MYDOCALM PILLS 50MG

Mydocalm tab.p / o 50mg №30. Release form, composition and packaging

Film Coated Tablets white or almost white, round, biconvex, with "50" engraved on one side, with a faint characteristic odor; on a break of white or almost white color.

Excipients: citric acid monohydrate, colloidal silicon dioxide (aerosil), stearic acid, talc, microcrystalline cellulose, corn starch, lactose (milk sugar).

Shell composition: colloidal silicon dioxide (aerosil), titanium dioxide (E171), lactose (milk sugar), macrogol 6000, hypromellose (hydroxypropylmethylcellulose).

10 pieces. - Contour cell packages (3) - cardboard packs.

Film Coated Tablets white or almost white, round, biconvex, with "150" engraved on one side, with a faint characteristic odor; on a break of white or almost white color.

Excipients: citric acid monohydrate, colloidal silicon dioxide (aerosil), stearic acid, talc, microcrystalline cellulose, corn starch, lactose (milk sugar).

Shell composition: colloidal silicon dioxide (aerosil), titanium dioxide (E171), lactose (milk sugar), macrogol 6000, hypromellose (hydroxypropylmethylcellulose).

10 pieces. - Contour cell packages (3) - cardboard packs.

Mydocalm tab.p / o 50mg №30. Clinico-pharmacological group

Muscle relaxant centrally acting

Mechanism of action

A muscle relaxant centrally acting. The mechanism of action is not fully understood. It has a membrane stabilizing, local anesthetic effect, inhibits the conduction of pulses in the primary afferent fibers and motor neurons, which leads to the blocking of spinal mono- and polysynaptic reflexes. It is also likely to retard the release of mediators for the second time by inhibiting Ca intake.2+into synapses. In the brainstem, it removes the relief of arousal along the reticulospinal pathway. Enhances peripheral blood flow regardless of the influence of the central nervous system. The weak spasmolytic and adrenoceptor 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 achieved in 0.5-1 hours. Bioavailability is about 20%.

Metabolism and excretion

Tolperisone is metabolized in the liver and kidneys. Pharmacological activity of metabolites is unknown. Excreted by the kidneys as metabolites (99%).

Indications for use of the drug

- Pathologically increased tone, spasms of striated muscles arising from organic neurological disease (lesions of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis, stroke);

- pathologically increased tone, muscle spasms, muscle contractures accompanying diseases of the musculoskeletal system (spondylosis, spondyloarthrosis, cervical and lumbar syndromes, arthrosis of large joints);

- rehabilitation treatment after orthopedic and traumatological operations;

- as part of a combination therapy for vascular disease obliterans (arteriosclerosis obliterans, diabetic angiopathy, thromboangiitis obliterans, Raynaud’s disease);

- as part of a combination therapy for diseases developing on the basis of vascular innervation disorders (acrocyanosis, intermittent angioedema);

- infantile cerebral spastic paralysis (Little's disease) and other encephalopathies accompanied by muscular dystonia.

Dosage and administration

Set individually depending on the clinical picture and tolerability of the drug.

For adults appoint 50 mg 2-3 times / day, gradually increasing the dose to 150 mg / day 2-3 times / day.

Tablets are taken after a meal, without chewing, with a small amount of water.

Children aged 1 to 6 years Mydocalm ® administered orally in a daily dose at the rate 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 doses. A coated pill should be rubbed if the child cannot swallow it. For children, only 50 mg pills are allowed.

Side effect

Gastrointestinal: nausea, vomiting, discomfort in the abdomen.

From the side of the central nervous system: headache.

Allergic reactions: rarely - pruritus, erythema, urticaria, angioedema, anaphylactic shock, bronchospasm.

Other: muscle weakness, hypotension.

When reducing the dose, side reactions usually disappear.

Contraindications to the use of the drug

- myasthenia gravis;

- children's age up to 1 year;

- hypersensitivity to the drug.

Use of the drug during pregnancy and lactation

The use of Mydocalm during pregnancy (especially in the first trimester) and in the period of lactation (breastfeeding) is possible only when the intended benefits to the mother outweigh the potential risk to the fetus or infant.

Special notes

Influence on ability to drive motor transport and control mechanisms

The use of the drug does not affect the ability of patients to perform work that requires increased attention and quickness of psychomotor reactions.

Overdosage

Symptoms: data overdose Mydocalm has been reported. Mydocalm® has a broad therapeutic index, described the case of taking the drug by the child inside in a dose of 600 mg without the appearance of severe toxic symptoms. When taking the drug inside a dose of 300-600 mg / day in a child in some cases, observed irritability.

When conducting preclinical studies of acute toxicity in animals with the introduction of the drug in high doses, ataxia, tonic-clonic convulsions, shortness of breath and respiratory paralysis were observed.

Treatment: there is no specific antidote, gastric lavage, general symptomatic and supportive therapy are recommended.

Drug interaction

Interaction data limiting the use of Mydocalm is not available.

With the simultaneous use of Mydocalm® enhances the effect of niflumic acid, so if you need to use this combination, you must reduce the dose of niflumic acid.

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.

General anesthesia, peripheral muscle relaxants, psychotropic drugs, clonidine enhance the effect of tolperisone.

Terms and conditions of storage

List B. The drug should be stored in a dry place inaccessible to children, at a temperature of from 15 ° to 30 ° C