MIDOKALM-RICHTER (Solution for in / and the / m)
Active material: Lidokain, Tolperisone
When ATH: M03BX04
CCF: Muscle relaxants centrally acting
ICD-10 codes (testimony): G04, G24, G35, G81.1, G82.1, G82.4, G95.9, I69, I73.0, I73.1, I73.9, I79.2, M15, M46, R25.2
When CSF: 02.10.01
Manufacturer: GEDEON RICHTER Ltd. (Hungary)
Pharmaceutical form, composition and packaging
Solution for in / and the / m colorless or slightly greenish, and odor.
| 1 ml | |
| tolperisone hydrochloride * | 100 mg |
| Lidocaine hydrochloride | 2.5 mg |
Excipients: metilparagidroksiʙenzoat, diethylene glycol monoethyl ether, water d / and.
1 ml – vials of dark glass (5) – trays, plastic (1) – packs cardboard.
* international non-proprietary name, recommended by the WHO – tolperizon.
Pharmacological action
Muscle relaxants centrally acting.
Tolperisone hydrochloride is a central muscle relaxant. The exact mechanism of action is unknown. As a result of the action of membrane impedes excitation in primary afferent fibers, blocking mono- and polysynaptic reflexes of the spinal cord. Probably, secondary mechanism of action is to block transmitter release by blocking the flow of calcium ions into synapses. Reduces reflex readiness reticulospinal ways brainstem. Strengthens the peripheral circulation. This action is not related to the effect of the drug on the central nervous system and can be attributed to weak and antispasmodic action of tolperisone antiadrenergicheskim.
Lidocaine hydrochloride has local anesthetic action and dosing Mydocalm®-Richter according to the instructions of the system has no actions.
Pharmacokinetics
Metabolism and excretion
Tolperisone hydrochloride is extensively metabolized in the liver and kidneys.
Report the news, almost exclusively (> 99%) as metabolites, pharmacological activity is unknown. T1/2 After i / v administration is about 1.5 no.
Testimony
- Treatment of pathologically increased tone and spasm striated muscle, arising from organic diseases of the CNS (incl. the defeat of the pyramidal tract, multiple sclerosis, stroke, myelopathy, encephalomyelitis);
- Treatment of body toning and muscle spasms, muscle contractures, accompanying diseases of movement (eg, spondylosis, spondylarthritis, cervical and lumbar syndromes, arthrosis of large joints);
- Medical rehabilitation after orthopedic and trauma operations;
- As part of combination therapy of vascular occlusive diseases (atherosclerosis, diabetic angiopathy, thromboangiitis obliterans, Raynaud's disease, diffuse scleroderma), Diseases, occurring disorders based on vascular innervation (acrocyanosis, intermittent angioneurotic disbaziya).
Dosage regimen
Adults administered in daily / m 100 mg 2 times / day, or in / on 100 mg 1 time / day.
Side effect
From the digestive system: nausea, vomiting, abdominal discomfort.
CNS: muscular weakness, headache.
Cardio-vascular system: hypotension.
Allergic reactions: rarely – skin rash, itching, эritema, hives, angioedema, anaphylactic shock, breathlessness.
Contraindications
- Myasthenia gravis;
- Children's age;
- Pregnancy;
- Lactation (breast-feeding);
- Hypersensitivity to the drug, incl. to lidocaine.
FROM caution use in patients with kidney and liver failure. No dose adjustment is required.
Pregnancy and lactation
Pregnancy, especially in the I trimester, and lactation (breast-feeding) possible in cases, when the expected benefit of therapy to the mother outweighs the potential risk to the fetus or infant.
Cautions
Effects on ability to drive vehicles and management mechanisms
Be careful when driving and occupation of other potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Overdose
Symptoms: ataxia, tonic and clonic seizures, dyspnoea, respiratory arrest.
Treatment: It recommended the holding of symptomatic and supportive therapy. No specific antidote.
Drug Interactions
Data on drug interactions, limiting the use of Mydocalm®-Richter, not available.
While tolperisone and affects the central nervous system, it does not cause sedation and therefore can be used in combination with sedatives, hypnotics and drugs, containing ethanol.
It does not change the effect of ethanol on the CNS.
It enhances the effect of NSAIDs, therefore, while the appointment may require dose reduction last.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be protected from light and away from children at a temperature of between 8 ° and 15 ° C. Shelf life – 3 year.
