Ethanolamine Oleate 5% Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 5%

Reference Brands: -

Category: Gastrointestinal Drugs

Ethanolamine oleate 5% injection, a sclerosant given by endoscopic injection to reduce rebleeding from oesophageal varices. For hospital pharmacies, endoscopy units, tender buyers and licensed importers.

Product Description:

Ethanolamine oleate is a sclerosant, a soap-like salt of oleic acid that irritates the inner lining of a vein, triggers inflammation and clotting, and leaves the vessel scarred and closed. The 5% injection, 50 mg per mL, is given directly into or beside a vein, most often through an endoscope into oesophageal varices. It is a hospital product for endoscopy units and theatres, supplied in single-use ampoules or vials. Older references also describe its use in sclerotherapy of leg varicose veins.

In current labelling it is used for oesophageal varices that have recently bled, to reduce the chance of further bleeding; it is not for varices that have never bled. Endoscopic band ligation is now generally preferred, so sclerotherapy is a second option where banding is not possible. The dose per session is limited and spread over several varices. Complications include chest pain, fever, oesophageal ulceration and stricture, pleural effusion, aspiration pneumonia and, rarely, anaphylaxis. Treatment of the underlying portal hypertension continues alongside it.

Sourcing notes. This is a sterile injection, so ask for sterility and bacterial endotoxin results on each batch CoA, together with assay, pH and appearance. Store it as labelled; it is not a cold-chain product. Confirm the fill volume and whether ampoules or vials are supplied. Request the GMP certificate covering sterile manufacture, a CoPP and a CTD or ACTD dossier with zone IVb stability data. Registrations are few, and some markets supply it through an unregistered-medicines import licence for a named hospital. State concentration, volume, container type and quantity.