OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to additional CAS RN 220045-89-6. Nadolol tablets are indicated for the long-term management of patients with angina pectoris and hypertension. The mechanism of the antihypertensive effects of beta-adrenergic receptor blocking agents has not been established. Nadolol is a nonselective beta blocker that competes with beta-adrenergic receptor agonists for available beta receptor sites. The exact antihypertensive mechanism of beta-adrenergic receptor blocking agents has not been established (2). It binds at beta-1 receptors in the heart and vascular smooth muscle, inhibiting the effects of epinephrine and norepinephrine and decreasing heart rate, cardiac output, and systolic and diastolic blood pressure (2, 4). This action is also thought to be the mechanism by which nadolol exerts its anti-anginal effects, thereby reducing the oxygen requirements of the heart and the velocity and extent of myocardial contraction (6). It also binds and blocks beta 2 receptors in bronchiole smooth muscle causing vasoconstriction. By binding beta 2 receptors in the kidney, nadolol inhibits the production of renin, thereby inhibiting angiotensin II and aldosterone production.

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

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HBEL

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