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ETHAMOLIN (ethanolamine oleate) Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.
ETHAMOLIN (ethanolamine oleate) 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 (ethanolamine oleate) has no beneficial effect upon portal hypertension, the cause of esophageal varices, so that recanalization and collateralization may occur, necessitating reinjection.
DOSAGE AND ADMINISTRATION
Local ETHAMOLIN (ethanolamine oleate) I njection sclerotherapy of esophageal varices should be performed by physicians who are familiar with an acceptable technique. The usual intravenous dose is 1.5 to 5.0 mL per varix. The maximum dose per treatment session should not exceed 20 mL. Patients with significant liver dysfunction (Child Class C) or concomitant cardiopulmonary disease should usually receive less than the recommended maximum dose. Submucosal injections are not recommended as they are reportedlymore likely to result in ulceration at the site of injection.
To obliterate the varix, injections may be made at the time of the acute bleeding episode and then after one week, six weeks, three months, and six months as indicated.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
ETHAMOLIN® (Ethanolamine Oleate) Injection, 5% is available in 2 mL ampules supplied as boxes of 10 ampules.
Store at controlled room temperature, 15°- 30°C (59°- 86°F). Protect from light.
Manufactured for QOL Medical, LLC. Kirkland, WA. FDA rev date: 9/20/2002
Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Ethamolin Information
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