Active substanceHydroxymethylquinoxaline dioxideHydroxymethylquinoxaline dioxide
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  • Dosage form: & nbspconcentrate for solution for infusion
    Composition:

    Active substance: hydroxymethylquinoxaline dioxide - 5 mg.

    Excipient: water for injection - up to 1 ml.

    Description:

    Light yellow with a greenish shade of clear liquid.

    Note: The crystals fall out during storage. In case of precipitation of crystals during storage, they are dissolved by heating the ampoules in a boiling water bath with shaking until the crystals are completely dissolved (clear solution). If, upon cooling to 36-38 ° C, the crystals do not fall out again, 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 Proteus vulgaris, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, Shigella dysenteriae, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella spp., Staphylococcus spp., Streptococcus spp., pathogenic anaerobes (Clostridium perfringens). It acts on strains of bacteria resistant to other antimicrobial medicines, including antibiotics of different groups.

    Possible development of drug resistance in bacteria.

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

    Pharmacokinetics:

    After a single intravenous injection, the maximum concentration in the blood (Cmax) is achieved after 1-2 hours, the therapeutic concentration of the drug persists for 4-6 hours. The drug penetrates well and quickly into all organs and tissues. Not exposed to metabolism, excreted by the kidneys. With repeated administration does not accumulate in the body.

    Indications:

    Treatment of various forms of purulent bacterial infection caused by sensitive microflora when other chemotherapeutic agents are ineffective or poorly tolerated.

    Severe septic conditions (including those with burn disease), purulent meningitis, severe purulent-inflammatory processes with symptoms of infection generalization.

    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 teratogenic, embryotoxic and mutagenic properties.

    The use of the drug in the period of breastfeeding is possible only after the child is fully transferred to artificial feeding.

    Dosing and Administration:

    Intravenously.

    Slowly drip.

    Inkjet introduction is unacceptable!

    Introduce a solution of the drug 5 mg / ml, which is previously diluted in a 5% solution of dextrose or in a 0.9% solution of sodium chloride to a concentration of hydroxymethylquinoxaline dioxide 1-2 mg / ml.The daily dose of the drug is administered once or in 3-4 divided doses. The drug is administered at a rate of 60-80 drops / min for 30 minutes.

    In severe septic states the maximum single dose is 300 mg (corresponding to 60 ml hydroxymethylquinoxaline dioxide solution 5 mg / ml), the daily dose is 600 mg (120 ml hydroxymethylquinoxaline dioxide solution 5 mg / ml).

    With purulent meningitis The daily dose is 600 mg of hydroxymethylquinoxaline dioxide (ie 120 ml of a solution of 5 mg / ml).

    In chronic purulent processes in the lungs in the acute stage with signs of generalization The daily dose is 500-600 mg of the drug (that is, 100-120 ml of a solution of 5 mg / ml).

    When treating a severe purulent urinary tract infection The daily dose is 200-400 mg of hydroxymethylquinoxaline dioxide (ie 40-80 ml of a solution of 5 mg / ml).

    For patients with impaired renal function the dose of the drug is reduced by half.

    When applying in elderly patients should take into account the possible age-related decline in kidney function, which should also be taken into account in determining the therapeutic dose.

    It is necessary to strictly observe the recommended doses, not allowing their excess, since the drug has a narrow therapeutic breadth.

    In the case of precipitation of crystals of hydroxymethylquinoxaline dioxide, the crystals are dissolved in ampoules with a solution, heating ampoules in a boiling water bath with shaking until the crystals dissolve completely (the solution should become transparent). If the crystals do not drop again when the ampoules with the drug are cooled to 36-38 ° C, the preparation is suitable for use.

    Side effects:

    Possible headache, chills, fever, muscle cramps, allergic reactions (rash, urticaria), photosensitizing effect (the appearance of pigmented spots on the body when exposed to sunlight), nausea, vomiting, diarrhea.

    Overdose:

    In case of overdose, it is possible to develop acute adrenal insufficiency (as the production of glucocorticoids is disturbed), which requires immediate withdrawal of the drug and appropriate hormone replacement therapy.

    Interaction:There is no information on the interaction of the drug with other drugs.
    Special instructions:

    Apply under strict medical supervision in a hospital.

    The drug VIUMKSIDIN® is prescribed only for severe forms of infectious diseases or for the ineffectiveness of other antibacterial drugs,including cephalosporins II-IV generations, fluoroquinolones, carbapenems.

    In chronic renal failure, the dose is reduced.

    When hypersensitivity to hydroxymethylquinoxaline dioxide (for example, when pigmented spots appear), the preparation VIUMXIDIN® is used simultaneously with antihistamines or calcium preparations, reduce the dose, if necessary, cancel.

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

    Not studied.

    Given the indications for the use of the drug VIUMKSIDIN® and the profile of its possible side effects with intravenous administration, during the treatment period it is necessary to refrain from driving and other potentially hazardous activities requiring an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Concentrate for solution for infusion, 5 mg / ml.

    Packaging:

    5 ml or 10 ml into ampoules of neutral glass or glass of the first hydrolytic class with a break point or a ring of fracture.

    For 10 ampoules together with instructions for use in a pack of cardboard.

    5 ampoules per contour plastic pallet or contour mesh packaging.

    For 1 or 2 plastic pallets or 1 or 2 contour packs with instructions for use in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003599
    Date of registration:04.05.2016 / 24.10.2016
    Expiration Date:04.05.2021
    The owner of the registration certificate:TRIVIUM-XXI, LLC TRIVIUM-XXI, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.02.2017
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