Please note, this OEL/ADE monograph also applies to Dexbudesonide, 22R-Budesonide (CAS RN 51372-29-3) and 22S-Budesonide (CAS RN 51372-28-2). Budesonide is a glucocorticoid steroid for the treatment of asthma and non-infectious rhinitis (including hay fever and other allergies), and for treatment and prevention of nasal polyposis. In addition, it is used for Crohn's disease (inflammatory bowel disease). Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. It binds to the glucocorticoid receptor with higher affinity than cortisol and prednisolone and suppresses endogenous cortisol concentrations and impairs the hypothalamus-pituitary-adrenal axis function (2, 4). In the inhaled formulation, a decrease in airway reactivity to histamine have been observed. Budesonide’s precise mechanism of action on inflammation in Crohn’s disease, asthma, or ulcerative colitis is not known.
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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