Tolperil-Zdorovye, the tab. п / about on 150 mg No. 10Õ3/on 50 of mg No. 10х3
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: M03B X04
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
International and chemical name: tolperil Structure: Tolperisonum hydrochloride
1 tablet contains hydrochloride Tolperisonum in terms of 100% substance of 50 mg or 150 mg; Excipients: cellulose microcrystallic (MKTs-101); lactose, monohydrate stearic acid starch potato starch corn, talc; citric acid, monohydrate, silicon dioxide colloid; gipromelloza; titanium dioxide (Е 171); macrogoal 6000. Main physical and chemical properties: tablets, coated, white or almost white color, a round form with a biconvex surface.
Pharmacological properties:
Pharmacological Tolperisonum hydrochloride muscle relaxant of the central action. The mechanism of action is caused by braking of conductivity of impulses of primary afferent fibers and motor neurons that leads to blocking of spinal mono-and polisinaptichesky reflexes. By braking of receipt of Sa 2 + in synapses for the second time interferes with an exit of mediators. Slows down 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 effect of Tolperisonum can play a role weak spasmolytic and Anti-adrenergic.
Pharmacokinetics. At intake it is well soaked up in a small intestine. The maximum concentration is reached in 0,5 - 1 hour; owing to considerable primary metabolism bioavailability makes 20%. It is intensively metabolized in a liver and kidneys. It is removed by kidneys, it is almost exclusive (99%) in the form of metabolites which pharmacological activity is unknown.
Indications to use:
Spasticity and hyper tone of cross-striped muscles, arising owing to organic diseases of a nervous system (damage of pyramidal ways, multiple sclerosis, a cerebrovascular stroke, a myelipathy, encephalomyelitis, etc.).
Muscle hyper tone, spasm at musculoskeletal system diseases (a spondylosis, a spondylarthrosis, cervical and lumbar syndromes, arthroses of large joints).
Rehabilitation after orthopedic and traumatologic operations.
The diseases which are followed by a spasm of arteries and disturbance of an innervation of vessels (a Crocq's disease, the alternating lameness (Sharko's syndrome)).
Littl's disease and encephalopathies at children which are followed by dystonia.
Route of administration and doses:
Drug is appointed inside. The doctor defines the mode of dosing and duration of a course of therapy individually depending on the course of a disease, efficiency and portability of therapy.
To adults and children 14 years are more senior appoint 150 - 450 mg a day, distributing on 3 receptions.
To children with body weight more than 30 kg on 5 mg/kg of body weight a day, distributing on 3 receptions.
To children at the age of 6 - 14 years: on 2 - 4 mg/kg a day, distributing on 3 receptions.
Features of use:
For prevention of complications drug should be used strictly according to testimonies of the doctor, especially at heart, pulmonary failure, diseases of kidneys and a liver, bronchial asthma in the anamnesis, hematologic diseases.
The list of planned researches of a condition of bodies and systems before use and at prolonged use of drug is defined by the doctor.
Ability to influence speed of response at control of motor transport or other mechanisms. Data are absent.
Use during pregnancy or feeding by a breast. In the absence of clinical trials of use of drug during pregnancy, especially in the I trimester, it is possible only when the expected advantage for mother exceeds potential risk for a fruit. Data on penetration Tolperisonum in breast milk are absent therefore in need of administration of drug in the period of a lactation feeding by a breast needs to be stopped.
Children. Drug is used at children with body weight by more than 30 kg to destination and under control of the doctor.
Side effects:
Usually drug is well transferred, side reactions are observed only in 2 - 3% of patients:
from TsNS: muscular weakness, headache;
from the alimentary system: nausea, vomiting, a sensation of discomfort in a stomach;
from cardiovascular system: arterial hypotension;
allergic reactions: in isolated cases - hypersensitivity reactions (an itch, an erythema, a small tortoiseshell, a Quincke's disease, an acute anaphylaxis, диспноэ).
Interaction with other medicines:
Data on interaction with medicines which limit use Tolperisonum, no.
Despite the central mechanism of action, Tolperisonum does not render sedation therefore it is possible to appoint it in a combination with sedative, hypnagogues and tranquilizers.
Drug does not influence effect of alcohol on the central nervous system.
Strengthens effect of a niflyuminovoa of acid at co-administration the acid niflyuminovoa dose decline can be required.
Contraindications:
Hypersensitivity to any of drug components.
Heavy myasthenia.
Feeding period breast.
Relative contraindication: pregnancy, especially I trimester
Overdose:
Data on overdose are not enough. Tolperisonum has a wide therapeutic index. The described case of reception by children internally 600 mg of drug which current passed without special serious toxic symptoms. In certain cases at children observed an acrimony after intake of 300 - 600 mg a day.
Treatment: symptomatic and maintenance therapy. There is no specific antidote.
Storage conditions:
To store in original packaging at a temperature not above 25 °C.
To store in the place, unavailable to children.
Period of validity - 3 years.
Issue conditions:
According to the recipe
Packaging:
Tablets on 50 mg or 150 mg No. 10? 3 in blisters in a box.