Active substanceAmoxicillin + Clavulanic acidAmoxicillin + Clavulanic acid
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  • Dosage form: & nbsppowder for solution for intravenous administration
    Composition:

    Per 1 bottle:

    Amoxicillin sodium-500 mg; 1000 mg (in terms of amoxicillin) + potassium clavulanate -100 mg; 200 mg (in terms of clavulanic acid).

    Description:White or white with a yellowish hue, crystalline, hygroscopic powder.
    Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic + beta-lactamase inhibitor
    ATX: & nbsp

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

    Pharmacodynamics:

    Clamosar is a combined preparation of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It acts bactericidal, inhibits the synthesis of the bacterial wall.

    It is active against aerobic Gram-positive bacteria (including strains producing beta-lactamases): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis.

    The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.;

    aerobic Gram-negative bacteria (including strains producing beta-lactamases): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida (formerly Pasteurella), Campylobacter jejuni;

    anaerobic gram-negative bacteria (including strains producing beta-lactamases): Bacteroides spp., including Bacteroides fragilis.

    Clavulanic acid suppresses II, III, IV and V types of beta-lactamases, is inactive for type I beta-lactamases, produced Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents enzymatic degradation of amoxicillin under the influence of beta-lactamases.

    Pharmacokinetics:

    After intravenous administration at doses of 1.0 / 0.2 and 0.5 / 0.1 g, the maximum concentration of the drug in plasma amoxicillin is 105.4 and 32.2 μg / ml, respectively, and clavulanic acid is 28.5 and 10 , 5 μg / ml, the maximum inhibitory concentration of 1 μg / ml for amoxicillin is similar when administered after 12 hours and 8 hours in both adults and children.

    Connection with plasma proteins: amoxicillin -17-20%, clavulanic acid - 22-30 %. Metabolised both components in the liver: amoxicillin - 10% of the administered dose, clavulanic acid - by 50%. It is excreted mainly by the kidneys.

    Indications:

    Bacterial infections caused by susceptible pathogens: infections of the lower respiratory tract (bronchitis, pneumonia, pleural empyema, lung abscess), infections of the otorhinolaryngological organs (sinusitis, tonsillitis, otitis media),infections of the genitourinary system and the pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, puerperal sepsis, pelvic inflammation, chancroid, gonorrhea), infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection), osteomyelitis, postoperative infections, prevention of infections in surgery.

    Contraindications:

    Hypersensitivity (including cephalosporins and others. 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:

    Severe hepatic insufficiency, diseases of the gastrointestinal tract (including colitis in history, associated with the use of penicillins), chronic renal failure.

    Pregnancy and lactation:

    Contraindicated in pregnancy, at the time of treatment should stop breastfeeding.

    Dosing and Administration:

    Intravenous (bolus, drip).

    The calculation is made by amoxicillin. The dosage regimen is set individually, depending on the severity of the course and localization of the infection, the sensitivity of the pathogen.

    With intravenous administration, adults and adolescents over 12 years of age are given 1000 mg 3 times a day, with severe infections 4 times a day. The maximum daily intake of adults and adolescents over 12 years of age (with a body weight of more than 40 kg) is 6000 mg. For children 3 months to 12 years - 25 mg / kg 3 times a day; in severe cases - 4 times a day; for children younger than 3 months with a body weight of less than 4 kg - 25 mg / kg every 12 hours, for children younger than 3 months with a body weight of more than 4 kg -25 mg / kg every 8 hours. In children younger than 3 months the drug should be administered only slowly infusion for 30-40 minutes. Duration of treatment - up to 14 days, acute otitis media - up to 10 days.

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

    For patients on hemodialysis, dose adjustment is based on the maximum recommended dose of amoxicillin.Initially, a dose of 1000 mg, followed by 500 mg every 24 hours and an additional 500 mg at the end of the hemodialysis session (to compensate for the decrease in plasma concentration of amoxicillin).

    For children on hemodialysis, a dose of 25 mg / kg is administered first every 24 hours and additionally (12.5 mg / kg) at the end of the hemodialysis session (to compensate for the reduction in amoxicillin concentration in the serum) and further (25 mg / kg) per day.

    In chronic renal failure, dose adjustment and frequency of administration are performed depending on the creatinine clearance: when the creatinine clearance is more than 30 ml / min, dose adjustment is not required; with the clearance of creatinine 10-30 ml / min - IV - 1000 mg, then 500 mg intravenously twice a day; when creatinine clearance is less than 10 ml / min -1000 mg, then 500 mg every 24 hours intravenously. For children with a creatinine clearance of more than 30 ml / min, dose adjustment is not required; with the clearance of creatinine (25 mg / kg) 2 times a day intravenously; when the creatinine clearance is less than 10 ml / min - (25 mg / kg) every 24 hours intravenously.

    Patients with impaired liver function are treated with caution, and liver function is monitored regularly. Currently, there is not enough data to change the dosing regimen for such patients.

    Preparation of a solution for intravenous injection.

    Intravenous injection slowly (within 3-4 minutes).

    Bottles

    Solvent

    (ml)

    The obtained volume (ml)

    500/100 mg

    10

    10,5

    1000/200 mg

    20

    20,9

    The solvent is water for injections.

    If the dose is 500/100 mg, then the drug is diluted in 10 ml of the solvent. To dilute the dose of 1000/200 mg, use a 20 ml syringe filled with water for injection. 10 ml of the solvent is injected into the vial without removing the needles, the contents of the vial are dissolved, after dissolution of the drug, the solution is taken into the syringe and for shaking the concentration is additionally shaken for 5-10 seconds.

    Clamosar should be administered within 20 minutes after the preparation of the solution for intravenous administration.

    During the breeding, a temporary pink staining of the solution may appear.

    The finished solution has a light yellow color.

    Preparation of a solution for intravenous intravenous infusion

    Clamosar can be administered as an intravenous infusion for 30-40 minutes. The resulting Klamosar solution at a dose of 500/100 mg and 1000/200 mg is immediately added to 50 ml and 100 ml of the infusion fluid, respectively.

    A sufficient concentration of antibiotics is maintained at 25 ° C in the recommended volumes of the infusion solutions listed below, and the infusion should be completed before the expiration of the period indicated in the table below.

    Standard solutions for IV infusion

    Stability period with 25 ° С

    Water for injections

    4h

    Sodium chloride chloride 0.9%

    4h

    Sodium lactate for intravenous infusion 1.85%

    3 hours

    Ringer's

    3 hours

    Dr. Hartman (Ringer Lactate)

    3 hours

    Potassium chloride (0.3%) and sodium chloride (0.9%) for intravenous infusion

    3 hours

    Do not use antibiotic solution residues.

    Side effects:

    From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of "liver" transaminases, cholestatic jaundice, hepatitis, increased alkaline phosphatase activity, liver failure (in the elderly, men, long-term therapy), pseudomembranous and hemorrhagic colitis (may also develop after therapy), enterocolitis, black "hairy" tongue, darkening of tooth enamel.

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

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

    Local reactions: phlebitis at the site of intravenous administration.

    Allergic reactions: urticaria, erythematous rash, multi forme erythema, anaphylaxis, angioneurotic edema, bullous exfoliative dermatitis, malignant erythema multiforme (Stevens-Johnson syndrome), allergic vasculitis syndrome similar to serum sickness, acute generalized exanthematous pustullez, pruritus, toxic epidermal necrolysis.

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

    Overdose:

    Symptoms: a violation of the function of the gastrointestinal tract and water electrolyte balance.

    Treatment: symptomatic. Hemodialysis is effective.

    Interaction:

    Bacteriostatic medicinal products (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

    Increases 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 of which parahaminobenzoic acid is formed, ethinyl estradiol - the risk of bleeding "breakthrough".

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

    Allopurinol increases the risk of skin rash.

    Pharmaceutical incompatibility: the drug should not be mixed with blood products, other protein fluids, such as protein hydrolysates, and lipid emulsions for intravenous administration. Do not mix in one syringe with aminoglycoside antibiotics due to loss of activity of the latter. Drug solutions should not be mixed with infusion solutions containing dextrose, dextran or sodium hydrogen carbonate.

    Special instructions:

    In patients with impaired liver function, liver function should be monitored regularly. Amoxicillin and clavulanic acid may provoke non-specific binding of immunoglobulins and albumins to the erythrocyte membrane, which may be the cause of a false positive Coombs test. During the administration of large doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain an adequate diuresis to reduce the likelihood of amoxicillin crystals. In case of an allergic reaction, it is necessary to stop treatment with the drug and begin therapy with an antibiotic of another group. In case of serious hypersensitivity reactions, appropriate measures should be taken immediately. Epinephrine, oxygen therapy, intravenous glucocorticosteroids, and airway patency, including intubation, may also be required. It is necessary to refrain from using the drug in case of suspected infectious mononucleosis, since in patients with this disease amoxicillin can cause a skinlike skin rash that makes diagnosis difficult. In the treatment of mild diarrhea (caused by Clostridium difficile) against the background of course treatment should avoid antidiarrhoeal drugs that reduce peristalsis of the intestine; it is possible to use kaolin- or attapulgite-containing antidiarrhoeal drugs. With severe diarrhea, you should see a doctor. Treatment necessarily continues for another 48-72 hours after the disappearance of clinical signs of the disease. With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin, it should be possible to use other or additional methods of contraception.

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

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

    Can give false positive results in determining glucose in the urine. In this case, it is recommended to use a glucose oxidant method for determining the concentration of glucose in the urine.

    In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics. Cases of development of necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes were revealed.

    Effect on the ability to drive transp. cf. and fur:

    Considering the possibility of vertigo as a side effect from the central nervous system, care should be taken when working with mechanisms and driving vehicles.

    Form release / dosage:Powder for the preparation of a solution for intravenous administration of 500 mg + 100 mg; 1000 mg + 200 mg of active substances.
    Packaging:

    In bottles of a glass tube with a capacity of 10 ml.

    1, 5 or 10 vials with the drug, along with the instructions for use, are placed in a pack of cardboard or 50 bottles with an equal number of instructions for the use of the drug placed in a box of cardboard (for hospitals).

    Storage conditions:

    In a dry place, protected from light and out of reach of children, at a temperature not exceeding 15 ° C.

    Shelf life:

    2 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000287
    Date of registration:30.01.2013 / 12.09.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.01.2018
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