Ethanolamine oleate

Ethanolamine oleate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

Dosage

• 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

• 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.

Adverse Reactions

Clinical Trials Experience

• 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 (see PRECAUTIONS). 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

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Ethanolamine oleate with respect to nursing mothers.

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Ethanolamine oleate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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