Midocalm (tolperisone hydrochloride) coated tablets 50 mg. №30

Description

Midocalm composition
active substance: tolperisone hydrochloride;
1 film-coated tablet contains 50 mg of tolperisone hydrochloride;
excipients: citric acid, monohydrate; colloidal anhydrous silica; stearic acid; talc; microcrystalline cellulose; corn starch; lactose monohydrate.

Dosage form
Film-coated tablets.

Pharmacological properties
Midocalm is a medication that reduces muscle tone (muscle relaxant) with a central action. It has a high affinity (degree of specific affinity) for the nervous tissue. The highest concentrations are reached in the spinal cord, brain stem, and peripheral nervous system (nerves and nerve endings). The most significant drug effect is its inhibitory effect on the reflex pathway of the spinal cord. This effect, combined with a depressing effect on the descending pathways, determines the effect of the drug.
The chemical structure of the active drug molecule is similar to that of lidocaine. Like the anesthetic lidocaine, it has a membrane-stabilizing effect, reduces the electrical excitability of motor neurons, primary afferent fibers. The drug inhibits the activity of voltage-gated Na-channels (dose-dependent). At the same time, the amplitude, the frequency of the action potential, decreases. The inhibitory effect on voltage-gated Ca-channels has also been proven. This indicates that the drug has not only a membrane-stabilizing effect, but is also capable of suppressing the release of transmitters (transmitter substances). In addition, the drug has weak properties of alpha-adrenergic receptor antagonists, has an antimuscarinic effect.

Indications
Tablets Midocalm are indicated for the symptomatic treatment of muscle spasm in adults (for example, after a stroke).

Contraindications
You can not prescribe Midocalm if you are allergic to the active substance (tolperisone) or similar in chemical composition to eperisone, excipients, for the solution – allergies to amide local anesthetics. Do not prescribe this medicine for Myasthenia gravis. Do not use the solution in children.

Application during pregnancy and lactation
Use during pregnancy is contraindicated. Due to the lack of significant clinical data, the appointment of Midocalm in the II-III trimesters is possible when the expected benefit to the mother, in the opinion of the doctor, outweighs the risk to the child.
Since the ability to penetrate active molecules (tolperisone) into breast milk is unknown, use during breastfeeding is contraindicated.

Method of administration and dosage
The duration of treatment is determined by the doctor, depending on the course of the disease, the effectiveness of treatment.
The tablets should be taken after meals with water. Insufficient food intake can reduce the bioavailability of the drug. The dose is selected by the doctor depending on the individual need, tolerance. Usually 150-450 mg / day in 3 divided doses.

Overdose
Data on overdose have been reported. The literature describes the oral administration of a dose of 600 mg in childhood without the manifestation of severe toxic symptoms. After oral administration of 300–600 mg of the drug per day in pediatric patients, irritability was observed in some cases. In experiments conducted on animals aimed at determining the toxicity of the drug, large doses caused impaired coordination of movements (ataxia), clonic and tonic convulsions, respiratory disorders, and paralysis of the respiratory muscles.
There is no specific antidote. In case of an overdose, it is recommended to carry out immediate gastric lavage, prescribe symptomatic, supportive treatment.

Side effects:

• Disorders of the blood system, lymphatic system: anemia (anemia), changes in the lymph nodes (lymphadenopathy).
• Immune system disorders: hypersensitivity reactions, incl. anaphylactic shock.
• Metabolic disorders: lack of appetite (anorexia), intense thirst (polydipsia).
• Mental disorders: insomnia, sleep disturbances, decreased activity, depression, confusion.
• Disorders from the nervous system: cephalalgia (headache), drowsiness, dizziness, impaired attention, tremors (tremors), convulsions, decreased superficial sensitivity (hypoesthesia), feeling of “creeping creeps”, burning (paresthesia), increased drowsiness, lethargy.
• Disorders from the organ of vision: visual impairment.
• Disorders from the organ of hearing, balance: vertigo (dizziness), tinnitus.
• Heart disorders: angina pectoris (“angina pectoris”), palpitations (tachycardia).
• Vascular disorders: decrease in blood pressure (bradycardia) or its increase (arterial hypotension).
• Disorders from the chest, mediastinal organs: difficulty breathing, shortness of breath, nosebleeds.
• Disorders from the digestive system: feeling of discomfort in the abdomen, loose stools (diarrhea), dryness of the oral mucosa, nausea, pain in the supra-gastric region, constipation, bloating (flatulence), vomiting.
• Disorders from the liver, biliary tract: mild liver dysfunction.
• Disorders of the skin, subcutaneous tissue: exanthema (skin rash), allergic dermatitis, excessive sweating (hyperhidrosis), itching, urticaria (urticaria).
• Disorders from the musculoskeletal system, connective tissue: myasthenia gravis (muscle weakness), myalgia (muscle pain), pain in the limbs, discomfort in the limbs, osteopenia (decrease in bone density).
• Disorders from the kidneys, urinary tract: enuresis (urinary incontinence), proteinuria (appearance of protein in the urine).
• General disorders, complications at the injection site: hyperemia (redness) of the skin at the injection site, asthenia (exhaustion), drunkenness, irritability, fever, thirst, fatigue, chest discomfort.
• Changes in laboratory results: an increase in the concentration of bilirubin, a change in the activity of liver enzymes, an increase in the concentration of creatinine in a biochemical blood test, a decrease in the number of platelets (thrombocytopenia), an increase in the number of leukocytes (leukocytosis).

Storage conditions and periods
The tablets should be stored at temperatures up to 30 ° С, the solution should be stored at a temperature of 8–15 ° С in the original packaging protected from light.
The shelf life is 3 years.