Active substanceAmoxicillin + Clavulanic acidAmoxicillin + Clavulanic acid
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  • Dosage form: & nbspPowder for solution for oral administration
    Composition:

    Each 5 ml of the finished suspension (one dosage spoon) contains: active ingredients:

    amoxicillin trihydrate (in terms of amoxicillin)

    125 mg

    250 mg

    potassium clavulanate (in terms of clavulanic acid)

    31.25 mg

    62.5 mg

    Excipients:

    lactulose

    200 mg

    400 mg

    aspartame

    5.5 mg

    5.5 mg

    silicon dioxide colloid (aerosil)

    16.885 mg

    16.885 mg

    xanthan gum

    10.0 mg

    10.0 mg

    crospovidone (clolidon CL-M)

    28.1 mg

    28.1 mg

    citric acid anhydrous

    2.165 mg

    2.165 mg

    sodium citrate dihydrate

    8.335 mg

    8.335 mg

    sodium benzoate

    2.085 mg

    2.085 mg

    talc

    25.0 mg

    25.0 mg

    orange flavoring

    4.0 mg

    4.0 mg

    Mannitol (mannitol) Up to the mass of the powder

    1.25 g

    1.25 g

    Description:

    Powder from white to almost white with a faint fruity smell. After dissolution in water, a suspension is formed from almost white to light yellow with a fruity odor.

    Pharmacotherapeutic group:Antibiotic - penicillin semisynthetic + beta-lactamase inhibitor.
    ATX: & nbsp

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

    Pharmacodynamics:

    The combined preparation of amoxicillin and clavulanic acid is a beta-lactamase inhibitor. Amoxicillin - a semisynthetic antibiotic of a wide spectrum; acts bactericidal, inhibiting the synthesis of the protein of the cell wall of sensitive bacteria at the growth stage. Clavulanic acid has a high affinity for bacterial beta-lactamases and forms a stable complex with them. Thus, the biodegradation of amoxicillin with beta-lactamases is prevented, and the bactericidal activity of the antibiotic is preserved. Clavulanic acid inhibits beta-lactamase II-V types according to Richmond-Sykes classification and is not active against type I beta-lactamases produced Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.

    The combined preparation of amoxicillin and clavulanic acid by the results of tests in vitro and clinical trials is active against the following microorganisms:

    Gram-positive aerobic microorganisms:

    Staphylococcus aureus (strains producing and non-producing beta-lactamases);

    Gram-negative aerobic microorganisms:

    Enterobacter spp. (despite the fact that most strains Enterobacter are stable in vitro, Clinically proved the effectiveness of the drug in the treatment of infectious diseases caused by this pathogen of the urinary system);

    Escherichia coli (strains producing and non-producing beta-lactamases); Haemophilus influenzae (strains producing and non-producing beta-lactamases);

    Klebsiella spp. (all known strains produce beta-lactamases);

    Moraxella catarrhalis (strains producing and non-producing beta-lactamases).

    Based on research results in vitro the sensitivity to a combination of amoxicillin and clavulanic acid of the following microorganisms is shown:

    Gram-positive aerobic microorganisms:

    Enterococcus faecalis **;

    Staphylococcus epidermidis (strains producing and non-producing beta-lactamases);

    Staphylococcus saprophyticus (strains producing and non-producing beta-lactamases);

    Streptococcus pneumoniae ** (beta-lactamase does not produce);

    Streptococcus pyogenes** (beta-lactamase does not produce);

    Streptococcus spp. groups viridans ** (beta-lactamase does not produce).

    Gram-negative aerobic microorganisms:

    Eikenella corrodens (strains producing and non-producing beta-lactamases);

    Neisseria gonorrhoeae ** (strains producing and non-producing beta-lactamases);

    Proteus mirabilis** (strains producing and non-producing beta-lactamases).

    Anaerobic microorganisms:

    Bacteroides spp., including Bacteroides fragilis (strains producing and non-producing beta-lactamases);

    Fusobacterium spp. (strains producing and non-producing beta-lactamases);

    Peptostreptococcus spp. (beta-lactamase does not produce).

    NOTE: ** - (clinically proven the effectiveness of amoxicillin in the treatment of a number of infections caused by these pathogens).

    Pharmacokinetics:

    Suction. After oral administration, both components of the drug are rapidly absorbed from the gastrointestinal tract. Absorption of active ingredients of the drug is optimal in case of its intake at the beginning of the meal.

    After ingestion in a dose of 125 mg + 31.25 mg:

    - FROMmah amoxicillin - 1.96 μg / ml, clavulanic acid - 0.77 μg / ml;

    - Tmah amoxicillin - 1.5 h, clavulanic acid - 1.0 h;

    - AUC amoxicillin - 9.19 mg / h, clavulanic acid - 2.69 mg / h.

    When the drug is used, concentrations of amoxicillin in the blood serum are similar to those for oral administration of equivalent doses of one amoxicillin.

    Distribution. Both components of the preparation are characterized by a good volume of distribution - therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid: lungs, middle ear, abdominal organs, pelvic organs (prostate gland, uterus, ovaries), skin; fatty, bone and muscle tissues; pleural, synovial and peritoneal fluids; plasma, bile, purulent discharge, sputum, bronchial secretion.

    Amoxicillin and clavulanic acid have a moderate degree of binding to plasma proteins, respectively, by 18% and 25%.

    Both components of the drug penetrate the placental barrier, but there is no published data on the negative effect on the fetus.

    Amoxicillin and clavulanic acid in low concentrations are found in breast milk.

    Metabolism, excretion. Approximately 60-70% of amoxicillin is excreted by the kidneys: by tubular secretion and glomerular filtration in an unchanged form, about 10-25 % in the form of inactive penicillic acid. Clavulanic acid is actively metabolized in the liver and is excreted by glomerular filtration (40-65%), partially in the form of metabolites. The smaller part is excreted by the intestine. With renal failure, the clearance of amoxicillin with clavulanic acid decreases, so dose adjustment is required.

    Indications:

    Infectious-inflammatory diseases caused by drug-susceptible pathogens:

    - infections of the lower respiratory tract (bronchitis, pneumonia);

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

    - infection of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, bacterial prostatitis, cervicitis,salpingitis, Salpingoophoritis, endometritis, bacterial vaginitis, septic abortion, chancroid, gonorrhea);

    - infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection);

    - infection of bones and joints (osteomyelitis).

    Contraindications:

    Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics), infectious mononucleosis, episodes of jaundice or impaired liver function as a result of amoxicillin / clavulanic acid in history, phenylketonuria (contains aspartame).

    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:

    The combined preparation of amoxicillin and clavulanic acid during pregnancy is recommended to be prescribed only in cases when the expected benefit from its administration for the mother exceeds the potential risk for the fetus.

    The drug can be used during breastfeeding. Except for the risk of sensitization,related to the penetration of the trace amounts of the active ingredients of this preparation into breast milk, no other adverse effects were found in infants fed breastfeeding.

    Dosing and Administration:

    Inside. The dosage regimen is set individually depending on the patient's body weight, severity of the course and localization of the infectious process, as well as the sensitivity of the pathogen.

    The minimum course of antibiotic therapy is from 5 days. Treatment should not be continued for more than 14 days without reviewing the clinical situation. The duration of treatment of acute uncomplicated otitis media is 5-7 days, in children under 2 years - 7-10 days.

    A single dose is established depending on the age and body weight (calculation for amoxicillin):

    - children up to 3 months - 30 mg / kg / day in 2 divided doses;

    - children from 3 months and older:

    - low doses (for treatment of skin and soft tissue infections, as well as chronic tonsillitis) - 20 mg / kg / day in 3 divided doses;

    - high doses (for treatment of otitis media, sinusitis, lower respiratory tract infections, urinary tract infections) - 40 mg / kg / day in 3 divided doses. Children weighing 40 kg or more should be given doses as adults.

    The suspension can be used in adults with difficulty swallowing.

    Recommended dosage regimen for adults: 20 ml of suspension in a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of suspension at a dosage of 250 mg + 62.5 mg / 5 ml 2-3 times a day.

    The maximum daily dose of amoxicillin for adults and children over 12 years is 6 g, for children under 12 years, 45 mg / kg of body weight.

    The maximum daily dose of clavulanic acid for adults and children over 12 years is 600 mg, for children under 12 years of age it is 10 mg / kg of body weight.

    Patients with impaired renal function:

    Correction of doses is based on the maximum recommended dose of amoxicillin and the value of creatinine clearance.

    - Children

    Creatinine clearance more than 30 ml / min dose adjustment is not required;

    Creatinine clearance 10-30 ml / min - 15 mg / 3.75 mg / kg 2 times a day, the maximum dose of 500 mg + 125 mg (20 ml of suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of a suspension in a dosage of 250 mg + 62.5 mg / 5 ml) twice a day;

    Creatinine clearance less than 10 ml / min - 15 mg / 3.75 mg / kg once a day, maximum daily dose of 500 mg + 125 mg (20 ml of suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of a suspension in a dosage of 250 mg + 62.5 mg / 5 ml);


    - Adults

    Creatinine clearance more than 30 ml / min dose adjustment is not required;

    Creatinine clearance 10-30 ml / min - 500 mg + 125 mg (20 ml suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml suspension at a dosage of 250 mg + 62.5 mg / 5 ml) 2 times in day;

    creatinine clearance less than 10 mL / min - 500 mg + 125 mg (20 ml of a suspension at a dose of 125 mg + 31.25 mg / 5 ml or 10 ml of the suspension at a dosage of 250 mg + 62.5 mg / 5 mL) 1 time per day ;

    Patients on hemodialysis:

    Correction of doses is based on the maximum recommended dose of amoxicillin

    - Children - 15 mg / 3.75 mg / kg once a day.

    Before a hemodialysis session, one additional dose of 15 mg / 3.75 mg / kg should be taken. To restore the concentration of the active components of the drug in the blood, a second additional dose of 15 mg / 3.75 mg / kg should be taken after a hemodialysis session.

    - Adults - 500 mg + 125 mg (20 ml of a suspension at a dose of 125 mg + 31.25 mg / 5 ml or 10 ml of the suspension at a dosage of 250 mg + 62.5 mg / 5 ml) once every 24 hours.

    Additional 1 dose during the dialysis session and one dose at the end of the dialysis session (to compensate for the reduction in serum concentrations of amoxicillin and clavulanic acid)

    Method of preparation of the suspension:

    Suspension is prepared immediately before use.

    Powder in vial pre-shaken, then adding a small amount of boiled and cooled to room temperature, water was stirred to give a uniform suspension, and then water was added to the mark on the vial.To accurately dispense the suspension, you should use a dosage double-sided spoon, which you need to rinse well with water after each application. After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

    Side effects:

    The drug is well tolerated. Side effects occur rarely, are mostly mildly expressed and are transient in nature.

    From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, cholestatic jaundice, hepatitis, liver failure (more common in the elderly, women, long-term therapy), colitis (including pseudomembranous), black "hairy" tongue, darkening of the tooth enamel, increased activity of " hepatic "transaminases, an increase in bilirubin and alkaline phosphatase activity.

    On the part of the organs of hematopoiesis: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.

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

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

    From the side of the kidneys and urinary tract: interstitial nephritis, crystalluria, hematuria.

    Other: Candidiasis, development of superinfection.

    Overdose:

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

    Treatment: symptomatic. Hemodialysis is effective.

    Interaction:

    It is not recommended to use a combined preparation of amoxicillin and clavulanic acid simultaneously with probenecid. Probenecid reduces the tubular secretion of amoxicillin, so their combined use can lead to an increase and persistence of amoxicillin concentration in the serum, while the serum concentration of clavulanic acid does not change.

    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).

    Antacids, glucosamine, laxatives slow down and reduce the absorption of amoxicillin; ascorbic acid - Increases.

    Allopurinol increases the risk of skin rashes.

    Like other broad-spectrum antibiotics, the combination drug amoxicillin and clavulanic acid may reduce the effectiveness of oral contraceptives, and patients should be informed about this.

    In the literature, rare cases of an increase in the international normalized ratio (INR) in patients with joint use of acenocoumarol or warfarin and amoxicillin are described. If simultaneous application of combined amoxicillin and clavulanic acid with indirect anticoagulants is necessary, prothrombin time or INR should be carefully monitored when the drug is prescribed or withdrawn.

    Special instructions:

    The severity of gastrointestinal symptoms decreases when taking the drug at the beginning of the meal.

    At 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 by selecting the resistant forms of the pathogen.

    There may be false-positive results in determining the glucose level in urine. In this case, it is recommended to use a glucose oxidase method to determine the concentration of glucose in the urine.

    In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

    In the case of suspected infectious mononucleosis, the drug should not be used because patients with this disease amoxicillin can cause a skinlike skin rash, which makes it difficult to diagnose the disease.

    Effect on the ability to drive transp. cf. and fur:Given the likelihood of side effects from the central nervous system, care should be taken when driving vehicles and working with moving mechanisms.
    Form release / dosage:

    Powder for the preparation of a suspension for ingestion 125 mg + 31.25 mg / 5 ml or 250 mg + 62.5 mg / 5 ml.

    Packaging:

    To 25 g in bottles of brown glass with a volume of 125 ml with a label and a screwed plastic lid.

    Each bottle together with a dosage double-sided spoon (small capacity of 2.5 ml, large - 5 ml) and instructions for use are placed in a pack of cardboard.

    Marking.

    On the label indicate the manufacturer, its trademark, country, the name of the drug with a warning mark, international non-proprietary names of active substances, dosage form, dosage in 5 ml of the finished suspension, the amount of medicinal product in the package, the conditions for storage of the powder, conditions and shelf life of the finished product suspend, "Shake before use", "Keep out of reach of children", "Use as directed by a doctor", "Read carefully the enclosed instructions before use", nome e series, "fit before".

    On the package indicate the manufacturer, its trademark, address, phone number, manufacturer's e-mail address, name of the preparation with a warning marking ®, international non-proprietary names of active substances, dosage form, dosage in 5 ml of the finished suspension, amount of medicinal product in the package,composition in 5 ml of the final suspension, the conditions of the powder storage conditions and shelf life of the finished suspension, "Shake before use", "Keep out of the reach of children", "Use on prescription", "Please read the attached instructions before use" method suspension, release conditions, "for ingestion," the number of the trademark certificate, patent number, serial number, bar code, batch number, "best before".

    The label for packaging indicate the manufacturer, his trademark, address, telephone number, email address, name of the drug with a warning markirovkoy®, international nonproprietary names of the active ingredients, dosage form, dosage of 5 ml of the final suspension, the amount of drug in the package, conditions of storage of the powder, "Keep out of the reach of children", "Use on prescription", registration number, serial number, "best before", the number of vials.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    The finished suspension is stored at a temperature of 2 ° C to 8 ° C in a tightly closed vial.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    The finished suspension is 7 days.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:PL-000379
    Date of registration:25.02.2011
    The owner of the registration certificate:STI-MED-SORB, OJSC STI-MED-SORB, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.05.2012
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