Ethanolamine Oleate
Ethanolamine Oleate is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Ethamolin. Available dosage form: injection, solution.
Drug Details
- Generic Name
- Ethanolamine Oleate
- Brand Names
- Ethamolin
- Application Number
- NDA019357
- Sponsor
- QOL Medical, LLC.
- NDC Codes
- 1
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- ETHANOLAMINE OLEATE
Indications and Usage
INDICATIONS AND USAGE ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled. There is no evidence that treatment of this population decreases the likelihood of bleeding. Sclerotherapy with ETHAMOLIN has no beneficial effect upon portal hypertension, the cause of esophageal varices, so that recanalization and collateralization may occur, necessitating reinjection.
Warnings
WARNINGS ETHAMOLlN Injection should be used in pregnant women only when clearly needed (see PRECAUTIONS). The practice of injecting varicosities of the leg with ETHAMOLlN Injection is not supported by adequately controlled clinical trials. Therefore, such use is not recommended.