Please note, this OEL/ADE monograph also applies to Otilonium bromide (CAS RN 26095-59-0), and Otilonium iodide (CAS RN 26095-58-9). Otilonium bromide is a member of the benzamides. Otilonium is indicated for irritable bowel syndrome (IBS) and the relief of abdominal pain, distension and motility disorders characterized by smooth-muscle spasm. Otilonium bromide is endowed with a marked spasmolytic action on the smooth muscle of the digestive tract. Otilonium bromide acts predominantly by modifying calcium (Ca2+) ion fluxes from cellular and extracellular sites and therefore reduces the trigger of contractile activity and visceral pain, most likely through the inhibition of L-type and T-type Ca-channels into intestinal smooth muscle cells and peripheral sensory neurons, respectively. Additionally, pharmacological effects could be exerted through the interaction with neurokinin(NK) 1 and NK2 tachykinin receptors.

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.


CAS Registry Number:
Trade names:
Spasmomen®, Spasmodox®, Bromotil®
$679 USD


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.

How to order

To order an OEL/ADE monograph for Otilonium, 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.
  • K. Rosenthal
  • Director of Manufacturing