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

    1 ml of the preparation contains:

    active substance: chondroitin sodium sulfate - 100 mg;

    Excipients: gasoline alcohol - 12 mg, 1% solution of sodium hydroxide or 0.1 M solution of hydrochloric acid - to pH 6.5-6.8, water for injection - up to 1 ml.

    Description:

    Transparent, slightly yellowish solution.

    Pharmacotherapeutic group:tissue repair stimulant
    ATX: & nbsp

    M.01.A.X.25   Chondroitin sulfate

    Pharmacodynamics:

    Has chondro-stimulating, regenerating, anti-inflammatory and analgesic action. Chondroitin sulfate is involved in the construction of the main substance of cartilage and bone tissue. Has chondroprotective properties, enhances metabolic processes in hyaline and fibrous cartilage, subchondrial bone; inhibits enzymes that cause degradation (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 subchondrial microcirculatory bed.

    Pharmacokinetics:

    After the / m introduction chondroitin sulfate sodium is easily absorbed. Already 30 minutes after the injection, it is found in the blood in significant concentrations. Maximum concentration chondroitin sulfate sodium in plasma is reached after 1 hour, then gradually decreases within 2 days.

    Chondroitin sodium sulfate accumulates, mainly, in the cartilaginous tissue that forms the joints. Synovial membrane is not an obstacle to penetration of the drug into the joint cavity. After 15 minutes after IM injection chondroitin sulfate sodium is found in the synovial fluid, then penetrates into the articular cartilage where its maximum concentration is reached after 48 hours.

    Indications:

    Degenerative and dystrophic diseases of the joints and spine:

    - osteoarthritis of peripheral joints;

    - intervertebral osteoarthritis and osteochondrosis.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - bleeding, tendency to bleeding;

    - thrombophlebitis;

    - children's age (efficacy and safety not established).

    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:

    The drug is given in / m 1 ml (100 mg chondroitin sulfate sodium) every other day. When good tolerability dose is increased to 2 ml (200 mg chondroitin sulfate-sodium) starting with the fourth injection.

    The course of treatment - 25-30 injections.

    If necessary, it is possible to conduct repeated courses of treatment after 6 months.

    Pediatric Use

    Data on the efficacy and safety of the drug DRASTOP children are not currently described.

    Side effects:

    Allergic reactions (skin itching, erythema, urticaria, dermatitis), pain and hemorrhages at the injection site, dyspepsia, angioedema.

    Overdose:

    Overdose is not described and unlikely.

    Interaction:

    It is possible to increase the effect of indirect anticoagulants, antiplatelet agents, fibrinolytic agents, which requires more frequent monitoring of coagulation rates when combined.

    Special instructions:

    To achieve a stable clinical effect, at least 25 injections of the drug are necessary. The effect persists for several months after the end of treatment.

    To prevent exacerbations, repeated courses of treatment are used.

    For allergic reactions or hemorrhages, treatment should be discontinued.

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

    DRASTOP does not affect the ability to drive vehicles and engage in potentially hazardous activities that require increased attention.

    Form release / dosage:

    Solution for intramuscular injection, 100 mg / ml.

    Packaging:

    For 2 ml of the drug in a vial of colorless glass with a ring of breaking white. 5 ampoules in the outline of the cell.

    1 or 2 contour packs together with instructions for use in a cardboard bundle.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003472
    Date of registration:26.02.2016
    Expiration Date:26.02.2021
    The owner of the registration certificate:World Medical Co., Ltd.World Medical Co., Ltd. Egypt
    Manufacturer: & nbsp
    Representation: & nbspTROKAS PHARMA LLCTROKAS PHARMA LLCRussia
    Information update date: & nbsp29.07.2016
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