Product Name : Flupirtine Maleate 40% Pellets
Dosage Form : Capsules
Dose : 100mg
Therapeutic Category : Anti-Inflammatory
Reference Product : Retense
API : DMF; Dossier — CTD : Available
Trade Name : Fludic-P
Originator : -
Flupirtine is used as an analgesic for acute pain, in moderate-to-severe cases. Its muscle relaxant properties make it popular for back pain and other orthopedic uses, but it is also used for migraines, in oncology, postoperative care, and gynecology.
Flupirtine is an aminopyridine that functions as a centrally acting non-opioid analgesic that was originally used as an analgesic for acute and chronic pain but in 2013 due to issues with liver toxicity, the European Medicines Agency restricted its use to acute pain, for no more than two weeks, and only for people who cannot use other painkillers. In February 2018 EMA's Pharmacovigilance Risk Assessment Committee has recommended that, the marketing authorisation for flupirtine be withdrawn. This recommendation was based on the finding that the restrictions introduced in 2013 have not been sufficiently followed in clinical practice, and cases of serious liver injury still occurred including liver failure. As of March 2018 the marketing authorisations of flupirtine-containing medicines are not yet withdrawn and a final decision is pending.