Mydocalmum
Producer: Gedeon Richter (Gideon Richter) Hungary
Code of automatic telephone exchange: M03BX04
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: Tolperisonum hydrochloride of 50 mg and 150 mg
Excipients: citric acid monohydrate, silicon dioxide colloid (aerosil), stearic acid, talc, microcrystallic cellulose, starch corn, lactose (sugar milk);
Structure of a cover: silicon dioxide colloid (aerosil), titanium dioxide 171, lactose (sugar milk), macrogoal 6000, gipromelloz (gidroksipropilmetiltsellyuloz).
Pharmacological properties:
Pharmacodynamics. Muscle relaxant of the central action. The action mechanism is completely not found out. Possesses membrane stabilizing, mestnoanesteziruyushchy action, brakes conductivity of impulses in primary afferent fibers and motor neurons that leads to blocking spinal mono - and polisinaptichesky reflexes. Also probably for the second time slows down allocation of mediators by braking of receipt of Sa2 + in synapses. In a brainstem eliminates simplification of carrying out excitement on a reticulospinal way.
Strengthens a peripheral blood stream irrespective of influence of the central nervous system. In development of this effect the weak spasmolytic and adrenobpokiruyushchy effect of Tolperisonum plays a role.
Pharmacokinetics. After reception Tolperisonum is well soaked up from digestive tract. The maximum concentration is reached 0,5-1 hour later, biological availability makes about 20%.
Tolperisonum is metabolized in a liver and kidneys. Removal happens through kidneys in the form of metabolites (more than in 99%).
Pharmacological activity of metabolites is unknown.
Indications to use:
Treatment patholologically the raised tone and spasms of cross-striped muscles arising owing to organic diseases of the central nervous system (defeat of pyramidal ways, multiple sclerosis, a brain stroke, a myelipathy, encephalomyelitis, etc.).
Treatment of the raised tone and muscular spasms, muscular contractures accompanying musculoskeletal system diseases (a spondylosis, a spondylarthrosis, cervical and lumbar syndromes, arthroses of large joints).
Recovery treatment after orthopedic and traumatologic operations.
As a part of a combination therapy of obliterating diseases of vessels (obliterating atherosclerosis, a diabetic angiopatiya, an obliterating thromboangitis, a Raynaud's disease), diseases evolving from frustration of an innervation of vessels (a Crocq's disease, an intermittent angioneurotic dysbasia).
Lipl's disease (children's brain paralysis) and other encephalopathies which are followed by muscular dystonia.
In order to avoid complications to apply strictly on doctor's orders!
Route of administration and doses:
Inside, after food, without chewing, washing down with a small amount of water.
Adult: Usually since 50 mg 2-3 times a day, gradually raising a dose to 150 mg 2-3 times a day.
For children: To children aged from 1 year up to 6 years Midokalm® appoint inside in a daily dose 5 mg/kg (in 3 receptions during the day); at the age of 7-14 years - in a daily dose of 24 mg/kg (in 3 receptions during the day). A tablet, coated, it is necessary to pound if the child is not capable to swallow it.
For children only use of tablets, coated on 50 mg is allowed.
Features of use:
Мидокалм® does not increase risk at the driving of the car and performance of work connected with the increased risk.
Side effects:
Muscular weakness, headache, lowering of arterial pressure, nausea, vomiting, feeling of discomfort in a stomach. At reduction of a dose by-effects usually pass.
In rare instances allergic reaction (a skin itch, an erythema, a small tortoiseshell, a Quincke's disease, an acute anaphylaxis, a bronchospasm) meets.
Interaction with other medicines:
Data on the interactions limiting use of Midokalma® are not available.
Though Tolperisonum has effect on the central nervous system, it does not cause sedation therefore it can be applied in a combination with sedative, the hypnagogues and drugs containing alcohol.
Does not influence effect of alcohol on the central nervous system.
Tolperisonum strengthens effect of nifluminovy acid, at simultaneous use of these drugs the dose decline of nifluminovy acid can be required.
Means for the general anesthesia, peripheral muscle relaxants, psychotropic drugs, a clonidine - strengthen effect of Tolperisonum.
Contraindications:
Hypersensitivity to one of drug components. A myasthenia, children's age till 1 year.
Pregnancy and period of a lactation
During pregnancy and in the period of a lactation (breastfeeding) of Midokalm® it can be applied (especially in the first trimester of pregnancy) only if the expected advantage exceeds risk of potential complications for a fruit.
Overdose:
Data on overdose of Midokalma® did not arrive.
Мидокалм® has broad therapeutic range, in literature even oral administration of drug in a dose of 600 mg at children's age without manifestation of more serious toxic manifestations is described. At oral administration of 300-600 mg of drug a day at patients of children's age in some cases observed irritability. In the experiments on toxicity made on animals, high doses of drug caused an ataxy, tonic and clonic spasms, short wind and paralysis of breath.
There is no specific antidote, at overdose of drug the gastric lavage, the general symptomatic and supporting treatment is recommended.
Storage conditions:
List B.
In the dry place at a temperature from 15 to 30 °C.
To store in the place, unavailable to children!
Issue conditions:
According to the recipe
Packaging:
Tablets, film coated 50 mg and 150 mg.
On 10 tablets in a blister strip packaging. On 3 blister strip packagings together with the application instruction in a pack.