Active substanceAmpicillin + SulbactamAmpicillin + Sulbactam
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  • Libaccil®
    powder w / m in / in 
    ABOLMED, LLC     Russia
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    SYNTHESIS, OJSC     Russia
  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:

    Composition per one vial

    0.5 g + 0.25 g

    1.0 g + 0.5 g

    2.0 g + 1.0 g

    Ampicillin sodium (in terms of ampicillin)

    0.5 g

    1.0 g

    2.0 g

    Sulbactam sodium (in terms of sulbactam)

    0.25 g

    0.5 g

    1.0 g

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

    J.01.C.R.   Combinations of penicillins (including those with beta-lactamase inhibitors)

    Pharmacodynamics:

    Libaccil® is an antibiotic that represents a combination of polysynthetic aminopenicillin ampicillin and an inhibitor of sulbactam beta-lactamase.

    Ampicillin is a broad-spectrum bactericidal antibiotic.The bactericidal effect of ampicillin is due to irreversible binding to bacterial transpeptidases involved in the biosynthesis of glycopeptides, the main component of the bacterial cell wall. Ampicillin is destroyed by beta-lactamases, enzymes produced by microorganisms, which significantly limits the spectrum of its action. Sulbactam is a derivative of the main nucleus of penicillin. Sulbactam does not have clinically significant antibacterial activity (except for Neisseriaceae, Acinetobacter spp.), but is an irreversible inhibitor of most of the major bacterial beta-lactamases (including plasmid beta-lactamases) that destroy penicillins and cephalosporins and determine the resistance of microorganisms to beta-lactam antibiotics. In this regard, Libacil® acquires the ability to act on stable (producing beta-lactamase) to ampicillin strains.

    It is active against gram-positive aerobes: Staphylococcus aureus (producing and non-producing beta-lactamase strains), Staphylococcus epidermidis (producing and non-producing beta-lactamase strains), Staphylococcus saprophyticus (producing and non-producing beta-lactamase strains), Enterococcus faecalis, Streptococcus pneumoniae (including strains resistant to penicillin), Streptococcus pyogenes, Streptococcus spp. groups viridans, Listeria monocytogenes; Gram-negative aerobes: Hemophilus influenzae (including strains resistant to ampicillin), Moraxella catarrhalis (producing and non-producing beta-lactamase strains), Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Morganella morganii, Neisseria gonorrhoeae (producing and non-producing beta-lactamase strains); clinically significant anaerobes: Clostridium spp. (Besides Clostridium difficile), Peptococcus spp., Peptostreptococcus spp., Bacteroides spp., including Bacteroides fragilis.

    Resistant: methicillin-resistant Staphylococcus spp., most strains Enterobacter spp., Citrobacter spp., Pseudomonas aeruginosa, Mycobacterium spp., Clostridium difficile, Chlamydia spp. and Mycoplasma.

    Pharmacokinetics:Maximum serum concentrations (CmOh) of ampicillin and sulbactam after intravenous (iv) administration of 1.5 g and 3.0 g of the drug are from 40 μg / ml to 71 μg / ml and from 109 μg / ml to 150 μg / ml for ampicillin, from 21 μg / ml to 40 μg / ml and from 48 μg / ml to 88 μg / ml for the sulbactam, respectively. After intramuscular (intramuscular) injection, 1.5 g of ampicillin + sulbactam CmOh Ampicillin varies from 8 μg / ml to 37 μg / ml, CmOh sulbactam - from 6 mcg / ml to 24 mcg / ml. The degree of binding to plasma proteins is 28% for ampicillin and 38% for sulbactam. Both components of the drug penetrate well and are distributed to many organs, tissues and body fluids.Therapeutic concentrations after intravenous and / m injections are created in peritoneal and pleural fluids, interstitial fluid, intestinal wall, pelvic organs, skin and subcutaneous tissue. Poorly penetrate through the blood-brain barrier, the permeability through which increases with inflammation of the meninges. The half-life (T1/2) ampicillin and sulbactam - about 1 hour. Both components of the drug are excreted mainly by the kidneys in an unchanged form. From 75% to 85% of the administered dose of ampicillin and sulbactam are excreted by the kidneys within the first 8 hours. In patients with impaired renal function T1/2 components of the drug is increased, which requires correction of doses and modes of administration.
    Indications:

    Bacterial infections of different localization of moderate and severe severity caused by sensitive microorganisms:

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

    -infection of respiratory organs (including pneumonia, abscess of the lungs, infected bronchiectasis, acute and exacerbation of chronic bronchitis, empyema of the pleura);

    -Bacterial meningitis;

    -infective endocarditis;

    - uncomplicated and complicated infections of the abdominal organs (cholecystitis, cholangitis, peritonitis, abscess of the abdominal cavity);

    -infection of the urinary tract (acute and exacerbation of chronic pyelonephritis, pyelitis);

    -infection of the skin and soft tissues (erysipelas, phlegmon, wound and postoperative infections);

    Infectious-inflammatory diseases of the pelvic organs (salpingitis, endometritis, tubo-ovarian abscess, pelvioperitonitis);

    - infection of bones and joints;

    -sepsis;

    -gonococcal infection.

    It is indicated for prophylaxis of postoperative complications in operations on the abdominal and pelvic organs.

    Contraindications:

    Hypersensitivity to any of the components of the drug and other penicillins, infectious mononucleosis, lymphocytic leukemia.

    Safety of ampicillin / sulbactam use in patients with terminal stage of chronic renal failure (creatinine clearance less than 5 ml / min / 1.73 m2) not installed.

    Carefully:

    Bronchial asthma, pollinosis and other allergic diseases, increased sensitivity to antibiotics of cephalosporin series and carbapenems, chronic gastrointestinal diseases in history,as well as previous colitis associated with the use of antibiotics, liver failure, severe renal dysfunction.

    Pregnancy and lactation:

    During pregnancy, appoint in cases where the intended benefit to the mother exceeds the possible risk to the fetus.

    Ampicillin and sulbactam penetrate into breast milk in low concentrations. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:

    Libaccil® is administered iv and i / m. The mode of administration depends on the severity of the infection and the chosen dose.

    In adults, for the treatment of infections of moderate severity, I / in or / m 1.5 g every 6 hours. In severe infections - 3 g every 6 hours. The maximum daily dose of sulbactam should not exceed 4 g, which corresponds to a daily dose of Libaccyl® 12 g.

    As a rule, the treatment is continued for another 48 hours after the normalization of body temperature and the disappearance of other symptoms of infection. The duration of the course of therapy is from 5 to 14 days, however, in more severe cases it can be increased or additionally assigned ampicillin.

    Have children from 1 month to 12 years (or a body weight of up to 40 kg) Libaccil® with a mild and moderate infection is administered at a dose of 150 mg / kg per day, which is divided into 3-4 injections. For the treatment of severe infections, the dose is increased to 300 mg / kg per day. Usually, the course of treatment with Libacilum® should not exceed 14 days.

    In preterm infants and children of the first week of life, The daily dose of Libaccil® is 75 mg / kg, divided by 2 IV.

    Children aged from 7 days to 28 days, appoint a dose of 150 mg / kg / day, divided into 3 intravenous injections.

    For perioperative prevention surgical infections Libaccil® is administered iv in a dose of 1.5-3 g together with premedication or anesthesia; if necessary, additionally administered at the same dose every 6-8 hours within 24 hours after the operation.

    Have patients with renal insufficiency because of the slow elimination of the components of the drug, it is required to increase the intervals between the administrations, as shown in the table:

    Creatinine clearance, ml / min / 1.73 m2

    T1/2, h

    Recommended mode of administration

    ≥30

    1

    1,5-3,0 g every 6-8 h

    15-29

    5

    1,5-3,0 g every 12 h

    5-14

    9

    1,5-3,0 g every 24 h

    In children with kidney failure (creatinine clearance less than 30 ml / min / 1.73 m2) are administered in usual single doses (50-75 mg / kg), increasing the intervals between administrations, as indicated for adults.

    Rules for solution preparation and introduction

    To prepare a solution for intravenous administration, sterile water for injection, 0.5% procaine solution, 0.5% or 2% lidocaine solutions is used as the solvent. To the vial containing 750 mg of the preparation, 2.0 ml, 1.5 g - 4 ml of solvent are added.

    For intravenous spraying: 10-15 ml of water for injection, 0.9% of sodium chloride solution are added to a vial containing 750 mg or 1.5 mg of Libaccil®. Enter iv slowly for 3-5 minutes.

    For IV injection: 1.5-3.0 g of the drug are dissolved in 15 ml of water for injection, then the resulting solution is added to 150-250 ml of a 0.9% sodium chloride solution or 5% solution of dextrose and injected at a rate of 60 -80 drops in min.

    Side effects:

    From the digestive system: nausea, vomiting, decreased appetite, diarrhea, increased activity of "liver" transaminases; rarely - pseudomembranous colitis.

    On the part of the blood system: hemolytic anemia, thrombocytopenia, eosinophilia, leukopenia, false positive Coombs test.

    From the nervous system: drowsiness, headache.

    From the laboratory indicators: azotemia, increased urea concentration, hypercreatininaemia.

    Allergic reactions: urticaria, skin hyperemia, itchy skin, angioedema, rhinitis, conjunctivitis, fever, arthralgia, in rare cases - anaphylactic shock, Stephen-Johnson syndrome, toxic epidermal necrolysis, multiform exudative erythema.

    Local reactions: with the / m introduction - soreness in the injection site; when / in - phlebitis.

    Other: malaise, with long-term treatment - superinfection caused by drug-resistant microorganisms (candidiasis).

    Overdose:

    Overdose Symptoms: neurological disorders in the form of convulsions.

    Treatment: anticonvulsant therapy; in severe cases - hemodialysis.

    Interaction:

    With simultaneous use with aminoglycosides, there is a pronounced synergism of bactericidal action against gram-positive and gram-negative bacteria.

    Pharmaceutically incompatible with aminoglycosides. When used simultaneously with aminoglycosides, they should not be mixed in one syringe or one infusion medium; with the / m introduction to enter into different parts of the body; when administered intravenously, separately, observing a certain sequence with as long as possible a time interval between injections (infusions),or use separate intravenous catheters.

    Probenecid reduces tubular secretion of ampicillin and sulbactam, increasing them T1/2 in blood.

    Simultaneous appointment of allopurinol and ampicillin increases the risk of skin rash.

    With simultaneous application ampicillin + sulbactam potentiates the effect of indirect anticoagulants.

    Special instructions:

    Libaccil® is the drug for the monotherapy of most mixed infections. With the likely etiological role of chlamydia and mycoplasmas (for example, inflammatory diseases of the pelvic organs in women) are combined with doxycycline or macrolides.

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

    If diarrhea occurs during treatment with Libaccil®, caution should be exercised because of the possible development of pseudomembranous colitis. If a diagnosis of antibiotic-associated diarrhea or pseudomembranous colitis is established, discontinue Libacil® immediately and prescribe appropriate treatment.

    It is possible to develop superinfection by increasing the microflora insensitive to Libacilum, which requires appropriate correction of antibacterial therapy.

    During treatment with Libacil®, a false positive Coombs reaction is possible; In the tests for glucosuria by the method of Benedict or Feling, and also with the use of Klinist®, false positive results can be observed. In patients receiving Libacil®, it is desirable to carry out tests with glucose oxidase.

    In the treatment of patients with sepsis, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

    Intramuscular injections are painful, therefore, to dissolve Libacil®, it is preferable to use a solution of local anesthetic (0.5-2% lidocaine solution).

    In persons with intolerance to local anesthetics DO NOT use lidocaine solution to prepare a solution for intravenous injection.

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

    There is no evidence indicating the negative impact of Libaccil® on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    When using a lidocaine solution as a solvent, care must be taken when driving vehicles and engaging in other potentially hazardous activities.

    Form release / dosage:

    Powder for solution for intravenous and intramuscular injection 0.5 g + 0.25 g; 1.0 g + 0.5 g; 2.0 g + 1.0 g.

    Packaging:

    0.5 g + 0.25 g into glass bottles with a capacity of 10 ml; 1.0 g + 0.5 g or 2.0 g + 1.0 g in bottles with a capacity of 20 ml.

    1 bottle with the drug, along with instructions for use, is placed in a pack of cardboard.

    Storage conditions:

    List B. 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 of the year. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005214/10
    Date of registration:07.06.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:ABOLMED, LLC ABOLMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp04.03.2018
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