Midokalm-Richter 100 mg / ml + 2.5 mg / ml 1 ml , 5 pcs.

Gideon Richter, Hungary

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Product Overview

Composition

Active substances:

tolperisone hydrochloride 100 mg,

lidocaine hydrochloride 2.5 mg;

Excipients:

methyl paraben

diethylene glycol monoethyl ether,

water d / and;

pharmachologic effect

Midokalm - muscle relaxant.

Pharmacodynamics

Muscle relaxant central action. The mechanism of action is not fully understood. It has a membrane-stabilizing, local anesthetic effect, inhibits the conduction of impulses in primary afferent fibers and motor neurons, which leads to blocking of spinal mono- and polysynaptic reflexes.

It is also likely that it slows down the release of mediators by inhibiting the entry of Ca 2+  into synapses. In the brain stem eliminates the facilitation of the excitation along the reticulospinal path.

Enhances peripheral blood flow regardless of the effect of the central nervous system. In the development of this effect, the weak antispasmodic and adrenoblocking effect of tolperisone plays a role.

Pharmacokinetics

After oral administration, tolperisone is well absorbed from the digestive tract. C max is  achieved after 0.5–1 h, bioavailability is about 20%.

Tolperisone is metabolized in the liver and kidneys. It is excreted in the urine in the form of metabolites (more than 99%). The pharmacological activity of metabolites is unknown.

Indications

  • treatment of pathologically increased muscle tone and spasms of striated muscles resulting from organic diseases of the central nervous system (pyramidal lesions, multiple sclerosis, cerebral stroke, myelopathy, encephalomyelitis);
  • treatment of increased tone and muscle spasms, muscle contractures accompanying diseases of the organs of motion (including spondylosis, spondylitis, cervical and lumbar syndromes, arthrosis of large joints);
  • rehabilitation treatment after orthopedic and traumatological operations;
  • in the combination therapy of obliterating vascular diseases (atherosclerosis obliterans, diabetic angiopathy, thromboangiitis obliterans, Raynaud's disease, diffuse scleroderma), diseases arising from vascular innervation disorders (acrocyanosis, intermittent angioneurotic dysbasia);
  • Little's disease (cerebral palsy) and other encephalopathies accompanied by muscular dystonia.

Contraindications

  • hypersensitivity to any of the components of the drug;
  • myasthenia gravis;
  • children under 3 years old.

Side effects

Muscle weakness, headache, arterial hypotension, nausea, vomiting, abdominal discomfort. With a decrease in dose, side effects usually disappear.

In rare cases, allergic reactions occur (skin itching, erythema, urticaria, angioedema, anaphylactic shock, bronchospasm).

Interaction

There is no evidence of an interaction limiting the use of Midokalm.
 
With the simultaneous use of Midokalm® enhances the effect of niflumic acid, therefore, if necessary, the use of this combination must reduce the dose of niflumic acid.
 
Although tolperisone has an effect on the central nervous system, the drug does not cause a sedative effect, so it can be used in combination with sedatives, hypnotics and drugs containing ethanol.
 
Does not affect the effect of ethanol on the central nervous system. Means for general anesthesia, peripheral muscle relaxants, psychotropic drugs, clonidine enhance the effect of tolperisone.

How to take, course of administration and dosage

100 mg 2 times a day is administered to adults i / m or i.v. (slowly) 100 mg once a day.

Overdose

Symptoms: no data on overdose of Midokalm have been reported. Midokalm® has a broad therapeutic index, a case of a child taking the drug inside with a dose of 600 mg without the appearance of severe toxic symptoms is described.
 
When taking the drug inside at a dose of 300-600 mg / day. in a child, in some cases, irritability was observed. In preclinical studies on the study of acute toxicity in animals with the introduction of the drug in high doses, ataxia, tonic-clonic convulsions, shortness of breath and respiratory paralysis were observed.
 
Treatment: there is no specific antidote, gastric lavage is recommended, general symptomatic and supportive therapy.

Special instructions

Influence on the ability to drive vehicles and control mechanisms
 
The use of the drug does not affect the ability of patients to perform work that requires increased attention and speed of psychomotor reactions.

Release form

injection

Storage conditions

In the dark place at a temperature of 8–15 ° C

Shelf life

3 years

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