ETHAMOLIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ETHAMOLIN (ETHAMOLIN).

How it works

Ethamolin (ethanolamine oleate) is a sclerosing agent that causes irritation of the vascular endothelium, leading to thrombosis, inflammation, and fibrosis of the vein wall, resulting in obliteration of varicose veins or esophageal varices.

What the body does with it

Metabolism	Ethanolamine oleate is metabolized in the liver via oxidation and conjugation; exact enzymes are not well characterized.
Excretion	Primarily renal excretion of unchanged drug and metabolites; >90% eliminated in urine within 24 hours, with less than 5% in feces.
Half-life	Terminal elimination half-life is approximately 5-6 hours in adults with normal renal function; may be prolonged in renal impairment.
Protein binding	Approximately 20-30% bound to plasma proteins, primarily albumin.
Volume of Distribution	Volume of distribution is approximately 0.5-0.8 L/kg, indicating distribution into extracellular fluid.
Bioavailability	Intravenous: 100%; intramuscular: approximately 90-95% due to first-pass metabolism.
Onset of Action	Intravenous administration: onset within 5-10 minutes; intramuscular: 15-30 minutes.
Duration of Action	Duration of action is 2-4 hours, corresponding to the distribution and elimination phases; clinical effect wanes as plasma concentration falls below therapeutic threshold.

Classification & Brands

Dosing & administration

5% solution intravenously, 0.1-0.3 mL per injection site, maximum 5 mL per site, repeated at 5-7 day intervals if needed.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for renal impairment.
Liver impairment	Contraindicated in severe hepatic disease (Child-Pugh class C). Use with caution in Child-Pugh class A or B; no specific dose modification established.
Pediatric use	Not recommended for use in children due to lack of safety and efficacy data.
Geriatric use	Use with caution; consider reduced dose due to increased risk of sclerotherapy complications. No specific dose adjustments established.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for ETHAMOLIN (ETHAMOLIN).

Breastfeeding	It is not known whether ethanolamine oleate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. M/P ratio: Not available.
Teratogenic Risk	Pregnancy Category D. Positive evidence of human fetal risk: Ethamolin (ethanolamine oleate) is contraindicated in pregnant women due to known teratogenicity in animal studies and potential for fetal harm. No adequate, well-controlled studies in pregnant women.

Warnings & precautions

■ FDA Black Box Warning

None explicitly required by FDA; however, severe adverse effects including anaphylaxis, renal failure, and esophageal ulceration have been reported.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to ethanolamine oleate or any component.","Active gastrointestinal bleeding (for elective sclerotherapy).","Severe hepatic impairment or portal hypertension with high risk of perforation.","Uncontrolled systemic infection."]

Clinical Precautions

Precautions	["Risk of anaphylaxis and hypersensitivity reactions; have emergency equipment available.","Risk of esophageal ulceration, stricture, or perforation when used for varices.","May cause hemolysis and hemoglobinuria; monitor renal function.","Use caution in patients with cardiopulmonary disease, as rapid injection may cause bradycardia or hypotension."]
Food/Dietary	No specific food interactions. Avoid oral intake immediately after procedure until gag reflex returns.

Clinical Tips & Counseling

Drug interactions

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ETHAMOLIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ETHAMOLIN (ETHAMOLIN).

How it works

What the body does with it

Metabolism	Ethanolamine oleate is metabolized in the liver via oxidation and conjugation; exact enzymes are not well characterized.
Excretion	Primarily renal excretion of unchanged drug and metabolites; >90% eliminated in urine within 24 hours, with less than 5% in feces.
Half-life	Terminal elimination half-life is approximately 5-6 hours in adults with normal renal function; may be prolonged in renal impairment.
Protein binding	Approximately 20-30% bound to plasma proteins, primarily albumin.
Volume of Distribution	Volume of distribution is approximately 0.5-0.8 L/kg, indicating distribution into extracellular fluid.
Bioavailability	Intravenous: 100%; intramuscular: approximately 90-95% due to first-pass metabolism.
Onset of Action	Intravenous administration: onset within 5-10 minutes; intramuscular: 15-30 minutes.
Duration of Action	Duration of action is 2-4 hours, corresponding to the distribution and elimination phases; clinical effect wanes as plasma concentration falls below therapeutic threshold.

Classification & Brands

Dosing & administration

5% solution intravenously, 0.1-0.3 mL per injection site, maximum 5 mL per site, repeated at 5-7 day intervals if needed.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for renal impairment.
Liver impairment	Contraindicated in severe hepatic disease (Child-Pugh class C). Use with caution in Child-Pugh class A or B; no specific dose modification established.
Pediatric use	Not recommended for use in children due to lack of safety and efficacy data.
Geriatric use	Use with caution; consider reduced dose due to increased risk of sclerotherapy complications. No specific dose adjustments established.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for ETHAMOLIN (ETHAMOLIN).

Breastfeeding	It is not known whether ethanolamine oleate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. M/P ratio: Not available.
Teratogenic Risk	Pregnancy Category D. Positive evidence of human fetal risk: Ethamolin (ethanolamine oleate) is contraindicated in pregnant women due to known teratogenicity in animal studies and potential for fetal harm. No adequate, well-controlled studies in pregnant women.

Warnings & precautions

■ FDA Black Box Warning

None explicitly required by FDA; however, severe adverse effects including anaphylaxis, renal failure, and esophageal ulceration have been reported.

Side Effect Profile

Serious Effects

Absolute Contraindications

Clinical Precautions

Precautions	["Risk of anaphylaxis and hypersensitivity reactions; have emergency equipment available.","Risk of esophageal ulceration, stricture, or perforation when used for varices.","May cause hemolysis and hemoglobinuria; monitor renal function.","Use caution in patients with cardiopulmonary disease, as rapid injection may cause bradycardia or hypotension."]
Food/Dietary	No specific food interactions. Avoid oral intake immediately after procedure until gag reflex returns.

Clinical Tips & Counseling

Drug interactions

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Clinical Pearls	Ethamolin (ethanolamine oleate) is a sclerosing agent used for esophageal varices. Administer via intravariceal injection; maximum dose per session is 20 mL. Monitor for anaphylaxis, chest pain, and esophageal ulceration. Do not use in patients with known hypersensitivity to ethanolamine or oleic acid.
Patient Advice	This medication is injected into the veins in your esophagus to stop bleeding. · You may experience chest pain or difficulty swallowing after the procedure. · Avoid eating or drinking until the numbing medicine wears off to prevent choking. · Report any signs of allergic reaction, such as hives, difficulty breathing, or swelling. · Follow up with your doctor for repeat procedures as needed.