Tolperizone plus lidocaine-Ferein (Solution) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

ATC Code

M03BX04 (Tolperisone)

Active Substance

Tolperisone (Rec.INN registered by WHO)

Dosage Form

Tolperisone with lidocaine-Ferein

Solution for intramuscular injection 100 mg/1 ml: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Excipients : lidocaine hydrochloride.
1 ml – dark glass ampoules (5) – plastic contour packs (1) – cardboard packs.

Clinical-Pharmacological Group

Centrally acting muscle relaxant

Pharmacotherapeutic Group

Centrally acting muscle relaxant

Pharmacological Action

Centrally acting muscle relaxant. The reduction of pathologically increased skeletal muscle tone is explained by the ability of tolperisone to suppress spinal polysynaptic reflexes and its inhibitory effect on the caudal part of the reticular formation. It has central n-cholinoblocking properties. It does not have a significant effect on the peripheral parts of the nervous system. It has a weak antispasmodic and vasodilating effect.

Indications

Spinal and cerebral palsies (hypertonia, muscle spasm, spinal automatism; limb contractures).

Diseases accompanied by dystonia, rigidity, muscle spasm; obliterating arterial diseases: obliterating atherosclerosis of limb vessels, diabetic angiopathy, obliterating thromboangiitis (Buerger’s disease), Raynaud’s syndrome.

Consequences of vascular innervation disorders (acrocyanosis, intermittent angioneurotic dysbasia).

Extrapyramidal disorders (postencephalitic and atherosclerotic parkinsonism).

Postthrombotic disorders of lymph circulation and venous circulation, trophic ulcer of the leg, infantile spastic paralysis (Little’s disease), epilepsy, encephalopathy of vascular origin; hypertonia combined with a violation of muscle tone of another type.

ICD codes

Dosage Regimen

Administer this solution by intramuscular injection only.

The standard adult dosage is 100 mg (1 ml) injected into a large muscle twice daily.

Do not exceed the maximum daily dose of 200 mg (2 ml).

Adjust the injection site for each administration to prevent local irritation.

The treatment duration is determined by the treating physician based on clinical response and underlying condition.

For oral administration of tolperisone tablets, initiate therapy at 50 mg two to three times daily.

Gradually titrate the oral dose upward to a maintenance dose of 150 mg two to three times daily as tolerated.

For intravenous use of other formulations, a common regimen is 100 mg administered once daily.

This parenteral product is contraindicated in children and adolescents under 18 years of age.

Adverse Reactions

Possible headache, myasthenia, arterial hypotension, nausea, vomiting, gastralgia, allergic reactions (anaphylactic shock, bronchospasm, urticaria, erythematous rashes, skin itching).

Contraindications

Myasthenia, pregnancy, lactation period, children and adolescents under 18 years of age, hypersensitivity to tolperisone.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 1 year of age.

Special Precautions

Effect on ability to drive vehicles and mechanisms

Use with caution in patients whose activities require increased attention and speed of psychomotor reactions.

Drug Interactions

The effect of tolperisone is enhanced with simultaneous use with drugs for general anesthesia, peripheral muscle relaxants, psychoactive drugs, and with clonidine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.