Active substanceChondroitin sulfateChondroitin sulfate
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  • Dosage form: & nbspsolution for intramuscular injection
    Composition:

    1 ml of the preparation contains:

    Active substance:

    Chondroitin sodium sulfate 100 mg

    Excipients:

    Benzyl alcohol 9 mg

    Sodium disulfite 1 mg

    1 M sodium hydroxide solution to pH 6.0 - 7.5

    Water for injection up to 1 ml

    Description:

    Transparent or slightly opalescent, colorless or slightly colored liquid with the smell of benzyl alcohol.

    Pharmacotherapeutic group:Reparation of tissue stimulant
    ATX: & nbsp

    M.01.A.X.25   Chondroitin sulfate

    Pharmacodynamics:

    Has chondro-stimulating, regenerating, anti-inflammatory and analgesic effect. Chondroitin sulfate participates in the construction of the main substance of cartilage and bone tissue. Has chondroprotective properties, enhances metabolic processes in hyaline and fibrous cartilage, subchondral bone; inhibits enzymes that cause degeneration (destruction) of articular cartilage; stimulates the production of chondrocytes proteoglycans.Helps reduce the release of synovial fluid mediators of inflammation and pain, suppresses the secretion of leukotrienes and prostaglandins. Slows the resorption of bone tissue and reduces calcium loss, accelerates the recovery of bone tissue.

    Chondroitin sulfate slows the progression of osteoarthritis and osteochondrosis. Promotes the restoration of the articular bag and the cartilaginous surfaces of the joints, prevents the collapse of connective tissue, normalizes the production of joint fluid.

    When using the drug, soreness decreases and mobility of affected joints improves, while the therapeutic effect persists for a long time after the end of the course of therapy. In the treatment of degenerative joint changes accompanied by a secondary synovitis, the effect is observed after 2-3 weeks from the start of the course.

    Having structural similarity with heparin, it can potentially prevent the formation of fibrin clots in the synovial and subchondral microcirculatory bed.

    Pharmacokinetics:

    30 minutes after intramuscular injection is found in the blood in significant concentrations; after 15 minutes - in the synovial fluid.Maximum concentration in blood plasma (FROMmOh) is achieved through 1 h, then the concentration of the drug gradually decreases within 2 days.

    It accumulates mainly in the cartilaginous tissue (the maximum concentration in articular cartilage is reached after 48 hours); the synovial membrane is not an obstacle to the penetration of the drug into the joint cavity. It is excreted by the kidneys.

    Indications:

    Degenerative and dystrophic diseases of the joints and spine: osteoarthritis and osteochondrosis of the spine.

    To accelerate the formation of bone callus in fractures.

    Contraindications:

    - Hypersensitivity to the drug or its components;

    - bleeding, tendency to bleeding;

    - thrombophlebitis;

    - children under 18 years of age (efficacy and safety not established).

    Carefully:

    No data.

    Pregnancy and lactation:

    It is not recommended to use the drug during pregnancy. During treatment, breastfeeding should be discontinued due to lack of data.

    Dosing and Administration:

    Intramuscularly, 100 mg every other day. With good tolerability, the dose is increased to 200 mg, starting with the fourth injection. The course of treatment - 25-35 injections.If necessary, after 6 months, a repeat course of treatment is possible.

    Side effects:

    Allergic reactions (pruritus, rash, erythema, urticaria, dermatitis, edema); bleeding at the injection site.

    Overdose:At present, cases of an overdose of chondroitin sulfate have not been reported.
    Interaction:

    It is possible to increase the effect of indirect anticoagulants, antiplatelet agents, fibrinolytic agents.

    Special instructions:

    When the drug is used together with indirect anticoagulants, antiplatelet agents, fibrinolytic drugs, more frequent monitoring of blood clotting parameters is required.

    In case of allergic reactions or the appearance of hemorrhages treatment should be discontinued.

    To achieve a stable clinical effect, at least 25 injections of the drug are necessary, but the effect persists for several months after the end of the course of treatment. To prevent exacerbations, repeated courses of treatment are indicated.

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

    The drug does not affect the ability to drive vehicles, work with mechanisms and engage in other activities,requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intramuscular injection 100 mg / ml.

    Packaging:

    By 1 or 2 ml into ampoules of colorless or colored glass 1 hydrolytic class or HC-3. By 5 or 10 ampoules in a contoured cell pack of a film of polyvinyl chloride or polyethylene terephthalate with a film of polymer or foil of aluminum lacquered, or without a polymer film and foil of aluminum lacquered, or in the form of a cardboard with cells for laying ampoules.

    1 the contour cellular packaging made of cardboard or form with 10 ampoules or blisters 2 or shapes from a cardboard of 5 ampoules together with instructions for use and a lancet ampulnam or without a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004149
    Date of registration:16.02.2017
    Expiration Date:16.02.2022
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.03.2017
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