Description overdue on 09/11/2014

  • Latin name: Mydocalm
  • ATC code: M03V H04
  • Active substance: Tolperisone (Tolperisone)
  • Manufacturer: Gedeon Richter Plc, Hungary
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  • Composition
  • Product form
  • Pharmacological action
  • Pharmacodynamics and pharmacokinetics
  • Indications Mydocalm: that heals and what helps drug
  • Contraindications
  • Side effects
  • Tablets Mydocalm: instructions for use, method and dosing regimen
  • Overdose
  • Cooperation
  • Terms of sale
  • Storage conditions
  • Shelf life
  • Cautions
  • With alcohol
  • During pregnancy (and lactation)
  • Analogs
  • Reviews
  • Price, where to buy

 Mydocalm

Composition

The international non-proprietary name of the drug (INN): Tolperisone .

One tablet contains Mydocalm incorporating 50 or 150 mg tolperisone hydrochloride   as active ingredient and auxiliary ingredients:

  • citric acid monohydrate (Acidum sitricum monohydrate);
  • colloidal silicon dioxide (Silicii dioxydum colloidale);
  • stearic acid (Acidum stearicum);
  • Talc (Talcum);
  • microcrystalline cellulose (Cellulosum microcrystallicum);
  • corn starch (Amylum maidis);
  • lactose monohydrate (Lactose monohydrate).

The film coating, which coated tablet contains:

  • colloidal silicon dioxide (Silicii dioxydum colloidale);
  • Titanium dioxide (Titanium dioxide);
  • lactose monohydrate (Lactose monohydrate);
  • macrogol 6000 (Macrogol 6000);
  • Valium (Hypromellose).

Product form

Mydocalm medicine is available as film-coated round biconvex shaped tablets. On one side of each tablet is engraved "50" or "150" (depending on the amount of active substance in it).

Color pills - white or almost white (including on a break), the smell - weakly expressed, specific.

Pharmacological action

Mydocalm belongs to the pharmacotherapeutic group " Muscle relaxants centrally acting "And it is a drug that reduce the tone of the skeletal muscles. The mechanism of action of the drug is not fully understood.

Pharmacodynamics and pharmacokinetics

Mydocalm prevents destruction cell membrane   and provides a distinct membrane-stabilizing effect. The mechanism of action is based on inhibition of peroxidation lipids   and modulating the activity of membrane-bound enzymes .


In addition, the drug acts as a local anesthetic, and also slows the conduction of nerve impulses in primary afferent (from the Latin. "Afferens" - bringing) nerve fibers   and motoneurons   - nerve cells Responsible for holding information to effectors (generally muscle) from CNS .

The latter results in blockage polysynaptic   and monosynaptic reflexes of the spinal cord .

It is considered likely that the second Mydocalm has the ability to inhibit the release of mediators processes. This is achieved through inhibition of entry of calcium ions (Ca2 +) in place of the functional contact between neurons In which the transmission of information from one cell to another (or, in other words in the synapses).

The brainstem Mydocalm eliminates facilitating the spread of excitation along the way retikulospinnomozgovomu (reticulospinal path).

Promotes strengthening of peripheral blood flow (regardless of the influence of the central nervous system), reduces pathologically increased muscle tone, eliminates muscle rigidity, reduces the severity of pain in the muscles, eliminates or reduces the severity of violations of arbitrary motion.

This effect is provided by the ability to Tolperisone   have poorly marked antispasmodic   and adrenoblokiruyuschee   action.

Through activity Tolperisone , Mydocalm also reduces the toxicity of the indole alkaloid strychnine, contributes to the suppression caused them to increase reflex excitability and has vasodilating properties.

Some evidence suggests that the drug has a selective inhibitory effect on the caudal (from the Latin. "Cauda" - the tail, the tail) part going to the thalamus in the rostral direction (ie, to the cortex) formation spinal cord . As a result, it decreases the severity of spastic phenomena.

According to Wikipedia, which is part of Mydocalm Tolperisone   It is also a central H-holinolitichesky effect.

Step H anticholinergic agents based on the fact that entering the body, they affect nicotinic receptors localized mainly in postsinaptichesih membranes located in skeletal muscle synapse ganglia autonomic , The tissues that form the medulla adrenal And tissue carotid sinus area .

Entering into interaction with receptors, H anticholinergics and, in particular, Tolperisone , Blocking their ability to perceive acetylcholine , So that a nerve impulse is not transmitted through disabled synapse. Thus, the neurotransmitter released but blocked receptors of the postsynaptic membrane is no longer able to respond to the stimulus.

Pronounced effect on peripheral nervous system Tolperisone   with no effect.

After taking the pill Mydocalm Tolperisone   well absorbed from gastrointestinal tract . The maximum concentration of a substance observed in about half an hour. Its biological activity is approximately 20%.

Tolperisone   Under intense biotransformation in the tissues liver   and kidney . The substance excreted from the body kidney   in the form of the end products metabolism   (more than 99%), the pharmacological activity of which is unknown.

Indications Mydocalm: that heals and what helps drug

Indications for Mydocalm are:

  • pathologically increased muscle tone and spasms of skeletal (striated) muscle tissue, which are the result of organic lesions CNS Including including multiple sclerosis . encephalomyelitis . stroke   marrow, etc .;
  • myogenic contractures, increased tone and spasticity caused by diseases of the musculoskeletal system (eg, lyubmago with sciatica . spondylosis Affecting large joints arthrosis .   Cervical syndrome   etc.);
  • noninflammatory diseases of the brain Accompanied by muscle tone disorders (e.g. children's cerebral palsy );
  • cholelithiasis ;
  • strongly expressed pain syndrome , Observed on the background of hemorrhoids ;
  • menstrual pain ;
  • threat of spontaneous abortion pregnancy   due to increased tone of the uterine muscle structures;
  • renal colic .

Use of the drug Mydocalm shown:

  • during the period of rehabilitation therapy after an orthopedic, surgical operations or trauma (this is due to the ability of   Tolperisone   have beneficial effects on the stretch ratio muscle fibers );
  • in the complex therapy of occlusive lesions vessels   (according to the summary, the tool is effective in diabetic angiopathy . Raynaud's syndrome . thromboangiitis obliterans   etc.);
  • for the symptomatic treatment muscle spasm   in adult patients who have undergone stroke ;
  • pathologies caused by disorders of innervation vessels   (grave breaches of the pathological gait or cyanosis of the extremities).

Why prescribe muscle relaxants in osteochondrosis?

As with other centrally acting muscle relaxants, may be appointed under Mydocalm osteochondrosis .

Evolving at osteochondrosis pain   It provokes a compensatory spasm of the deep layers of muscles. This in turn causes miofixation spinal column   and limiting the mobility of the vertebral-motor segments.

The consequence of this musculo-tonic imbalance is the deterioration of the disease and reducing the therapeutic efficacy of interventions.

Muscle relaxants   at osteochondrosis   are assigned in order to eliminate the imbalance. Preparations of this pharmacotherapeutic group:

  • have a sedative effect;
  • relieve symptoms pain ;
  • inhibit spinal reflexes;
  • relieve muscle tension.

Thanks to these qualities muscle relaxants enhance the effectiveness of other therapeutic measures: massage, physiotherapy, traction therapy, etc .. They also have the ability to potentiate the action of blockades and other painkillers and physiotherapy.

When this muscle relaxants have a number of contraindications to the use and may provoke undesired side effects (in particular, long-term treatment of patients is often impaired function hepatobiliary system   and increased body weight).

However, unlike preparatov- chondroprotectors They really improve the condition of patients suffering from osteochondrosis   (which is provided by removing the abnormal miofixation), and improve the efficiency of conservative therapy.

For treatment osteochondrosis   accept muscle relaxants   It recommended a very short courses. Yet, remembering the abundance of side effects, clinicians cautiously include these drugs in the regimen of their patients.

Contraindications

Contraindications to the appointment tablets Mydocalm:

  • age up to one year;
  • persistent abnormal weakness and fatigue of skeletal muscle tissue ( myasthenia );
  • Individual hypersensitivity to any component of the drug.

Before you take the tablets at Mydocalm osteochondrosis It should also take into account that all muscle relaxants are contraindicated in patients:

  • have now or in the history of increased seizure activity;
  • suffering from Parkinson's disease ;
  • suffering from chronic kidney   and / or hepatic insufficiency ;
  • suffering from seizures ;
  • having a history of the life of drug addiction;
  • with a history acute psychosis .

Side effects Mydocalm

The safety profile of tablets containing in its composition Tolperisone It based on data from more than 12 thousand patients.

Statistics show that most often after supplementation Tolperisone   there were adverse reactions such as violations of a systemic nature, disorders of the skin and subcutaneous tissue, as well as nervous disorders   and indigestion .

Post-marketing surveillance revealed that 50-60% of the cases in the side effects associated with drug administration Tolperisone They represent individual hypersensitivity reaction.

Most of these reactions do not threaten the health of the patient, does not require the appointment of a specific treatment and are alone.

The reactions of individual hypersensitivity, carrying life-threatening, were reported in a few cases.

According to the medical dictionary of regulatory activities MedDRA all side effects occur during treatment with the drug or otherwise, are classified as frequent, infrequent, rare and very rare.

For infrequent (there are not more than once in a thousand cases), side effects that have been observed after administration of Mydocalm, include:

  • eating disorders and metabolism, which are expressed in the form anorexia ;
  • insomnia Sleep disorders;
  • Headache . dizziness , Increased drowsiness ;
  • hypotension ;
  • abdominal discomfort, diarrhea , Increased dryness of mucous membranes in the mouth, dyspeptic symptoms, nausea;
  • muscle weakness, pain in the extremities, muscle pain;
  • asthenia , Feeling of general discomfort, fatigue.

Rare side effects that occur more than once in a thousand cases, but at least once every ten thousand cases:

  • anaphylactic reaction;
  • decreased activity, depression;
  • attention deficit disorder, tremor , Increased seizure activity, hypoesthesia   (decrease in sensitivity to the effects of stimuli)   paresthesia , Hypersomnia;
  • noise in ears,   vertigo ;
  • angina . tachycardia , Palpitations, reduced blood pressure;
  • hyperemia   skin;
  • Shortness of breath, nosebleeds, shortness of breath;
  • epigastric pain, constipation, flatulence Vomiting;
  • mild forms of dysfunction liver ;
  • atopic dermatitis , Increased sweating, itching, hives , Skin rash;
  • discomfort in the limbs;
  • enuresis . proteinuria ;
  • feeling of intoxication, hot flashes, irritability, increased thirst;
  • level increase bilirubin , Changes in the activity of enzymes liver , Reduction Platelet . leukocytosis .

Very rarely (no more than one in ten thousand cases) may occur:

  • anemia , Lymphadenopathy ( lymphadenopathy );
  • anaphylaxis (anaphylactic shock);
  • polydipsia ;
  • confused mind;
  • bradycardia ;
  • osteopenia ;
  • discomfort in the chest;
  • level increase creatinine   in blood.

Tablets Mydocalm: instructions for use, method and dosing regimen

The drug is intended for oral administration. Optimally, take it immediately after a meal, with liquid squeezed small amounts of liquid.

Adults are recommended to begin treatment with a drug dose of 100-150 mg per day, which is divided into 2 or 3 doses. Further treatment involves the gradual increase of a single dose of 150 mg. The multiplicity of techniques, however, remains unchanged (2-3 per day).

Typically, dosage is selected depending on muscle tone Intensity pain , The presence of the patient and contraindications related chronic diseases.

On the basis of these data, the doctor also specifies how many days to take the pills. The duration of the therapeutic course is usually does not exceed ten days .

According to the instructions for use Mydocalm, children under fourteen years of age were allowed to prescribe pills that contain 50 mg Tolperisone .

Children aged up to six years, the drug Mydocalm given in a dose of 5 mg Tolperisone   per kilogram of body weight per day in a child. This dosage during the day divided into 3 doses. In cases where the child is unable to swallow the whole tablet, it pre-rubbed.

Children from seven to fourteen years, and instructions for use Mydocalm appoint a drug in a daily dose of 2 to 4 mg Tolperisone   per kilogram body weight of the child. The multiplicity of techniques is 3.

After oral administration of the drug takes effect after about forty minutes. Duration of action varies from 4 to 6 hours (depending on how well the renal blood filtration system).

Treatment of certain diseases complement complex physiotherapy activities, gymnastics, massage course, rubbing ointments, etc ..

Overdose

Data on overdose Mydocalm absent. The drug is nontoxic and is characterized as having a wide range of therapeutic action. The literature also contains descriptions of oral administration in pediatric patients doses Tolperisone Of 600 mg. And without any major toxic effects.

Oral Child dose of 300-600 mg, and in some cases may be accompanied by increased irritability.

The drug has no specific antidote. If you exceed the recommended dose and the instructions appears on the background of any adverse symptoms of the patient is recommended gastric lavage and then - symptomatic and supportive therapy.

Cooperation

Data on interactions with other drugs that would restrict the use of Mydocalm absent.

Although   Tolperisone   has the ability to affect the CNS It does not cause sedation. For this reason, it is allowed to combine with sedatives means , Sleeping pills and alcohol-containing medications.

Tolperisone   It does not influence the effect of alcohol on CNS . Active substances increase:

  • preparations general anesthesia ;
  • peripherally acting muscle relaxants;
  • psychotropic drugs ;
  • clonidine   (a substance having hypotensive activity).

Movalis, Mydocalm and Milgamma - compatible products

Milgamma . Movalis   Mydocalm and are well combined with each other medications. Therefore, they are often prescribed as part of combination therapy in patients with pathologies musculoskeletal system .

Patients with this type of disease in the vast majority of cases suffer from severe pain in the joints. Application together Movalis   and to reduce the severity of Mydocalm pain , Remove muscle spasm and hypertonicity . Besides that, Movalis   It is characterized by a neutral effect in relation to the cartilage .

The preparation Milgamma   It refers to the pharmacological group " B vitamins "And is used as a general tonic. He has expressed metabolic, analgesic and neuroprotective effects.

Belonging to the group in neurotropic vitamins   a beneficial effect on inflammatory and degenerative diseases affecting nervous system   and locomotion.

The dosage regimen " Movalis - Milgamma -Midokalm "Is determined by the attending physician.

Terms of sale

The drug belongs to the category of prescription.

Storage conditions

Mydocalm should be stored out of the reach of children. The optimal temperature - not above 30 ° C.

Shelf life

Tablets usable for 3 years from date of manufacture.

Cautions

Mydocalm does not increase the risks of driving and the performance of potentially hazardous operations.

Compatible with alcohol

Combination and Mydocalm acceptable alcohol (particularly can simultaneously receive the drug from the drug containing alcohol).

Mydocalm during pregnancy and lactation

Appointment Mydocalm pregnant   and lactating women   allowed, but only when the expected benefit to the mother outweighs the risk to her baby.

What does the pill help with Mydocalm pregnancy ?

In the first trimester drug is indicated for women who have a spontaneous threat abortion   due to increased muscle tone uterus .

Analogs Mydocalm

Analogs Mydocalm - is medicaments which have similar pharmacological properties to them, but contain in their composition other active substance, and characterized by a different mechanism of action.

By analogues of the drug are:

  • Sirdalud   (active substance - Tizanidine );
  • Miolgin   (aktvnye substances - Paracetamol   and Chlorzoxazone );
  • Leksotan   (active ingredient - B romazepam );
  • Baclofen   (active substance - B aklofen ) Etc ..

The average price of analogues on the Ukrainian market varies from 65 to 140 UAH. In Russia, they can be purchased at an average of 220-380 rubles. So:

  • the average cost of packaging of tablets Sirdalurd   - 110 UAH / 220 Russian rubles;
  • average cost per unit Miolgina   - 140 UAH;
  • average price of pellets Baclofen   10 mg - 65 UAH / 230 Russian rubles.

Many people ask, "What is better - Sirdalurd   or Mydocalm? Baclofen   or Mydocalm? ". The unequivocal answer to this question does not exist, because each drug has its own advantages.

When compared with Mydocalm Sirdalurdom , Both the drug pharmacotherapeutic belong to one group, but their composition as an active ingredient includes various substances.

nausea   or hives .

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