Composition
Active ingredient:
Tolperisone hydrochloride;
Auxiliary substances:
citric acid monohydrate;
colloidal silicon dioxide;
stearic acid;
talc;
MCC;
corn starch;
lactose monohydrate;
Film shell:
colloidal silicon dioxide;
titanium dioxide (E 171-77891);
lactose monohydrate;
macrogol 6000;
hypromellose
Pharmacological action
Mydocalm is a muscle relaxant.
Pharmacodynamics
A 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 retards 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 pathway. Increases peripheral blood flow regardless of the influence of the central nervous system. The weak antispasmodic and adrenoblocking effect of Tolperisone plays a role in the development of this effect.
Pharmacokinetics
After oral use, Tolperisone is well absorbed from the gastrointestinal tract. Cmax is reached after 0.5-1 h, bioavailability is about 20%.
Tolperisone is metabolized in the liver and kidneys. It is excreted in the urine in the form of metabolites (more than 99%). The pharmacological activity of the metabolites is unknown.
Indications
- treatment of pathologically increased muscle tone and spasms of striated muscle, arising from organic diseases of the Central nervous system (loss of pyramidal pathways, multiple sclerosis, cerebral stroke, myelopathy, encephalomyelitis);
- treatment increased tone and spasticity, muscle contractures, accompanying diseases of the organs of motion (including spondylosis, spondylosis, cervical and lumbar syndromes, arthritis of large joints);
- medical rehabilitation after orthopaedic and trauma surgeries;
- in a combination therapy of occlusive vascular diseases (atherosclerosis, diabetic angiopathy, thromboangiitis obliterans, Raynaud’s disease, diffuse scleroderma), diseases resulting from disorders of innervation of the vessels (acrocyanosis, intermittent angioneurotic dysbasia);
- little’s disease (infantile cerebral paralysis) and other encephalopathy accompanied by muscle dystonia.
Use during pregnancy and lactation
Medication Mydocalm is contraindicated during pregnancy, breast-feeding and children under 3 years of age.
Contraindications
- hypersensitivity to any of the components of the drug;
- myasthenia gravis.
Side effects
- drowsiness,
- nausea,
- dizziness
- dry mouth,
- constipation,
- diarrhea,
- decreased blood pressure
- feeling tired,
- sleep disorders,
- confusion.
Interaction
Data on interactions that limit the use of the drug Midocalm, not available.
Although Tolperisone has an effect on the central nervous system, it does not cause sedation, so it can be used in combination with sedatives, sleeping pills and drugs containing alcohol.
It does not affect the effect of alcohol on the central nervous system.
Tolperisone enhances the effect of niflumic acid, with the simultaneous use of these drugs, it may be necessary to reduce the dose of niflumic acid.
General anaesthetics, peripheral muscle relaxants, psychotropic drugs, and clonidine enhance the effect of Tolperisone.
How to take, course of use and dosage
In most cases, adults are prescribed 150 mg 3 times a day.
Children aged 1 to 6 years of age are prescribed Mydocalm orally at a daily dose of 5-10 mg/kg (in 3 doses during the day); at the age of 7-14 years-at a daily dose of 2-4 mg / kg in 3 doses.
Overdose
No data on overdose with Mydocalm have been reported.
Special instructions
Use strictly as prescribed by your doctor to avoid complications.
Influence on the ability to drive vehicles and mechanisms.
Studies have not been conducted, but for many years of practice using the drug, such information has not been received.
Form of production
Pills.
Storage conditions
In a dry place, at a temperature of 15-30 °C
Shelf life
3 years
Active ingredient
Tolperisone
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For children over 3 years of age, For adults as prescribed by a doctor, For children as prescribed by a doctor
Indications
Osteoarthritis, Arthritis, Lumbago, Stroke Effects, Sciatica, Osteoarthritis, Muscle Spasm
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