Please note, this OEL/ADE monograph also applies to lyssine clonixin (CAS RN 17737-65-4). Lysine clonixinate is a non-steroidal anti-inflammatory drug (NSAID) indicated for use in the relief of pain, the management of chronic arthritic conditions, and certain soft tissue disorders associated with pain and inflammation. Lysine clonixinate is a non-narcotic analgesic, derived from anthranilic acid, that is presumed to function similarly to other NSAIDs by inhibiting cyclooxygenase enzymes 1 and 2 responsible for prostaglandin production, resulting in vasodilation and analgesia (2, 4). Prostaglandins PGE and PGF 2 are directly responsible for the stimulation of pain neuroreceptors, and when lysine clonixinate blocking its production, the uptake of painful sensitivity is prevented, regardless of the cause. It has also been shown that lysine clonixinate inhibits the bradykinin and PGF 2 already produced, so it is considered as a direct antagonist of pain mediators.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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