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: & nbspPowder for suspension for oral administration
    Composition:

    Composition for 5 ml of the prepared suspension for a dosage of 125 mg + 125 mg / 5 ml:

    Active substance: amoxicillin trihydrate - 143,500 mg (equivalent to amoxicillin-125 mg); sulbactam pivoxil - 186,200 mg (equivalent to sulbactam - 125 mg).

    Excipients: Carboxymethylcellulose sodium - 2,500 mg, sodium chloride - 5,000 mg, sodium benzoate - 5,000 mg, silicon colloidal dioxide - 12,500 mg, banana flavor - 6,670 mg, dye quinoline yellow - 0.208 mg, sucrose - 2138.422 mg.

    Composition for 5 ml of the prepared suspension for a dosage of 250 mg + 250 mg / 5ml:

    Active substance: amoxicillin trihydrate - 287,000 mg (equivalent to amoxicillin - 50 mg); sulbactam pivoxil - 372,000 mg (equivalent to sulbactam - 250 mg).

    Excipients: Carboxymethylcellulose sodium - 2,500 mg, sodium chloride - 5,000 mg, sodium benzoate - 5,000 mg, silicon dioxide colloid -12,500 mg, flavoring banana - 6,670 mg, dye quinoline yellow - 0.208 mg, sucrose -1808.722 mg.

    Description:White or white with a yellowish tinge powder with a characteristic fruity odor.
    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 with bactericidal action against sensitive microorganisms, including strains that produce beta-lactamases.

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

    Sulbactam 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 in- 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 (incl.strains that produce beta-lactamase):

    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, Acihetobacter 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 (TCmOh) - 2 hours after administration. Period and elimination 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 - 5-0 %.

    Sulbactam

    TSmSulbactam, as well as for amoxicillin, is -2 hours. The connection with blood plasma proteins is 40%. The half-life is h. Sulbactam does not affect 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:

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

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

    -infection of the biliary tract (cholecystitis, cholangitis);

    - intestinal infections (shigellosis, salmonellosis);

    -for eradication Helicobacter pylori as part of complex therapy;

    -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);

    -infection of the skin and soft tissues (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 (creatinine clearance <30 mL / min) (for this dosage form).

    In connection with the presence of sucrose: a deficiency of sugar / isomaltase, intolerance to fructose and glucose-galactose malabsorption.

    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.

    Each 5 ml of the reconstituted 25 mg + 25 mg suspension contains 25 mg of amoxicillin and 25 mg of sulbactam.

    Every 5 ml reconstituted suspension 250 mg + 250 mg contain 250 mg of amoxicillin and 250 mg of sulbactam.

    The dosage regimen (doses are given in terms of amoxicillin) are set individually depending on the severity of the course and localization of the infection, the sensitivity of the pathogen.

    A single dose is established depending on the age: for children aged 6-2 years - 250-500 mg, 2-6 years - 250 mg, up to 2 years - 125 mg, multiplicity of appointment - 3 times a day. When preparing the suspension, water should be used as the solvent. Water is added to the label indicated on the label of the vial, the contents of the vial are shaken to a homogeneous mass, then again brought to the marked label with water.

    When the suspension is standing, it is possible to form a small precipitate that is easily resuspended with agitation. Shake before each use!

    Adults and adolescents over 2 years are recommended to use the drug in the form of tablets of 250 mg 3 times a day. In severe infections, 500 mg 3 times a day or 1 g 2 times a day.

    When chronic renal failure, the dose is calculated in - depending on the creatinine clearance. In this regard, to facilitate the selection of an adequate dose, parenteral administration of Trifamox IBL® is recommended.

    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.

    Co side of the digestive system: nausea, vomiting, diarrhea, dyspepsia, epigastric pain, pseudomembranous colitis, increased activity of hepatic transaminases, cholestatic jaundice, hepatitis.

    Co sides of hemopoiesis: 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.

    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 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 (control required of coagulation factors blood). Reduces the effectiveness of oral contraceptives. When combined with allopurinol increases the risk of skin allergic reactions.
    Special instructions:

    Patients with diabetes should note that in the preparation of Trifamox IBL® powder for the preparation of a suspension for oral administration of 25 mg + 25 mg / 5 ml and 250 mg + 250 mg / 5 ml contains sucrose. Each 5 ml of the prepared suspension of Trifamox IBL® 25 mg + 25 mg contains - 238.422 mg sucrose (corresponding to 0.8 XE).

    Every 5 ml of the prepared suspension of Trifamox IBL® 250 mg + 250 mg contains 808.722 mg sucrose (corresponding to 0.5 XE).

    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 catheter, therefore, periodic monitoring of the catheter's patency is necessary.

    Amoxicillin can reduce the concentration of total protein in the blood plasma. Available false-positive result of reactions during the tests for the determination of glucose in urine by colorimetric method, reversible increase in prothrombin time.

    With prolonged use of the drug may increase the activity of hepatic transaminase.

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

    With prolonged use, the drug should be periodically monitored kidney function, liver and general blood test.

    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 suspension for oral administration 25 mg +25 mg / 5 ml and 250 mg + 250 mg / 5 ml.

    Packaging:For 30 g and 60 g of powder in a vial of high-density polyethylene, closed screwed plug.

    Each vial with a measuring cap is placed in a cardboard box along with the medical use.

    Storage conditions:

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

    The prepared suspension should be stored at 2-8 ° C in a tightly closed container.

    Shelf life:

    2 of the year.

    Shelf life of the prepared suspension is 7 days.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000805
    Date of registration:01.04.2011
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp20.01.2014
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