Please note, this OEL/ADE monograph also applies to sildenafil citrate (CAS RN 171599-83-0). Sildenafil is indicated to treat erectile dysfunction and pulmonary hypertension. Additionally, this monograph contains the pediatric ADE (pADE). Sildenafil citrate is an inhibitor of cGMP specific phosphodiesterase type-5 (PDE5) in smooth muscle, where PDE5 is responsible for degradation of cGMP. Sildenafil citrate increases cGMP within vascular smooth muscle cells resulting in relaxation and vasodilation. In patients with pulmonary hypertension, this leads to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilation in the systemic circulation. In patients with erectile dysfunction, sildenafil citrate enhances the effect of nitric oxide (NO) by inhibiting PDE5 in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil citrate causes increased levels of cGMP resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. The OEL and ADE for both sildenafil and sildenafil citrate is covered by this monograph.
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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