Memonia with renal failure. Measurement - instructions for use

  • Merronic Instructions
  • Composition of the drug Meronem
  • Indications of the drug Merream
  • Conditions for storing the drug Merream
  • The shelf life of the drug Merream

Release form, composition and packaging

lyophilisate d / quotation. P-RR D / V / in Introduction 1 g: FL. 10 pieces.
Reg. №: RK-LS-5-№ 017669 from 03/31/2011 - Existing

Excipients: Sodium carbonate anhydrous.

Glass bottles of 30 ml (10) - cardboard boxes.

lyophilisate d / quotation. p-ra d / c / in introduction 500 mg: Fl. 10 pieces.
Reg. №: RK-LS-5-№ 017668 from 03/31/2011 - Existing

Lyophilisate for the preparation of a solution for in / in administration In the form of a powder from white to white with a yellowish colors.

Excipients: Sodium carbonate anhydrous.

Glass bottles of 10 ml volume (10) - cardboard boxes.
Glass bottles of 20 ml (10) - cardboard boxes.

Description of the medicinal preparation Meronem Based on officially approved instructions for the use of the drug and made in 2011. Renewal date :..0


pharmachologic effect

Antibiotic group of carbapenes. Created for parenteral applicationThe relatively resistant to the dehydropptidase-1 (DGP-1) of a person does not require additional administration of the DGP-1 inhibitor.

Meropene has a bactericidal effect due to the impact on the synthesis of the cell wall of bacteria. The powerful bactericidal action of the meropenem against the wide range of aerobic and anaerobic bacteria It is explained by the high ability of the Meropemy to penetrate the cell wall of bacteria, high levels Stability to most β-lactamas and significant affinity to proteins binding penicillin (BSP).

Minimum bactericidal concentrations (MBC) are usually the same as the minimum inhibitory concentrations (MIK). For 76% of tested species of bacteria, the ratio of the MBC / MIK was less than or equal to 2.

Meropeneme is stable in the tests of determining the sensitivity of the pathogen. In vitro tests show that Meropene is acting synergistic with various antibiotics. In vitro and in vivo tests, it is shown that Meropenem has a post-antibiotic effect.

  • the diameter of the zone and MIC, defined for the corresponding pathogens.

The spectrum of antibacterial activity of Meropenem In Vitro includes most clinically significant gram-positive and gram-negative aerobic and anaerobic strains of bacteria.

Gram-positive aerobes: Bacillus SPP., Corynebacterium Diphtheriae, Enterococcus Liquifaciens, Enterococcus Avium, Listeria Monocytogenes, Lactobacillus SPP., Nocardia Asteroides, Staphylococcus Aureus (Penicillinase-negative and positive), Staphylococcus SPP. (Coagulase negative, including, Staphylococcus saprophyticus, Staphylococcus capitis, Staphylococcus cohnii, Staphylococcus xylosus, Staphylococcus warneri, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus intermedius, Staphylococcus sciuri, Staphylococcus lugdunensis), Streptococcus pneumoniae (sensitive and penicillin-resistant), Streptococcus agalactiae , Streptococcus Pyogenes, Streptococcus Equi, Streptococcus Bovis, Streptococcus Mitis, Streptococcus MiTior, Streptococcus Milleri, Streptococcus Sanguis, Streptococcus Viridans, Streptococcus Salivarius, Streptococcus Morbillorum, Streptococcus SPP. G, Streptococcus SPP. F, Rhodococcus Equi.

Gram negative aerobes:Achromobacter xylosoxidans, Acinetobacter anitratus, Acinetobacter lwoffii, Acinetobacter baumannii, Aeromonas hydrophila, Aeromonas sorbria, Aeromonas caviae, Alcaligenes faecalis, Bordetella bronchiseptica, Brucella melitensis, Campylobacter coli, Campylobacter jejuni, Citrobacter freundii, Citrobacter diversus, Citrobacter koseri, Citrobacter amalonaticus, Enterobacter aerogenes , Enterobacter (Pantoea) agglomerans, Enterobacter cloacae, Enterobacter sakazakii, Escherichia coli, Escherichia hermannii, Gardnerella vaginalis, Haemophilus influenzae (including β-lactamase-positive and ampicillin-resistant strains), Haemophilus parainfluenzae, Haemophilus ducreyi, Helicobacter pylori, Neisseria meningitidis, Neisseria gonorrhoeae (including strains of β-lactamase-positive, resistant to penicillin and spectinomycin), Hafnia alvei, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella ozaenae, Klebsiella oxytoca, Moraxella (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Pr oteus vulgaris, Proteus penneri, Providencia rettgeri, Providencia stuartii, Providencia alcalifaciens, Pasteurella multocida, Plesiomonas shigelloides, Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas alcaligenes, Burkholderia (Pseudomonas) cepacia, Pseudomonas fluorescens, Pseudomonas stutzeri, Pseudomonas pseudomallei, Pseudomonas acidovorans, Salmonella spp . (Including Salmonella enteritidis typhi), Serratia marcescens, Serratia liquefaciens, Serratia rubidaea, Shigella sonnei, Shigella flexneri, Shigella boydii, Shigella dysenteriae, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica.

Anaerobic bacteria:Actinomyces odontolyticus, Actinomyces meyeri, Bacteroides spp., Prevotella spp., Porphyromonas spp., Bacteroides fragilis, Bacteroides vulgatus, Bacteroides variabilis, Bacteroides pneumosintes, Bacteroides coagulans, Bacteroides uniformis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides eggerthii, Bacteroides capsillosis , Prevotella buccalis, Prevotella corporis, Bacteroides gracilis, Prevotella melaninogenica, Prevotella intermedia, Prevotella bivia, Prevotella splanchnicus, Prevotella oralis, Prevotella disiens, Prevotella rumenicola, Bacteroides ureolyticus, Prevotella oris, Prevotella buccae, Prevotella denticola, Bacteroides levii, Porphyromonas asaccharolytica, Bifidobacterium spp., Bilophilia wadsworthia, Clostridium perfringens, Clostridium bifermentans, Clostridium ramosum, Clostridium sporogenes, Clostridium cadaveris, Clostridium sordellii, Clostridium butyricum, Clostridium clostridiiformis, Clostridium innocuum, Clostridium subtermin ale, Clostridium tertium, Eubacterium lentum, Eubacterium aerofaciens, Fusobacterium mortiferum, Fusobacterium necrophorum, Fusobacterium nucleatum, Fusobacterium varium, Mobiluncus curtisii, Mobiluncus mulieris, Peptostreptococcus anaerobius, Peptostreptococcus micros, Peptostreptococcus saccharolyticus, Peptococcus saccharolyticus, Peptostreptococcus asaccharolyticus, Peptostreptococcus magnus, Peptostreptococcus prevotii, PropioniBacterium Acnes, PropioniBacterium Avidium, PropioniBacterium Granulosum.

To Meropem sustainable: Stenotrophomonas Maltophilia, Enterococcus Faecium, Methicillin-resistant staphylococci.

Pharmacokinetics

Suction

In Introduction For 30 minutes, one dose of Meronema is a healthy volunteer leads to C Max in the blood plasma 11 μg / ml for a dose of 250 mg, 23 μg / ml for a dose of 500 mg and 49 μg / ml for a dose of 1 g.

However, with respect to C MAX and AUC there is no absolute pharmacokinetic proportional dependence on the administered dose. There is a decrease in plasma clearance from 287 to 205 ml / min for doses of 250 mg to 2 g.

C / in bolus injection of one dose of Meronema Healthy volunteers for 5 min leads to C Max in plasma 52 μg / ml for a dose of 500 mg and 112 μg / ml - for a dose of 1 g.

C max in plasma at B / in the introduction of 1 g of the drug for 2 minutes, 3 min and 5 minutes amounted to 110, 91 and 94 μg / ml, respectively.

6 hours after B / in the introduction of 500 mg, the level of the Meropem in the blood plasma decreases to 1 μg / ml values \u200b\u200band below.

With repeated introduction of a meropenem with an interval of 8 hours to patients with a normal kidney function of the drug cumulation, it is not observed. In patients with normal kidney function T 1/2 is approximately 1 h.

Distribution

Binding with plasma proteins - 2%.

Meropenemo penetrates well in most of the fabrics and body fluids, incl. In the cerebrospinal fluid of patients with bacterial meningitis, reaching concentrations exceeding the bacterial required to suppress them.

Metabolism

The only metabolite of Meropenem is microbiologically inactive.

Election

Under the modes of administration of 500 mg every 8 h or 1 g, every 6 hours did not observe the cumulation of the meropenem in the blood plasma and in the urine in volunteers with normal liver function.

About 70% in / in the dose of the MERONEM is excreted in the urine unchanged for 12 hours, after which a minor excretion with urine is determined. The concentrations of the meropenem in the urine exceeding 10 μg / ml are maintained for 5 hours after administration of a dose of 500 mg.

Pharmacokinetics in special clinical cases

patients S. renal failure It was shown that the clearance of the meropenem correlates with the QC. Such patients need a dose adjustment.

Research Pharmacokinetics U. patients with liver diseases It has shown that these pathological changes do not affect the pharmacokinetics of the Meropenem.

Study of Pharmacokinetics U. elderly patients Revealed a decrease in clearance of a meropenem, which correlated with the age reduction of the QC.

Studies have shown that Pharmacokinetics Meronea children And in adults is similar. T 1/2 Meropem in children up to 2 years is approximately 1.5 - 2.3 hours, in the dose range of 10-40 mg / kg, a linear dependence is observed.

Indications for use

Merreon for C / in administration is shown for treatment in children and adults of the following infections caused by one or more sensitive to Meropene Meropeneuces:

  • pneumonia (including internal hospitals);
  • urinary system infections;
  • infections of the abdominal cavity;
  • gynecological infections (including endometritis, inflammatory diseases small pelvis organs);
  • skin infections and its structures;
  • meningitis;
  • septicemia;
  • empirical treatment in the form of monotherapy or combination with antiviral or antifungal agents in suspected adult patients with infection with febrile neutropenia symptoms;
  • monotherapy or combination with other antimicrobial agents for the treatment of polyimicrobial infections.

Dosing mode

W. adults The dosing mode and the duration of therapy should be established depending on the type and severity of the infection and the patient's condition.

For treating pneumonia, urinary tract infections, gynecological infections (including endometritis), skin infections and skin structures It is recommended to assign to / in 500 mg / day every 8 hours.

For treatment hospital pneumonia, peritonitis, suspicion of bacterial infection in patients with neutropenia symptoms, as well as septicemia It is recommended to assign to / in 1 g / day every 8 hours.

W. adult patients with impaired kidney function (QC<51 мл/мин) The dose should be reduced as follows:

    Meropene is excreted during hemodialysis. If long-term treatment is required, it is recommended that the dose unit (based on the type and severity of infection) is introduced at the end of the hemodialysis procedure to restore the effective concentration in the blood plasma.

    Experience in applying Meronea patients exposed to peritoneal dialysis, absent.

    W. adult patients with hepatic insufficiency No need for a dose adjustment.

    W. Elderly patients with normal kidney or kk\u003e 50 ml / min No dose adjustment is required.

    For children aged from 3 months to 12 years The recommended dose for C / in administration is 10-20 mg / kg every 8 hours, depending on the type and severity of infection, the sensitivity of the pathogenic microorganism and the patient's condition.

    W. children with body weight more than 50 kg You should use dosages for adults.

    Experience in the use of the drug Children with impaired kidney function absent.

    Rules for the preparation of solutions for in / in administration

    Merreon for B / for use can be administered in the form of a B / in bolus injection for at least 5 minutes, or in the form of a / in infusion for 15-30 minutes, using appropriate infusion fluids for dilution.

    Meonom for in / in bolus injections It should be dissociated with sterile water for injections (5 ml per 250 mg of meropenem), while the concentration of the solution is about 50 mg / ml. The resulting solution is a transparent colorless or light yellow liquid.

    Meonom for in / in infusions It can be divorced by a compatible infusion fluid (from 50 to 200 ml).

    Meonone should not be mixed or added to other drugs.

    Meoniam is compatible with the following infusion fluids:

    • 0.9% Sodium chloride solution, 5% or 10% Dextrose solution (glucose), 5% Dextrose solution (glucose) with 0.02% sodium solution of bicarbonate, 0.9% Sodium solution chloride and 5% Dextrose solution (glucose), 5% dextrose solution (Glucose) glucose) with 0.225% solution of chloride sodium, 5% dextrose solution (glucose) with 0.15% solution of chloride potassium, 2.5% or 10% mannitol solution.

    When breeding, Meronea should comply with the standard antiseptic mode.

    Before use, the diluted solution should be shaken.

    All bottles are intended only for one-time application.

Side effects

Serious adverse reactions are rare.

From the digestive system:

  • abdominal pain, nausea, vomiting, diarrhea;
  • in some cases, the pseudommbranous colitis, an increase in the bilirubin serum concentration, transaminases, parasites, LDH (separately or in combination).

From the hematopopitation system: reversible thrombocytemy, eosinophilia, thrombocytopenia, leukopenia and neutropenia;

  • very rare - agranulocytosis;
  • in some cases, a decrease in partial thromboplastinetime, positive direct or indirect Cumbac sample.
  • From the CNS and the peripheral nervous system:

    • headache, paresthesia, convulsions (causal communication with the reception of the meronema is not established).

    Allergic reactions: Systemic - angioedema edema, anaphylaxis, rash, itching, urticaria, multiform (exudative) erythema, Stevens-Johnson syndrome, toxic epidermal necroliz.

    Local reactions:

    • inflammation, thrombophlebitis, pain in the place of administration.

    Others:

    • vaginal Candidiasis, Candidiasis of the oral mucosa.

    Contraindications for use

    FROM caution It should be used the drug in patients with gastrointestinal complaints, colitis.

    Also follow caution With the simultaneous use of a meronema with potentially nephrotoxic drugs.

    Application in pregnancy and breastfeeding

    Since the safety of the use of Meronem in women during pregnancy was not studied, the use of the drug during pregnancy is possible only when the alleged benefit for the mother exceeds the potential risk to the fetus. In each such case, the drug should be applied under the direct supervision of the doctor.

    Experimental studies Animals did not show any adverse effects on developing fruit. The only adverse phenomenon identified in the course of research in animals on the effect of the drug on the reproductive system was an increased frequency of abortions in monkeys when the dose is 13 times higher than those recommended for humans.

    If necessary, the use of the drug during the lactation should be resolved the issue of termination breastfeeding. Meropene is highlighted with breast milk animals in very low concentrations.

    special instructions

    When using a meropenem as a monotherapy in patients in critical condition with the identified infection of the lower respiratory tract caused by a blue rod (or with suspected of it), a regular test of sensitivity to this antibiotic and caution is recommended.

    In rare cases, the use of pseudomambranous colitis, which can vary in gravity from the lungs to the threatening life of the forms, is observed. In the case of diarrhea, against the background of Meronem administration, the risk of "pseudommbranous colitis" should be taken into account. Although studies have shown that the toxin produced by the causative agent of CLOSTRIDIILE (Clostridium difficile) is one of the main causes of the colitis associated with the use of an antibiotic, however, it is necessary to bear in mind other reasons.

    There are clinical I. laboratory signs Partial cross allergy between other carbapenes and beta-lactam antibiotics, penicillins and cephalosporins. Despite the fact that allergic reactions when using beta-lactam antibiotics, it was quite frequent, on the reactions of hypersensitivity during the introduction of the Meronema rarely reported.

    Before starting therapy, the Meropem should be carefully interviewed by the patient, paying special attention to the reaction of hypersensitivity to beta-lactam antibiotics in an anamnesis. Meonia should be used with caution in patients with instructions in the history of similar phenomena. If an allergic response on a meropene arise, it is necessary to stop the administration of the drug and take appropriate measures.

    The use of merronic in patients with liver diseases should be carried out under a thorough control of the level of transaminase and bilirubin.

    The prevailing growth of insensitive microorganisms is possible, and therefore it is necessary to continuously monitor the patient.

    The use of the drug in infections caused by metieticillin-resistant staphylococcus is not recommended.

    Use in pediatrics

    Efficacy and tolerance of the drug children under 3 months Not assessed, in connection with which the use of the drug in children under this age is not recommended. There is no experience in the use of the drug in children with impaired liver and kidney function.

    The experience of using the drug in pediatric practice in patients with neutropenia or with primary or with secondary immunodeficiency is not.

    Impact on the ability to driving vehicles and control mechanisms

    Meonone does not affect the ability to control the car and other technique.

    Overdose

    Random overdose is possible during treatment, especially when treating patients with impaired kidney function.

    Treatment: symptomatic. Normally, fast elimination of the drug through the kidneys occurs. In patients with renal impairment, hemodialysis effectively removes meropenem and its metabolites.

    Medicinal interaction

    The probenecide competes with a meropenem for the active channel secretion, inhibiting renal excretion and causing an increase in T 1/2 and the concentration of the merebenem in the plasma. Since the effectiveness and duration of the action of the measurement introduced without a probenecide is adequate, the simultaneous use of a meringue with a measurement is not recommended.

    The possible impact of the meronem for the binding of other drugs with proteins or metabolism has not been studied. The binding of a mereonema with proteins is low (about 2%), it is assumed that interactions with other drugs based on the displacement of plasma proteins should not be.

    The use of Meronea during the reception of other drugs was not accompanied by the development of adverse pharmacological interaction.

    Merreon can reduce the concentration of valproic acid in the blood plasma. In some patients, the concentration may be lower therapeutic. However, specific data on the possible medicinal interaction not.

    The shelf life of the drug

    Shelf life - 4 years.

    Merreon, diluted, as described above, retains satisfactory efficacy when storing at room temperature (below 25 ° C) or when stored in the refrigerator (up to 4 ° C) for the time specified in the following table:

        Solvent Storage duration (h)
        at 15-25 ° C at 4 ° C
        Vials divided by water for injection intended for bolus injection 8 48
        Solutions (1-20 mg / ml) cooked with:
        0.9% sodium chloride 8 48
        5% dextrose (glucose) 3 14
        5% dextrose (glucose) and 0.225% sodium chloride 3 14
        5% dextrose (glucose) and 0.9% sodium chloride 3 14
        5% dextrose (glucose) and 0.15% potassium chloride 3 14
        2.5% dextrose (glucose) or 10% mannithol for in / in infusion 3 14
        10% dextrose (glucose) 2 8
        5% dextrose (glucose) and 0.02% sodium bicarbonate for in / in infusion 2 8

    Merreon - antibiotic from the group of carbapenes, which has a bactericidal effect against a wide range of anaerobic and aerobic bacteria.

    Release form and composition

    Merone is produced in the form of a powder for making a solution for intravenous administration from white to pale yellow (at a dose of 500 mg in glass vials with a volume of 10 ml and 20 ml, and at a dose of 1000 mg in bottles with a capacity of 30 ml, with a rubber plug, an aluminum crimp ring and plastic cap; in a cardboard pack with the first control Opening of 10 bottles).

    The composition of the powder in 1 bottle:

    • Active substance: Meropenem trihydrate - 570 mg and 1140 mg, which is equivalent to anhydrous meropenem - 500 mg and 1000 mg, respectively;
    • Additional components: sodium carbonate (anhydrous).

    Indications for use

    • Pneumonia (including in-hospital);
    • Infections of the abdominal cavity;
    • Infections of the urinary system;
    • Infectious and inflammatory lesions of small pelvis organs (such as endometrite);
    • Skin infections and its structures;
    • Septicemia;
    • Meningitis.

    The drug is used as empirical treatment adult patients both in the form of monotherapy and in combination with antivirus or antifungal drugs With suspected infection with the symptoms of febrile neutropenia. The effectiveness of the means during combination with others has been proven. antimicrobial drugs and in monotherapy mode in the treatment of polyimicrobial infections.

    Contraindications

    • Age up to 3 months;
    • Increased sensitivity to Meropenemia, as well as pronounced hypersensitivity (heavy skin reactions, anaphylactic reactions) to any antibacterial agents having a beta-lactam structure (including penicillin or cephalosporins).

    With caution, the agent for gastrointestinal complaints is used, especially in the presence of colitis, as well as in combination with potentially nephrotoxic drugs.

    Meonone is not recommended to use during pregnancy and breastfeeding, his reception is admissible only when the expected benefit from treatment exceeds possible risk Development adverse Reactions. The use of the drug is required under the direct supervision of the doctor.

    During the period of lactation, if necessary, the means should be made to decide on the refusal of breastfeeding.

    Method of application and dosage

    The duration of therapy and the dosage mode are mounted depending on the severity and nature of infection, as well as the patient's condition. The following are the recommended average daily doses for adults administered intravenously with such lesions:

    • Pneumonia, gynecological infections (endometritis), urinary tract infections, skin infections and its structures: at a dose of 500 mg every 8 hours;
    • Hospital pneumonia, peritonitis, septicemia, as well as alleged bacterial infection in patients with signs of neutropenia: at a dose of 1000 mg every 8 hours;
    • Meningitis: 2000 mg every 8 hours.

    Patients with kidney violations during clearance of creatinine 50 ml per minute and less required dosing mode correction (the drug is administered 1-2 times a day in one or ½ dose unit). Since the measurement is derived during hemodialysis, with long-term treatment to restore its effective plasma concentration, it is recommended to introduce a unit of a dose after the completion of the hemodialysis procedure.

    The experience of using the tool with patients who show the procedure for peritoneal dialysis is absent.

    With violations of the liver, as well as elderly patients, the drug is introduced in conventional dosages.

    Children from 3 months and up to 12 years are recommended for intravenous dose, which makes 10-20 mg per 1 kg of body weight, introduced 3 times a day at equal intervals (every 8 hours). With the weight of the body, more than 50 kg are prescribed the same doses as adults. For the treatment of meningitis, it is recommended to use 40 mg of the drug per 1 kg of body weight every 8 hours.

    The experience of using the drug in children with violations of the kidney and liver is missing.

    Merone is administered intravenously in the form of bolus injections (at least 5 minutes) and infusions (for 15-30 minutes), it is recommended to use a freshly prepared solution. For bolus administrations, sterile water for injection in an amount of 5 ml per 250 mg of the preparation is used as a solvent. The concentration of the solution representing a transparent colorless or pale yellow liquid is about 50 mg / ml.

    For intravenous infusions, the powder is divorced by one of the compatible infusion fluids in an amount of from 50 to 200 ml, and include:

    • 5 or 10% dextrose solution;
    • 0.9% sodium chloride solution;
    • 0.9% sodium chloride solution and 5% dextrose solution;
    • 5% dextrose solution with a 0.02% sodium hydrocarbonate solution;
    • 5% dextrose solution with 0.15% solution of potassium chloride;
    • 5% dextrose solution with 0.225% sodium chloride solution;
    • 2.5 or 10% mannitol solution.

    All bottles are intended for disposable, before use, the finished solution is required to shake. Meonone cannot be mixed with solutions containing other drugs.

    Side effects

    There is a good tolerance of the means, severe adverse reactions are rarely observed. There are information about the following undesirable effects:

    • Digestive system: often - nausea, diarrhea, vomiting, abdominal pain; Rarely - Increased blood (reversible) level of transaminases, bilirubin, lactate dehydrogenase (LDH) and alkaline phosphatase (SFC) separately or in combination; extremely rarely pseudommbranous colitis;
    • Dermatological reactions: infrequent - urticaria, rash, itching; Very rare - multiform (exudative) erythema, toxic epidermal necroliz, Stevens-Johnson syndrome;
    • Blood-formation system: often - reversible thrombocytosis, infrequently thrombocytopenia, eosinophilia, neutropenia and leukopenia (including extremely rare agranulocytosis cases); rarely - a decrease in partial thromboplastin time, very rarely hemolytic anemia;
    • Kidney I. urinary Ways: rarely - an increase in the concentration of creatinine and urea in the blood;
    • Nervous system: infrequently - paresthesia, headache; with an unidentified causal relationship with the drug reception, rarely convulsions;
    • Allergic reactions: very rarely - anaphylactic reactions, angioedema edema;
    • Local reactions: often - thrombophlebitis, inflammation, pain in the place of administration;
    • Others: Rarely - Candidiasis of the oral mucosa, vaginal candidiasis.

    Also reported cases of positive direct or indirect Cumbas sample.

    During treatment, random overdose is possible, especially in patients with violation of the kidney activities. At the same time, symptomatic therapy is prescribed, a quick elimination of the drug through the kidneys is observed, hemodialysis is prescribed during the renal disorders.

    special instructions

    In pediatric practice, the experience of using the drug in patients with primary or with secondary immunodeficiency or with neutropenia is not available.

    Also as with the use of other antibiotics when using a monotherapy in the form of monotherapy in patients with a diagnosed Pseudomonas Aeruginosa infection, or when suspicion of it in a critical condition, it is necessary to regularly carry out sensitivity tests to the antibiotic.

    Very rarely during the reception of the means (as well as using almost all antibiotics), the development of pseudo-membrane colitis can be observed, the severity of the manifestation of which can vary from light to the threatening life of the form. When the treatment of diarrhea appears on the background, it is important to take into account the possibility of the occurrence of pseudommbranous colitis.

    Before starting the course of therapy, it is recommended to carry out a thorough patient's survey, paying particular attention to the previously occurring hypersensitivity reactions to beta-lactam antibiotics, as there are laboratory and clinical signs of cross-allergy of carbapenes and beta-lactam antibiotics (cephalosporins and penicillins). It is necessary to use measurement with extreme caution in the presence of similar effects in the history.

    When appearance allergic reaction On Meropene, it is necessary to immediately stop the introduction of a solution and take the necessary measures.

    During therapy, an overweight increase in insensitive microorganisms may be noted, as a result, constant monitoring of the patient is required.

    Patients with liver lesions need to monitor the level of bilirubin and transaminases.

    Care should be taken when driving motor transport and other complex mechanisms, given the likelihood of such unwanted phenomena, as paresthesia, headache, cramps.

    Medicinal interaction

    Merone can contribute to lowering the level of valproic acid in serum.

    Terms and conditions of storage

    Store in place inaccessible to children, at a temperature not exceeding 30 ° C.

    Shelf life - 4 years.

    Composition and form of release

    in bottles of glass capacity 10 or 20 ml, closed with rubber plug, compressed by an aluminum ring and plastic cap; In a pack of cardboard with the control of the first opening of 10 bottles.

    in bottles of glass with a capacity of 30 ml, closed with rubber plug, compressed by an aluminum ring and plastic cap; In a pack of cardboard with the control of the first opening of 10 bottles.

    Description of the dosage form

    Powder from white to light yellow color.

    pharmachologic effect

    pharmachologic effect - Antibacterial.

    Indications of the drug Merream ®

    Merreon ® is shown to treat in children (over 3 months) and adults of the following infectious inflammatory diseases caused by one or more sensitive to Meropenee:

    Pneumonia, including nosocomial pneumonia;

    Urinary system infections;

    Infections of the abdominal cavity;

    Infectious inflammatory diseases of the small pelvis organs, such as endometritis;

    Skin infections and its structures;

    Meningitis;

    Septicemia.

    Empirical therapy of adult patients with an estimated infection with symptoms of febrile neutropenia in monotherapy mode or in combination with antiviral or antifungal drugs.

    The effectiveness of the drug Merone ® is proven both in monotherapy mode and in combination with other antimicrobial means in the treatment of polyimicrobial infections.

    Contraindications

    hypersensitivity to Meropene or other preparations of group of carbapenams in history;

    pronounced hypersensitivity (anaphylactic reactions, heavy skin reactions) to any antibacterial mediumhaving a beta-lactam structure (i.e. to penicillins or cephalosporins);

    children up to 3 months.

    Carefully: simultaneous use with potentially nephrotoxic drugs; Patients with complaints from the gastrointestinal tract (diarrhea), especially suffering colitis.

    Application in pregnancy and breastfeeding

    Pregnancy

    The safety of the use of the drug Merrem ® in women during pregnancy was not studied. Animal studies have not shown any adverse effects on developing fruit.

    Merone ® should not be applied during pregnancy, except when the potential advantage for the mother of its application exceeds the possible risk to the fetus. In each case, the drug should be applied under the strict observation of the doctor.

    Lactation

    Meropenem is determined in breast milk of animals in very low concentrations. Merone ® should not be used during breastfeeding period, except in cases where the potential advantage for the mother from the use of the drug exceeds the possible risk for the child. Assessing the advantage for the mother, it is necessary to decide on the cessation of breastfeeding or cancellation of the drug Meleon ®.

    Side effects

    In general, Meropenem is characterized by good tolerance. In rare cases side effects led to cancellation of therapy. Serious adverse reactions are rare.

    The frequency of adverse reactions is shown below in the form of the following gradation: very often (≥1 / 10); Often (≥1 / 100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1/10000).

    Blood formation system *: often - thrombocytosis; infrequently - eosinophilia, thrombocytopenia; rarely leukopenia, neutropenia, agranulocytosis; Very rarely - hemolytic anemia.

    Nervous system: Nechast - Golovnya Para, Parestsia, Synmok **, Halcucinations **, Depression **, Anxiety **, Increased excitability **, insomnia **; Rarely - cramps.

    PCT: often - nausea, vomiting, diarrhea, increasing the activity of hepatic transaminases, SFF, LDH and bilirubin concentration in serum; Necharan - constipation **, cholestatic hepatitis **; Very rarely - pseudommbranous colitis.

    Leather and subcutaneous fiber: Infrequently - rash, urticaria, skin itching; Very rarely - Multiform Erythema, Stevens-Johnson syndrome, toxic epidermal necroliz.

    The immune system: Very rarely - angioedema swelling, manifestations of anaphylaxis.

    SCC: Necharano - Heartless Laughty **, Stavzta Hearts **, Tachycardia **, Bradycardia **, Inectarkt Miocardial **, Reduced or enhanced ad **, thromboembolism of pulmonary artery branches **.

    Kidneys and urinary ways: Infrequently - an increase in the concentration of creatinine in the blood, an increase in the concentration of urea in the blood.

    Respiratory tract: Infrequently - Disnaise **.

    Others: often - local reactions (inflammation, thrombophlebitis, pain in the place of administration); Rarely - vaginal candidiasis and candidiasis of the oral mucosa.

    * Reported on cases of positive direct or indirect Cumbac sample, as well as cases of decline in partial thromboplasty time.

    ** The causal relationship with the reception of the drug Merrem ® is not established. The side effects were observed in the study, which included 2904 immunocompetent adult patients treated with therapy with Meleon® (500 or 1000 mg every 8 h) due to infections that do not affect CNS. In 36 patients therapy was discontinued due to unwanted phenomena. In 5 cases, the connection of the fatal outcome with the therapy is not excluded. Against the background of the severe condition of patients, numerous diseases and multiple concomitant therapy with other drugs, it was not possible to conclude a conclusion about the association of a side effect with therapy with Meleon® drug.

    Method of application and dose

    Adults.

    Dosage and duration of therapy should be established depending on the type and severity of the infection and the patient's condition.

    500 mg in / every 8 hours in the treatment of pneumonia, urinary tract infections, gynecological infections, such as endometritis, skin infections and skin structures;

    1 g in / every 8 hours in the treatment of nosocomial pneumonia, peritonitis, suspected of a bacterial infection in patients with neutropenia symptoms, as well as septicemia.

    The safety of the dose of 2 g in the form of a bolus injection is not sufficiently studied.

    Dose in adult patients in violation of the kidney function

    In patients with Creatinine CL, less than 51 ml / min dose should be reduced as follows:

    Clement Creatinine, ML / Min Dose (based on unit doses 500 mg, 1 g, 2 g) Frequency of administration
    26-50 One dose unit every 12 ch
    10-25 0.5 dose units every 12 ch
    <10 0.5 dose units every 24 ch

    Meropene is excreted during hemodialysis. If a long-term treatment with Meonone ® is required, it is recommended that the dose unit (based on the type and severity of infection) is introduced upon completion of the hemodialysis procedure to restore the effective concentration in the blood plasma.

    Currently, there is no data on the experience of using the drug Merreon ® for administering patients located on peritoneal dialysis.

    Dosing in adult patients with impaired liver function

    In patients with hepatic insufficiency, there is no need to correct the dose (see the "Special Instructions" section).

    Elderly patients

    The elderly patients with normal kidney function or CL creatinine more than 50 ml / min do not require a dose correction.

    Children

    For children aged from 3 months to 12 years, the recommended dose for in / in administration is 10-20 mg / kg every 8 hours depending on the type and severity of infection, the sensitivity of the pathogenic microorganism and the patient's condition. In children weighing a body more than 50 kg should use doses for adults.

    The safety of the dose of 40 mg / kg in the form of a bolus injection is not sufficiently studied.

    There is no experience in the use of the drug in children with impaired liver and kidney function.

    Method of administration

    Merreon ® for C / for use can be administered in the form of a B / in bolus injection for at least 5 minutes, or in the form of a / in infusion for 15-30 minutes, using appropriate infusion fluids for dilution.

    The possibility of using a meropenem in extended infusion mode (up to 3 hours) is based on pharmacokinetic and pharmacodynamic parameters. To date, clinical data and security data confirming this mode are limited.

    If a decision is made on the patient's therapy by the method of extended infusion, it should be paid to data on the stability of compatible infusion liquids (see table below).

    Merone ® for B C / in bolus injections should be breed sterile water for injections (5 ml per 250 mg of meropenem), while the concentration of the solution is about 50 mg / ml. The resulting solution is a transparent colorless or light yellow liquid.

    Merone ® for in / in infusions can be divorced by a compatible infusion fluid (from 50 to 200 ml).

    Merone ® should not be mixed or added to other drugs.

    Merone ® compatible with the following infusion fluids:

    0.9% sodium chloride solution;

    5 or 10% dextrose solution;

    5% dextrose solution with a 0.02% sodium hydrocarbonate solution;

    0.9% sodium chloride solution and 5% dextrose solution;

    5% dextrose solution with 0.225% sodium chloride solution;

    5% dextrose solution with 0.15% solution of potassium chloride;

    2.5 or 10% mannitol solution.

    When diluting the drug Merreon ®, the standard aseptic mode should be observed. It is necessary to shake the diluted solution before administration.

    All bottles are intended only for one-time application.

    For in / in injection and infusion, it is recommended to use a freshly prepared solution of the drug Merreon ®

    Merone ®, diluted, as described above, retains efficiency when storing at room temperature (below 25 ° C) or when stored in the refrigerator (up to 4 ° C) during the time specified in the following table:

    Solvent Storage duration, h
    at 15-25 ° C at 4 ° C

    Preparation, diluted with water for injection, intended for bolus injection

    8 24

    solutions (1-20 mg / ml) prepared using:

    0.9% sodium chloride 8 48
    5% dextrose 3 14
    5% dextrose and 0.225% sodium chloride 3 14
    5% dextrose and 0.9% sodium chloride 3 14
    5% dextrose and 0.15% potassium chloride 3 14
    2.5% dextrose or 10% mannithol for in / in infusion 3 14
    10% dextrose 2 8
    5% dextrose and 0.02% sodium bicarbonate for in / in infusion 2 8

    The solution of the drug Merreon ® should not be frozen.

    Overdose

    Random overdose during treatment is possible, especially in patients with impaired kidney function.

    Treatment: symptomatic. Normally, fast elimination of the drug through the kidneys occurs. In patients with violations of the kidney function, hemodialysis effectively removes meropenem and its metabolite.

    special instructions

    The experience of using the drug in pediatric practice in patients with neutropenia or with primary or with secondary immunodeficiency is not.

    As with the use of other antibiotics when applying a monotherapy mode in patients who are critical with the identified infection of the lower respiratory tract caused by Pseudomonas Aeruginosa or, if it is suspected, it is recommended to regularly carry out sensitivity test.

    In rare cases, when using the drug Merreon ®, as with the use of almost all antibiotics, the development of pseudo-memory colitis is observed, which can vary in gravity from the lungs to the threatening life of the forms. It is important to remember the possibility of the development of pseudommabranous colitis when diarrhea occurs on the background of the use of the drug Merrem ®.

    There are clinical and laboratory signs of cross-allergic reactions between other carbapenes and beta-lactam antibiotics, penicillins and cephalosporins. There are rare messages about cases of hypersensitivity reactions (including, with a fatal outcome) when using the drug Meleon ®, as well as other beta-lactam antibiotics (see the section "Sidey action"). Before starting therapy, the Meropem must carefully interrogate the patient, paying special attention to the reaction of hypersensitivity to beta-lactam antibiotics in an anamnesis. Merreon ® should be used with caution in patients with instructions in the history of similar phenomena. If an allergic reaction occurs on a meropenem, then it is necessary to stop the administration of the drug and take appropriate measures.

    The use of drug measure ® in patients with liver diseases should be carried out under a thorough control of the activity of transaminase and bilirubin concentration.

    As in the case of the use of other antibiotics, an excess increase in insensitive microorganisms is possible, and therefore continuously monitor patient.

    The prevalence of the acquired antibiotic resistance of various pathogens may vary depending on the region and time, it is desirable to preserve current information on the resistance of common pathogens in a particular region, especially in the treatment of severe infections. In case the resistance is such that the effectiveness of the drug in relation to at least some infections becomes doubtful, the expert should be consulted.

    The use of the drug in infections caused by a metieticillin-resistant staphylococcus is not recommended.

    Impact on the ability to drive a car and work with technology. There was no research on the effect of the drug Merrem ® on the ability to control the car and other technique. Nevertheless, it should be taken into account that when taking the drug Merrem ®, there may be headaches, paresthesia and convulsions.

    Comment

    Before using the drug, you need to read the instructions for use.

    Conditions of vacation from pharmacies

    On prescription.

    Conditions for the storage of the drug Merrem ®

    At a temperature not higher than 30 ° C.

    Keep out of the reach of children.

    The shelf life of the drug Merream ®

    4 years.

    Do not apply after the expiration date indicated on the package.

    Synonyms of nosological groups

    Rubric ICB-10Synonyms for diseases of the ICD-10
    A39 Meningococcal infectionAsymptomatic carriage of Meningokokkov
    Infection Meningokokokova
    Meningococcosity
    Epidemic Meningitis
    A41.9 Septicemia UncomfortableBacterial septicemia
    Hard course bacterial infections
    Generalized infections
    Generalized system infections
    Generalized infections
    Wounded Sepsis
    Septico-toxic complications
    Septicopemia
    Septicemia
    Septicemia / Bacteremia
    Septic diseases
    Septic conditions
    Septic shock
    Septic condition
    Toxic-infectious shock
    Septic shock
    Endotoxin shock
    A49 bacterial infection of unspecified localizationBacterial infection
    Bacterial infections
    Bacterial infections
    Infectious diseases
    G00 bacterial meningitis not classified in other categoriesMeningheal infections
    Meningitis
    Meningitis bacterial etiology
    PAHIMENINGIT Outdoor
    Epidurist purulent
    J18 pneumonia without refinementAlveolar pneumonia
    Outpatient atypical pneumonia
    Non-hospital pneumonia Nepnemokokokovaya
    Pneumonia
    Inflammation of the lower respiratory tract
    Inflammatory lung disease
    Pneumonia
    Respiratory tract infections and lungs
    Infections of the lower respiratory tract
    Cough with inflammatory lung and bronchial diseases
    Brewing pneumonia
    Lymphoid interstitial pneumonia
    Nosocomial pneumonia
    The aggravation of chronic pneumonia
    Acute over-hospital pneumonia
    Acute pneumonia
    Heat pneumonia
    Abscessive pneumonia
    Pneumonia bacteria
    Pneumonia brunette
    Pneumonia focal
    Pneumonia with difficulty wetting wet
    Pneumonia in Patients with AIDS
    Pneumonia in children
    Septic pneumonia
    Chronic obstructive pneumonia
    Chronic pneumonia
    K65 peritonitAbdominal infection
    Intraperitoneal infections
    Intrably infections
    Diffuse peritonit
    Abdominal infections
    Abdominal cavity infections
    Infection of the abdominal cavity
    Infection of the gastrointestinal tract
    Spontaneous bacterial peritonitis
    L08.9 Local skin and subcutaneous infection infectious infectionAbscess soft tissues
    Bacterial or fungal skin infection
    Bacterial skin infections
    Bacterial infections of soft tissues
    Bacterial skin infections
    Bacterial lesions of the skin
    Viral skin infection
    Viral skin infections
    Inflammation of fiber
    Skin inflammation in injection places
    Inflammatory skin diseases
    Putting skin disease
    Punchy skin diseases
    Purve and inflammatory skin disease and soft tissues
    Purve and inflammatory skin diseases
    Purulent-inflammatory diseases of the skin and its appendages
    Purve and inflammatory diseases of soft tissues
    Purulent skin infections
    Purulent infections of soft tissues
    Skin infection
    Skin and skin infections
    Infectious skin damage
    Skin infectious diseases
    Skin infection
    Skin infection and its appendages
    Skin infection and subcutaneous structures
    Skin and mucous membranes infection
    Skin infection
    Skin bacterial infections
    Uncorrecting subcutaneous infections
    Uncomplicated skin infections
    Uncomplicated infections of soft tissues
    Surface erosion of skin with secondary infection
    Underfloor infection
    Mixed skin infections
    Specific infectious processes in the skin
    Superinfection of the skin
    N39.0 urinary tract infection without localizationAsimptomatic bacteriuria
    Bacterial urinary tract infections
    Bacterial infections of urinary tract
    Bacterial infections of the urogenital system
    Bacteriuria
    Bacteriuria asymptomatic
    Chronic latent bacteriuria
    Asymptomatic bacteriuria
    Asymptomatic massive bacteriuria
    Inflammatory urinary tract disease
    Inflammatory disease of the urinary tract
    Inflammatory diseases of the bladder and urinary tract
    Inflammatory urinary system diseases
    Inflammatory diseases of urinary tract
    Inflammatory diseases of the urogenital system
    Fungal diseases of the urogenital tract
    Fungal lesions of urinary tract
    Urinary tract infections
    Urinary tract infections
    Urinary system infections
    Urinary tract infections
    Urinary tract infections
    Urinary tract infections caused by enterococci or mixed flora
    Uncomplicated urinary tract infections
    Urinary tract infections complicated
    Infections of the organs of the urogenital system
    Urogenital infections
    Infectious diseases of urinary tract
    Urinary tract infection
    Urinary tract infection
    Infection of the urinary system
    Urinary tract infection
    Urinary tract infection
    Infection of the urogenital tract
    Uncomplicated urinary tract infections
    Uncomplicated urinary tract infections
    Uncomplicated infections of the urogenital system
    The aggravation of chronic urinary tract infection
    Retrograde kidney infection
    Recurrent urinary tract infections
    Recurrent urinary tract infections
    Recurrent infectious diseases of urinary tract
    Mixed urethral infections
    Urogenital infection
    Urogenital infectious inflammatory disease
    Urogenital mycoplasmosis
    Urological disease of infectious etiology
    Chronic urinary tract infection
    Chronic inflammatory diseases of the small pelvis organs
    Chronic urinary tract infections
    Chronic infectious diseases of the urinary system
    N71 Inflammatory uterus diseases except the cervixIntrauterine infections
    Inflammatory diseases of female genitals
    Inflammatory diseases of female genital organs
    Infection of genital organs
    Chronic endomyometrist
    Chronic inflammatory disease
    Endometritis
    Endomiometrist
    R78.8.0 * BactemeyBacteremia
    Persistent bacteremia
    T88.9 Completion of surgical and therapeutic intervention uncomputedPain syndrome in the postoperative period
    Pain syndrome in the postoperative period after orthopedic operations
    Pain syndrome after diagnostic procedures
    Pain syndrome after diagnostic interventions
    Pain syndrome after operations
    Pain syndrome after operating interventions
    Pain syndrome after orthopedic operations
    Pain syndrome after removing hemorrhoidal nodes
    Pain syndrome after surgical interventions
    Pain syndrome when applying an excimer laser
    Pain syndrome in injuries and after surgery
    Pain syndromes in dental practice
    Painful diagnostic interventions
    Painful diagnostic manipulations
    Painful instrumental diagnostic procedures
    Painful instrumental manipulations
    Painful healing procedures
    Painful manipulations
    Painful dressings
    Painful therapeutic interventions
    Painful surgical interventions
    Pain in the field of operating room
    Pain in the postoperative period
    Pain after diagnostic interventions
    Pain after orthopedic operations
    Pain after surgical interventions
    Pain in diagnostic procedures
    Pain in therapeutic procedures
    Pain in orthopedics
    Pain in the postoperative period
    Pain after diagnostic interventions
    Pain after sclerosing therapy
    Pain after dental interventions
    Pain after surgical interventions
    Postoperative pain
    Postoperative and post-traumatic pain
    Tooth extraction pain
    Inflammation after operations and injuries
    Inflammation after orthopedic operations
    Inflammatory processes after surgery
    Inflammatory syndrome after operating interventions
    Jointed postoperative fistulas
    Operating wound
    Complications after the removal of the tooth
    Postoperative pain
    Postoperative pain
    Postoperative pain syndrome
    Postoperative pain

    There are many diverse preparations that are used in medicine for various purposes. You will not know everyone. But when it comes to your health, you immediately begin to think about this or that drug, what is his side effects, which is included in its composition and other nuances. All this you need to know in order not to harm yourself. Today it will be about the drug called "Merreon". This drug is produced in the form of powder from white to light yellow for intravenous injection solutions. Refers to the pharmacotherapeutic group of carbapenem antibiotics. Description of the drug we will be made according to the directories of drugs "Vidal".

    Composition "Merreon" of the drug

    The composition of one bottle (0.5 grams) includes such active substances:

    1. trihydrate - 570 milligrams.
    2. Equivalent to Meropene Anhydrous - 500 milligrams.

    As an auxiliary substance is anhydrous sodium carbonate - 104 milligrams.

    Pharmacological properties

    Pharmacodynamics

    - Antibiotic group of carbapenes, which is intended for parenteral use, to the human dehydropptidase, it is relatively stable and the additional introduction of the inhibitor does not require. It has a bactericidal effect due to the fact that it affects the synthesis of the wall of the cell bacteria. The high level of the bactericidal activity of the meropenemia with respect to a wide range of anaerobic and aerobic bacteria is due to its high ability to penetrate through the cellular bacterial wall, a large level of stability to a multitude of beta - lactamas and significant affinity to different proteins of Pennitillin binding.

    Bactericidal minimal concentration Basically the same as inhibiting minimum concentrations. For those 76% of the types of bacteria that have been tested, the ratio of these two concentrations did not exceed 2 numbers.

    In Vitro tests show that Meropenem acts with different antibiotics synergistically.

    In these tests, it is also shown that this substance has a post - an antibiotic effect.

    Can microorganisms have one or several mechanisms resistance For Meonom:

    1. Beta-lactamaz products, under the influence of which carbapenes are hydrolylized.
    2. Lowering affinity for final PSB.
    3. Due to the disturbed synthesis of pyrins, the permeability of the cell wall of the gram-negative bacteria can be disturbed.

    Pathogens that are sensitive to Meropene

    Helping aircomes

    1. Streptococcus Pyogenes Group A.
    2. Streptococcus Pneumoniae.
    3. Group Streptococcus Milleri.
    4. Streptococcus Agalactiae Group in.
    5. Rank Staphylococcus.
    6. Staphylococcus aureus.
    7. Enterococcus faecalis.

    Helm-negative aerobes

    Gram-positive anaerobes

    1. Rank Peptostreptococcus.
    2. Peptoniphilus asaccharolyticus..
    3. Clostridium Perfringens.

    Anaerobes gram-negative

    1. Prevotella Disiens..
    2. Prevotella Bivia..
    3. InTeroes Fragilis.
    4. Bacteroides Caccae.

    Pathogens, which the problem of acquired resistance is relevant

    1. Help Hostess - Enterococcus Faecium.
    2. Helm-negative aerobes - Pseudomonas Aeruginosa,Burkholderia Cepacia,rank Acinetobacter.

    Pathogens that have natural resistance

    These include aerobes gram-negative - Legionella SPP,Stenotrophomonas Maltophilia.

    Other pathogens include: Coxiella Burnetii,Chlamydophila psittaci,Chlamydophila pneumoniae,Mycoplasma Pneumoniae.

    Pharmacokinetics

    Within 30 minutes, the introduction of intravenous drug "Meront" a healthy person leads to a blood plasma to the maximum concentrationwhich is approximately equal to:

    1. For a dose of 250 milligrams - 11 μg / ml.
    2. For a dose of 500 milligrams - 23 μg / ml.
    3. For a dose of 1 gram - 49 μg / ml.

    After 6 hours after the introduction of intravenous 500 milligrams, the concentration of the meropenem decreases in the blood plasma to a mark of 1 μg / ml and below.

    Approximately 70% of the administered dose of the drug "Meront" unchanged output kidneys for 12 hours. After that, renal minor excretion can be determined.

    In the urine, the concentration of the meropenem, which exceeds 10 μg / ml marks is maintained for 5 hours after the dose of 500 mg administered. At volunteers with a normal liver function, when administered every 8 hours of a dose of 500 mg or every 6 hours - 1 gram in the urine and in the plasma of the cumulation was not observed.

    The only metabolite of Meropenem is that it is inactive microbiologically.

    In children, research has shown that pharmacokinetics with adults of this drug is similar.

    In children by age up to 2 years old, the half-life of the Meropem is approximately 90 - 140 minutes. Linear dependence is observed in the dose range from 10 to 40 mg / kg.

    Disadvantage of renal

    In patients with renal failure, studies have shown that creatine clearance correlates with Meropenem clearance. For such patients, the dose must be adjusted.

    In the elderly study Pharmacokinetics revealed a decrease in the clearance of a meropenem that correlates with the age reduced clearance of creatinine. Merotion with clearance during hemodialysis is approximately 4 times higher than the clearance of the meropenem in people with Anuria.

    In patients suffering from liver diseases, pharmacokinetics studies have shown that pathological changes do not affect the pharmacokinetics of the Meropenem.

    Meronem - instructions for use

    Merreon is intended for treatment in adults and children (reached 3 months) of inflammatory infectious diseases that were caused causative agentsMeropene Sensitive:

    1. Septicemia.
    2. Meningitis.
    3. Skin infections and its structure.
    4. Infections of the abdominal cavity.
    5. Urinary system infections.
    6. Pneumonia and pneumonia are nosocomial.



    Empirical therapy Patients are more adults with infection intended with symptoms of febrile neurophenia in monotherapeutic mode or in combination with antifungal or antiviral drugs.

    The effectiveness of this drug is proved in all cases.

    Contraindications for use

    Contraindicated "Merreon" people with hypersensitivity to Meropenem or other medications of the group of carbapenams in an anamnesis.

    With pronounced hypersensitivity (heavy skin reactions and anaphylactic reactions) to any means of antibacterial, which have beta - lactam structure (to cephalosporins and penicillins). And this antibiotic is contraindicated to children up to three months.

    With caution you need to simultaneously take with potentially nephrotoxic substances. As well as people with complaints about the gastrointestinal tract (diarrhea), and especially those who suffer from colitis.

    Eating during bearing and feeding kid chest

    During the period of tooling the baby, the safety of the use of the drug "Meront" was not studied. And those studies that were carried out on pregnant animals did not show any adverse effects on the fruit that develops.

    For pregnancy "Merone" should not be applied by women. The exceptions are those cases when the potential advantage of its consumption exceeds the risk possible for the fetus. In each case, the medication must be taken under strict medical supervision.

    In the breastfeeding period, it was observed that Meropene was excreted together with breast milk. That is why it should not be taken "Merone" during breastfeeding period.

    The exception is only a case when for the mother the potential advantage of the application of the substance exceeds the possible risk for the kid. When assessing the risk for the mother, it is worth deciding whether to stop breastfeeding or canceling the use of the drug "Meront".

    Method of application and dosage

    In adults

    The duration and dosage of the therapy used are mounted depending on the state of the patient, as well as gravity and type of infection. Recommended such daily dosage:

    1. For the treatment of structures and infections of skin cover, endometritis, urinary channel infections, pneumonia is assigned to use every 8 hours of 500 milligrams intravenously.
    2. For the treatment of septicemia, if the infection is suspected, bacterial in patients with neutropenia symptoms, for the treatment of peritonitis, nosocomial pneumonia is prescribed to use every 8 hours intravenously 1 gram.
    3. For the treatment of meningitis, it is recommended to use every 8 hours of 2 grams intravenously. Such a dosage of application is not sufficiently studied.

    Adult dosage with renal impairment

    For people with clearance creatinine less than 51 ml / min Dosage needed reduce in the following way:

    1. When creatinine clearance, 26-50 ml / min should be administered every 12 hours of 1 gram.
    2. When clearance, 10-25 every 12 hours it is necessary to enter 500 milligrams.
    3. With clearance of creatinine less than 10 every 24 hours it is necessary to enter 500 milligrams.

    Output Meropenem with hemofiltration and hemodialysis. If treatment with the drug "Merone" requires a long period of application, it is recommended to enter it at the end of the hemodialysis procedure. This is necessary to restore the effective concentration in the blood plasma.

    For the use of patients in peritoneal dialysis, no data currently available.

    Dosage for adults with impaired liver function

    For such patients, it is not necessary to adjust the dosage.

    Dosage for elderly patients

    If an elderly person does not suffer renal and liver diseases, it should not be adjusted to the dosage.

    Dosage for children

    Children from three months to 12 years for intravenous administration, the recommended dosage is 10-20 mg / kg. The dose must be administered every 8 hours depending on the severity and type of infection, the state of the patient and the sensitivity of the pathogenic microorganism. Children, whose body weight exceeds 50 kilograms, uses dosage for adults. In the treatment of meningitis, the drug must be introduced every 8 hours. The required dosage in this case is 40 mg / kg. Such a dosage is not studied enough. And the experiments were not conducted on children who have a kidney and liver functions.

    Method of administration

    "Merone" intravenous use can be introduced into the human body in the form of a bolus intravenous injection for no less than 5 minutes. Another way of administration is intravenous infusion for 15 to 30 minutes. In order to dilute this drug, it is necessary to apply the corresponding infusion fluids.

    In order to cook solution For bolus intravenous injection, it is necessary to dissolve the drug in special sterile water (by 250 milligrams of Meropenem 5 milliliters of water). The concentration of the solution should be 50 mg / ml. This solution at a temperature of 25 degrees for three hours retains stability. And when stored in the refrigerator (temperature range from 2 to 8 degrees) - for 16 hours.

    In order to prepare a solution for intravenous infusion you need to dissolve the sodium solution of chloride sodium (0.9%) for infusion or 5% glucose solution (dextrose). The concentration of the solution should be from 1 to 20 mg / ml.

    Such a solution at a temperature of 25 degrees retains stability for 3 hours, and at a temperature of 2 to 8 degrees, then for 24 hours, if in order to prepare it was used a solution of chloride sodium (0.9%).

    If a solution of 5% glucose was used for the preparation, then use the injection immediately.

    It is forbidden to freeze the solution "Meromen".

    Side effects

    In rare cases, such heavy sidelies were noticed. effects:

    Overdose

    During treatment is random overdose. This is especially true of patients with impaired renal function. In this case, symptomatic treatment is carried out. Normally, the elimination of medication by the kidneys occurs. People with impaired renal hemodialysis effectively removes meropenem and metabolites from it.

    special instructions

    In pediatric practice, the experience of using medication in patients with primary or secondary immunodeficiency and neutropenia is not.

    It is recommended that the sensitivity test is recommended for suspected or already identified respiratory infections. This applies to patients who are in critical condition and Meropenem are used in monotherapy mode.

    Very rarely, at the reception of this drug, the development of pseudommabranous colitis is observed. Its forms of manifestation can range from lungs to those who are life-threatening. It is necessary to remember the possible development of the colitis of the pseudomembranous when the diarrhea occurs, which appeared against the background of using this drug.

    If the colitis pseudommabranous appeared, then it is necessary to abandon this type of antibiotic.

    The use of medicines that brake intestinal peristalsis is contraindicated.

    It is worth abiding for special caution when receiving this medication to people with a reduced sorry readiness threshold. This is due to the fact that there were cases of convulsion.

    Allergic reactions occur when applying carbapenes and cephalosporins, penicillins and beta lactams.

    In some cases, patients complained about hypersensitivity from the drug. Therefore, before appointing you this kind of antibiotic, the doctor should learn in detail your reaction to hypersensitivity To beta antibiotics - lactam in history. If you have an allergy to this antibiotic, it should immediately stop its introduction and carry out appropriate treatment measures.

    The use of medication in patients with impaired liver function is carried out under special controlling the level of bilirubin and transaminase activity.

    Interaction with other medicines

    The meropenem competes a probenacide for the channel active secretion, thereby inhibits the excretion of the renal meropenem. This causes an increase in the half-life of the substance and its concentration in the blood plasma. Due to the fact that the duration of action and the effectiveness of "Meronema" without probecid - adequate, then it is not recommended to introduce them together.

    For metabolism and binding to proteins, the possible effect of "Meronem" and other drugs has not been studied. But taking into account the fact that a very low level of binding of blood plasma proteins and a meropenem should not be combined with "Merone" with other medicines.

    In blood serum, "Merone" can reduce the amount of valproic acid. In some people, the level may decrease below the therapeutic.

    Release form, storage conditions and vacation from pharmacies

    In the form of release "Merremon" is powder To prepare a solution of intravenous administration of 500 milligrams and 1 gram. In a glass bottle of 500 milligram of the active substance, there are 10 and 20 milliliters, and 1 gram is 30 milliliters. The vials are closed with rubber caps, which are covered with aluminum ring aluminum and plastic cap. The paint on the outside of the bottle is caused by the AZ logo. The bottles are stacked in a cardboard box of 10 pieces. An instruction is attached to them, and then the box is used to the first autopsy control ribbon.

    Keep "Merone" needed in places that for children unavailable. The air temperature in the room where the drug is stored should not exceed 30 degrees.

    Shelf life - 48 months. After the deadline that the manufacturer pointed out the package, as the final date of use, the drug should be disposed of. Apply it after this date is strictly prohibited.

    From Pharmacies "Meront" is released only by the recipe, which discharges the attending physician.

    Merreon is a medicine related to the group of antibiotics. It effectively copes with malicious bacteria of aerobic and anaerobic character. The active ingredient of this drug penetrates the cells of microorganisms and blocks their synthesis. The result becomes a complete getting rid of infection. It is possible to apply this medicine only after consulting with your doctor. Otherwise, there is a high probability of harm to health.

    Composition and form of release

    The main indicator of the admission of drug intake is its presence in the drug register (RLS). Merone can be purchased in pharmacies of any city. To do this, you will need not only a big amount, but also a doctor's recipe. Without it, legal to buy the medicine will not work.

    The price of an antibiotic measurement (MNN Meropem) directly depends on the amount of active substance located in the preparation. It is produced in glass bottles with a capacity of 10, 20 or 30 milliliters. They are tightly closed with rubber plug and compressed by an aluminum ring. From above there is a plastic lid. Vials are packaged in cardboard boxes of 10 pieces.

    Merone consists of the following components:

    1. Meropenem trihydrate. This chemical compound acts as an active substance. In one bottle, its content ranges from 570 to 1140 mg (corresponds to 500 mg of anhydrous meropenem). The volume depends on the size of the tank and the concentration of the drug.
    2. Anhydrous sodium carbonate. It is added in measure as an excipient. Its quantity can vary from 104 to 208 mg.

    A drug is available only in the form of a powder that can have white or light yellow. The manufactured drug is packaged into bottles of 0.5 or 1 gram. This powder is intended for self-preparation of a solution that is introduced intravenously.

    Indications for use

    This medicine can be used for both adults and children. The only difference in the application will be dosage.

    This drug is prescribed under the following diseases and conditions:

    • inflammation of the lungs and any other problems with respiratory authorities;
    • inflammation in a small pelvis;
    • endometritis;
    • diseases of the urogenital system;
    • gynecological complications after childbirth;
    • bacterial meningitis;
    • peritonitis, appendicitis and other inflammation in the abdominal cavity;
    • blood poisoning;
    • various infectious diseases of the skin and soft tissues (impetigo, face, dermatosis);
    • neurophenia (reducing the number of neutrophils in the blood).


    Contraindications

    Meront, like any other drug, has several contraindications. They must be taken into account before admission, as negligence can lead to exacerbation of the disease, as well as a strong deterioration of health.

    It is forbidden to use medicine in such cases:

    • individual intolerance of the active substance (meropenem trihydrate);
    • hypersensitivity to sodium carbonate;
    • during pregnancy and breastfeeding;
    • anaphylactic reactions to some antibiotics (cephalosporin, penicillin);
    • infant age up to 3 months;
    • simultaneously with nephrotoxic antibiotics;
    • colutes, diarrhea and other problems with the gastrointestinal tract (you can take, but with extreme caution).

    Instructions for use

    It is possible to use measurement only after consulting with your doctor. Only a specialist can determine the optimal admission schedule and pick up the most efficient dosages. All these characteristics are selected on the basis of the current state of the patient and the severity of the disease.

    For adults

    Patients over 18 years old are much better tolerant of this antibiotic than minors and children. Therefore, the duration of the course and the dosage of the medication is large for them.

    1. In the gynecological diseases, the pathologies of urinary tract, pneumonia, as well as skin infections. Intravenous injections should be made (up to 500 mg for one injection). Such procedures must be performed no more than three times a day. The frequency of injections and their number determines the attending physician.
    2. For the treatment of peritonitis, nosocomial pneumonia, bacterial diseases (in people suffering from symptoms of neutropenia and septicemia). 1 gram medication for one procedure. Crims should be done every 8 hours for 5-10 days.
    3. When meningitis at any stage of the disease. A standard dose of up 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.
    4. For people with impaired kidney functions. With such diseases, it is recommended to reduce not only the dosage of the medication, but also the frequency of injection. These two parameters depend on the cryatinine clearance indicator. If it is less than 51 ml / min, you should switch to disposable injections with a measure of 500 mg. The drug is derived from the organism during hemodialysis, so the new dose must be entered only after the completion of this procedure.
    5. With liver diseases. People with liver failure can use measure the same as the rest. In this case, no restrictions are provided.

    Children and Elderly Patients

    Otherwise, you should use a measure for children and the elderly. They require special dosages and the right approach to choosing the amount of injection.

    Dosages:

    1. Children from 3 months to 12 years. A dose for intravenous administration to 10-20 mg / kg should be reduced and calculated on the basis of the child's weight. If the body weight exceeds 50 kg, you can make "adults" injections. The frequency of injections is selected depending on the type of disease, stage, sensitivity of bacteria and patient states.
    2. From 12 to 18 years. Most often a full dose of medicine is introduced. The only exception is teenagers with a weight of up to 50 kg. For them, the special amount of the drug is determined.
    3. Elderly people. The amount of medication can only be reduced in case of problems with the kidneys and the urinary system.

    Pregnant and lactating women

    It is especially important to correctly determine the dosage and duration of the course of treatment with merronic during pregnancy. The mistake of doctors can lead to the most serious health issues and the child. To this not happen, it is necessary to consider such rules:

    1. You can enter the medicine intravenously only under the supervision of a specialist.
    2. It is forbidden to use even minimal dosages at individual intolerance to the drug.
    3. It is impossible to make injections if the positive effects of the medication on the mother exceeds the potential risk for the child.

    In the period of breast feeding should be abandoned from the use of merine. If this is not done, that is, the high probability of getting medicine into the kid's body. In extreme cases, when antibiotic treatment is vital, mothers should abandon breast feeding.

    Side effects

    With incorrect drug intake, some side effects may occur. However, serious pathologies are extremely rare.

    The main ones are:

    1. Circulatory system. Patients often observed platelet and eosinophilia. In rare cases, leukopenia, agranulocytosis, anemia can appear.
    2. Nervous system. In addition to headaches, rare hallucinations or fainting may occur. Meonone can increase the anxiety, excitability or provoke depression. In rare cases, such disorders lead to insomnia.
    3. Gastrointestinal tract. In case of improper use of the drug is possible nausea, vomiting, diarrhea, colitis. Infrequent manifestation - constipation, cholestatic hepatitis.
    4. Skin cover. On the surface of the skin there may be rashes, urticaria, as well as felt strong itching. Sometimes multiform erythema and epidermal necroliz.
    5. The immune system. Merreon practically does not have any impact, but it can sometimes cause anaphylaxis and angioedema edema.
    6. The cardiovascular system. The consequence of medication can be light tachycardia or bradycardia. In the most extreme cases, heart failure, myocardial infarction, as well as a heart stop is possible.

    In addition to all listed side effects, thrombophlebitis, pain in injection injection places and small inflammations may be observed.

    Interaction with other drugs

    During the reception, the Meronee should pay attention to its interaction with other drugs. Some combinations can cause side effects and significantly worsen health.

    1. It is forbidden to take a measure with heparin.
    2. Sharing an antibiotic with nephrotoxic means increases the likelihood of hazardous complications.
    3. A combination with valproic acid can reduce the effectiveness of the fight against causative agents of the disease.
    4. The reception of meronema and probelecids contribute to the rapid removal of the antibiotic from the body and increases its concentration in the circulatory system.

    Analogs

    Medicine producers have developed several dozen mereonem analogs. All of them have a similar action and differ only worth. The price of the drug in Moscow may vary from 8 to 15 thousand rubles, depending on the size of the bottle.

    Analogs of funds are more accessible to most patients and can cost within 2,000 rubles. The price of merronic in St. Petersburg and other major cities of Russia is practically no different from Moscow.

    Most popular analogues:

    1. Medshop. The medicine is performed as a soluble injection powder. The main advantage is low price, and the disadvantage is the presence of a large number of contraindications.
    2. Invaz. This drug copes well with most malicious bacteria. It can be used in diabetes mellitus, but it is forbidden to take with high sensitivity to lidokain.
    3. Measure. Produced in the form of a powder for the manufacture of a solution. The drug is much better tolerated than Merreon and has fewer side effects. The only drawback is a relatively high price.

    Merreon is a qualitative and effective medicine that helps to cope with many malicious bacteria. With proper application and compliance with all the recommendations of doctors, you can not be afraid of any side effects and cure the most quickly as possible.

    Have questions?

    Report typos

    The text that will be sent to our editors: