Please note that this monograph also contains the pediatric ADE. Tadalafil is indicated for the treatment of benign prostate growth, erectile dysfunction, and pulmonary high blood pressure. The exact mechanism of action of tadalafil in benign prostatic hyperplasia is not known. Tadalafil selectively inhibits phosphodiesterase type 5 (PDE5) and increases cyclic guanosine monophosphate (cGMP) levels. The smooth muscle cells of the prostate, bladder and surrounding vasculature also contain PDE5; inhibiting PDE5 and increasing cGMP levels in these tissues may cause smooth muscle relaxation, as observed in the corpus cavernosum and pulmonary arteries.
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:
To order an OEL/ADE monograph for Tadalafil, just click the ADD TO CART button.
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Affygility Solutions’ 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.