Trifamox IBL® (Trifamox IBL®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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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: & nbspfilm coated tablets
    Composition:

    1 tablet, film-coated with a dosage of 250 mg + 250 mg contains:

    Tablet core composition:

    Active substances: amoxicillin trihydrate 287.0 mg (equivalent to amoxicillin - 250,00mg), sulbactam pivoxil - 372.4 mg (equivalent to sulbactam - 250.0 mg).

    Excipients:

    Povidone - 7.7 mg, macrogol - 12.0 mg, silicon dioxide colloid - 2.5 mg, croscarmellose sodium - 24.0 mg, magnesium stearate - 7.0 mg, microcrystalline cellulose - 87.4 mg.

    Composition of the tablet shell:

    Drop off white II YS-30-18056 - 31.2 mg (lactose monohydrate (40%), hypromellose (40%), titanium dioxide (10%), triacetin (10%)), iron oxide dye oxide - 0.96 mg.

    1 tablet, film-coated with a dosage of 500 mg + 500 mg contains:

    Tablet core composition:

    Active substances: amoxicillin trihydrate - 573.944 mg (equivalent to amoxicillin - 500,00 mg), sulbactam pivoxil - 744.673 mg (equivalent to sulbactam - 500.0 mg). Excipients:

    Povidone 15.4 mg, macrogol 24.0 mg, silicon colloidal dioxide 5.0 mg, croscarmellose sodium 48.0 mg, magnesium stearate 14.0 mg, microcrystalline cellulose 174.9 mg.

    Composition of the tablet shell:

    Drop off white II YS-30-.18056 - 62.4 mg (lactose monohydrate (40%), hypromellose (40%), titanium dioxide (10%), triacetin (10%)), iron oxide pigment oxide yellow -1.9 mg.

    Description:

    Oval, biconcave, film-coated tablets of yellow color with a risk on both sides.

    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 effect 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 proteins of bacteria, exhibits synergism with simultaneous use with beta-lactam antibiotics. Stable in aqueous solution, has an independent antibacterial activity against Neisseria gonorrhoeae and Acineiobacler 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, Corynebacterium 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:

    After oral administration, both active components of the drug are rapidly absorbed from the gastrointestinal tract (GIT).

    Amoxicillin

    The bioavailability of amoxicillin after oral administration is approximately 80%; eating does not affect the absorption of amoxicillin. Time to reach the maximum concentration in the blood plasma (TCmax) 1 - 2 hours after administration. Half-life from blood plasma - 1 h.

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

    Sulbactam

    TCmax sulbactam, as well as for amoxicillin, is 1-2 hours. The connection with blood plasma proteins is 40%. The half-life is 1 hour. Sulbactam has no 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 sensitive to amoxicillin and microorganisms:

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

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

    - bile duct infection (cholecystitis, cholangitis);

    - intestinal infections (shigellosis, salmonellosis);

    - for eradication Helicobacter pylori as part of complex therapy;

    - infections 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.

    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.

    Chronic renal failure with clearance of creatinine <30 ml / min (for this dosage form).

    In connection with the presence of lactose: hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

    Children under 3 years (for this dosage form).

    Carefully:

    Severe hepatic insufficiency, diseases of the gastrointestinal tract, chronic renal failure (creatinine clearance> 30 ml / min), elderly 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:

    Inside. Regardless of food intake.

    Usual recommended dose:

    for adults and children over 12 years of age:

    depending on the severity of the course or localization of the infection, 1 tablet (250 mg + 250 mg or 500 mg + 500 mg) 3 times a day or 2 tablets (500 mg + 500 mg) 2 times a day.

    for children aged 6 to 12 years:

    depending on the severity of the course or localization of infection for 1 tablet (250 mg + 250 mg or 500 mg + 500 mg) 3 times a day.

    for children aged 3 to 6 years:

    Po 1 tablet (250 mg + 250 mg) 3 times a day.

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

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

    Patients with impaired renal function:

    In chronic renal failure (creatinine clearance> 30 ml / min) correction of the dosing regimen is not required.

    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.

    From the hematopoiesis: anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis.

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

    Other: candidamycosis, interstitial nephritis; development of superinfection.

    Overdose:

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

    In case of an overdose, it is recommended that you stop taking the medication. 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 damage to the kidneys is reversible: the function of the kidney is restored after stopping the drug.

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

    Interaction:

    Antacids, glucosamine, laxative drugs - slow down and reduce the absorption of the drug Trifamox IBL®; ascorbic acid - increases the absorption of Trifamox IBL®.

    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:

    Tablets, film-coated 250 mg + 250 mg and 500 mg + 500 mg.

    Packaging:For 8 tablets in a blister of PVC / aluminum. For 1 or 2 blisters are 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:15.01.2014
    Date of registration:19.09.2011
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp15.01.2014
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