Active substanceAmoxicillin + SulbactamAmoxicillin + Sulbactam
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  • Trifamox IBL®
    powder w / m in / in 
    VALEANT, LLC     Russia
  • Trifamox IBL®
    pills inwards 
    VALEANT, LLC     Russia
  • Trifamox IBL®
    powder inwards 
    VALEANT, LLC     Russia
  • Trifamox IBL® DUO
    pills inwards 
    VALEANT, LLC     Russia
  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:

    1 bottle contains:

    Active substance: amoxicillin sodium - 530.09 mg (corresponding to amoxicillin - 500,00 mg) or amoxicillin sodium - 1060.18 mg (corresponding to amoxicillin - 1000,00 mg). Sulbactam sodium - 273.55 mg (corresponding to sulbactam - 250.00 mg) or sodium sulbactam - 547.10 mg (corresponding to sulbactam - 500.00 mg).

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

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

    Pharmacodynamics:

    Trifamox IBL® is a combined preparation that has a bactericidal action against amoxicillin-sensitive microorganisms, including strains, producing beta-lactamases.

    Amoxicillin is a semisynthetic penicillin with a broad spectrum of activity from the group of aminopenicillins, inhibits the synthesis of proteins of the cell wall of pathogenic microorganisms.

    Sulbactam is an irreversible beta-lactamase inhibitor; expands the spectrum of amoxicillin activity against resistant strains, the resistance of which develops under the influence of beta-lactamases; does not change the activity of amoxicillin against sensitive strains; by binding to certain penicillin-binding bacteria proteins, exhibits synergism with simultaneous use with beta-lactam antibiotics. Stable in aqueous solution, has an independent antibacterial activity against Neisseria gonorrhoeae and Acinetobacter spp. and is resistant to the action of most plasmid beta-lactamases.

    Amoxicillin is active against the following microorganisms (including strains producing beta-lactamases):

    Aerobic Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus groups viridans, Enterococcus faecalis, Corynebacteriurri spp., Listeria monocytogenes.

    Anaerobic Gram-positive bacteria: Clostridium spp., Peptococcus spp., Peptostreptococcus spp.

    Aerobic Gram-negative bacteria: Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella spp., Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Haemophilus influenzae, Yersinia multocida, Campylobacter jejuni, Acinetobacter spp.; Helicobacter pylori.

    Anaerobic Gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis.

    Pharmacokinetics:

    Amoxicillin

    Connection with blood plasma proteins - 20%. Amoxicillin is distributed in most tissues and body fluids, penetrates the placental barrier and is found in breast milk. Half-life from blood plasma - 1 h.

    It is excreted mainly by the kidneys (glomerular filtration and tubular secretion) - 70-80 % and with bile - 5-10 %.

    Sulbactam

    Connection with blood plasma proteins - 40%. Half-life is 1 hour. Sulbactam is not has an effect on the pharmacokinetics of amoxicillin. Sulbactam is almost completely unchanged in the form of kidneys (75-85%). Sulbactam penetrates the placental barrier.

    Indications:

    Infectious-inflammatory diseases caused by strains of microorganisms sensitive to amoxicillin:

    - infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis, acute and chronic otitis media, zaglugal abscess, tonsillitis, pharyngitis);

    - infections of the lower respiratory tract (acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);

    - bile duct infection (cholecystitis, cholangitis);

    - intestinal infections (salmonellosis);

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

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

    - postoperative infections;

    - prevention of infectious and inflammatory diseases in surgery.

    Contraindications:

    Hypersensitivity to any of the components of the drug and other beta-lactam antibiotics; infectious mononucleosis (including when a measles-like rash appears), ulcerative colitis; Crohn's disease; herpesviral infection.

    Simultaneous reception of allopurinol (in the presence of skin allergic reactions when using penicillins).

    Colitis in the anamnesis associated with the use of penicillins.

    Carefully:

    Severe liver failure, gastrointestinal tract diseases, chronic renal failure (CRF), advanced age (due to possible renal failure).

    Pregnancy and lactation:

    Use during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.If it is necessary to use the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    The dosage regimen is set individually, depending on the severity of the course and localization of the infection, the sensitivity of the pathogen. Treatment should be continued for at least another 2-3 days after the disappearance of the clinical symptoms of the disease, but no more than 14 days.

    In the treatment of infections caused by beta-hemolytic streptococci, the drug is recommended to apply for at least 10 days.

    The drug is administered intramuscularly, intravenously, injectively or intravenously infusion.

    Doses are given in terms of amoxicillin:

    The usual recommended dose for adults and children over 12 years of age: Enter 1.0 g 2-3 times a day;

    For the prevention of postoperative infections in operations lasting less than 1 hour during introductory anesthesia, the drug is administered intravenously at a dose of 1.0 g.

    With longer operations - 1.0 g every 6 hours during the day. With a high risk of infection, administration can be continued for several days.

    For children from 6 to 12 years: 500 mg 3 times a day;

    For children from 2 to 6 lept, 250 mg 3 times a day;

    For children under 2 years: 40-60 mg / kg 2-3 times a day;

    In severe infections, the daily dose of the drug (in terms of amoxicillin) can be increased to 100 mg / kg / day, especially caused by gram-negative pathogens.

    Patients with impaired renal function:

    The dosage regimen is changed depending on the creatinine clearance of the CCJ.

    With QC greater than 30 ml / min, a change in the dosing regimen is not required; with CC 10-30 ml / min, treatment is initiated with on / in the 1.0 g, followed by 500 mg / 2 times per day; with CC less than 10 ml / min - 1.0 g, then 500 mg / day iv once a day.

    Hemodialysis reduces the concentration in the blood plasma, and therefore during and at the end of dialysis is further added with 500 mg drug / in.

    In children with chronic renal failure, the usual single doses are used, increasing the intervals between administrations, as indicated for adults.

    Method of preparation of solutions:

    For the / m introduction to the contents of the vial (500 mg + 250 mg or 1000 mg + 500 mg) is added 5 ml of water for injection.

    Use freshly prepared solutions.

    For intravenous administration a single dose is dissolved in a 0.9% solution NaCl or 5% dextrose (glucose) solution in a volume of 10 ml (for IV injection) to 100 - 200 ml (for IV infusion introduction).

    For intravenous infusion dilution is possible with lactated Ringer's solution.

    When diluted with lactated Ringer's solution, the solution is prepared in 2 stages: first, sterile water for injection is used, then the resulting solution is diluted with a lactated Ringer's solution.

    With iv injection the prepared solution is introduced slowly.

    With IV infusion introduction the prepared solution is slowly added dropwise for 15-60 minutes.

    Side effects:

    Allergic reactions: urticaria, Quincke's edema, respiratory disorders, multiforme exudative erythema, anaphylactic shock, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis.

    From the digestive system: nausea, vomiting, diarrhea, dyspepsia, epigastric pain, pseudomembranous colitis, increased activity of "liver" transaminases, cholestatic jaundice, hepatitis.

    On the part of the organs of hematopoiesis: anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis.

    From the central nervous system: hyperactivity, agitation, anxiety, insomnia, confusion, behavior change.

    Other: candidamycosis, interstitial nephritis; development of superinfection.

    Local reactions: burning and pain at the injection site, in some cases - phlebitis in the place of intravenous administration.

    Overdose:

    Symptoms: disorders of the gastrointestinal tract (nausea, vomiting, diarrhea) and water-electrolyte balance.

    In case of an overdose, it is recommended to stop the medication administration. A small number of reports related to the occurrence of interstitial nephritis with an oliguric renal failure due to an overdose of amoxicillin. Such drug-induced kidney damage is reversible: the kidney function is restored after discontinuation of the drug administration.

    Treatment: symptomatic. Amoxicillin and sulbactam can be removed from the body by dialysis.

    Interaction:

    The drug Trifamox IBL® is incompatible with aminoglycosides, blood derivatives and protein lysing products, so they can not be mixed in one container.

    Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

    The use of probenecid can cause a decrease in renal tubular secretion, which leads to a prolonged increase in the concentration of amoxicillin in the blood plasma. The drug Trifamox IBL® slows the excretion of methotrexate.

    Trifamox IBL® improves the effectiveness of indirect anticoagulants (blood coagulation monitoring is necessary). Reduces the effectiveness of oral of contraceptives.

    When combined with allopurinol increases the risk of skin allergic reactions.

    Special instructions:

    Treatment of patients suffering from asthma, eczema or pollinosis should be conducted under the supervision of a physician.

    Due to the high concentration of amoxicillin in the urine, it can be deposited on the walls of the catheter, therefore it is necessary to periodically check the patency of the catheter. Amoxicillin can reduce the concentration of total protein in the blood plasma. A false positive result of reactions during the tests for the determination of glucose in the urine by the colorimetric method is possible, a reversible increase in prothrombin time.

    With prolonged use of the drug may increase the activity of "liver" transaminases.

    As amoxicillin reduces the effectiveness of oral contraceptives for women taking progestin and estrogenic contraceptives, it is recommended to use alternative or additional methods of contraception.

    With prolonged use of the drug, periodic monitoring of the kidneys, liver and general blood analysis is necessary.

    A high concentration of amoxicillin helps to reduce the concentration of glucose in the blood.

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

    Data on the adverse effects of Trifamox IBL® in recommended doses on the ability to drive a vehicle or work with mechanisms are not present.

    However, given the likelihood of side effects from the central nervous system, caution should be exercised when engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Powder for the preparation of solution for intramuscular and intravenous administration of 500 mg + 250 mg, 1000 mg + 500 mg.

    Packaging:

    Primary packaging:

    500 mg of amoxicillin + 250 mg of sulbactam or 1000 mg of amoxicillin plus 500 mg of sulbactam are placed in a glass vial covered with a rubber stopper and rolled up with an aluminum cap with a protective plastic lid.

    Secondary packaging:

    The bottle with powder is placed in a cardboard box together with instructions for medical use.
    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000807
    Date of registration:29.09.2011
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp05.02.2014
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