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

    1 bottle contains:

    500 mg + 250 mg

    1000 mg + 500 mg

    Active substances



    Ampicillin sodium

    500 mg

    1000 mg

    (in terms of ampicillin)



    Sulbactam sodium

    250 mg

    500 mg

    (in terms of sulbactam)



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

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

    Pharmacodynamics:

    Sultasin® is a broad-spectrum bactericidal antibiotic that is acid-fast. Block the synthesis of peptidoglycan cell walls of microorganisms. The current beginning is ampicillin - semisynthetic penicillin antibiotic of a wide spectrum of action, destroyed by beta-lactamases.

    The second component (sulbactam), without antibacterial activity (the exception is Neisseriaceae Hacinetobacter), inhibits beta-lactamases, and in connection with this, ampicillin acquires the ability to act on stable (producing beta-lactamase) 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 ruogenes, 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); anaerobes: Clostridium spp. (Besides Clostridium difficile), Peptococcus spp., Peptostreptococcus spp., Bacteroides spp., including Bacteroides fragilis. Resistant: methicillin-resistant Staphylococcus spp., most strains Enterobacter, spp., Cirobacter spp., Pseudomonas aeruginosa, Mycobacterium spp., Clostridium. difficile, Chlamydia spp. and Mycoplasma.
    Pharmacokinetics:

    Penetrates into most tissues and body fluids; at an inflammation permeability in a spinal fluid sharply increases.

    After intravenous and / or intravenous administration, high concentrations of sulbactam and ampicillin are achieved in the blood. T1 / 2 - 1h (for ampicillin and sulbactam). It is excreted by the kidneys - 70-80%, mostly unchanged, and also with bile and breast milk. Sulbactam is almost not subjected to metabolic transformations and is excreted by the kidneys mainly in the unchanged state and only about 25% in the form of metabolites.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

    infections of the respiratory system (including pneumonia, chronic bronchitis);

    infection of the ENT organs (including angina, sinusitis, tonsillitis, otitis media);

    urinary tract infection and genital tract (pyelonephritis, pyelitis, cystitis, urethritis, uncomplicated gonorrhea, cervicitis).

    infection of the biliary tract (cholecystitis, cholangitis);

    infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses); infections of the gastrointestinal tract (peritonitis, abscess of the abdominal cavity); infection of bones and joints; septic endocarditis, meningitis, sepsis;

    Prevention of postoperative complications in operations on the abdominal and pelvic organs.

    Contraindications:

    Hypersensitivity, infectious mononucleosis, lactation (during breastfeeding).

    Carefully:

    Liver and / or kidney failure, pregnancy.

    Pregnancy and lactation:

    Sultasin® is contraindicated in the period of breastfeeding.

    In pregnancy, Sultasin® should be used only if the expected effect of therapy exceeds the potential risk to the fetus.
    Dosing and Administration:

    Intramuscularly (in / m), intravenously (iv).

    In / in (drip at a speed of 60-80 cap / min, jet - slowly, for 3-5 minutes).

    In / in 5-7 days, then, if necessary, continue treatment, go to the / m introduction.

    The following are the total doses of ampicillin and sulbactam (in a 2: 1 ratio).

    With a light infection, 1.5-3 g / day in 2 injections; at an average flow - 3-6 g / day in 3-4 injections; at heavy currents -12 g / day in 3-4 injections.

    With uncomplicated gonorrhea - 1.5 grams, once.

    For the prevention of surgical infections - 1,5-3 g during anesthesia; then within 24 hours after the operation in the same dose every 6-8 hours.

    Children - in a daily dose of 150 mg / kg (100 mg / kg ampicillin and 50 mg / kg sulbactam); multiplicity - 3-4 times a day.

    In children from 1 month to 12 years of age (or weighing up to 40 kg) in the treatment of severe infections, the dose is increased to 300 mg / kg per day.

    Newborns under the age of 1 week and premature babies are usually prescribed dose 75 mg / kg (50 mg / kg ampicillin and 25 mg / kg sulbactam) per day every 12 hours.

    A course of treatment - 5-14 days (if necessary, can be extended). After normalization of temperature and disappearance of other pathological symptoms, treatment is continued for another 48 hours.

    If the kidney function is impaired and the creatinine clearance is lower than 30 ml / min, it is advisable to increase the intervals between administrations to 12-24 hours.

    The solution for parenteral use is prepared immediately before use. To prepare the solution for intramuscular injection, 2 or 4 ml of water for injection, 0.5 % solution of procaine or 0.9 % solution of sodium chloride.

    For the / m introduction, a dilution of 0.5 % lidocaine solution.

    For intravenous administration, a single dose is dissolved in 0.9 % solution of sodium chloride or 5 % a solution of dextrose in a volume of 10 to 200 ml.
    Side effects:

    Allergic reactions: urticaria, skin hyperemia, angioedema, rhinitis, conjunctivitis, fever; arthralgia, eosinophilia, anaphylactic shock.

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

    From the nervous system: drowsiness, malaise, headache.

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

    On the part of the organs of hematopoiesis and the system of hemostasis: anemia, leukopenia / thrombocytopenia.

    Laboratory indicators: azotemia, increased urea concentration, hypercreatininaemia.

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

    If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor about it.

    Overdose:

    Symptoms: manifestation of toxic effects on the central nervous system (especially in patients with renal insufficiency); nausea, vomiting, diarrhea, violation of water-electrolyte balance (as a consequence of vomiting and diarrhea).

    Treatment is symptomatic. It is excreted by hemodialysis.

    Interaction:

    Pharmaceutically incompatible with blood products, or protein hydrolysates, aminoglycosides. In cases where Sultasin® and aminoglycosides are administered jointly, they should be administered at different sites and with a time difference between injections of at least 1h.

    Bactericidal antibiotics (including cephalosporins, cycloserine, vancomycin, rifampicin), aminoglycosides exert a synergistic effect; bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines) - antagonistic. Increases the effectiveness of indirect anticoagulants (suppresses the intestinal microflora, reduces the synthesis of vitamin K, increases prothrombin time); reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism of which paraaminobenzoic acid is formed and ethinyl estradiol (risk of bleeding "breakthrough"). Diuretics reduce the clearance of penicillins; allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs, probenecid - reducing tubular secretion, increase the concentration of penicillins in the plasma.

    Allopurinol increases the risk of allergic reactions (skin rashes).

    If you are taking other drugs, you should consult your doctor.
    Special instructions:

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

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

    Perhaps the development of superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapies.

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

    Effect on the ability to drive transp. cf. and fur:Data on the adverse effect of Sultasin® in the recommended doses on the ability to drive vehicles and control mechanisms are absent.
    Form release / dosage:Powder for the preparation of solution for intravenous and intramuscular injection 500 mg + 250 mg, 1000 mg +500 mg.
    Packaging:For 500 mg + 250 mg, 1000 mg + 500 mg in glass bottles with a capacity of 10 or 20 ml, hermetically sealed with stoppers rubber, crimped aluminum caps or caps combined aluminum with plastic caps.
    1, 5, 10 bottles with instructions for use are placed in packs of cardboard.
    50 bottles with an equal number of instructions for use are placed in carton boxes for delivery to hospitals.
    Solvents:
    "Sodium chloride solvent for the preparation of medicinal forms for injection 0.9%" in glass ampoules of 5 ml;
    "Water for injection" in glass ampoules of 5 ml.
    1 bottle with the preparation, 1 or 2 ampoules with a solvent in a contoured cell pack of a polyvinylchloride film and aluminum foil printed lacquered.
    1 contour cell package with ampoule scarifier and instructions for use of the drug in a pack of cardboard.
    1 bottle with the drug, 1 or 2 ampoules with a solvent, instruction for the use of the drug, ampoule scapegrator in a pack or box of cardboard.
    5 bottles with the drug in a contoured cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.
    1 contour cell package with the preparation, 1 or 2 contoured cell packs (5 ampoules each) of the solvent, instructions for the use of the preparation and ampullar in a pack of cardboard.
    When using ampoules with a kink ring or with a notch and a scarification-rampule point, do not invest.
    Storage conditions:

    In a dry, protected from light place, at a temperature not exceeding 20 ° С.

    Keep out of the reach of children.

    Shelf life:2 years. Do not use after expiration of the expiration date stated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N003619 / 01
    Date of registration:25.05.2009
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.11.2012
    Illustrated instructions
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