MIDOKALM

Active material: Tolperisone
When ATH: M03BX04
CCF: Muscle relaxants centrally acting
ICD-10 codes (testimony): G04, G24, G35, G80, G81.1, G82.1, G82.4, G93.4, G95.9, I69, I73.0, I73.1, I73.9, I79.2, R25.2
When CSF: 02.10.01
Manufacturer: Gideon RICHTER-RUS ZAO (Russia)

Pharmaceutical form, composition and packaging

Pills, Film-coated white or nearly white, round, lenticular, Engraved “50” on one side, with a faint characteristic odor; to break white or nearly white.

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

The composition of the shell: colloidal silicon dioxide (aэrosyl), Titanium dioxide (E171), lactose (milk sugar), macrogol 6000, gipromelloza (hydroxypropyl).

10 PC. – packings Valium planimetric (3) – packs cardboard.

Pills, Film-coated white or nearly white, round, lenticular, Engraved “150” on one side, with a faint characteristic odor; to break white or nearly white.

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

The composition of the shell: colloidal silicon dioxide (aэrosyl), Titanium dioxide (E171), lactose (milk sugar), macrogol 6000, gipromelloza (hydroxypropyl).

10 PC. – packings Valium planimetric (3) – packs cardboard.

* international non-proprietary name, recommended by the WHO – tolperizon.

Pharmacological action

Muscle relaxants centrally acting. The mechanism of action is not fully elucidated. It has a membrane, Valium action, inhibits conduction pulses in primary afferent fibers and motoneurons, which leads to blocking spinal mono- and polysynaptic reflexes. Also, probably, secondarily inhibits the release of mediators by inhibiting receipt Ca²⁺in synapses. The brain stem eliminates facilitate excitation by way reticulospinal. Enhances peripheral blood flow, regardless of the influence of the central nervous system. In the development of this effect plays the role of a weak antispasmodic and adrenoceptor blocking effect of tolperisone.

Pharmacokinetics

Absorption

After oral tolperisone is well absorbed from the gastrointestinal tract. C_max achieved through 0.5-1 no. Bioavailability – about 20%.

Metabolism and excretion

Tolperisone is metabolised in the liver and kidneys. The pharmacological activity of the metabolites is unknown. Excreted by the kidneys as metabolites (99%).

Testimony

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

- Pathologically increased tone, muscle spasms, muscle contractures, Accompanying diseases of the musculoskeletal system (spondylosis, spondylarthritis, cervical and lumbar syndromes, arthrosis of large joints);

- Medical rehabilitation after orthopedic and trauma operations;

- As part of combination therapy of vascular occlusive diseases (arteriosclerosis obliterans, diabetic angiopathy, thromboangiitis obliterans, Raynaud's disease);

- As part of combination therapy of diseases, developing on the basis of violations of vascular innervation (acrocyanosis, intermittent angioneurotic disbaziya);

- Spastic cerebral palsy (Little's disease) and other encephalopathies, accompanied by muscle dystonia.

Dosage regimen

Set individually, depending on the clinical picture and tolerability.

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

The tablets are postprandial, without chewing, with a little water.

Children aged 1 Year to 6 years Midokalm^® appointed interior in a daily dose rate 5 mg / kg (in 3 receiving during the day); aged 7-14 years – daily dose 2-4 mg / kg 3 admission. Tablet, the coated, should rub, if the child can not swallow. For children it is only permitted the use of tablets, coated, 50 mg.

Side effect

From the digestive system: nausea, vomiting, abdominal discomfort.

CNS: headache.

Allergic reactions: rarely – itching, эritema, hives, angioedema, anaphylactic shock, bronchospasm.

Other: muscular weakness, hypotension.

As the dose side effects usually disappear.

Contraindications

- Myasthenia;

- Children up to age 1 year;

- Hypersensitivity to the drug.

Pregnancy and lactation

Application Mydocalm^® Pregnancy (especially in the I trimester) and lactation (breast-feeding) possibly only, when the intended benefits to the mother outweighs the potential risk to the fetus or infant.

Cautions

Effects on ability to drive vehicles and management mechanisms

Use of the drug has no effect on the ability of patients to perform work, require increased attention and psychomotor speed reactions.

Overdose

Symptoms: Data on overdose Mydocalm^® It has been reported. Midokalm^® It has a wide therapeutic index, described the case of the drug at a dose of baby inside 600 mg without causing severe toxic symptoms. Before the drug orally at a dose 300-600 mg / day, the child occasionally observed irritability.

In preclinical studies of acute toxicity in animals when administered at high doses of the drug were observed ataxia, tonic-clonic seizures, shortness of breath and respiratory paralysis.

Treatment: No specific antidote, recommended gastric lavage, general symptomatic and supportive therapy.

Drug Interactions

Data on cooperation, limiting the use of Mydocalm^®, not available.

In an application Mydocalm^® niflumic enhances the action of acid, so if you need to use a combination of the need to reduce the dose of acid niflumic.

While tolperisone has an effect on the central nervous system, the drug does not cause sedation, however possible to use in combination with a sedative, hypnotics and drugs, containing ethanol.

It does not affect the effect of ethanol on the CNS.

General anesthetics, Peripheral muscle relaxants, psychotropic drugs, clonidine enhance the effect of tolperisone.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, reach of children, at a temperature from 15 ° to 30 ° C.. Shelf life – 3 year.