Midokalm® Richter (Mydocalm®-Richter)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTolperisone + LidocaineTolperisone + Lidocaine
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  • Kalmireks ®
    solution w / m in / in 
    FarmSirma Soteks, ZAO     Russia
  • Midokalm® Richter
    solution w / m in / in 
    GEDEON RICHTER-RUS, CJSC     Russia
    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Active substances: 100 mg tolperisone hydrochloride and 2.5 mg lidocaine hydrochloride in each 1 ml ampoule.

    Excipients: methyl parahydroxybenzoate, diethylene glycol mono-etyl ether, water for injection.

    Description:
    Colorless or slightly greenish solution with a specific odor.
    Pharmacotherapeutic group:Miorelaxant of central action
    ATX: & nbsp

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

    M.03.B.X.04   Tolmoreyson

    Pharmacodynamics:

    Tolperisone hydrochloride is the central muscle relaxant. The exact mechanism of action is unknown. As a result of membrane-stabilizing action, it prevents the excitation in primary afferent fibers, blocking mono- and polysynaptic reflexes of the spinal cord. Probably, the secondary mechanism of action is to block the release of the transmitter by blocking the entry of calcium ions into the synapses.

    Reduces reflex readiness in the reticulospinal tract of the brainstem.

    Strengthens the peripheral circulation.This action is not related to the effect of the drug on the central nervous system and may be due to the weak antispasmodic and anti-adrenergic action of tolperisone.

    Lidocaine hydrochloride has a local anesthetic effect and does not have a systemic effect when dosed with Miodocalma-Richter.

    Pharmacokinetics:

    Tolperisone hydrochloride is subject to intensive metabolism in the liver and kidneys. It is excreted by the kidneys, almost exclusively (> 99%) in the form of metabolites whose pharmacological activity is unknown. With intravenous administration, the elimination half-life is ~ 1.5 h.

    Lidocaine hydrochloride: Absorption is complete (the rate of absorption depends on the site of administration and the dose). ТСmах with the / m introduction - 30-45 min. The connection with plasma proteins is 50-80%. Rapidly distributed in tissues and organs. It penetrates the GEB and the placental barrier, is secreted with the mother's milk (40% of the concentration in the mother's plasma). Metabolised in the liver (by 90-95%) with the participation of microsomal enzymes by dealkylation of the amino group and breaking of the amide bond with the formation of active metabolites. It is excreted with bile (part of the dose is reabsorbed in the digestive tract) and kidneys (up to 10% unchanged).

    Indications:

    Hypertonus and spasm of the striated musculature, arising from organic diseases of the central nervous system (including the defeat of pyramidal tracts, multiple sclerosis, stroke, myelopathy, encephalomyelitis), musculoskeletal system (including spondylosis, spondyloarthrosis, cervical and lumbar syndromes, arthrosis of large joints).

    Restorative treatment after orthopedic and traumatological operations.

    As part of complex therapy: obliterating vascular diseases (obliterating atherosclerosis, diabetic angiopathy, obliterating thromboangiitis, Raynaud's disease, diffuse scleroderma); diseases arising from the disorder of vascular innervation (acrocyanosis, intermittent angioedema dysbasia).

    Contraindications:
    Hypersensitivity to any of the components of the drug (including lidocaine), severe myasthenia gravis, children under 18, pregnancy, lactation (due to lack of data).
    Carefully:
    Use with caution in patients with renal and hepatic insufficiency. Correction of the dose is not required.
    Pregnancy and lactation:
    The drug can be used in the case when the expected benefit for the mother exceeds the potential risk to the fetus (especially in the first trimester of pregnancy).
    Dosing and Administration:
    Adults every day 1 ml 2 times a day, intramuscularly or 1 ml 1 time per day intravenously.
    Side effects:

    Muscle weakness, headache, arterial hypotension, nausea, vomiting, a feeling of discomfort in the abdomen.

    Rarely: allergic reactions (skin rash, including erythematous, urticaria, itching, angioedema, anaphylactic shock, dyspnea).

    Overdose:

    Symptoms: ataxia, tonic and clonic convulsions, dyspnea and respiratory arrest.

    Treatment: there is no specific antidote, overdose is recommended symptomatic and supportive treatment.

    Interaction:

    There are no data on the interaction with drugs that limit the use of Midokalm.

    It is possible to use the drug in combination with sedatives, hypnotics and preparations containing ethanol. Does not increase the effect of ethanol on the central nervous system.

    Increases the effect of non-steroidal anti-inflammatory drugs (NSAIDs), so with a simultaneous appointment, you may need to reduce the dose of NSAIDs.

    Effect on the ability to drive transp. cf. and fur:Care must be taken when driving vehicles and other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Solution for intravenous and intramuscular injection 100 mg + 2.5 mg / ml.
    Packaging:

    1 ml of preparation in a vial made of brown glass with a point for fracture.

    5 ampoules per plastic pallet. On 1 plastic pallet along with instructions for use in cardboard pack.

    Storage conditions:

    At a temperature of 8 to 15 ° C in a dark place.

    Keep out of the reach of children.

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N014846 / 01
    Date of registration:31.10.2008 / 19.08.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER-RUS, CJSC GEDEON RICHTER-RUS, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER-RUS CJSCGEDEON RICHTER-RUS CJSCRussia
    Information update date: & nbsp24.04.2018
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