Instructions for use Mydocalm drug in tablets and solution for injection

Mydocalm belongs to the muscle relaxant drugs and has a direct impact on the different structures of the nervous system.Widely used in neurological diseases, among the symptoms which present an increased tone of the striated muscle.

also used to treat angiopathy, in preparation for surgical intervention for relief of emergency conditions.It is characterized by the rapid removal of spasm of smooth muscle and a significant decrease in the sensitivity of nerve endings.

ongoing basis preparation is tolperizona hydrochloride - a muscle relaxant direct action.

FarmGruppa: central muscle relaxants (direct) action.

Formulation

available in two dosage forms:

  • tablets of 50 and 150 mg for oral administration;
  • solution for parenteral intramuscular or intravenous administration.
active substance Excipients shell

Tablets, 50 mg

50 mg of tolperisone hydrochloride 0,73 mg of citric acid monohydrate, 0.8 mg colloidalsilica, 1.7 mg of stearic acid, 4.5 mg of talc, 14 mg MCC 29.77 mg
corn starch 48.5 mg lactose monohydrate
0,045 mg colloidal silicon dioxide, 0.244 mg of titanium dioxide, 0.392 mg of lactose monohydrate, 3.927 mg hypromellose

Tablets, 150 mg

150 mg of tolperisone hydrochloride 2,19 mg of citric acid monohydrate, 2.4 mg of colloidal silica, 5.1 mg of stearic acid, 13.5mg talc 42 mg MCC, 89.31 mg of corn starch, 145.5 mg of lactose monohydrate 0,089 mg colloidal silicon dioxide, titanium dioxide 0.487 mg, 0.785 mg of lactose monohydrate, 0.785 mg of macrogol 6000, 7,854 mg hypromellose

solution

100 mg of tolperisone hydrochloride, 2.5 mg of lidocaine hydrochloride methyl parahydroxybenzoate (E218), diethylene glycol monoethyl ether Water for injection

release form, price

  • tablets filmsheath almost white, round biconvex shape having a characteristic odor and engraving 150 or 50 to 30 pieces per pack.
    • Mydocalm 50 mg - the price of 277-392 rubles,
    • Mydocalm 150 mg - the price of 318-419 rubles.
  • solution for injection, transparent color and odor in sterile ampoules of 1 ml and 5 vials in a pack.
    Price - 470-673 rub.

Pharmacological action

  • Action tolperisone having a high affinity for nervous tissue, has been insufficiently studied.
  • As centrally acting muscle relaxant, and has a membrane stabilizing action local anesthetic, inhibits the passage of nerve impulses in motoneurons and primary afferent fibers from the internal organs to the central nervous system.This results in a suspension of mono- and polysynaptic spinal reflexes.
  • Promotes secondary inhibition of mediator release by suspending the flow of calcium ions into the nerve synapses.
  • Enhances peripheral blood circulation by expanding blood vessels, has antispasmodic and adrenoceptor blocking action.Reduces hypertonicity, spasticity, and muscle rigidity.
  • Improves activity of voluntary movements, increasing their amplitude.
  • Reduces pain threshold.
  • Injection due to the content of lidocaine eliminates soreness and swelling at the injection site.

Pharmacokinetics

tablets. active substance is adsorbed well through the digestive tract, have achieved after 0.5-1 hour maximum operating concentration in the blood, the duration of action of 4-6 hours.The bioavailability of the dosage form is about 20%.

solution. therapeutic blood reached a maximum 30-45 minutes after injecting the drug.The half - about 1.5 hours.

Metabolism and excretion .Tolperisone hydrochloride is metabolized by the liver and the kidneys, excreted in the urine (99%) in the form of metabolites.Lidocaine is metabolized by the liver and excreted in the bile.

Indications

  • hypertonicity and spasticity of the skeletal muscles in the background of organic CNS lesions (after a stroke, multiple sclerosis, pyramidal system lesions, spinal cord injury, toxic or viral inflammation of the brain and spinal cord, etc.)
  • Diseasesproceeding with muscular dystonia
  • recovery period after orthopedic, surgical and trauma operations
  • conditions with vascular obliteration: atherosclerosis, syndrome of Raynaud
  • disorders innervation vessels

  • Myogenic contracture and spasticity of muscles caused by abnormalitiesmusculoskeletal (spondylosis, lumbago with sciatica, arthritis of large joints, cervical syndrome);
  • brain disease noninflammatory character with disorders of muscle tone (infantile paralysis)
  • cholelithiasis
  • Pain syndrome on the background of hemorrhoids
  • Menstrual pain
  • Tonus uterus, threatening miscarriage
  • Renal colic
  • osteochondrosis.

Contraindications and limitations

  • Myasthenia gravis;
  • Hypersensitivity to the components of the drug;
  • seizure activity;
  • Parkinson's disease;
  • Chronic kidney and liver failure, severe;
  • Drug Addiction;
  • acute psychosis;

Tablets

Injection

  • Children under 1 year;
  • Pregnant and nursing mothers are allowed in the presence of acute indications and at the highest expected benefit to the mother than the potential risk to the fetus or child
  • the age of 18;
  • Pregnancy;
  • Lactation.

Dosage Duration of treatment is determined by the doctor.

Tablets

Injection

  • Take immediately after meals, not liquid, squeezed water
  • Children 3-6 years 5 mg / kg daily dose
  • Kids 7-14 years 2-4 mg / kg, in 3 divided doses during the day
  • Children from 14 years and adults - 50 mg two or three times a day, gradually increasing the initial dose of 150 mg with a two-three-time reception.
  • Enter parenterally, intravenously or intramuscularly.
  • / m - 2 times a day with 100 mg (1 ampoule)
  • V / a - 1 time a day, slowly, 100 mg (1 ampoule)

Side effects

skin flushing ininjection site (the application solution).

Less:

  • Anorexia;
  • Insomnia;
  • Drowsiness;
  • Headaches;
  • Hypotension;
  • Dyspepsia;
  • weakness and muscle pain;
  • discomfort, fatigue.

extremely rare:

  • Increased lymph nodes;
  • Anemia;
  • tireless thirst;
  • Confusion;
  • Anaphylaxis;
  • sharp decline in heart rate.

Very rare:

  • Hypersensitivity reactions;
  • Depression, irritability;
  • Reduced physical activity;
  • Excessive sleepiness;
  • disorder attention;
  • cramps, tremors;
  • coordination disorder;
  • Tinnitus;
  • Angina;
  • Shortness of breath, difficulty in breathing;
  • Epistaxis;
  • Abdominal pain, constipation;
  • Liver;
  • Urinary incontinence;

Overdose The drug is non-toxic at therapeutic doses and is much greater than that.In some cases, receiving 300-600 mg tablet formulation may cause irritation.A large overdose of parenteral solution Mydocalm leads to the development of ataxia, difficulty breathing, seizures up to respiratory arrest.

Drug Interactions

  • Mydocalm With the introduction of the solution can not mix it in the same syringe with other drugs.
  • Mydocalm permissible combination with sedatives, hypnotics, and alcohol containing medicines (parallel treatment).
  • The appointment of other drugs from the muscle relaxant group addressed the issue of reducing the daily dose Mydocalm.

Increases the following groups of products:

  • NSAIDs;
  • funds for general anesthesia;
  • Muscle relaxants with peripheral action;
  • psychotropic drugs;
  • Wegetotropona funds.

Cautions

avoid complications and adverse effects should strictly comply with the dosage.No effect on the ability to drive motor vehicles.

Analogs - muscle relaxants

  • tolperisone - Mydocalm, tolperisone
  • tizanidine - Sirdalud, Tizalud, Tizanil
  • tolperisone

50 mg.30 pcs.150-200 rub.

150 mg.30 pcs.180 rubles.

  • Sirdalud

2mg.30 pcs.240 rubles

  • Tizalud

2mg.30 pcs.140 rubles

  • Tizanil

2mg.30 pcs.170 rubles.