Active substanceHydroxymethylquinoxaline dioxideHydroxymethylquinoxaline dioxide
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  • Dosage form: & nbspRA mortar for intracavity and external administration
    Composition:

    Active substance: hydroxymethylquinoxaline dioxide - 10.0 mg;

    Excipient: water for injection - up to 1 ml.

    Description:

    Transparent liquid is greenish-yellow in color.

    Note: It is allowed to drop crystals in ampoules during storage. In case of precipitation of crystals, they are dissolved by heating the ampoules in a boiling water bath with shaking until the crystals are completely dissolved (clear solution). If the crystals do not fall again upon cooling to 36-38 ° C, the preparation is usable.

    Pharmacotherapeutic group:Antimicrobial agent - quinoxaline
    ATX: & nbsp

    J.01.X.X   Other antibacterial drugs

    Pharmacodynamics:

    Antibacterial bactericidal preparation of a wide spectrum of action from the group of quinoxaline derivatives.

    Active with respect to:

    Gram-negative aerobic microorganisms: Escherichia coli, Klebsiella pneumoniae (Friedlander's wand), Proteus vulgaris, Pseudomonas aeruginosa, Salmonella spp., Shigella dysenteriae, Shigella flexneri. Shigella boydii, Shigella sonnei;

    Gram-positive aerobic microorganisms: Staphylococcus spp., Streptococcus spp .; pathogenic anaerobic microorganisms: Clostridium perfringens.

    It acts on strains of bacteria resistant to other antimicrobial medicines, including antibiotics of different groups. Possible development of drug resistance of bacteria.

    The mechanism of bactericidal action of hydroxymethylquinoxaline dioxide is in damage to the biosynthesis of the DNA of a microbial cell.

    Treatment of burns and purulent-necrotic wounds promotes faster cleaning of the wound surface, stimulates reparative regeneration and marginal epithelization and favorably influences the course of the wound process.

    Pharmacokinetics:

    With external application partially absorbed from the wound or burn surface, excreted by the kidneys.

    Indications:

    Treatment of various forms of purulent bacterial infection,caused by a sensitive microflora, if other antimicrobial drugs are ineffective or poorly tolerated.

    Intracavitary introduction - Purulent processes in the thoracic and abdominal cavity: purulent pleurisy, empyema of the pleura, peritonitis; cystitis, prevention of infectious complications after catheterization of the bladder; wounds with the presence of deep purulent cavities (abscess of soft tissues, phlegmon of the pelvic fat, postoperative wounds of the urinary and bile ducts, purulent mastitis).

    External application - wound and burn infection (superficial and deep wounds of various locations, long-term healing wounds and trophic ulcers, phlegmon of soft tissues, infected burns, purulent wounds in osteomyelitis).
    Contraindications:

    Hypersensitivity to hydroxymethylquinoxaline dioxide, other drugs of the quinoxaline group, adrenal insufficiency (including anamnesis), pregnancy, breast-feeding period, children under 18 years of age.

    Carefully:Renal failure.
    Pregnancy and lactation:

    During pregnancy and during breastfeeding, the drug is contraindicated.In preclinical studies it was shown that hydroxymethylquinoxaline dioxide has a teratogenic and embryotoxic effect, has mutagenic properties.

    The use of the drug during lactation is possible only after the transfer of the child to artificial feeding.

    Dosing and Administration:

    Intracavernal administration

    In the cavity, depending on its size, a day from 10 to 50 ml of a 1% solution of hydroxymigylquinoxaline dioxide is administered. The solution is injected into the cavity through a catheter, drain tube or syringe.

    The maximum daily dose for administration in the cavity is 70 ml of a 1% solution.

    The drug is injected into the cavity usually once a day. According to the indications, it is possible to administer a daily dose of 2 doses. With good tolerability and the presence of indications, the drug can be administered daily for 3 weeks or more. If necessary, repeat courses are conducted after 1-1.5 months.

    For patients with impaired renal function, the dose of the drug is reduced by a factor of 2. In elderly patients, a dose reduction may be required in case of renal dysfunction.

    External application

    Apply 0.1-1% solutions of hydroxymethylquinoxaline dioxide.To obtain a solution of the desired concentration, the drug is diluted with a sterile 0.9% solution of sodium chloride or water for injection.

    For the treatment of superficial purulent wounds on the wound surface, previously cleaned from purulent necrotic masses, apply napkins moistened with 0.5-1% solution. Bandages are changed daily or every other day, depending on the condition of the wound or the course of the wound process. Deep wounds after treatment loosely swabbed with tampons moistened with 1% solution. Dressings are done once a day.

    The maximum daily dose of hydroxymethylquinoxaline dioxide is 2.5 g (250 ml of 1% solution).

    Duration of treatment - up to 3 weeks.

    For the treatment of deep purulent wounds in osteomyelitis (wounds of the hand, feet) apply 0.5-1% solution of the drug in the form of trays or special treatment of the wound with the drug for 15-20 minutes (insertion of the solution into the wound at this time), followed by the application of dressings moistened with 1% solution.

    For the prevention of infections after surgery, 0.1-0.5% solution of the drug is used.

    According to the indications (patients with osteomyelitis) and with good tolerability treatment can be carried out daily for 1.5-2 months.

    It is allowed to drop crystals in ampoules during storage.In case of precipitation of crystals, they are dissolved by heating the ampoules in a boiling water bath with shaking until the crystals are completely dissolved (clear solution). If the crystals do not fall again upon cooling to 36-38 ° C, the preparation is usable.

    Side effects:

    Allergic reactions.

    With intracavitary injection possible headache, chills, fever, dyspeptic disorders, muscle cramps, photosensitizing effect (the appearance of pigmented spots on the body when exposed to sunlight).

    With external application - itching, dermatitis.

    Overdose:

    When an overdose of the drug may develop acute adrenal insufficiency, which requires the immediate withdrawal of the drug and appropriate replacement therapy.

    Interaction:

    There is no information on the interaction of the drug with other drugs.

    Special instructions:

    The drug is used under strict medical supervision in a hospital.

    The drug can not be used for intravenous administration (because of instability of the solution when stored at low temperatures).

    Before the beginning of the course of treatment, a sample is not tolerated, for which 10 ml of the preparation is injected into the cavity. In the absence of side effects during 3-6 h (dizziness, chills, fever) begin course treatment. Otherwise, Imibact® is not prescribed.

    It is prescribed only for severe forms of infectious diseases or for ineffectiveness of other antibacterial drugs, including cephalosporins II-IV generation, fluoroquinolones, carbapenems.

    Hydroxymethylquinoxaline dioxide is characterized by a narrow therapeutic latitude (strict control over compliance with recommended doses is necessary), therefore it is necessary to strictly follow the recommended doses and not to allow their excess.

    To prevent adverse reactions, it is recommended to use in combination with antihistamines and calcium preparations.

    If adverse reactions occur, reduce the dose, prescribe antihistamines, and if necessary, cancel the drug.

    With renal failure, the dose is reduced.

    When used in elderly people, the age-related decrease in renal function should be considered, which may require a reduction in the dose of the drug.

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

    During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intracavitary administration and external application, 10 mg / ml.

    Packaging:

    For 5 or 10 ml in ampoules of colorless or light-protective glass.

    10 ampoules in boxes of cardboard.

    5 ampoules in contour cell packs from polyvinylchloride film and aluminum foil printed lacquered or foil-free.

    1 or 2 contour packs of 5 ampoules in a pack of cardboard.

    Each instruction pack or box is supplied with instructions for use, the ampoule scaler.

    When using ampoules with a kink ring or with a notch and a dot the ampoule scaper is not inserted.

    Storage conditions:

    In the dark place at a temperature of 18 ° C to 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:LP-003610
    Date of registration:12.05.2016
    Expiration Date:12.05.2021
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp24.10.2017
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