Mydocalm: instructions for use in tablets andinjection solution

Update: October 2018

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

Also used to treat angiopathy, in preparation for
operational interventions for the relief of emergency conditions.
It is characterized by rapid removal of smooth muscle spasm and significant
reduced sensitivity of nerve endings.

The active basis of the drug is tolperisone hydrochloride.
– direct muscle relaxant.

Farmgroup: Myorelaxant of the central (direct) action.

The composition of the drug

Available in two dosage forms:

  • Tablets of 50 and 150 mg for oral administration;
  • Solution for parenteral intramuscular or intravenous
    introduction.
Active substance Excipients Shell

Tablets, 50 mg

50 mg tolperisone hydrochloride 0.73 mg citric acid monohydrate, 0.8 mg colloidal
silicon dioxide, 1.7 mg stearic acid, 4.5 mg talc, 14 mg
MCC, 29.77 mg of corn starch, 48.5 mg of monohydrate
lactose
0.045 mg of colloidal silicon dioxide, 0.244 mg of titanium
диоксида, 0,392 мг моногидрата lactose, 3,927 мг гипромеллозы

Tablets, 150 mg

150 mg tolperisone hydrochloride 2.19 mg citric acid monohydrate, 2.4 mg colloidal
silicon dioxide, 5.1 mg stearic acid, 13.5 mg talc, 42 mg
MCC, 89.31 mg of corn starch, 145.5 mg of monohydrate
lactose
0.089 mg of colloidal silicon dioxide, 0.487 mg of titanium
диоксида, 0,785 мг моногидрата lactose, 0,785 мг макрогола 6000,
7,854 mg of hypromellose

Solution

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

Release form, price

  • Tablets with a film cover of almost white color, round
    biconvex shape, having a characteristic smell and engraving 150
    or 50, 30 pieces in a pack.

    • Mydocalm 50 mg – price 277-392 rubles,
    • Mydocalm 150 mg – price 318-419 rubles.
  • Solution для инъекций, прозрачного цвета со специфическим
    a smell in sterile ampoules on 1 ml, 5 ampoules in a pack. Price –
    470-673 rub.

pharmachologic effect

  • The action of tolperisone, which has a high affinity for the nervous
    tissue, not well understood.
  • Being a centrally acting muscle relaxant, has
    local anesthetic and membrane stabilizing effect, inhibits
    passage of nerve impulses in motor neurons and primary
    afferent fibers from the internal organs to the central nervous
    the system. This leads to blocking of mono and polysynaptic
    spinal reflexes.
  • Promotes secondary inhibition of mediator release by
    suspension of calcium ions in the nerve synapses.
  • Enhances peripheral circulation through expansion
    vessels, has antispasmodic and adrenoblokiruyuschee effect.
    Снижает гипертонус, спастичность и ригидность muscle
  • Improves the activity of voluntary movements, increasing them
    amplitude.
  • Reduces the threshold of pain sensitivity.
  • Solution для инъекций за счет содержания лидокаина устраняет
    soreness and swelling at the injection site.

Pharmacokinetics

Pills. Active substance хорошо адсорбируется через ЖКТ,
after 0.5-1 hours, the maximum effective is reached
blood concentration, duration of action 4-6 hours.
Bioavailability of the dosage form according to the instructions for
Mydocalm’s use is about 20%.

Solution. The therapeutic maximum in blood is reached through
30-45 minutes after parenteral administration of the drug
drug. The half-life is about 1.5 hours.

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

Indications for use

  • Hypertonicity and spasticity of skeletal muscles on the background of organic
    lesions of the central nervous system (after a stroke, multiple sclerosis, lesions
    pyramidal system, spinal cord damage, toxic or
    viral inflammation of the spinal cord and brain, etc.)
  • Diseases with muscular dystonia
  • The recovery period after orthopedic, surgical and
    trauma surgery
  • Diseases occurring with the obliteration of blood vessels: obliterating
    atherosclerosis, Raynaud’s syndrome
  • Vascular innervation disorders
  • Myogenic contractures and muscle spasticity due to
    pathologies of the musculoskeletal system (spondylosis, lumbago with sciatica,
    arthrosis of large joints, cervical syndrome);
  • Non-inflammatory brain diseases with
    muscle tone disorders (infantile paralysis)
  • Cholelithiasis
  • Pain on the background of hemorrhoids
  • Menstrual pain
  • Uterus tonus threatening miscarriage
  • Renal colic
  • Osteochondrosis.

Contraindications and restrictions

  • Myasthenia gravis;
  • Hypersensitivity to the drug;
  • Convulsive activity;
  • Parkinson’s disease;
  • Chronic severe renal and hepatic failure
    degrees;
  • Drug addiction;
  • Acute psychosis;

Pills

Solution для инъекций

  • Children’s age up to 1 year;
  • Pregnant and lactating mothers are allowed in the presence of acute
    indications and with a high expected benefit for the mother, exceeding
    possible risks to the fetus or child
  • Age up to 18 years;
  • Pregnancy;
  • Lactation.

Dosage

The duration of treatment is not indicated in the instructions, because
determined by the doctor.

Pills

Solution для инъекций

  • Accept immediately after food, without chewing, washing down with water
  • Children 3-6 years 5 mg / kg daily dose
  • Children 7-14 years old 2-4 mg / kg, in 3 doses during the day
  • Children from 14 years old and adults – 50 mg twice or three times a day,
    gradually increasing the initial dose to 150 mg with two to three times
    by reception.
  • Injected parenterally, intravenously or
    intramuscularly.
  • V / m – 2 times a day, 100 mg (1 ampoule)
  • In / in – 1 time per day, slowly, 100 mg (1 ampoule)

Side effect

Hyperemia of the skin at the injection site (when applying
solution).

Less often:

  • Anorexia;
  • Insomnia;
  • Drowsiness;
  • Headaches;
  • Hypotension;
  • Dyspepsia;
  • Weakness and pain in the muscles;
  • Discomfort, fatigue.

Rarely:

  • Swollen lymph nodes;
  • Anemia;
  • Tireless thirst;
  • Confusion;
  • Anaphylactic shock;
  • A sharp decrease in heart rate.

Very rarely:

  • Hypersensitivity reactions;
  • Depression, irritability;
  • Decreased physical activity;
  • Excessive sleepiness;
  • Attention disorder;
  • Cramps, tremor;
  • Coordination disorder;
  • Noise in ears;
  • Angina pectoris;
  • Shortness of breath, difficulty breathing;
  • Nose bleed;
  • Abdominal pain, constipation;
  • Liver damage;
  • Urinary incontinence;

Overdose

The drug is non-toxic at a therapeutic dose and
much higher than that. In some cases, receiving 300-600
mg tablet form can lead to irritability.
Significant overdose of parenteral solution
Mydocalm leads to the development of ataxia, difficulty breathing,
convulsions down to stop breathing.

Drug interactions

  • With the introduction of the solution Myodocalm can not mix it in one
    syringe with other drugs.
  • Acceptable combination of Mydocalm with sedatives,
    sleeping pills and alcohol containing drugs
    (parallel treatment).
  • If necessary, the appointment of other drugs from the group
    muscle relaxants solved the question of reducing the daily dose
    Mydocalma

Enhances the effect of the following groups of drugs:

  • NSAIDs;
  • Agents for general anesthesia;
  • Muscle relaxants with peripheral action;
  • Psychotropic drugs;
  • Vegetotropic funds.

special instructions

To avoid complications and undesirable effects, one should strictly
comply with the dosage. Does not affect driving ability
motor vehicles.

Analogs – muscle relaxants

  • Tolperisone – Mydocalm, Tolperisone
  • Tizanidine – Sirdalud, Tizalud, Tizanil
  • Tolperisone

50 mg. 30 pieces 150-200 rubles

150 mg. 30 pieces 180 rub.

  • Sirdalud

2mg 30 pieces 240 rub

  • Tizalud

2 mg. 30 pieces 140 rub

  • Tizanil

2mg 30 pieces 170 rub.

Автор: врач-гигиенист, эпидемиолог

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