Ethamolin (Ethanolamine Oleate) - Indications and Dosage

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.

DOSAGE AND ADMINISTRATION

Local ETHAMOLIN Injection 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 reportedly more 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.

HOW SUPPLIED

ETHAMOLIN^® (Ethanolamine Oleate) Injection, 5% is available in 2 mL ampules supplied as boxes of 10 ampules.

Storage

Store at controlled room temperature, 15°− 30°C (59°− 86°F). Protect from light.

CAUTION: Federal law prohibits dispensing without prescription.

Manufactured for QOL Medical, LLC.

QOL Medical, LLC

5400 Carillon Point
Kirkland, WA 98033

www.ethamolin.net
phone 1-866-528-4750
fax 1-866-528-4749

PL041/Rev. 05