Midocalm-Richter

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Midocalm-Richter: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Drug interactions
14. Analogs
15. Terms and conditions of storage
16. Terms of dispensing from pharmacies
17. Reviews Midocalme-Richter
18. Price in pharmacies

Latin name: Mydocalm-Richter

ATX code: M03BX04

Active ingredient: tolperisone + lidocaine (tolperisone + lidocaine)

Producer: JSC "Gedeon Richter" (Hungary)

Description and photo updated: 20.11.2018

Prices in pharmacies: from 439 rubles.

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Mydocalm-Richter is a centrally acting muscle relaxant drug.

Release form and composition

Dosage form Midocalma-Richter - solution for injection: slightly greenish or colorless, with a characteristic odor (1 ml in brown glass ampoule, 5 ampoules in a plastic tray, 1 pallet in a cardboard box).

Composition of one ampoule:

active ingredients: tolperisone hydrochloride - 100 mg, lidocaine hydrochloride - 2.5 mg;
auxiliary components: methyl parahydroxybenzoate, diethylene glycol monoethyl ether, water for injection.

Pharmacological properties

Pharmacodynamics

Tolperisone hydrochloride belongs to centrally acting muscle relaxants, since the substance affects the first motor neurons of the spinal cord. The mechanism of its action is not fully understood. The pharmacological action is due to the membrane stabilizing effect, which prevents the propagation of excitation in the primary afferent fibers, due to the blocking of monosynaptic and polysynaptic reflexes of the spinal cord. The secondary mechanism of action of the drug probably consists in blocking the entry of calcium ions into the presynaptic endings and thereby inhibiting the conduction of an impulse from the spinal cord.

Tolperisone helps to reduce reflex readiness in the reticulospinal tracts of the brain. It has the effect of enhancing the intensity of peripheral circulation, which is not associated with the effect of the drug on the central nervous system, but may be caused by a weak antiadrenergic and antispasmodic effect of the active substance.

In addition, tolperisone helps to reduce the threshold of pain sensitivity, reduce muscle spasticity, muscle rigidity and pathologically increased muscle hypertonicity, facilitate voluntary active movements and increase their amplitude. The drug has a vasodilating effect.

Lidocaine hydrochloride has a local anesthetic effect, characterized by the ability, depending on the dose, to inhibit the activity of sodium channels, which blocks the generation of impulses in the endings of sensory nerves and the conduction of impulses along nerve fibers. Lidocaine, when dosing the drug according to the instructions, does not have a systemic effect on the body.

Pharmacokinetics

Tolperisone hydrochloride is extensively metabolized in the liver and kidneys with the formation of metabolites, the pharmacological activity of which has not been determined. Excretion occurs through the kidneys, more than 99% of the excreted substance is in the form of metabolites. The half-life (T _1/2) with intravenous administration of the drug is 1.5 hours.

Lidocaine hydrochloride is completely absorbed, the rate of absorption depends on the administered dose and the site of administration. The time to reach the maximum concentration in blood plasma (T _max) with intramuscular administration is 30–45 minutes. From 50 to 80% of the substance binds to blood plasma proteins. Lidocaine has the properties to be rapidly distributed in tissues and organs, to penetrate the blood-brain and placental barriers, and to be secreted in breast milk (40% of the concentration in the mother's blood plasma). 90–95% of metabolism occurs in the liver with the participation of microsomal enzymes, as a result of dealkylation of the amino group and cleavage of the amide bond, the formation of active metabolites occurs. Lidocaine is excreted in the bile (part of the substance is reabsorbed in the gastrointestinal tract) and in the urine (unchanged up to 10%).

Indications for use

pathologically increased tone and spasms of striated muscles arising from organic diseases of the central nervous system (including multiple sclerosis, lesions of the pyramidal pathways, stroke, encephalomyelitis, myelopathy);
increased tone and muscle spasms accompanying diseases of the musculoskeletal system (including spondyloarthrosis, spondylosis, arthrosis of large joints, lumbar and cervical syndromes);
postponed traumatological and orthopedic operations - for rehabilitation therapy;
obliterating vascular diseases (diabetic angiopathy, obliterating atherosclerosis, Raynaud's disease, thromboangiitis obliterans, diffuse scleroderma), diseases arising from disorders of vascular innervation (intermittent angioedema, acrocyanosis) - as part of a combination treatment.

Contraindications

severe myasthenia gravis;
pregnancy, lactation period;
age up to 18 years;
increased individual sensitivity to any component of the drug (including lidocaine).

The use of Mydocalma-Richter in patients with impaired renal and / or liver function requires caution.

Instructions for use Midocalm-Richter: method and dosage

Solution Midocalm-Richter is administered intramuscularly or intravenously.

Recommended dosage regimen:

intramuscularly - 1 ampoule (1 ml) twice a day;
intravenously - 1 ampoule (1 ml) once a day.

The duration of the course of therapy is determined by the attending physician, taking into account the severity of the disease and the response of the patient's body to the treatment.

Side effects

from the central nervous system: headache, muscle weakness;
from the digestive system: abdominal discomfort, nausea, vomiting;
from the side of the cardiovascular system: arterial hypotension;
allergic reactions: rarely - skin itching, rash, urticaria, erythema, shortness of breath, angioedema, anaphylactic shock.

Overdose

In case of an overdose of Mydocalma-Richter, the following symptoms may occur: ataxia, clonic and tonic convulsions, shortness of breath, respiratory arrest.

In this case, symptomatic and supportive therapy is recommended. There is no specific antidote for tolperisone.

special instructions

Preclinical studies of Mydocalm-Richter on pharmacological safety, the level of its toxicity during course use, genotoxicity (the ability to potentially provoke the development of tumors or gene mutations), the effect on reproductive function and specific risks for patients did not reveal.

Negative effects were noted only in those cases when the administered dose of the muscle relaxant significantly exceeded the maximum allowable for humans.

Influence on the ability to drive vehicles and complex mechanisms

During treatment with the drug, care should be taken when driving vehicles and performing actions that require a high concentration of attention and a quick motor / mental reaction.

Application during pregnancy and lactation

At this time, there is no information about the safety of using Mydocalma-Richter for the treatment of pregnant and breastfeeding women. Therefore, it is not recommended to prescribe it to this category of patients.

If necessary, it is allowed to prescribe the drug in the second and third trimester of pregnancy only if the attending physician makes such a decision after carefully studying the benefit / risk ratio.

If it is necessary to inject a muscle relaxant to a woman during lactation, the issue of stopping breastfeeding during the course of therapy should be resolved.

Pediatric use

According to the instructions, Midocalm-Richter is contraindicated in children and adolescents under 18 years of age.

With impaired renal function

Since the experience of using Mydocalma-Richter in patients with renal insufficiency is limited, it must be prescribed with caution in such patients. No dose adjustment is usually required in such cases.

For violations of liver function

Use Mydocalm-Richter in patients with impaired liver function with caution. There is no need to adjust the dose.

Drug interactions

There is currently no information on drug interactions that would limit the use of the drug.

Since tolperisone does not cause sedation when influenced by the central nervous system, it can be used simultaneously with hypnotics, sedatives and ethanol-containing drugs.

Tolperisone has no effect on the effect of ethyl alcohol on the central nervous system.

Mydocalm-Richter enhances the effect of non-steroidal anti-inflammatory drugs, therefore, when used together, a decrease in their dose may be required.

Analogs

An analogue of Midocalma-Richter is Kalmirex.

Terms and conditions of storage

Store in a dark place at a temperature of 8-15 ° C.

Keep out of the reach of children.

Shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Midocalme-Richter

In reviews of Midocalm-Richter, it is mainly said about its side effects. Unfortunately, quite often after the injection, the patient feels palpitations, dizziness, visual discomfort, impaired coordination, insomnia, anxiety. Some patients even report loss of consciousness.

Price for Midocalm-Richter in pharmacies

The average price for Midocalm-Richter is 470 rubles for a package of 5 ampoules.