Ethanolamine oleate

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Ethanolamine oleate is a cardiovascular agent that is FDA approved for the treatment of bleeding esophageal varices. Common adverse reactions include pleural effusion, retrosternal pain, esophageal ulcer, fever and stricture.

• ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.

• 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 theacute bleeding episode and then after oIie 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.

• ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled. There is no evidence that treatment of this population decreases the likelihood of bleeding.

• Sclerotherapy with ETHAMOLIN has no beneficial effect upon portal hypertension, the cause of esophageal varices, so that recanalization and collateralization may occur, necessitating reinjection.

• There is limited information regarding Off-Label Guideline-Supported Use of Ethanolamine oleate in adult patients.

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Ethanolamine oleate in adult patients.

• There is limited information regarding FDA-Labeled Use of Ethanolamine oleate in pediatric patients.

• There is limited information regarding Off-Label Guideline-Supported Use of Ethanolamine oleate in pediatric patients.

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Ethanolamine oleate in pediatric patients.

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

• ETHAMOLlN Injection should be used in pregnant women only when clearly needed.

• 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%), retrosterual 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. 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. Anaphylactic shock and acute renal failure with spontaneous recovery have occurred . 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

• There is limited information regarding Postmarketing Experience of Ethanolamine oleate in the drug label.

There is limited information regarding Ethanolamine oleate Drug Interactions in the drug label.

Pregnancy Category (FDA): 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.

Pregnancy Category (AUS):

• There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ethanolamine oleate in women who are pregnant.

• There is no FDA guidance on use of Ethanolamine oleate during labor and delivery.

• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ETHAMOLlN Injection is administered to a nursing woman.

• Safety and effectiveness in pediatric patients have not been established

There is no FDA guidance on the use of Ethanolamine oleate with respect to geriatric patients.

There is no FDA guidance on the use of Ethanolamine oleate with respect to specific gender populations.

There is no FDA guidance on the use of Ethanolamine oleate with respect to specific racial populations.

There is no FDA guidance on the use of Ethanolamine oleate in patients with renal impairment.

There is no FDA guidance on the use of Ethanolamine oleate in patients with hepatic impairment.

There is no FDA guidance on the use of Ethanolamine oleate in women of reproductive potentials and males.

There is no FDA guidance one the use of Ethanolamine oleate in patients who are immunocompromised.

• Intravenous

• There is limited information regarding Monitoring of Ethanolamine oleate in the drug label.

• There is limited information regarding IV Compatibility of Ethanolamine oleate in the drug label.

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

• When injected intravenously, ETHAMOLIN Injection acts primarily by irritation of the intimal endothelium of the vein and produces a sterile dose-related inflammatory response. This results in fibrosis and possible occlusion of the vein. ETHAMOLIN Injection also rapidly diffuses through the venous wall and produces a dose-related extravascular inflammatory reaction.

• The oleic acid component of ETHAMOLIN Injection is responsible for the inflammatory response, and may also activate coagulation in vivo by release of tissue factor and activation of Hageman factor. The ethanolamine component, however, may inhibit fibrin clot formation by chelating calcium, so that a procoagulant action of ETHAMOLIN has not been demonstrated.

• After injection, ETHAMOLIN disappears from the injection site within five minutes via the portal vein. When volumes larger than 20 mL are injected, some ETHAMOLIN also flows into the azygos vein through the periesophageal vein. In human autopsy studies it was found that within four days after injection there is neutrophil infiltration of the esophageal wall and hemorrhage within six days. Granulation tissue is first seen at ten days, red thrombi obliterating the varices by twenty days, and sclerosis of the varices by two and a half months. The time course of these findings suggests that sclerosis of esophageal varices will be a delayed rather than an immediate effect of the drug.

• The minimum lethal dose of ETHAMOLIN Injection administered intravenously to rabbits is 130 mg/kg.

• ETHAMOLIN® (Ethanolamine Oleate) Injection is a mild sclerosing agent. Chemically it is C17H33COOH•NH2CH2CH2OH. It has the following structure:

• The empirical formula is C20H41NO3, representing a molecular weight of 343.55.

• ETHAMOLIN Injection consists of ethanolamine, a basic substance, which when combined with oleic acid, forms a clear pale-yellow to straw-colored, deliquescent oleate. The pH ranges from 8.0 to 9.0.

• ETHAMOLIN Injection is a sterile, apyrogenic, aqueous solution containing in each mL approximately 50 mg of ethanolamine oleate with benzyl alcohol 2% by volume as preservative.

• There is limited information regarding Pharmacodynamics of Ethanolamine oleate in the drug label.

There is limited information regarding Pharmacokinetics of Ethanolamine oleate in the drug label.

There is limited information regarding Nonclinical Toxicology of Ethanolamine oleate in the drug label.

There is limited information regarding Clinical Studies of Ethanolamine oleate in the drug label.

• Store at controlled room temperature, 15°- 30°C (59°- 86°F). Protect from light.

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• There is limited information regarding Patient Counseling Information of Ethanolamine oleate in the drug label.

• Alcohol-Ethanolamine oleate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

• ETHAMOLIN®^[1]

There is limited information regarding Ethanolamine oleate Look-Alike Drug Names in the drug label.

The contents of this FDA label are provided by the National Library of Medicine.