Active substanceAmoxicillin + Clavulanic acidAmoxicillin + Clavulanic acid
Similar drugsTo uncover
  • Amovicomb®
    powder in / in 
  • Amoxivan®
    powder in / in 
    ELFA NPC, CJSC     Russia
  • Amoxiclav®
    pills inwards 
    Lek dd     Slovenia
  • Amoxiclav®
    powder in / in 
    Lek dd     Slovenia
  • Amoxiclav®
    powder inwards 
    Lek dd     Slovenia
  • Amoxiclav® Quicactab
    pills inwards 
    Lek dd     Slovenia
  • Amoxiclav® Quicactab
    pills inwards 
    Sandoz d.     Slovenia
  • Pfizer Inc.     USA
  • VIAL, LLC     Russia
  • KRASFARMA, JSC     Russia
  • Arlet®
    pills inwards 
    POLLO, LLC     Russia
  • Augmentin®
    pills inwards 
  • Augmentin®
    powder in / in 
  • Augmentin®
    powder inwards 
  • Augmentin®
    pills inwards 
  • Augmentin®
    pills inwards 
  • Augmentin®
    powder inwards 
  • Augmentin® EC
    powder inwards 
  • Augmentin® SR
    pills inwards 
  • Bactoklave®
    powder inwards 
  • BetaClave®
    pills inwards 
  • Verklav
    powder in / in 
    RUSYUROFARM, LLC     Russia
  • Clamosar®
    powder in / in 
  • Medoklav
    powder in / in 
    Medocemi Co., Ltd.     Cyprus
  • Medoklav
    pills inwards 
    Medocemi Co., Ltd.     Cyprus
  • Medoflav®
    pills inwards 
    Medocemi Co., Ltd.     Cyprus
  • Medoklav
    powder inwards 
    Medocemi Co., Ltd.     Cyprus
  • Novaklav
    powder in / in 
    JODAS EKSPOIM, LLC     Russia
  • Panklaw 2X
    powder inwards 
    Hemofarm AD     Serbia
  • Panklaw 2X
    pills inwards 
    Hemofarm AD     Serbia
  • Ranclave®
    pills inwards 
  • Rapiklav®
    pills inwards 
  • Rapiklav®
    pills inwards 
  • Fibell
    powder in / in 
  • Fleymoclav Solutab®
    pills inwards 
    Astellas Farma Europe BV     Netherlands
  • Fleymoclav Solutab®
    pills inwards 
    Astellas Farma Europe BV     Netherlands
  • Foraclav
    powder in / in 
    FORTYUN MED, LTD     Russia
  • Ecoclave®
    powder inwards 
    STI-MED-SORB, OJSC     Russia
  • Ecoclave®
    pills inwards 
    AVVA RUS, OJSC     Russia
  • Dosage form: & nbsppowder for solution for intravenous administration
    Composition:

    One bottle contains amoxicillin sodium (in terms of amoxicillin) - 500 mg or 1000 mg and potassium clavulanate (in terms of clavulanic acid) - 100 mg or 200 mg.

    Description:White or almost white powder.
    Pharmacotherapeutic group:Antibiotic - penicillin semisynthetic + beta-lactamase inhibitor
    ATX: & nbsp

    J.01.C.R.02   Amoxicillin in combination with enzyme inhibitors

    Pharmacodynamics:

    Amovicomb® is a combination of amoxicillin and clavulanic acid. Amoxicillin (semisynthetic aminopenicillin) inhibits the synthesis of the peptidoglycan of the cell wall during the growth phase of the microorganism by competitive inhibition of transpeptidases.

    Clavulanic acid has a weak intrinsic antibacterial activity, but irreversibly binds beta-lactamases (forms a stable complex with them), ensuring the stability of amoxicillin to the action of beta-lactamases produced by microorganisms.

    Clavulanic acid inhibits beta-lactamase II-V type according to the Richmond-Sykes classification is not active against type I beta-lactamases produced Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.

    The combination of amoxicillin and clavulanic acid has a broad spectrum of antibacterial action, showing activity against amoxicillin-sensitive strains, including strains producing beta-lactamases:

    Gram-positive aerobes: Streptococcus Group A, B, C, G (Strep, pneumoniae, viridans, milled, faecalis, pyogenes, anthracis, agalactiae, bovis); Staphylococcus aureus, epidermidis (except methicillin-resistant strains); Enterococcus faecalis, faecium; Corynebacterium spp.; Listeria monocytogenes; Nocardia asteroides;

    gram-matic aerobes: Aeromonas spp.; Bordetella pertussis; Branhamella catarrhalis; Brucella spp.; Campylobacter jejuni; Citrobacter spp. (moderately sensitive); Escherichia coli; Eikenella corrodens; Gardnerella vaginalis; Haemophilus ducreyi, influenzae; Helicobacter pylori; Klebsiella spp., K. pneumoniae; Moraxella catarrhalis; Morganella spp. (moderately sensitive); Neisseria gonorrhoeae, meningitidis; Pasteurela multocida; Proteus mirabilis, vul­garis; Salmonella spp.; Shigella spp.; Vibrio cholerae; Yersinia enterocolitica (moderately sensitive).

    Gram-positive anaerobes: Actinomyces israeli; Clostridium spp. (Besides Cl. difficile); Fusobacterium spp .; Peptococcus spp .; Peptostreptococcus spp .; Prevotella melaninogenica; Propionibacterium spp .;

    gram-negative anaerobes: Bacteroides spp. (at Tom number of AT. fragilis).

    Pharmacokinetics:

    The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar, and in combination they do not affect the pharmacokinetics of each other.

    The peak plasma concentrations after intravenous administration at doses of 500/100 mg and 1000/200 mg for amoxicillin are 32.2 and 105.4 μg / ml, respectively, and for clavulanic acid - 10.5 and 28.5 μg / ml, respectively.

    The peak of concentrations in body fluids is observed 1 hour after reaching the peak of plasma concentrations.

    The bioavailability of amoxicillin is about 90%, the bioavailability of clavulanic acid is about 60%, the connection with plasma proteins amoxicillin and clavulanic acid is 17-20% and 22-30 % respectively.

    Both components are characterized by a good distribution in tissues and body fluids - high concentrations of the drug are found in plasma, sputum, bronchial secretion, lung tissue, middle ear, prostate gland, peritoneal abscess, gallbladder, uterus, ovaries, adipose tissue, muscles, bones, skin, biological fluids (including in synovial, peritoneal, pleural, bile, purulent discharge).

    Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier in non-inflamed meninges.

    Amoxicillin and clavulanic acid penetrate the placental barrier and in trace concentrations are excreted into breast milk.

    Amoxicillin is excreted mainly by the kidneys through tubular secretion and glomerular filtration,practically unchanged; Clavulanic acid is extensively metabolized in the liver and is excreted by glomerular filtration, partly in the form of metabolites. Small amounts can be excreted through the intestines and lungs.

    The half-life of amoxicillin and clavulanic acid is 1-1.5 hours. In patients with severe renal failure, the elimination half-life increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid, which necessitates correction of the dosage regimen.

    Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

    Indications:

    Bacterial infections caused by susceptible pathogens:

    - infections of the lower respiratory tract (bronchitis, pneumonia, empyema of the pleura, lung abscess);

    - infection of ENT organs (sinusitis, tonsillitis, otitis media);

    - infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, chancroid, gonorrhea);

    - infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatitis, abscesses, cellulitis, wound infection;

    - osteomyelitis;

    - postoperative infections;

    - prevention of infections in surgery.

    Contraindications:

    Hypersensitivity to amoxicillin, clavulanic acid, penicillin, cephalosporins and other beta-lactam antibiotics, infectious mononucleosis (including when a morbilliform rash), jaundice episodes or abnormal liver function as a result of amoxycillin / clavulanic acid in the anamnesis.

    Carefully:

    With caution, the drug is prescribed for pregnancy and lactation; as well as in the treatment of patients with allergic diathesis, bronchial asthma, urticaria or pollinosis; in severe hepatic failure, diseases of the gastrointestinal tract (including a history of colitis associated with penicillins), chronic renal failure (creatinine clearance less than 30 mL / min); in preterm infants and children under 1 year.

    Pregnancy and lactation:

    The use of Amovicomb® during pregnancy and lactation is possible,that the expected benefit for the mother exceeds the potential risk to the fetus and the baby. When prescribing the drug, it should be borne in mind that amoxicillin and clavulanic acid penetrate into breast milk in small amounts.

    Dosing and Administration:

    Intravenously.

    Doses are given in terms of both active substances (amoxicillin+ clavulanic acid). The dosage regimen is set individually, depending on the severity of the course, the localization of the infection and the sensitivity of the pathogen.

    Duration of treatment: 5-14 days. Treatment should not exceed 14 days without repeated medical examination!

    Adults and adolescents over 12 years of age or weighing more than 40 kg - by (1000 + 200) mg every 8 hours, with severe infections - every 4-6 hours.

    For children weighing less than 40 kg the dose is calculated depending on the body weight:

    - children aged 3 months to 12 years - by (25 + 5) mg / kg every 8 hours, with severe infections - every 6 hours;

    - children under 3 months of age with a body weight of more than 4 kg - (25 + 5) mg / kg every 8 hours;

    - children under 3 months of age with a body weight of less than 4 kg - (25 + 5) mg / kg every 12 hours.

    In children younger than 3 months, the drug should be injected only slowly infusion for 30-40 minutes.

    For the prevention of postoperative infections at operations, less than 1 hour, during the introductory anesthesia is administered intravenously in a dose (1000 + 200) mg. With longer operations - by (1000 + 200) mg every 6 hours during the day. With a high risk of infection, administration can be continued for several days.

    Preparation of solutions for intravenous injection:

    Dosage (500 + 100) mg: dissolve the contents of the vial in 10 ml of water for injection. Dosage (1000 + 200) mg: dissolve the contents of the vial in 20 ml of water for injection. Enter slowly, for 3-4 minutes.

    Preparation of a solution for intravenous infusion:

    Dosage (500 + 100) mg: dissolve the contents of the vial in 10 ml of water for injection and add the resulting solution to 50 ml of infusion fluid.

    Dosage (1000 + 200) mg: dissolve the contents of the vial in 20 ml of water for injection and add the resulting solution to 100 ml of infusion fluid.

    Infusion is carried out for 30-40 minutes.

    Stability and compatibility:

    Intravenous injections should be made immediately after dissolution. Do not freeze the solution. Do not use the solution left after the intravenous injection. Intravenous infusions can be carried out in various solutions:

    Infusion liquids:

    Stability at 25 ° С

    Water for injections

    4 hours

    A solution of sodium chloride 0.9%

    4 hours

    Ringer's solution

    3 hours

    Solution of potassium chloride and sodium chloride complex for intravenous administration

    3 hours

    Preparations are less stable in infusion solutions containing dextrose, dextran or sodium bicarbonate.

    Therapy, initiated with intravenous administration, in the case of a positive reaction of the patient, can be continued with the corresponding oral form of the drug.

    Dosage for renal failure:

    For patients with impaired renal function, the dose and / or interval between drug administrations should be adjusted according to the degree of renal failure:

    Age

    Creatinine clearance

    Dosage

    Adults

    Easy insufficiency (> 30 ml / min)

    Correction of dose is not required

    Insufficiency of medium degree (10-30 ml / min)

    The initial dose is -1.2 g (1000 mg + 200 mg), then 600 mg (500 mg + 100 mg) every 12 hours

    Severe insufficiency (<10 ml / min)

    The initial dose is -1.2 g (1000 mg + 200 mg), then 600 mg (500 mg + 100 mg) every 24 hours

    Children

    Appropriate dose adjustment is required

    Dosage with functional liver failure:

    Patients with signs of liver damage should regularly check its function. If necessary, the dose should be reduced.

    Side effects:

    From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of "liver" transaminases, in isolated cases - cholestatic jaundice, hepatitis, hepatic insufficiency (more often in the elderly, men, with prolonged therapy), pseudomembranous and hemorrhagic colitis (may also develop after therapy), enterocolitis, increased bilirubin concentration.

    From the hematopoiesis: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.

    From the nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions.

    Local reactions: in some cases, phlebitis at the site of intravenous administration.

    Allergic reactions: urticaria, erythematous eruptions, rarely - multiforme exudative erythema, anaphylactic shock, angioedema, extremely rare - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustules.

    Other: Candidamycosis, development of superinfection, interstitial nephritis, crystalluria, hematuria.

    Overdose:

    Due to the fact that the combination of amoxicillin and clavulanic acid is not toxic, its overdose is unlikely. When there are symptoms of an overdose - nausea, diarrhea, vomiting - symptomatic treatment. In acute overdose, hemodialysis is effective.

    Interaction:

    Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs (NSAIDs) and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

    Antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption. Bacteriostatic medicinal products (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

    Methotrexate - simultaneous use increases the toxicity of methotrexate.

    Allopurinol increases the risk of skin rash.

    Amovicomb® improves the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor blood coagulability. Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which produces paraaminobenzoic acid (PABA), ethinyl estradiol - there is a risk of bleeding "breakthrough".

    Do not use concomitantly with disulfiram.

    Do not mix in one syringe or infusion bottle with other medicines.

    During treatment and a few days later, avoid drinking alcohol. Individual patients described a disulfiram-like effect characterized by "hot flashes", sweating, headache and tachycardia, when taken with alcohol.
    Special instructions:

    In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.

    To reduce the risk of side effects from the gastrointestinal tract should take the drug during meals.

    It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.

    In patients who are highly susceptible to antibiotics of the cephalosporin series, there is a risk of developing cross-allergic reactions. In this case, treatment should be discontinued.

    Do not use the drug if you suspect an infectious mononucleosis, t. in such patients, the likelihood of erythematous skin rashes (korepodobnoj rashes) increases.

    In patients with gonorrhea and with suspected primary syphilis, serological tests must be performed for at least four months before treatment is prescribed.

    High concentrations of amoxicillin can give a false positive reaction to urine glucose when using a Benedict reagent or Felling solution (non-enzyme methods for determining glucose in the urine). It is recommended to use enzymatic reactions with glucose oxidase.

    It can influence the determination of urobilinogen and leads to positive results of a direct antiglobulin test.

    Do not administer intramuscularly.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care should be taken when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:

    Powder for solution for intravenous administration.

    Packaging:

    For 500 mg + 100 mg, 1000 mg + 200 mg of active substances in a vial of colorless glass, sealed with a stopper of bromobutyl rubber and a cap combined aluminum-plastic.

    1 bottle together with the instruction for use is placed in a cardboard box.

    10 packets are placed in a cardboard box.
    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001242
    Date of registration:17.11.2011
    Expiration Date:17.11.2016
    The owner of the registration certificate:Juhai United Laboratories Co., Ltd.Juhai United Laboratories Co., Ltd. China
    Manufacturer: & nbsp
    Representation: & nbspInstitute of Health CJSCInstitute of Health CJSC
    Information update date: & nbsp18.08.2017
    Illustrated instructions
      Instructions
      Up