Tolperisone-OBL (Tolperizon-OBL)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTolmoreysonTolmoreyson
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    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
    • Dosage form: & nbspfilm coated tablets
    Composition:
    1 tablet contains:
    active substance: tolperisone hydrochloride 50 mg (for a dosage of 50 mg) or 150 mg (for a dosage of 150 mg);
    auxiliary substances: citric acid, lactose monohydrate (milk sugar), giprolose (hydroxypropyl cellulose), crospovidone, stearic acid
    auxiliary substances for the shell: Opadrai II (Series 85) [polyvinyl alcohol, macrogol (polyethylene glycol), talc, titanium dioxide]

    Description:
    Tablets covered with a film coat of white or almost white color, biconvex, oblong with rounded ends, with a risk.

    Pharmacotherapeutic group:central muscle relaxant
    ATX: & nbsp

    M.03.B.X   Other muscle relaxants of central action

    M.03.B.X.04   Tolmoreyson

    Pharmacodynamics:
    Miorelaxant of the central mechanism of action. Has a membrane-stabilizing effect, inhibits the conduction of nerve impulses in primary afferent fibers and motor neurons, which leads to blockage of spinal mono- and polysynaptic reflexes. Probably mediates the blocking of mediator secretion by inhibition of Ca + 2 intake into synapses. It stops the excitation on the reticulospinal path in the brainstem. Regardless of the influence of the central nervous system, it increases peripheral blood flow. In the development of this effect, the weak antispasmodic and anti-adrenergic effect of tolperisone may play a role.

    Pharmacokinetics:
    After oral administration tolperisone well absorbed from the small intestine. The maximum concentration in blood plasma is reached after 30 min-1 h after administration, bioavailability due to pronounced presystemic metabolism is about 20%. Tolmoreyson Extensively metabolized in the liver and kidneys. Excreted in the urine almost exclusively (more than 99%) in the form of metabolites. Pharmacological activity of metabolites is unknown.

    Indications:
    Treatment of pathologically increased tone and spasms of transverse striated muscles, caused by organic neurological pathology (including the defeat of pyramidal tracts, multiple sclerosis, stroke, myelopathy, encephalomyelitis).
    Treatment of increased tonus and muscle spasms, muscle contractures accompanying diseases of the musculoskeletal system (spondylosis, spondyloarthrosis, arthrosis of large joints, cervical and lumbar pain syndromes).
    Restorative treatment after surgical interventions in orthopedics and traumatology.
    As part of a combination therapy for obliterating vascular diseases (obliterating atherosclerosis, diabetic angiopathy, thromboangiitis obliterans, Raynaud's disease), as well as diseases resulting from violation of vascular innervation (acrocyanosis, intermittent angioedema dysbasia).

    Contraindications:
    Myasthenia gravis, age under 18, hypersensitivity to the components of the drug, pregnancy, lactation. Due to the presence of lactose, patients with lactose intolerance, lactase deficiency or glucose galactose malabsorption should not take the drug.

    Dosing and Administration:
    Inside. Adults with an initial dose of 50 mg 2-3 times a day, with a gradual increase to 150 mg 2-3 times a day.
    The length of the course of treatment depends on the severity and nature of the course of the disease.

    Side effects:
    Muscle weakness, headache, arterial hypotension, nausea, vomiting, gastralgia (usually occur with a decrease in dose), rarely - hypersensitivity reactions (skin itching, erythema, urticaria, angioedema, bronchospasm, anaphylactic shock).

    Overdose:
    Symptoms: depression of respiration and cardiac activity, lowering of blood pressure.
    Treatment: symptomatic.

    Interaction:
    Tolperisone has an effect on the central nervous system, but does not cause sedation, so it can be used in combination with sedatives, hypnotics, tranquilizers. Does not enhance the effect of alcohol on the central nervous system. Increases the severity of the action of niflumic acid, so when they are used simultaneously, you can reduce the dose of the latter. Medicines for general anesthesia, peripheral muscle relaxants, psychoactive drugs, clonidine enhance the effect.

    Special instructions:
    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:
    Tablets, film-coated 50 mg and 150 mg.

    Packaging:
    At 5, 7, 10, 14, 15, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
    For 1, 2, 3 or 4 contour squares, together with the instructions for use, are placed in a pack of cardboard.

    Storage conditions:
    In a dry, the dark place 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 printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008179/10
    Date of registration:17.08.20101
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp14.09.2015
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