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.
There are no dosage adjustments provided in the manufacturer's labeling.
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.
Refer to adult dosing.
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)
Hypersensitivity to ethanolamine, oleic acid, ethanolamine oleate, or any component of the formulation.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Ethamolin: 5% (2 mL) [contains benzyl alcohol]
No
Solution (Ethamolin Intravenous)
5% (per mL): $288.24
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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).
Esophageal varices: Treatment of esophageal varices that have recently bled, to prevent rebleeding.
Ethamolin may be confused with ethanol
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted.
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.
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.
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