Kalmireks ® (Kalmirex®)

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: & nbspRAsterol for intravenous and intramuscular administration
    Composition:

    For one ampoule:

    Active substances: tolperisone hydrochloride (in terms of dry matter) 100 mg, lidocaine hydrochloride (in terms of anhydrous substance) 2.5 mg;

    Excipients: methylparahydroxybenzoate 0.6 mg, diethylene glycol monoethyl ether 0.3 ml, hydrochloric acid concentrated to pH 3.0-4.5, water for injection up to 1 ml.

    Description:

    Transparent, colorless or slightly greenish liquid 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 - muscle relaxant of the central mechanism of action. Has a membrane-stabilizing, local anesthetic effect, inhibits the conduction of nerve impulses in primary afferent fibers and motor neurons, which results in blocking of spinal mono- and polysynaptic reflexes. Probably mediates the blocking of mediator excretion by inhibiting the entry of calcium ions into the synapses. It stops the excitation on the reticulospinal path in the brainstem.Regardless of the effect on the central nervous system (CNS), it increases peripheral blood flow. In the development of this effect, the weak antispasmodic and anti-adrenergic effect of tolperisone may play a role.

    Lidocaine hydrochloride has a local anesthetic effect and does not have a systemic effect when dosed according to the instructions.

    Pharmacokinetics:

    Tolperisone hydrochloride

    Tolperisone is extensively metabolized in the liver and kidneys. Excreted in the urine almost exclusively (> 99%) in the form of metabolites. Pharmacological activity of metabolites is unknown. The half-life (T1/2) after intravenous administration - about 1.5 h.

    Lidocaine hydrochloride

    Absorption is complete (the rate of absorption depends on the site of administration and the dose). The time to reach the maximum concentration in the blood plasma with intramuscular injection is 30-45 min. The connection with plasma proteins is 50-80%.

    Rapidly distributed in tissues and organs. It penetrates the blood-brain barrier (GEB) and the placental barrier, penetrates into 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 gastrointestinal tract (GIT)) 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 the components of the drug, incl. to lidocaine;

    - severe myasthenia gravis;

    - period of pregnancy and lactation;

    - children's age and adolescence under 18 years.

    Carefully:

    With caution should be used in patients with renal and hepatic insufficiency.Correction of the dose is not required.

    Dosing and Administration:

    Adults are prescribed intramuscularly 100 mg twice a day or intravenously 100 mg once a day.

    Side effects:

    Frequency of side effects: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rarely (from≥1 / 10000 to < 1/1000), very rarely (<1/10000), the frequency is unknown (can not be estimated from available data).

    Violations of the blood and lymphatic system: very rarely - anemia, lymphadenopathy.

    Immune system disorders: rarely - hypersensitivity reactions, anaphylactic reactions; very rarely - anaphylactic shock.

    Disorders from the metabolism and nutrition: infrequently - anorexia; very rarely - polydipsia.

    Disorders of the psyche: infrequently - insomnia, sleep disorders; rarely - loss of activity, depression.

    Disturbances from the nervous system: infrequently - headache, dizziness, drowsiness; rarely - attention deficit disorder, tremor, convulsions, loss of sensitivity, sensitivity disorder, lethargy.

    Disturbances on the part of the organ of sight: rarely - visual impairment.

    Hearing disorders and labyrinthine disorders: rarely - ringing in the ears, vertigo.

    Heart Disease: rarely - angina, tachycardia, heart palpitations; very rarely - a bradycardia.

    Vascular disorders: infrequently - arterial hypotension; rarely - the tides of blood.

    Disturbances from the respiratory system, chest and mediastinal organs: rarely - shortness of breath, nosebleed, rapid breathing.

    Disorders from the gastrointestinal tract: infrequently - gastrointestinal discomfort, diarrhea, dry mouth, dyspepsia, nausea; rarely - pain in epigastrium, constipation, flatulence, vomiting.

    Disturbances from the liver and bile ducts: rarely - violations of the liver.

    Disturbances from the skin and subcutaneous tissues: rarely - allergic dermatitis, sweating, skin itching, urticaria, skin rash.

    Disturbances from musculoskeletal and connective tissue: infrequently - muscle weakness, myalgia, pain in the limbs; rarely - discomfort in the limbs; very rarely - osteopenia.

    Disorders from the kidneys and urinary tract: rarely - enuresis, proteinuria.

    General disorders and disorders at the site of administration: often - redness of the injection site; infrequently - asthenia (weakness), malaise, fatigue; rarely - a feeling of intoxication, a feeling of heat, irritability, thirst; very rarely - a feeling of discomfort in the chest.

    Laboratory and instrumental data: rarely - lowering blood pressure, increasing the concentration of bilirubin, impaired functional tests of the liver, reducing the number of platelets, increasing the number of leukocytes; very rarely - an increase in the level of creatinine.

    Overdose:

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

    Treatment: it is recommended to carry out symptomatic and maintenance therapy. There is no specific antidote.

    Interaction:

    There is no data on the interaction with drugs that limit the use of the preparation KALMREREKS®. Although tolperisone and has an effect on the central nervous system, it does not cause sedation, and therefore can be used in combination with sedatives, hypnotics and drugs containing ethanol.

    Does not enhance the effect of ethanol on the central nervous system.

    Strengthens the action of non-steroidal anti-inflammatory drugs, so with a simultaneous appointment, you may need to reduce the dose of the latter.

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

    Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 2.5 mg / ml + 100 mg / ml.

    Packaging:

    1 ml per ampoule of light-protective glass with a color fracture ring or with a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding are additionally applied to the ampoules.

    By 5 ampoules in a contour cell box made of a polyvinylchloride film and aluminum foil or a polymer film, or without a foil and film.

    1 or 2 contour mesh packages together with instructions for use in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of 8 to 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 of the year.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003821
    Date of registration:06.09.2016
    Expiration Date:06.09.2021
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp26.11.2017
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