Dosing and uses of Ethamolin (ethanolamine oleate)
Adult dosage forms and strengths
injectable solution
- 50mg/mL
Bleeding Esophageal Varices
20 mL maximum per session
Injections may be made at time of bleeding, then after 1 week, 6 week, 3 month and 6 month
Hepatic Impairment
Hepatic impairment (Child-Pugh Class C)/Concomitant cardiopulmonary disease: Reduce dose
Pediatric dosage forms and strengths
Esophageal Varices (Orphan)
Orphan designation for prophylactic use in pediatric patients (aged 0 through 16 yr) with esophageal varices that are at risk of bleeding to obliterate varices and to prevent bleeding
Orphan sponsor
- QOL Medical, LLC; 4445 North Highway A1A, 241; Vero Beach, FL 32963
Ethamolin (ethanolamine oleate) adverse (side) effects
1-10%
Esophageal ulcer (2.1%)
Pleural effusion (2.1%)
Pyrexia (1.8%)
Retrosternal pain (1.6%)
Esophageal stricture (1.3%)
Pneumonia (1.2%)
Frequency not defined
Fever
Esophagitis
Sloughing of the mucosa overlying the injected varix
Anaphylactic shock
Acute renal failure (reversible)
Warnings
Contraindications
Hypersensitivity to ethanolamine oleate, oleic acid or ethanolamine
Not indicated for esophageal varices that have not bled
Cautions
Risk of severe esophageal necrosis (potentially fatal)
Risk of severe aspiration pneumonia (potentially fatal especially in elderly)
Caution in hepatic impairment, cardiopulmonary disease, the elderly and critically ill patients
Submucosal injections not recommended
Extreme anaphylactic reaction may be treated with 0.25 mL of 1:1000 epinephrine IV & side effects controlled by antihistamines; fatal anaphylactic shock reported
Do not use if solution has particulate matter or discoloration
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ethamolin (ethanolamine oleate)
Mechanism of action
Sclerosing agent, produces a sterile inflammatory response leading to fibrosis and vein occlusion
Oleic acid is the inflammatory component
