adjusted according to creatinine clearance:

Creatinine clearance (ml / min) Single dose: proportion of the recommended single dose corresponding to the pathology (500 mg, or 1000 mg, or 2000 mg) Interval of administration of

26-50100% After 12 h

10-2550% After 12 hours

<1050% After 24 hours

Meropenem is excreted during hemodialysis. To restore the effective plasma concentration at the end of the hemodialysis procedure, it is necessary to introduce a single dose of meropenem recommended for the corresponding pathology.

Kids:

- at the age of 3 months to 12 years (or with a body weight of less than 50 kg) a single dose for intravenous administration -10-20 mg / kg 3 times a day

- children with a body weight of more than 50 kg are used doses for adults

- with meningitis 40 mg / kg every 8 hours.

There is no experience with children with impaired renal function.

Side effects of the

From the digestive system: epigastric pain, nausea, vomiting, diarrhea, constipation, anorexia, jaundice candidiasis of the oral mucosa pseudomembranous colitis.

From the urinary system: dysuria, edema, impaired renal function (hypercreatininemia, increased plasma urea concentration), hematuria.

Allergic reactions: itching of the skin, skin rash, urticaria, erythema multiforme exudative, malignant exudative erythema (Stevens-Johnson syndrome), angioedema, anaphylactic shock.

From the nervous system: headache, dizziness, paresthesia is very rare - agitation, impaired consciousness, epileptiform seizures, convulsions.

On the part of laboratory indicators: thrombocytosis, eosinophilia, thrombocytopenia, decreased hemoglobin (Hb), hematocrit, leukopenia, shortening of prothrombin and partial thromboplastin time, leukocytosis, hypokalemia of gtperbilrubinferase, alkaline phosphatase (activity), alumina phosphatase, activity ), lactate dehydroginase (LDH).

Local reactions: inflammation, phlebitis, thrombophlebitis, soreness, swelling at the injection site, tissue damage with a concomitant rise in creatine phosphokinase (CPK) - with intramuscular injection.

Other: positive direct or indirect Coombs tests, anemia, hypervolemia, vaginal candidiasis.

A causal relationship with taking meropenem has not been established: fainting, hallucinations, depression, anxiety, increased irritability, insomnia, cholestatic hepatitis, heart failure (HF), shortness of breath, tachycardia, bradycardia, cardiac arrest or decrease in blood pressure, myocardial infarction, pulmonary embolism (pulmonary embolism).

Drug Interaction

Compatible with 0.9% sodium chloride solution, 5-10% dextrose solution, 0.02% gndrocarbonate sodium solution, 5% dextrose solution with 0.225% sodium chloride solution, 5% dextrose solution with 0.15% chloride solution, 0.15% chloride solution % and 10% mannitol solution. Reduces the plasma concentration of valproic acid, which can reduce the anticonvulsant effect. Drugs that block tubular secretion, slow the excretion and increase the plasma concentration.

Overdose

Accidental overdose is possible during treatment, especially in patients with impaired renal function.

Treatment: symptomatic. In patients with impaired renal function, meropenem and its metabolites are excreted in hemodialysis.

Storage conditions

In a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Expiration

Expiration: 2 years.

Do not use after the expiry date.

Deystvuyuschee substances

Meropenem

Terms of delivery from

pharmacies Prescription

Dosage form

Dosage form

infusion solution



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