How to take Mydocalm: instructions for use. Mydocalm tablets - how to take: what the drug helps with, price and analogues of the drug, reviews of the action of the Medikal drug
Active ingredient
Tolperisone hydrochloride (tolperisone)
Release form, composition and packaging
white or almost white, round, biconvex, with “50” engraved on one side, with a faint characteristic odor; Tablets on the break are white or almost white.
Film shell composition:
Tablets, coated film-coated white or almost white, round, biconvex, with “150” engraved on one side, with a faint characteristic odor; Tablets on the break are white or almost white.
Excipients: citric acid monohydrate, colloidal silicon dioxide, stearic acid, talc, microcrystalline cellulose type 102, corn starch, lactose monohydrate.
Film shell composition: colloidal silicon dioxide, titanium dioxide (E171), lactose monohydrate, macrogol 6000, hypromellose.
10 pcs. - blisters (3) - cardboard packs.
Pharmacological action
Muscle relaxant central action. The exact mechanism of action is not fully understood. Tolperisone has a high affinity for nerve tissue, reaching highest concentrations in the brain stem spinal cord and peripheral nervous system. The main effect of tolperisone is mediated by inhibition of spinal reflex arcs. Probably, this effect, together with the elimination of the facilitation of excitation along descending pathways, provides the therapeutic effect of tolperisone.
The chemical structure of tolperisone is similar to that of. Like lidocaine, it has a membrane-stabilizing effect and reduces the electrical excitability of motor neurons and primary afferent fibers. Tolperisone dose-dependently inhibits the activity of voltage-gated sodium channels. Accordingly, the amplitude and frequency of the action potential decreases.
An inhibitory effect on voltage-gated calcium channels has been proven.
It is assumed that in addition to its membrane-stabilizing effect, tolperisone may also inhibit transmitter release. Tolperisone has some weak alpha-adrenergic antagonist and antimuscarinic properties.
Pharmacokinetics
Suction
After oral administration, tolperisone is well absorbed into small intestine. Plasma Cmax is observed 0.5-1.0 hours after administration. Due to pronounced first-pass metabolism, bioavailability is about 20%. A high-fat meal increases the bioavailability of oral tolperisone by approximately 100% and increases plasma Cmax by approximately 45% compared with fasting, delaying the time to reach Cmax by approximately 30 minutes.
Metabolism
Tolperisone is extensively metabolized in the liver and kidneys. The pharmacological activity of the metabolites is unknown.
Removal
Almost completely (more than 99%) is excreted by the kidneys in the form of metabolites. T1/2 after oral administration – about 2.5 hours.
Indications
- symptomatic treatment of spasticity in adults caused by stroke;
- treatment of painful muscle spasms associated with diseases of the musculoskeletal system (spondylosis, spondyloarthrosis, cervical and lumbar syndromes, arthrosis of large joints);
- Little's disease ( cerebral palsy in children) and other encephalopathies accompanied by muscular dystonia.
Contraindications
- hypersensitivity to any of the components of the drug or chemically similar epirezone;
- myasthenia gravis;
- pregnancy;
- breastfeeding period;
- children under 3 years of age;
- galactose intolerance, lactase deficiency, glucose-galactose malabsorption.
With caution: the drug should be used with caution in women, patients with hypersensitivity to lidocaine and/or other drugs or with a history of allergies (see section " Special instructions"), in patients with renal and.
If the patient has any of the above conditions/diseases, be sure to consult a doctor before taking the drug.
Dosage
The tablets are taken orally, after meals, without chewing, with a glass of water. The bioavailability of tolperisone decreases when taken on an empty stomach.
The dose of the drug is selected based on the individual needs of the patient and tolerability of the drug.
Children aged 3 to 6 years Mydocalm is prescribed in daily dose 5 mg/kg body weight, divided into 3 doses; aged 7-14 years- in a daily dose of 2-4 mg/kg, divided into 3 doses. Given the small dose, children should be prescribed the drug in the form of film-coated tablets, 50 mg.
Patients with renal failure
Experience with the use of tolperisone in patients with renal failure is limited; adverse reactions occurred more often in this category of patients. Therefore, in patients with impaired renal function medium degree It is necessary to select the dose of tolperisone with careful monitoring of the patient's health and monitoring of renal function. At severe defeat kidney administration of tolperisone is not recommended.
Patients with liver failure
Experience with the use of tolperisone in patients with liver failure is limited; adverse reactions occurred more often in this category of patients. Therefore, in patients with moderate liver dysfunction, it is necessary to select the dose of tolperisone with careful monitoring of the patient’s health and monitoring of liver function. In case of severe liver damage, the use of tolperisone is not recommended.
Side effects
The safety profile of tolperisone was assessed based on post-marketing data from more than 12,000 patients.
According to these data most frequent there were disorders of the skin and subcutaneous tissues, general disorders, disorders of nervous system and gastrointestinal tract.
During post-marketing use, hypersensitivity reactions accounted for 50-60% of all adverse reactions. Most adverse reactions were not serious and resolved on their own. Life-threatening hypersensitivity reactions were recorded very rarely.
Adverse reactions are listed below according to MedDRA classification and frequency: uncommon (from ≥1/1000 to<1/100); редко (от ≥1/10 000 до <1/1000); очень редко (<1/10 000); частота неизвестна (невозможно оценить на основании имеющихся данных).
From the blood and lymphatic system: very rarely - anemia, lymphadenopathy.
From the immune system: rarely - hypersensitivity reaction, anaphylactic reaction; very rarely - anaphylactic shock; frequency unknown - angioedema, including swelling of the face and lips.
From the side of metabolism: infrequently - anorexia; very rarely - polydipsia.
Mental disorders: infrequently - insomnia, sleep disturbances; rarely - decreased activity, depression; very rarely - confusion.
From the nervous system: infrequently - headache, dizziness, drowsiness; rarely - disturbance of attention, tremor, epilepsy, hypoesthesia, paresthesia, lethargy.
From the side of the organ of vision: rarely - blurred vision.
Hearing and labyrinth disorders: rarely - tinnitus, vertigo.
From the heart: rarely - angina pectoris, tachycardia, palpitations; very rarely - bradycardia.
From the side of blood vessels: infrequently - arterial hypotension; rarely - hot flashes.
From the respiratory system: rarely - shortness of breath, nosebleeds, rapid breathing.
From the digestive system: uncommon - abdominal discomfort, diarrhea, dry mouth, dyspepsia, nausea; rarely - pain in the epigastric region, constipation, flatulence, vomiting.
From the liver and biliary tract: rarely - mild liver failure.
For the skin and subcutaneous tissues: rarely - allergic dermatitis, increased sweating, itching, urticaria, rash.
From the kidneys and urinary tract: rarely - enuresis, proteinuria.
From the musculoskeletal system: infrequently - muscle weakness, myalgia, pain in the extremities; rarely - discomfort in the limbs; very rarely - osteopenia.
General reactions: infrequently - asthenia, discomfort, fatigue; rarely - a feeling of intoxication, a feeling of heat, irritability, thirst; very rarely - chest discomfort.
Laboratory and instrumental data: rarely - decreased blood pressure, hyperbilirubinemia, changes in the activity of liver enzymes, thrombocytopenia, leukocytosis; very rarely - an increase in the concentration of creatinine in the blood.
Overdose
Overdose symptoms most often include: drowsiness, gastrointestinal disorders (nausea, vomiting, epigastric pain), tachycardia, increased blood pressure, bradykinesia and vertigo. In severe cases, convulsions and coma.
Treatment: There is no specific antidote; symptomatic therapy is recommended.
Drug interactions
Pharmacokinetic drug interaction studies have shown that co-administration of tolperisone with the CYP2D6 isoenzyme substrate dextramethorphan increases the blood concentration of drugs that are predominantly metabolized by the CYP2D6 isoenzyme, for example, tolterodine, venlafaxine, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol and perphenazine.
In vitro studies on human liver microsomes and human hepatocytes have not confirmed significant inhibition or induction of other isoenzymes (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
An increase in tolperisone exposure is not expected following concomitant administration of CYP2D6 substrates and/or other drugs due to the diversity of tolperisone's metabolic pathways.
The bioavailability of tolperisone decreases when taken on an empty stomach, so use of the drug is recommended after meals.
Although tolperisone affects the central nervous system, its potential for sedation is low. In case of co-administration with other centrally acting muscle relaxants, the need to reduce the dose of tolperisone should be assessed.
Tolperisone enhances the effect of niflumic acid, so the dose of niflumic acid or other NSAIDs should be reduced when used simultaneously with tolperisone.
Special instructions
The most common adverse reactions when using tolperisone in the post-registration period were hypersensitivity reactions. Their severity varies from mild skin reactions to severe systemic reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include erythema, rash, urticaria, pruritus, angioedema, tachycardia, hypotension, or shortness of breath.
Women and patients with hypersensitivity to other drugs or a history of allergies may be at higher risk of hypersensitivity to tolperisone.
In cases of known hypersensitivity to lidocaine, increased caution should be exercised when using tolperisone due to possible cross-reactions.
Patients should be advised to be alert to possible allergy symptoms. Patients should be advised that if allergy symptoms occur, stop taking tolperisone and seek immediate medical attention.
After an episode of hypersensitivity to tolperisone, the drug cannot be re-prescribed.
The drug Mydocalm contains lactose monohydrate. Patients with rare hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption should not take Mydocalm.
Impact on the ability to drive vehicles and machinery
Tolperisone does not affect the ability to drive vehicles and machines. Patients who experience dizziness, drowsiness, impaired attention, epilepsy, blurred vision, or muscle weakness while taking tolperisone should consult their doctor.
Pregnancy and lactation
Experimental studies on animals did not reveal the teratogenic effect of tolperisone. Due to the lack of significant clinical data, tolperisone should not be used during pregnancy unless the expected benefit clearly justifies the potential risk to the fetus.
Since there is no data on the excretion of tolperisone in breast milk, its use during breastfeeding is contraindicated.
Use in childhood
Contraindicated for use in children under 3 years of age.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years. Do not use after the expiration date stated on the package.
Mydocalm is a muscle relaxant drug that affects various structures of the nervous system.
This is an effective and safe centrally acting muscle relaxant intended for the treatment of neurological syndromes associated with trophic disorders, pain and increased skeletal muscle tone. The main active ingredient of the drug, tolperisone hydrochloride, has a local anesthetic effect and helps reduce hypertonicity and muscle rigidity.
Its action is carried out through the central nervous system. By suppressing the increased excitability of the spinal cord, it inhibits the transmission of pathological nerve impulses. Due to this, muscle relaxation is achieved, swelling is eliminated and pain is relieved. In addition to reducing musculoskeletal tension, the drug promotes vasodilation, improves blood circulation and lymphatic drainage.
Clinical and pharmacological group
Centrally acting muscle relaxant.
Conditions for dispensing from pharmacies
Dispensed with a doctor's prescription.
Prices
How much does Amaryl cost? The average price in pharmacies is 350 rubles.
Release form and composition
Mydocalm is produced in film-coated tablets of 50 mg and 150 mg.
They produce an injection solution (injections) (in ampoules of 100 mg and 2.5 mg/ml) called Mydocalm-Richter.
Active ingredient: tolperisone hydrochloride, containing 50 or 150 mg in each film-coated tablet.
Pharmacological effect
Mydocalm is used to eliminate neurological syndrome that provokes pain, trophic disorders, and increased muscle tone. The active component shows a local effect, copes with the clinical picture of osteochondrosis, patients who have had a heart attack and other pathologies.
Regular use of the drug shows a lot of positive effects:
- promotes the occurrence of indirect analgesic effect;
- effectively eliminates muscle tension;
- starts blood circulation, lymphatic drainage;
- promotes dilation of blood vessels.
After oral administration, the drug is quickly absorbed from the gastrointestinal tract, the maximum concentration of the active substance is observed half an hour after use. The drug is metabolized in the kidneys and liver and excreted by the kidneys.
Indications for use
Indications for the use of Mydocalm are:
- Traumatic and orthopedic operations - with the aim of speedy recovery of the patient.
- Muscle contractures, muscle spasms and increased tone that accompany diseases of the movement organs (for example, arthrosis of large joints, spondyloarthrosis, spondylosis, lumbar and cervical syndromes).
- Spasm and pathologically increased tone of striated muscles, developing as a result of organic diseases of the central nervous system (multiple sclerosis, myelopathy, damage to the pyramidal tracts, encephalomyelitis, cerebral stroke).
- Pathologies arising from impaired vascular innervation (intermittent angioedema, acrocyanosis) - as part of combination therapy.
- Obliterating vascular diseases (diffuse scleroderma, diabetic angiopathy, obliterating arteriosclerosis, Raynaud's disease, thromboangiitis obliterans) - as a combination treatment.
- Spastic cerebral palsy and other encephalopathies that cause muscle dystonia.
Why is Mydocalm prescribed for osteochondrosis?
Like other centrally acting muscle relaxants, Mydocalm can be prescribed for osteochondrosis.
The pain syndrome that develops with osteochondrosis provokes a compensatory spasm of the deep layers of the back muscles. And this, in turn, causes myofixation of the spinal column and limitation of mobility of the spinal motion segments. The consequence of such a muscular-tonic imbalance is a worsening of the course of the disease and a decrease in the therapeutic effectiveness of all measures taken.
Muscle relaxants for osteochondrosis are prescribed in order to eliminate this imbalance.
Drugs from this pharmacotherapeutic group:
- suppress spinal reflexes;
- have a sedative effect;
- relieve pain symptoms;
- relieve muscle tension.
Thanks to these qualities, muscle relaxants increase the effectiveness of other therapeutic interventions: massage, physical therapy, traction therapy, etc. They also have the ability to potentiate the effect of blockades, other painkillers and physiotherapeutic procedures.
Contraindications
Taking Mydocalm tablets is contraindicated in several pathological and physiological conditions of the body, which include:
- Myasthenia gravis is a pathological muscle weakness.
- Children up to 3 years old.
- Hypersensitivity to the active substance and auxiliary components of the drug.
Before you start taking Mydocalm tablets, you should make sure that there are no contraindications to their use.
Use during pregnancy and lactation
No studies have been conducted on pregnant or lactating women. The drug is quite safe, there is no data on the presence of teratogenic effects. Mydocalm is prescribed with caution if the expected benefit to the mother outweighs the risk to the fetus or newborn.
Dosage and method of administration
The instructions for use indicate that Mydocalm tablets are taken orally, after meals, without chewing, with a small amount of water.
- Adults and children over 14 years of age are prescribed 50 mg 2-3 times a day at the beginning of treatment, gradually increasing the dose to 150 mg/day 2-3 times a day.
- For children aged 3 to 6 years, Mydocalm is prescribed in a daily dose of 5 mg/kg (in 3 doses during the day); at the age of 7-14 years - in a daily dose of 2-4 mg/kg (in 3 divided doses during the day).
When using Mydocalm injections, the following is administered:
- Intramuscularly - 200 mg per day, divided into two doses;
- The drug is administered intravenously slowly, once a day, 100 mg.
There are no data limiting the use of Mydocalm with other medications. The drug can be used simultaneously with sedatives, hypnotics and drugs containing ethanol. However, it should be borne in mind that Mydocalm enhances the effect of niflumic acid.
Mydocalm can be used during pregnancy, especially in the first trimester, as well as during lactation only according to strict indications.
Side effects
There are few side effects of Mydocalm; they develop, as a rule, with an individual high response of the body to the active substance. Among them, the most common are:
- nausea, vomiting;
- feeling of discomfort in the abdomen;
- headache;
- skin itching;
- erythema;
- hives;
- angioedema;
- anaphylactic shock;
- bronchospasm;
- muscle weakness;
- arterial hypotension.
Rapid parenteral administration may result in a decrease in blood pressure. Reducing dosages eliminates all negative effects in 95% of cases.
Overdose
Cases of overdose are extremely rare, since the maximum therapeutic threshold of Mydocalm is quite high. Doses up to 600 mg do not, as a rule, cause signs of overdose. If the patient nevertheless experiences an overdose, this is manifested by ataxia, convulsions, shortness of breath, and paralysis of the respiratory center. Immediately after these signs appear, gastric lavage can be an effective treatment.
There is no specific antidote therapy for Mydocalm.
Special instructions
The drug must be used strictly following the recommendations of the attending physician to avoid complications.
No studies have been conducted, but over many years of practice, there is no information on the effect of the drug Mydocalm on the ability of patients to perform work that requires increased attention and speed of psychomotor reactions.
Drug interactions
Does not affect the effect of ethanol on the central nervous system.
There are no data on interactions limiting the use of Mydocalm.
Although tolperisone has an effect on the central nervous system, the drug does not cause a sedative effect, so it can be used in combination with sedatives, hypnotics and drugs containing ethanol.
General anesthesia, peripheral muscle relaxants, psychotropic drugs, clonidine enhance the effect of tolperisone.
With simultaneous use, Mydocalm enhances the effect of niflumic acid, therefore, if it is necessary to use this combination, it may be necessary to reduce the dose of niflumic acid.
Mydocalm (active ingredient - tolperisone) is a central muscle relaxant (agents that promote muscle relaxation). The mechanism of action of this drug has not been fully understood, which does not prevent its successful use in such pathological conditions as increased tone and muscle spasms. It has a membrane-stabilizing and local analgesic effect, reduces the sensitivity to pain of peripheral nerves, prevents the transmission of impulses along afferent (sensitive) and motor neurons, which, in turn, blocks mono- and polysynaptic reflexes of the spinal cord. Another possible, but not completely established property of mydocalm is the ability to prevent the release of biologically active substances - mediators due to inhibition of the flow of calcium ions into presynaptic nerve endings. In the spinal trunk, mydocalm puts a barrier to the spread of excitation along the reticulospinal tract. Reduces the activity of a certain area of the brain responsible for muscle contractions - the caudal part of the reticular formation. This entire kaleidoscope of pharmacologically significant “technical and tactical characteristics” of mydocalm allows us to reduce pathologically high muscle tone, reduce their rigidity (rigidity, inelasticity) and susceptibility to spasms, facilitate functional motor activity, while dulling painful sensations.
The drug can also be prescribed to elderly patients; it is quite well tolerated, does not have a toxic effect on the cardiovascular system, does not have a sedative effect and does not impair mental performance and other higher brain functions.
Mydocalm is available in tablets and ampoules (in the latter case, the designation “Richter” is added to the name of the drug). The instructions for it strongly recommend using this drug strictly as prescribed by a doctor. Actually, it’s unlikely to work out any other way, because... Mydocalm is dispensed from pharmacies only with a doctor's prescription. The tablets should be taken after meals and washed down with a small amount of liquid, preferably water. The standard starting dose for adults and adolescents over 14 years of age is considered to be 50 mg, subject to 2-3 times daily dosing; subsequently, it is allowed to increase the dose of the drug to 150 mg with exactly the same frequency of dosing. For younger age categories, the dose is calculated depending on body weight: 2-4 mg per 1 kg with three daily doses (patients 7-14 years old) and 5 mg per 1 kg per day (patients 3-6 years old). When administering the drug by injection, a single dose is 1 ml of solution administered twice a day (intramuscularly) or once a day (intravenously).
Pharmacology
Centrally acting muscle relaxant. The mechanism of action is not fully understood. It has a membrane-stabilizing, local anesthetic effect, inhibits the conduction of impulses in primary afferent fibers and motor neurons, which leads to blocking of spinal mono- and polysynaptic reflexes. It also probably secondarily inhibits the release of mediators by inhibiting the entry of Ca 2+ into synapses. In the brain stem, it eliminates the facilitation of excitation along the reticulospinal tract. Increases peripheral blood flow regardless of the influence of the central nervous system. The weak antispasmodic and adrenergic blocking effect of tolperisone plays a role in the development of this effect.
Pharmacokinetics
Suction
After oral administration, tolperisone is well absorbed from the gastrointestinal tract. Cmax is reached in 0.5-1 hour. Bioavailability is about 20%.
Metabolism and excretion
Tolperisone is metabolized in the liver and kidneys. The pharmacological activity of the metabolites is unknown. Excreted in urine in the form of metabolites (more than 99%).
Release form
White or almost white, film-coated tablets, round, biconvex, engraved “50” on one side, with a slight characteristic odor; on the fracture, white or almost white.
Excipients: citric acid monohydrate - 0.73 mg, colloidal silicon dioxide - 0.8 mg, stearic acid - 1.7 mg, talc - 4.5 mg, microcrystalline cellulose - 14 mg, corn starch - 29.77 mg, lactose monohydrate - 48.5 mg.
Film shell composition: colloidal silicon dioxide - 0.045 mg, titanium dioxide (E171) - 0.244 mg, lactose monohydrate - 0.392 mg, macrogol 6000 - 0.392 mg, hypromellose - 3.927 mg.
10 pcs. - blisters (3) - cardboard packs.
Dosage
The tablets are taken orally, after meals, without chewing, with a small amount of water.
Adults and children over 14 years of age are prescribed 50 mg 2-3 times a day at the beginning of treatment, gradually increasing the dose to 150 mg/day 2-3 times a day.
For children aged 3 to 6 years, Mydocalm ® is prescribed in a daily dose of 5 mg/kg (in 3 doses during the day); at the age of 7-14 years - in a daily dose of 2-4 mg/kg (in 3 divided doses during the day).
Overdose
There have been no reports of overdose with Mydocalm ®.
There is no specific antidote. In case of overdose, gastric lavage and symptomatic therapy are recommended.
Interaction
There are no data on interactions limiting the use of Mydocalm ® .
Although tolperisone has an effect on the central nervous system, the drug does not cause a sedative effect, so it can be used in combination with sedatives, hypnotics and drugs containing ethanol.
Does not affect the effect of ethanol on the central nervous system.
With simultaneous use, Mydocalm ® enhances the effect of niflumic acid, therefore, if it is necessary to use this combination, it may be necessary to reduce the dose of niflumic acid.
General anesthesia, peripheral muscle relaxants, psychotropic drugs, clonidine enhance the effect of tolperisone.
Side effects
From the central and peripheral nervous system: muscle weakness, headache.
From the cardiovascular system: arterial hypotension.
From the digestive system: nausea, vomiting, feeling of discomfort in the abdomen.
Allergic reactions: rarely - skin itching, erythema, urticaria, angioedema, anaphylactic shock, bronchospasm.
When the dose is reduced, side effects usually go away.
Indications
- treatment of pathologically increased tone and spasms of striated muscles resulting from organic diseases of the central nervous system (damage to the pyramidal tracts, multiple sclerosis, cerebral stroke, myelopathy, encephalomyelitis);
- treatment of increased tone and muscle spasms, muscle contractures accompanying diseases of the movement organs (for example, spondylosis, spondyloarthrosis, cervical and lumbar syndromes, arthrosis of large joints);
- rehabilitation treatment after orthopedic and traumatological operations;
- as part of combination therapy for obliterating vascular diseases (obliterating arteriosclerosis, diabetic angiopathy, thromboangiitis obliterans, Raynaud's disease, diffuse scleroderma);
- as part of combination therapy for diseases arising from disorders of vascular innervation (acrocyanosis, intermittent angioedema);
- Little's disease (cerebral spastic palsy) and other encephalopathies accompanied by muscular dystonia.
Mydocalm in injections is an injection solution prescribed to patients with high blood pressure, which is provoked. The action of the drug is aimed at relaxing muscles, relieving and providing an analgesic effect.
At the same time, the drug does not affect consciousness and the state of the central nervous system as a whole. Mydocalm in ampoules is of central action and belongs to the aminoketone group.
One Mydocalm ampoule contains a dose of 1 ml, the main chemical composition of the solution:
- 100 mg - tolperisone hydrochloride;
- 2.5 mg – lidocaine.
Excipients:
- preservative and antiseptic – methyl parahydroxybenzoate;
- diethylene glycol monoethyl ether, obtained using ethylene oxide with ethanol;
- distilled water for injection.
Pharmacological profile
A drug that helps reduce the tone of the skeletal system, which is associated with a decrease in motor functions, the worst option of which is a complete restriction of movements.
The mechanism of action of the drug is aimed at normalizing the transmission of information signals from the brain to the upper spinal cord, while reducing the level of reflex excitability of the latter.
Mydocalm Richter
Promotes the transmission of intracellular signals in skeletal muscle tissue, is an H-cholinergic. Tolperisone contained in the drug reduces muscle spasms and reduces the impact of diseases that are accompanied by increased tone or.
The secondary effect of the drug is a decrease in the transmission of nerve impulses during the intake of calcium saturated with ions into the body. Normalizes the stability of motor functions. Lidocaine contained in the drug has local anesthetic properties.
Chemical reactions that occur during exposure to the drug are metabolized at high speed in organs of the digestive system such as the liver and kidneys. Mydocalm is excreted in the urine by more than 99% within about an hour and a half.
Mechanism of action
This direction has not been fully studied, but the main function of the drug is aimed at correcting the transmission of impulses from the brain to the spinal cord, as well as reducing the increased excitability of the latter. Regulates the transmission of signals between nerve cells throughout the body.
Causes a slowdown in the action of biologically active substances for the transmission of nerve impulses or the flow of calcium ions to the points of contact between neurons.
Indications and contraindications for use
Main indications for the use of Mydocalm: 
- , which increases with load or tension, and which causes resistance even with slight movement;
- skeletal muscle tissue, which provokes stiffness of movement, poor orientation of the limbs in space and;
- at ;
- neurological nature.
Hypertonicity and spasticity, in turn, can be caused by the following diseases (which means Mydocalm injections can be used in complex therapy):
- after ;
- with damage to nerve structures that affect the connectivity and complexity of movements;
- after various spinal cord injuries;
- with inflammation of the spinal cord and brain caused by intoxication, allergic reactions or viruses;
- during spinal dystrophy;
- for arthrosis;
- chronic diseases of the spinal column;
- stiffness of the muscles of the cervical and shoulder region;
- lumbar syndrome, which is caused by lumbar or thoracic osteochondrosis.
What else does Mydocalm help with?
In interaction with other drugs, the drug can be prescribed for:
- complications caused by diabetes;
- chronic arterial diseases, the symptoms of which are initially expressed by numbness of the limbs or lameness;
- diffuse scleroderma, accompanied by fibroids of the skin and internal organs;
- Raynaud's syndrome, which develops due to capillary spasm;
- lack of blood supply to the capillaries.
The use of Mydocalm is contraindicated in the following cases:
- individual intolerance;
- period of pregnancy and lactation;
- a severe form of myasthenia gravis, affecting the muscles of the face, tongue and neck.
The drug is not prescribed to persons under 18 years of age.
Injection and dosage regimen
Mydocalm injections were specially created to prevent the medicine from entering the stomach. The drug is administered intramuscularly or 
intravenously.
- intramuscularly- prescribe 100 mg twice a day;
- intravenously– 100 mg daily, but the administration should be slow or the drip method should be chosen.
The drug, used in the form of injections, acts quickly. The number of injections is determined by the attending physician, depending on the development and neglect of the disease.
Cases of overdose and side effects
There is no exact data on the body's reactions during an overdose of the drug. According to studies conducted on rats, it was found that in cases of an increase in the concentration of the active substance in the blood above the norm, the following are observed:
- some disorders of coordination of movements, which is provoked by muscle weakness;
- difficulty in the respiratory functions of the body, possibly leading to complete cardiac arrest and death.
In general, the following side effects are observed when Mydocalm is abused:
- increased irritability;
- convulsions;
- shortness of breath, contributing to respiratory paralysis.
Special instructions
During the period of use of the product, caution is required when performing work that is accompanied by an increased concentration of attention, including responsibility for the health of oneself and others. For example, driving vehicles, working on machinery with exposed rotating parts and working at heights.
As strange as this may seem, Mydocalm and alcohol are compatible, since the medicine does not increase the effect of alcohol on the body.
However, you should refrain from taking alcohol-containing drinks during treatment, otherwise the drug may cause a negative effect on the body.
Thus, with heightened sensitivity, the appearance of headaches, nausea, decreased appetite and gastrointestinal disorders cannot be ruled out. Itching, angioedema, suffocation and anaphylactic shock may be caused.
In case of impaired liver and kidney function, the drug is used under the strict supervision of a doctor, and in the presence of severe diseases of these organs, it is not prescribed. If negative factors are identified, the medicine is discontinued.
There is an increased interaction of the drug with psychotropic drugs, anesthesia drugs and drugs that reduce skeletal muscle tone. This is most noticeable with the effective action of Mydocalm.
During the period of gestation, if the risk is justified, then in the first three months injections are allowed, but under the supervision of a specialist and in the absence of concomitant diseases and contraindications.
Since there is no data on the penetration of the drug’s chemicals into breast milk, it is advisable to avoid using the drug during lactation. Injections are contraindicated for children.
Registration number P N002409/01
Trade name: Mydocalm®
International nonproprietary name: tolperisone
Chemical name: 2-methyl-1-(4-methylphenyl)-3-(1-piperidinyl)-1-propanone hydrochloride
Dosage form: film-coated tablets
Compound
Active ingredient: tolperisone hydrochloride 50 mg and 150 mg
Excipients: citric acid monohydrate 0.730 mg and 2.190 mg; colloidal silicon dioxide 0.800 mg and 2.400 mg; stearic acid 1,700 mg and 5,100 mg; talc 4,500 mg and 13,500 mg; microcrystalline cellulose 14,000 mg and 42,000 mg; corn starch 29.770 mg and 89.310 mg; lactose monohydrate 48,500 mg and 145,500 mg;
Film shell composition: colloidal silicon dioxide 0.045 mg and 0.089 mg; titanium dioxide (color Ind. 77891, E 171) 0.244 mg and 0.487 mg; lactose monohydrate 0.392 mg and 0.785 mg; macrogol 6000 0.392 mg and 0.785 mg; hypromellose 3.927 mg and 7.854 mg.
Description
50 mg tablets: white or almost white, film-coated tablets, round, biconvex, with a slight characteristic odor and engraved “50” on one side. The tablets are white or almost white when broken.
150 mg tablets: white or almost white, film-coated tablets, round, biconvex, with a slight characteristic odor and engraved “150” on one side. The tablets are white or almost white when broken.
Pharmacotherapeutic group: centrally acting muscle relaxant
ATX Code: M03BX04
Pharmacological properties
Pharmacodynamics
Centrally acting muscle relaxant. The mechanism of action is not fully understood. It has a membrane-stabilizing, local anesthetic effect, inhibits the conduction of impulses in primary afferent fibers and motor neurons, which leads to blocking of spinal mono- and polysynaptic reflexes. It also probably secondarily inhibits the release of mediators by inhibiting the entry of Ca2+ into synapses. In the brain stem, it eliminates the facilitation of excitation along the reticulospinal tract. Increases peripheral blood flow regardless of the influence of the central nervous system. The weak antispasmodic and adrenergic blocking effect of tolperisone plays a role in the development of this effect.
Pharmacokinetics
After administration, tolperisone is well absorbed from the gastrointestinal tract. The maximum concentration is reached after 0.5-1 hour, bioavailability is about 20%.
Tolperisone is metabolized in the liver and kidneys. Excreted in urine in the form of metabolites (more than 99%).
The pharmacological activity of the metabolites is unknown.
Indications for use
Treatment of pathologically increased tone and spasms of striated muscles resulting from organic diseases of the central nervous system (damage to the pyramidal tracts, multiple sclerosis, cerebral stroke, myelopathy, encephalomyelitis, etc.).
Treatment of increased tone and muscle spasms, muscle contractures accompanying diseases of the movement organs (for example, spondylosis, spondyloarthrosis, cervical and lumbar syndromes, arthrosis of large joints).
Rehabilitation treatment after orthopedic and traumatological operations.
As part of combination therapy for obliterating vascular diseases (obliterating atherosclerosis, diabetic angiopathy, thromboangiitis obliterans, Raynaud's disease, diffuse scleroderma), diseases arising from a disorder of vascular innervation (acrocyanosis, intermittent angioedema).
Little's disease (infantile cerebral palsy) and other encephalopathies accompanied by muscular dystonia.
Contraindications
Hypersensitivity to any of the components of the drug. Myasthenia gravis, children under 3 years of age.
Due to the lack of data on use during pregnancy and breastfeeding, the use of Mydocalm® during these periods is not recommended.
Directions for use and doses
Take orally after eating, without chewing, with a small amount of water.
Adults and children over 14 years of age: usually starting with 50 mg 2-3 times a day, gradually increasing the dose to 150 mg 2-3 times a day.
For children: children aged 3 to 6 years Mydocalm® is prescribed orally at a daily dose of 5 mg/kg (in 3 doses during the day); at the age of 7-14 years - in a daily dose of 2-4 mg/kg (in 3 divided doses during the day).
Side effect
Muscle weakness, headache, hypotension, nausea, vomiting, abdominal discomfort. When the dose is reduced, side effects usually go away.
In rare cases, allergic reactions occur (skin itching, erythema, urticaria, angioedema, anaphylactic shock, bronchospasm).
Overdose (intoxication) of the drug
There have been no reports of overdose with Mydocalm®.
There is no specific antidote; in case of drug overdose, gastric lavage and symptomatic therapy are recommended.
Interaction with other drugs
There are no data on interactions that limit the use of Mydocalm®.
Although tolperisone has an effect on the central nervous system, it does not cause a sedative effect, so it can be used in combination with sedatives, hypnotics and drugs containing alcohol.
Does not affect the effect of alcohol on the central nervous system.
Tolperisone enhances the effect of niflumic acid; when using these drugs simultaneously, a reduction in the dose of niflumic acid may be required.
General anesthesia, peripheral muscle relaxants, psychotropic drugs, clonidine - enhance the effect of tolperisone.
Special instructions
Use strictly as prescribed by your doctor to avoid complications!
The effect of the drug on the ability to drive vehicles and machinery.
No studies have been conducted, but no such information has been reported over many years of use of the drug.
Release form
Film-coated tablets, 50 mg and 150 mg.
10 tablets per PVC/Al blister. 3 blisters in a cardboard box with attached instructions for use.
Storage conditions
In a dry place at a temperature of 15 to 30 °C.
Keep out of the reach of children!
Best before date
3 years.
Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies
According to the recipe.
Manufacturers:
1. JSC "GEDEON RICHTER-RUS"
Under license from JSC Gedeon Richter, Budapest, Hungary;
2. JSC "Gedeon Richter"
1103 Budapest, st. Dymroyi, 19-21, Hungary.
Consumer complaints should be sent to:
CJSC "GEDEON RICHTER - RUS"
140342 Russia, Moscow region, pos. Shuvoe.