Lidamitol, 100 mg/ml +2, 5 mg/ml 1 ml 5 pcs

Tolperisone hydrochloride is a central myorelaxant. The exact mechanism of action is unknown. As a result of membrane-stabilizing action, it interferes with the conduction of excitation in primary afferent fibers, blocking mono- and polysynaptic reflexes of the spinal cord. Probably the secondary mechanism of action is to block the release of the transmitter by blocking the entry of calcium ions into the synapses.

Decreases reflex readiness in the reticulospinal pathways of the brainstem.

It enhances peripheral blood flow. This action is not related to the effects of the drug on the central nervous system and may be due to the mild antispasmodic and antiadrenergic effects of tolperisone.

Lidocaine hydrochloride has a local anesthetic effect and has no systemic action when dosed by Lidamy Gol according to the instructions.

Indications

– Symptomatic treatment of spasticity in adults due to stroke.

– Treatment of painful muscle spasm associated with diseases of the musculoskeletal system (spondylosis, spondyloarthrosis, cervical and lumbar syndromes).

Composition

1 ml of the drug contains:

The active ingredients:

Tolperisone hydrochloride 100 mg

Lidocaine hydrochloride monohydrate (in terms of lidocaine hydrochloride) 2.5 mg

Associates:

Methyl parahydroxybenzoate 0.6 mg

Propylene glycol 0.3 ml

1 M hydrochloric acid solution to pH 3.0-4.5

Injection water up to 1 ml.

Interaction

Directions for use

Adults: 1 ml 2 times daily intramuscularly or 1 ml once daily intravenously.

Polymer ampoule procedure:

1. Take the ampoule and shake it by holding the neck.

2. With a twisting motion, rotate and separate the valve from the ampoule.

3. immediately connect the luer of the syringe to the ampoule through the hole that is created.

4. draw the contents of the ampoule into the syringe.

5. Attach the needle to the syringe.

Features

Tolperisone hydrochloride undergoes intensive metabolism in the liver and kidneys. It is excreted by the kidneys, almost exclusively (> 99%) as metabolites, the pharmacological activity of which is unknown. With intravenous administration, the elimination half-life is about 1.5 h.

Lidocaine hydrochloride is completely absorbed (absorption rate depends on place of administration and dose). Time of reaching maximum concentration when administered intramuscularly is 30-45 min. Binding with plasma proteins is 50-80%. It is rapidly distributed in tissues and organs. It penetrates through the blood-brain barrier and placental barrier, is secreted with the mother’s milk (40% of the concentration in the mother’s plasma). Metabolized in the liver (90-95%) with microsomal enzymes by dealkylation of the amino group and breaking the amide bond to form active metabolites. It is excreted with bile (part of the dose is reabsorbed into GIH) and by the kidneys (up to 10% unchanged).

Contraindications

Hypersensitivity to any of the components of the drug (including lidocaine), severe myasthenia gravis, childhood under 18 years, pregnancy, lactation (due to lack of data).

Cautions should be taken in patients with renal and hepatic impairment. No dose adjustment is necessary.

Side effects

World Health Organization (WHO) recommended side effect frequency classification: very common (≥1/10), common (≥1/100 and < 1/10), infrequent (≥1/1000 and < 1/100), rare (≥1/10000 and < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated based on available data).

Blood and lymphatic system disorders: very rare – anemia, lymphadenopathy.

Intune system disorders: rare – hypersensitivity reactions, anaphylactic reactions; very rare – anaphylactic shock.

Disorders of metabolism and nutrition: infrequent – anorexia; very rare – polydipsia.

Mental disorders: infrequent – insomnia, sleep disorders, rarely – loss of activity, depression.

Nervous system disorders: infrequent – headache, dizziness, somnolence; rare – attention deficit syndrome, tremor, seizures, loss of sensitivity, sensory disorders, lethargy.

Visual disorders: rare – visual perception disorders.

Hearing organ disorders and labyrinth disorders: rarely – tinnitus, vertigo.

Chronic disorders: rare – angina, tachycardia, palpitations; very rare – bradycardia.

Vascular disorders: infrequent – arterial hypotension; rarely – hot flashes.

Respiratory system disorders. thoracic and mediastinal organs: rarely – shortness of breath, nasal bleeding, rapid breathing.

Gastrointestinal disorders: infrequent – gastrointestinal discomfort, diarrhea, dry mouth, dyspepsia, nausea; rarely – pain in epigastrium, constipation, flatulence, vomiting.

Liver and biliary tract disorders: rarely – liver function disorders.

Skin and subcutaneous tissue disorders: rare – allergic dermatitis, sweating, skin itching, urticaria, skin rash.

Muscular and connective tissue disorders: infrequent – muscle weakness, myalgia, pain in extremities; rare – discomfort in extremities; very rare – osteopenia.

Renal and urinary tract disorders: rarely – enuresis, proteinuria.

General disorders and disorders at the injection site: often – redness of the injection site; infrequently – asthenia (weakness), malaise, fatigue; rarely – feeling of intoxication, feeling of heat, irritability, thirst; very rarely – feeling of discomfort in the chest.

Laboratory and instrumental data: rarely – decreased blood pressure, increased bilirubin concentration, impaired liver function tests, decreased platelet count, increased white blood cell count; very rarely – increased creatinine level.

Overdose

Symptoms: ataxia, tonic and clonic convulsions, dyspnea and respiratory arrest.

Treatment: symptomatic and supportive therapy is recommended. There is no specific antidote.