Ethanolamine Oleate

Mechanism-of-action class: Sclerosing Activity.

• 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.

• ETHAMOLIN Injection should not be administered to subjects with a known hypersensitivity to ethanolamine, oleic acid, or ethanolamine oleate.contraindicated

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 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.

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.

The reported frequency of complications/adverse events per injection session was 13%. The most common complications were pleural effusion/infiltration (2.1%), esophageal ulcer (2.1 %), pyrexia (1.8%), retrosternal pain (1.6%), esophageal stricture (1.3%), and pneumonia (1.2%). Other adverse local esophageal reactions have also been reported at rates of 0.1 to 0.4%, including esophagitis, tearing of the esophagus, sloughing of the mucosa overlying the injected varix, ulceration, stricture, necrosis, periesophageal abscess and perforation (see PRECAUTIONS). These complications appear to be dependent upon the dose and the patient's clinical state. Bacteremia has been observed in patients following injection of esophageal varices with ETHAMOLlN. Pyrexia and retrosternal pain are not infrequently observed during the post-injection period. Fatal aspiration pneumonia has occurred in patients with esophageal varices who underwent ETHAMOLIN Injection Sclerotherapy (see PRECAUTIONS). Anaphylactic shock and acute renal failure with spontaneous recovery have occurred (see PRECAUTIONS). A case of disseminated intravascular coagulation has been reported. Spinal cord paralysis due to occlusion of the anterior spinal artery has been reported in one child eight hours after ETHAMOLIN sclerotherapy.

Pregnancy: (Teratogenic Effects: Pregnancy Category C) Animal reproduction studies have not been conducted with ETHAMOLlN Injection. It is also not known whether ETHAMOLIN Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ETHAMOLIN Injection should be given to a pregnant woman only if clearly needed.

Overdosage of ETHAMOLIN Injection can result in severe intramural necrosis of the esophagus. Complications resulting from such overdosage have resulted in death.

• Dec 22, 1988NDANDA019357Qol Medcl

1. 1Oesophageal Varices Haemorrhage528%
2. 2Portal Vein Thrombosis317%
3. 3Product Use In Unapproved Indication317%
4. 4Off Label Use211%
5. 5Abdominal Pain15.6%
6. 6Abdominal Pain Upper15.6%
7. 7Anaemia15.6%
8. 8Arterial Haemorrhage15.6%
9. 9Ascites15.6%
10. 10Cataract15.6%
11. 11Disseminated Intravascular Coagulation15.6%
12. 12Dry Eye15.6%
13. 13Essential Thrombocythaemia15.6%
14. 14Gastrointestinal Ischaemia15.6%
15. 15Haemorrhagic Ascites15.6%

Recent PubMed references pinned to Ethanolamine Oleate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Dietary oleic acid contributes to the regulation of food intake through the synthesis of intestinal oleoylethanolamide.
  Frontiers in endocrinology · 2022 · Igarashi M, Iwasa K, Hayakawa T, et al.
  PMID 36733808DOI 10.3389/fendo.2022.1056116
• Update on Anti-Inflammatory Molecular Mechanisms Induced by Oleic Acid.
  Nutrients · 2023 · Santa-María C, López-Enríquez S, Montserrat-de la Paz S, et al.
  PMID 36615882DOI 10.3390/nu15010224
• Intestinal GPR119 activation by microbiota-derived metabolites impacts feeding behavior and energy metabolism.
  Molecular metabolism · 2023 · Igarashi M, Hayakawa T, Tanabe H, et al.
  PMID 36462626DOI 10.1016/j.molmet.2022.101649
• Combination of Oleic Acid and the gp41 Fusion Peptide Switches the Phosphatidylethanolamine-Induced Membrane Fusion Mechanism from a Nonclassical to a Classical Stalk Model.
  The journal of physical chemistry. B · 2022 · Joardar A, Pattnaik GP, Chakraborty H, et al.
  PMID 35580344DOI 10.1021/acs.jpcb.2c00307
• Transdermal permeation of bacteriophage particles by choline oleate: potential for treatment of soft-tissue infections.
  Future microbiology · 2020 · Campos WF, Silva EC, Oliveira TJ, et al.
  PMID 32716215DOI 10.2217/fmb-2019-0290
• Treatment of Non-Alcoholic Steatosis: Preclinical Study of a New Nutraceutical Multitarget Formulation.
  Nutrients · 2020 · Micheli L, Pacini A, Di Cesare Mannelli L, et al.
  PMID 32570937DOI 10.3390/nu12061819
• Oleic acid stimulates monoamine efflux through PPAR-α: Differential effects in diet-induced obesity.
  Life sciences · 2020 · Jagannathan L, Socks E, Balasubramanian P, et al.
  PMID 32479954DOI 10.1016/j.lfs.2020.117867
• Oleic Acid Prevents Isoprenaline-Induced Cardiac Injury: Effects on Cellular Oxidative Stress, Inflammation and Histopathological Alterations.
  Cardiovascular toxicology · 2020 · Singh PK, Gari M, Choudhury S, et al.
  PMID 31154622DOI 10.1007/s12012-019-09531-y

The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Ethanolamine Oleate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma
  Completed · Interventional · 20 enrolled · Alexandria University
  NCT05099081updated 2021-10-29
• Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection
  Unknown · Phase 3 · Interventional · 113 enrolled · Sherief Abd-Elsalam
  NCT03388125updated 2018-04-24
• Scleroligation for Eradication of Gastroesophageal Varices.
  Unknown · Phase 3 · Interventional · 90 enrolled · Sherief Abd-Elsalam
  NCT02646202updated 2017-12-27
• Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
  Completed · Interventional · 54 enrolled · Universidade Estadual de Ciências da Saúde de Alagoas
  NCT01931826updated 2013-08-29
• Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies
  Withdrawn · Phase 1 · Phase 2 · Interventional · 0 enrolled · M.D. Anderson Cancer Center
  NCT01101412updated 2013-02-15
• Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate
  Unknown · Interventional · 20 enrolled · University of Sao Paulo
  NCT00804037updated 2008-12-08
• A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
  Completed · Phase 4 · Interventional · 38 enrolled · Federal University of São Paulo
  NCT00799851updated 2008-12-01

Frequently asked questions

How does Ethanolamine Oleate work?

Mechanism-of-action class: Sclerosing Activity.

What is Ethanolamine Oleate used for?

According to FDA labeling, Ethanolamine Oleate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ethanolamine Oleate?

Ethanolamine Oleate is classified as Sclerosing agents for local injection, Sclerosing Activity, Vascular Sclerosing Activity.

What are the brand names for Ethanolamine Oleate?

Ethanolamine Oleate is marketed under brand names including Ethamolin.

What are the contraindications for Ethanolamine Oleate?

Ethanolamine Oleate labeling lists contraindications including: ETHAMOLIN Injection should not be administered to subjects with a known hypersensitivity to ethanolamine, oleic acid, or ethanolamine oleate.. Always consult the full prescribing information and a clinician.