Gedeon Richter Plc. Updates Instructions for Midocalm-Richer Injection

Gedeon Richter Plc. has updated the usage instructions for its pharmaceutical product, Midocalm-Richer, a solution for intramuscular injection. The medication is indicated for the symptomatic treatment of spasticity in adults resulting from stroke, and for moderate to severe myofascial pain syndrome, including muscle spasms associated with dorsopathies.

The active ingredients are tolperisone hydrochloride and lidocaine hydrochloride. Each 1 ml ampoule contains 100 mg of tolperisone hydrochloride and 2.5 mg of lidocaine hydrochloride. The solution also contains excipients including methylparahydroxybenzoate, diethylene glycol monoethyl ether, and water for injections.

The updated guidance specifies contraindications, including hypersensitivity to the active substances or excipients, myasthenia gravis, pregnancy, and breastfeeding. It is also not intended for use in individuals under 18 years of age. Caution is advised for patients with moderate renal or hepatic impairment, with an emphasis on careful monitoring and dose adjustment. The instructions highlight a risk of hypersensitivity reactions, ranging from skin reactions to anaphylactic shock, and advise immediate discontinuation and medical consultation if symptoms arise. Patients with a history of hypersensitivity to other medications may be at higher risk.

Information regarding drug interactions has also been updated. Co-administration with tolperisone may increase blood levels of certain drugs metabolized by the CYP2D6 enzyme. While tolperisone has minimal sedative effects, concurrent use with other centrally acting muscle relaxants may require dose reduction. Furthermore, tolperisone can potentiate the effects of non-steroidal anti-inflammatory drugs (NSAIDs).

The drug is contraindicated during pregnancy and lactation due to a lack of sufficient clinical data and potential risks. While animal studies have not shown teratogenic effects, its use is limited to situations where the potential benefit clearly outweighs the fetal risk. No data is available on excretion into breast milk. The product does not affect the ability to drive or operate machinery, although dizziness may occur in some individuals.