Description overdue on 08/09/2014

• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Instructions for use Mydocalm Richter: method of use and dosage of the drug
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Cautions
• Analogs
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

The composition of the solution for injection Mydocalm Richter includes active components Tolperisone hydrochloride   and Lidocaine Hydrochloride As well as auxiliary substances:

• methyl parahydroxybenzoate (preservative E218);
• monoethyl ether;
• water for injections.

Product form

The drug is available in 1 ml ampoules as a solution for intravenous and intramuscular administration. One carton contains a plastic tray with 5 ampoules and instruction for use of the solution for injection Mydocalm.

The solution has the form of a clear, colorless (or slightly greenish) liquid with a characteristic specific smell.

Pharmacological action

The drug belongs to the pharmacotherapeutic group "Muscle relaxants (muscle relaxants), the central mechanism of action" and is characterized by the ability to provide:

• Valium;
• muscle relaxant;
• membrane-stabilizing   effects.

Pharmacodynamics and pharmacokinetics

The mechanism of action of the incoming solution Tolperisone   is not fully understood. It is known that the substance has a high affinity (from Lat. Affinitas - "affinity") to neural tissue . The highest concentrations are found in brainstem . spinal cord   and PNS   (peripheral nervous system).

The most important ability is considered to be Tolperisone   have an inhibitory effect on the reflex centers spinal cord . It is likely that this effect, coupled with an inhibitory effect on the efferent (descending) pathways determines the therapeutic effect Tolperisone .

Tolperisone   It has the ability to prevent the destruction of cell membranes, and reduces the performance of electrical excitability of the motor (motor) neurons   and primary afferent processes of nerve cells Conducting sensory impulses from a variety of tissues and organs to CNS (central nervous system).

In addition, the substance:

• It reduces the pain threshold;
• blocks spinal-stem monosynaptic   and   polisinapticheskie reflexes;
• selectively reduces the activity of the caudal part of the complex neural structures, localized in the central parts of the tire stem of the brain   in its entirety (so-called reticular formation brainstem );
• reduce spasticity muscle ;
• reduces pathologically elevated hypertonus muscles ;
• reduces muscle rigidity;
• reduces the intensity of pain;
• It facilitates arbitrary active movements and increase their amplitude;
• increases the intensity of peripheral blood flow;
• It has a vasodilatory effect;
• prevents release of neurotransmitters at the synapse (similar effect is most likely, again, due to the deceleration in the flow of calcium ions (Ca2 +) in the presynaptic (nerve) end).

Tolperisone   It has a weak spasmolytic action and has the properties of H-central anticholinergic actions.

This is reflected in the ability of a substance to prevent or reduce the effects mainly nikotinopodobnoe acetylcholine   (main neurotransmitter in parasympathetic nervous system ) And cholinomimetic agents.

Thus a pronounced effect on peripheral nervous system Tolperisone   It does not have.

Tolperisone   characterized by a good tolerance (in particular, it is well tolerated by patients of advanced age) does not cause the development of cardiotoxic effects   and violations cognitive functions , Deprived Sedation .

The safety profile   Tolperisone   based on data from clinical studies, which involved patients with muscular hypertonicity   of different etiology, and based on spontaneous reporting data about any adverse reactions.

Preclinical studies of pharmacological safety, toxicity levels in the exchange application, genotoxicity (the ability to potentially provoke gene mutations, or the development of tumors), the ability to affect the reproductive function of the specific risks for patients have been identified.

Adverse effects were observed only in cases where the dosage administered will substantially exceed the maximum permitted for the person. The latter indicates a minor significance for clinical use.

Lidocaine   It acts as a local anesthetic and is characterized by the ability to dose-dependently inhibit the activity of Na + channel (voltage-dependent sodium channels), which in turn prevents the generation of pulses in the endings of sensitive nerve fibers   and conduction of impulses through them. And not only the substance inhibits pain impulses, but also pulses and other modalities.

When applied topically, provokes expansion vessels , Without causing any irritant action.

When dosing the drug Mydocalm Richter in accordance with the diagrams in the instructions for use, Lidocaine   It has no systemic effect on the patient.

Tolperisone hydrochloride   biotranformiruetsya extensively in the tissues liver   and kidney Then almost completely eliminated from the body kidney   as products metabolism   (more than 99% of substances entering the body). Precise data on the pharmacological activity metabolites   no.

After adding the solution Mydocalm / in half-life Tolperisone hydrochloride   one and a half hours.

Lidocaine hydrochloride , Getting into the body, completely absorbed. Moreover, the rate of absorption depends on the site of administration and dose. The time at which the maximum concentration of the substance after intramuscular injection varies between half an hour to 45 minutes.

FROM lidocaine plasma proteins   It binds 50-80%. The distribution of the substance in different tissues and organs occurs quickly enough.

It has the ability to penetrate the blood-brain (BBB) ​​and plasma barrier and is excreted in breast milk of lactating women. Moreover, the concentration of lidocaine   milk is 40% of the concentration of the substance in plasma   mother.

Metabolization lidocaine performed in tissues liver (about 90-95%) under the influence microsomal liver enzymes   by dealkylation of the amino group and amide bond cleavage. As a result of this process are distinguished pharmacologically active metabolites.

From the patient's body Lidocaine   excreted with bile   (the substance is partially exposed in the reabsorption gastrointestinal tract ) And kidney   (up to 10% lidocaine excreted unchanged).

Indications

Indications Mydocalm Richter:

• gipertonus   and spasticity   skeletal muscle tissue caused by organic lesions CNS   (transferred stroke , Lesions of the pyramidal system damage spinal cord   various etiologies, multiple sclerosis , Inflammation brain and spinal cord   toxic-allergic or viral etiology, etc.);
• gipertonus   and spasticity   skeletal muscle tissue, due to lesions musculoskeletal system (degenerative processes of anatomical structures spine . arthrosis   large joints, spondyloarthrosis   spine cervicobrachial neuralgia . Lumbar syndrome   etc.);
• diseases accompanied muscular dystonia ;
• replacement therapy after surgery (orthopedic, trauma, surgery).

In combination with other therapeutic measures Mydocalm ampoules recommended:

• patients who are diagnosed pathologies associated with obliteration of vessels ( diabetic angiopathy . atherosclerosis . diffuse scleroderma . Raynaud's syndrome   etc.);
• patients with pathologies caused by disorders of innervation of blood vessels (e.g., acrocyanosis ).

Contraindications

Contraindication to Mydocalm Richter are:

• hypersensitivity to any of the active or excipients, a part of the preparation (including the lidocaine   and other amide drugs Having Valium action);
• myasthenia   severe;
• pregnancy ;
• lactation .

Also, the drug has an age restriction: drug injections are contraindicated to persons under 18 years of age.

Side effects

Most often the patient's body reacts to the jabs Mydocalm hyperemia   the skin at the injection site.

Infrequently individual may experience such reactions as:

• anorexia ;
• sleep disorders;
• headache   and dizziness , Excessive drowsiness ;
• hypotension ;
• diarrhea and dyspepsia ;
• weakness and muscle soreness, pain in the limbs;
• symptoms   asthenic syndrome , Feeling of general discomfort, fatigue.

It rarely adverse reactions that occur less than one case in a thousand, but more often than once every ten thousand cases include:

• hypersensitivity reactions;
• depression , Decreased physical activity;
• attention disorders, convulsions , Excessive sleepiness,   hypoesthesia . tremor   etc.;
• visual disturbances;
• noise in ears; loss of balance, accompanied by a sense of his own body rotation around objects or vice versa - the rotation of objects around the body;
• palpitations, angina , Reduced Blood Pressure ;
• hyperemia   leather;
• nosebleeds, breathing difficulties, breathlessness ;
• stomach ache, constipation . flatulence Vomiting;
• defeat   liver   (usually benign);
• skin reactions   (itching, burning, sweating, rash, etc.);
• urinary incontinence , Increasing the concentration Protein in the urine   (above the physiological norm);
• irritability, thirst, the emergence of feelings of intoxication;
• changing the values ​​of laboratory parameters (changes in the concentrations of   blood bilirubin , Violation of activity liver enzymes   etc.).

In single cases:

• anaphylactic shock ;
• increase lymph nodes ;
• unnaturally strong, unquenchable thirst;
• confusion;
• decreased heart rate (up to a frequency of less than 55 beats per minute);
• osteopenia ;
• increasing the concentration of the blood creatinine .

Instructions for use Mydocalm Richter: method of use and dosage of the drug

According to the instructions for use, injections Mydocalm shown exclusively patients over 18 years . The solution was administered parenterally   - A vein or into a muscle.

Intramuscular injections involve administering to a patient twice daily dose of 100 mg Tolperisone   (the contents of one ampoule).

The drug is recommended to enter a vein once a day at a dose of 100 mg Tolperisone , So slow.

How many days stabbing Mydocalm Richter, determined by the attending physician according to the severity of the disease and the response of the patient to the prescribed therapy.

Experience of treatment of patients with impaired liver   and / or kidney   limited. However, in this group of patients with adverse events associated with the use Mydocalm, observed more frequently than in patients with a healthy liver / kidney .

For this reason, for patients with moderately severe lesions kidney   and / or liver   the optimal dose is individually titrated. It is recommended to carefully monitor the patient's condition and all the changes in the function liver / kidney .

Patients with severe lesions liver and / or kidney Tolperisone   contraindicated.

Overdose

Data on cases of overdose Mydocalm limited. The product is characterized by a wide therapeutic index.

According to preclinical studies of acute toxicity of a solution with the introduction of the drug in doses much higher than therapeutic, marked symptoms such as:

• disorders of coordination of movements of various muscles in patients without the patient's muscle weakness (ataxia );
• tonic-clonic seizures;
• Shortness of breath (until it stops).

The specific antidote for Tolperisone   absent. If you exceed the recommended dose to the patient it is recommended to do a gastric lavage. The following shows the symptomatic and supportive therapy.

Cooperation

Data for the study of the compatibility Mydocalm not, therefore, before the introduction of the solution should not be mixed in the same syringe with other drugs. The drug is administered separately from other medications.

Despite the fact that Mydocalm Richter characterized by the ability to influence CNS Likely to develop Sedation   when used offline. Permitted use of the drug in combination with a sedative, hypnotic, as well as the means, which include alcohol.

No effect on the effect of alcohol on CNS .

The appointment Mydocalm Richter in combination with other muscle relaxants central action should be considered to reduce the daily dose Tolperisone .

Tolperisone   potentiates the pharmacological action niflumic acid and other nonsteroidal anti-inflammatory drugs, because of which the last dose while taking them Tolperisone   It recommended to reduce.

Pharmacological effects   Tolperisone   reinforce the following drugs:

• means for common anesthesia ;
• muscle relaxants   peripheral actions;
• psychotropic drugs ;
• clonidine .

Terms of sale

The drug belongs to the category of potent drugs and therefore released from pharmacies by prescription only.

Storage conditions

Keep the solution should be in the original packaging in remote areas for the children, keeping the temperature regime from 8 to 15 ° C.

Shelf life

Usable for 3 years after the date of manufacture.

Cautions

During treatment with Mydocalm Richter should be careful when driving and performing of risk to life and health work, as well as jobs that require high concentration and speed of psychomotor reactions.

Analogs Mydocalm Richter

Analogs injections Mydocalm Richter - it's drugs have on the body muscle relaxant action, but containing in its composition than the active components Mydocalm substance. These include:

• Baclofen ;
• Intrathecal Liorezal ;
• Mefedol .

Appointment injections Mydocalm pregnant and lactating women

Studies on animals have shown that Tolperisone   no adverse effects on fetal development. Nevertheless, to date data on the safety of the drug for the treatment of pregnant   and   lactating women   no.

The drug is in the form of solution for injection is contraindicated in the first trimester . It allowed his appointment at a later date, but only if, in the opinion of the physician, the expected therapeutic effect for women is higher than the risk of complications for the fetus or infant.

Because it is unknown whether Tolperisone   passes into breast milk, use of the drug during lactation is contraindicated. If the purpose of injections to avoid Mydocalm Richter still can not, at the time of treatment should decide the issue of termination of lactation.

Reviews Mydocalm Richter

The drug has been used successfully to treat patients around the world. It is well tolerated, does not have a sedative effect, which is confirmed by numerous randomized trials, during which a placebo was used.

Reviews injections Mydocalm Richter left patients overwhelmingly positive. The product is described as an effective and affordable medicines. Only occasionally can find negative reviews, which declares the ineffectiveness of treatment injections Mydocalm.

Some people point out that the most effective in the treatment of certain diseases (in particular, osteochondrosis ) Was achieved using Mydocalm in combination with other drugs.

Doctors confirm this view and often prescribe injections Mydocalm in combination with vitamin preparations restorative action (for example, Milgamma or Kombilipenom ) And non-steroidal anti-inflammatory drugs (e.g. Movalis ).

Price Mydocalm Richter

The difference is how much of the drug vials are Mydocalm Richter certainly is.

Price vials Mydocalm the Ukrainian market varies from 25 hryvnia (as the average price of a vial of the drug in pharmacies of Kiev) to 133 hryvnia (per pack with five ampoules of solution for injection).

The average price of jabs in the Russian pharmaceutical market is 385 rubles.

Buy drug can be in almost any drugstore. However, before you ask the question "how many vials are Mydocalm? "And go to the store, you should consult with your doctor.