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Ethanolamine oleate: Drug information

Ethanolamine oleate: Drug information
(For additional information see "Ethanolamine oleate: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ethamolin
Pharmacologic Category
  • Sclerosing Agent
Dosing: Adult
Esophageal varices

Esophageal varices: IV: 1.5 to 5 mL per varix (maximum: 20 mL per treatment session). Treatments may be made at the time of the acute bleed and then repeated after 1 week, 6 weeks, 3 months, and 6 months as indicated. Note: Patients with cardiopulmonary disease should usually receive less than the maximum recommended dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; patients with Child-Pugh class C hepatic impairment should usually receive less than the recommended maximum dosage.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Substernal pain (2%)

Gastrointestinal: Esophageal stenosis (1%), esophageal ulcer (2%)

Respiratory: Pleural effusion (≤2%, including infiltration), pneumonia (1%)

Miscellaneous: Fever (2%)

<1%: Gastrointestinal: Disease of esophagus (including esophageal perforation, esophagitis, local tissue necrosis, periesophageal abscess, and tissue sloughing)

Postmarketing:

Gastrointestinal: Biliary tract disease (biliary stricture) (Luman 1994)

Hematologic & oncologic: Disseminated intravascular coagulation, hematoma (esophageal) (Bak 1988)

Hypersensitivity: Anaphylaxis

Renal: Acute kidney injury

Respiratory: Pulmonary edema (Lee 1994)

Contraindications

Hypersensitivity to ethanolamine, oleic acid, ethanolamine oleate, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Fatal anaphylactic shock following an injection of a larger than normal volume has been reported following administration.

• Injection necrosis: Severe injection necrosis may result from direct injection of sclerosing agents, especially if excessive volumes are used; fatal case of extensive esophageal necrosis and death has been reported.

• Renal effects: Acute renal failure with spontaneous recovery has been reported.

Disease-related concerns:

• Cardiorespiratory disease: Use with caution in patients with concomitant cardiorespiratory disease; minimize total dose per treatment session and monitor carefully.

• Hepatic impairment: Use with caution in patients with Child-Pugh class C hepatic impairment, as they are more likely to develop esophageal ulceration; less than the maximum dose is recommended.

Special populations:

• Critically ill patients: Use with caution in critically ill patients due to increased risk of aspiration pneumonia.

• Older adult: Use with caution in the elderly due to increased risk of aspiration pneumonia (has been fatal).

Other warnings/precautions:

• Appropriate use: Not indicated for the treatment of esophageal varices that have not bled or for varicosities of the leg; submucosal injection is not recommended due to ulceration, necrosis, and delayed esophageal perforation complications.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Ethamolin: 5% (2 mL) [contains benzyl alcohol]

Generic Equivalent Available: US

No

Pricing: US

Solution (Ethamolin Intravenous)

5% (per mL): $288.24

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Use acceptable injection technique to avoid necrosis (may result from direct injection of sclerosing agents), especially if excessive volumes are use. Avoid submucosal injections (risk of ulceration and necrosis).

Use: Labeled Indications

Esophageal varices: Treatment of esophageal varices that have recently bled, to prevent rebleeding.

Medication Safety Issues
Sound-alike/look-alike issues:

Ethamolin may be confused with ethanol

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if ethanolamine oleate is excreted in breast milk. The manufacturer recommends that caution be exercised when administering ethanolamine oleate to nursing women.

Mechanism of Action

Ethanolamine oleate produces a sterile dose-related inflammatory response resulting in fibrosis and possible occlusion of the vein; a dose-related extravascular inflammatory reaction occurs when the drug diffuses through the venous wall.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Ethamolin;
  • (BR) Brazil: Ethamolin;
  • (CO) Colombia: Antivar;
  • (EC) Ecuador: Ethamolin;
  • (GB) United Kingdom: Ethanolam olea | Ethanolamine;
  • (JO) Jordan: Ethanolamine Oleat;
  • (JP) Japan: Oldamin;
  • (KR) Korea, Republic of: Ethanolamine | Ethanolamine Far;
  • (PR) Puerto Rico: Ethamolin;
  • (VE) Venezuela, Bolivarian Republic of: Ethamolin
  1. Bak YT, Yu ZM, Cho JY, Kim JH, Kim JG, Lee CH. Intramural hematoma of the esophagus: unusual complication of esophageal variceal sclerotherapy. Korean J Intern Med. 1988;3(1):92-94. doi:10.3904/kjim.1988.3.1.92 [PubMed 3153802]
  2. Ethamolin (ethanolamine) [prescribing information]. Vero Beach, FL: QOL Medical; August 2012.
  3. Lee JY, Moon SH, Lee SM, et al. A case of noncardiogenic pulmonary edema by ethanolamine oleate. Korean J Intern Med. 1994;9(2):125-127. doi:10.3904/kjim.1994.9.2.125 [PubMed 7865488]
  4. Luman W, Hudson N, Choudari CP, Eastwood MA, Palmer KR. Distal biliary stricture as a complication of sclerosant injection for bleeding duodenal ulcer. Gut. 1994;35(11):1665-1667. doi:10.1136/gut.35.11.1665 [PubMed 7828994]
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