Ethanolamine oleate is an intravenous sclerosing agent. It is indicated to prevent rebleeding in varices that have bled. Ethanolamine has not been shown to be effective for prophylaxis. Ethanolamine causes irritation of the intimal endothelium of the vein and produces an inflammatory response. This drug was approved by the FDA in 1988.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
Intravenous Administration
-Local ethanolamine injection sclerotherapy of esophageal varices should only be administered by healthcare providers who are familiar with an acceptable technique of administering sclerosing agents.
-NOTE: Submucosal injections are not recommended due to ulceration at the injection site.
Spinal cord paralysis due to anterior spinal artery occlusion was reported in one child eight hours after ethanolamine sclerotherapy.
Local esophageal adverse reactions can occur and appear to be dependent upon dose of ethanolamine used and the clinical condition of the patient. Esophageal ulceration (2.1%) and esophageal stricture (1.3%) are among the most common complications reported during ethanolamine therapy. The direct injection of sclerosing agents, such as ethanolamine, may result in severe injection tissue necrosis especially if excessive volumes. One fatal case of extensive esophageal necrosis has been reported. Complications of ulceration, delayed esophageal perforation, and necrosis appear to occur more frequently when ethanolamine is injected submucosally; this route of administration is not recommended. Other local esophageal reactions reported at rates of 0.1-0.4% include esophagitis, tearing of the esophagus, sloughing of the mucosa overlying the injected varix, tissue necrosis, periesophageal abscess, and esophageal perforation. Ethanolamine should be administered by healthcare providers trained with the proper administration of sclerosing agents.
Some of the most common adverse reactions associated with ethanolamine therapy include pleural effusion and pleural infiltration (2.1%), fever or pyrexia (1.8%), retrosternal pain (1.6%), and pneumonia (1.2%). Pneumonitis, infection, and pulmonary edema also have been reported. Bacteremia, pyrexia, and retrosternal pain may occur post-injection. Fatal aspiration pneumonia has occurred in elderly patients. Aspiration appears to be procedure-related rather than drug-related, but aspiration of blood and/or stomach contents can occur in patients with bleeding esophageal varices. Special precautions should be taken when ethanolamine is administered to the elderly, those with cardiopulmonary disease, and the critically ill.
Acute renal failure (unspecified) with spontaneous recovery was reported in two women following injection of 15-20 mL of ethanolamine.
One case of disseminated intravascular coagulation (DIC) has been reported with ethanolamine therapy.
One fatal case of anaphylactic shock has been reported following a larger than normal dose of ethanolamine injection into a male patient with known allergies. Three additional cases of anaphylaxis have also been reported with ethanolamine. Although rare, healthcare providers should be prepared for allergic and anaphylactoid reactions and have immediate access to appropriate medications (e.g., epinephrine and antihistamines) and equipment.
Ethanolamine injection should not be administered to patients with a known hypersensitivity to ethanolamine, oleic acid, or ethanolamine oleate.
Severe injection necrosis may result from direct injection of ethanolamine, especially if excessive volumes are used and if administered submucosally. Administration requires an experienced clinician familiar with the proper technique of administering sclerosing agents.
Use caution when administering ethanolamine to patients with significant hepatic disease. Esophageal ulceration is more likely to occur in patients in Child-Pugh Class C than in those in Classes A and B. Furthermore, necrosis, delayed esophageal perforation, and necrosis are more likely to occur when ethanolamine is administered submucosally; this route is not recommended.
Use caution when administering ethanolamine to patients with concomitant cardiac disease and/or respiratory insufficiency. Pneumonitis, pleural effusion, pulmonary edema, and pulmonary infiltration have been reported with the use of ethanolamine. The manufacturer recommends to use the lowest dose possible and carefully monitor these patients for signs of respiratory illness.
Fatal aspiration pneumonia has been reported in geriatric patients being treated for esophageal varices with ethanolamine sclerotherapy. Use special precautions to prevent aspiration in geriatric patients and in critically ill patients undergoing sclerotherapy with ethanolamine.
Ethanolamine is classified as FDA pregnancy risk category C and should be administered to a pregnant woman only if clearly needed. Animal reproductive studies have not been conducted. It is not known whether ethanolamine can cause fetal harm or adversely affect reproduction capacity.
According to the manufacturer, it is not known whether ethanolamine is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
The safety and efficacy of ethanolamine in neonates, infants, children, and adolescents have not been established.
For the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding:
NOTE: Ethanolamine is not indicated for the treatment of esophageal varices that have not bled, as supportive data that ethanolamine will decrease the likelihood of bleeding in this population are lacking. Sclerotherapy with ethanolamine has no effect on portal hypertension, the cause of esophageal varices. Recanalization and collateralization may occur, requiring further treatment.
Intravenous dosage:
Adults: 1.5-5 mL IV per varix. To obliterate the varix, injections may be made at the time of the acute bleeding episode and then after 1 week, 6 weeks, 3 months, and 6 months, if needed. Maximum dose per treatment should not exceed 0.4 mL/kg or 20 mL. Patients with concomitant cardiopulmonary disease should receive less than the recommended maximum dose.
Neonates, Infants, Children, and Adolescents: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
0.4 mL/kg IV OR up to 20 mL IV per varices treatment session.
-Geriatric
0.4 mL/kg IV OR up to 20 mL IV per varices treatment session.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; however, patients with significant hepatic dysfunction (Child-Pugh Class C) are more likely to develop esophageal ulceration. Doses less than the maximum (20 mL) per treatment session are recommended.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Ethanolamine products.
Ethanolamine oleate acts primarily by irritating the intimal endothelium of the vein and producing a dose-related inflammatory response. This results in fibrosis and possible occlusion of the vein. Ethanolamine oleate also rapidly diffuses through the venous wall and produces a dose-related extravascular inflammatory reaction. The oleic acid component of the injection produces the inflammatory response and may activate coagulation by release of tissue factor and activation of Hageman factor. The ethanolamine component of the injection may inhibit fibrin clot formation. A coagulant effect of ethanolamine has not been demonstrated.
Sclerotherapy with ethanolamine has no effect on portal hypertension, the cause of esophageal varices. Recanalization and collateralization may occur, requiring further treatment.
Ethanolamine oleate injection is administered intravenously. Within 5 minutes of injection, ethanolamine is eliminated from the injection site via the portal vein. If volumes in excess of 20 ml are utilized, some of the ethanolamine dose may flow into the azygos vein through the periesophageal vein.
Granulation is seen at 10 days, red thrombi obliterating the varices by 20 days, and sclerosis of the varices by 75 days, suggesting that sclerosis of the esophageal varices is a delayed rather than an immediate effect of ethanolamine.