Roflumilast is a phosphodiesterase inhibitor used to treat chronic obstructive pulmonary disease (COPD). It is not a bronchodilator and should not be used for acute bronchospasm. Roflumilast and its active metabolite (roflumilast N-oxide) inhibit phosphodiesterase 4 leading to increases in intracellular cyclic AMP. The specific mechanism by which it exerts its therapeutic action is not well defined, but it is thought to be related to increases in cyclic AMP in lung cells and the ability to decrease swelling in the lungs.
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), and to obtain the following information:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.