FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
ETHAMOLIN® (Ethanolamine Oleate) Injection is a mild sclerosing agent. Chemically it is C17H33COOH•NH2CH2CH2OH. It has the following structure:
The empirical formula is C20H41NO3, representing a molecular weight of 343.55.
ETHAMOLIN Injection consists of ethanolamine, a basic substance, which when combined with oleic acid, forms a clear pale-yellow to straw-colored, deliquescent oleate. The pH ranges from 8.0 to 9.0.
ETHAMOLIN Injection is a sterile, apyrogenic, aqueous solution containing in each mL approximately 50 mg of ethanolamine oleate with benzyl alcohol 2% by volume as preservative.
Sources
Ethamolin Manufacturers
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Qol Medical, Llc.
Ethamolin | Qol Medical, Llc.
Local ETHAMOLIN Injection sclerotherapy of esophageal varices should be performed by physicians who are famillar 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 reportedly are more likely to result in ulceration at the site of injection.
To obliterate the varix, injections may be made at the time of theacute bleeding episode and then after oIie 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.
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