Ethanolamine Oleate (Ethamolin)
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Ethanolamine Oleate (Ethamolin)

Ethamolin®
(ethanolamine oleate) Injection, 5%

For Local Intravenous Use Only

DRUG DESCRIPTION

ETHAMOLIN® (Ethanolamine Oleate) Injection is a mild sclerosing agent. Chemically it is C17H33COOH•NH20H2CH2OH.

It has the following structure:

The empirical formula is C20H41N03, representing a molecular weight of 343.55.

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

ETHAMOLIN (ethanolamine oleate) 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.

What are the possible side effects of ethanolamine oleate (Ethamolin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • cough or hiccups (may be a sign of fluid buildup around the lungs);
  • fever, chills, cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath; or
  • severe pain or burning in your upper stomach.

Less serious side effects may include:

  • low fever; or
  • trouble...

Read All Potential Side Effects and See Pictures of Ethamolin »

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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

ETHAMOLIN (ethanolamine oleate) 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 (ethanolamine oleate) has no beneficial effect upon portal hypertension, the cause of esophageal varices, so that recanalization and collateralization may occur, necessitating reinjection.

DOSAGE AND ADMINISTRATION

Local ETHAMOLIN (ethanolamine oleate) I njection sclerotherapy of esophageal varices should be performed by physicians who are familiar 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 are reportedlymore likely to result in ulceration at the site of injection.

To obliterate the varix, injections may be made at the time of the acute bleeding episode and then after one 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.

HOW SUPPLIED

ETHAMOLIN® (Ethanolamine Oleate) Injection, 5% is available in 2 mL ampules supplied as boxes of 10 ampules.

Storage

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

Manufactured for QOL Medical, LLC. Kirkland, WA. FDA rev date: 9/20/2002

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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%), retrosternal 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 ETHAMOLIN (ethanolamine oleate) . 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 (ethanolamine oleate) Injection Sclerotherapy (see PRECAUTIONS). Anaphylactic shock and acute renal failure with spontaneous recovery have occurred (see PRECAUTIONS). 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 (ethanolamine oleate) sclerotherapy.

Read the Ethamolin (ethanolamine oleate) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

ETHAMOLIN (ethanolamine oleate) Injection should be used in pregnant women only when clearly needed (see PRECAUTIONS).

The practice of injecting varicosities of the leg with ETHAMOLIN (ethanolamine oleate) I njection is not supported by adequately controlled clinical trials. Therefore, such use is not recommended.

PRECAUTIONS

Fatal anaphylactic shock was reported following injection of a larger than normal volume of ETHAMOLIN (ethanolamine oleate) Injection into a male who had a known allergic disposition. Although there are only three known reports of anaphylaxis, the possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately. In extreme emergencies, 0.25 mL of a 1:1,000 intravenous solution of epinephrine (0.25 mg) should be used and allergic reactions should be controlled with antihistamines.

Acute renal failure with spontaneous recovery followed injection of 15 to 20 mL of ETHAMOLIN (ethanolamine oleate) Injection into two women.

The physician should bear in mind that severe injection necrosis may result from direct injection of sclerosing agents, especially if excessive volumes are used. At least one fatal case of extensive esophageal necrosis and death has been reported. The drug should be administered by physicians who are familiar with an acceptable injection technique.

Patients in Child Class C are more likely to develop esophageal ulceration than those in Classes A and B. Complications of ulceration, necrosis, and delayed esophageal perforation appear to occur more frequently when ETHAMOLIN (ethanolamine oleate) Injection is injected submucosally. This route is not recommended.

In patients with concomitant cardiorespiratory disease, careful monitoring and minimization of the total dose per session is recommended.

Fatal aspiration pneumonia has occurred in elderly patients undergoing esophageal variceal sclerotherapy with ETHAMOLIN (ethanolamine oleate) Injection. This adverse event appears to be procedure-related rather than drug-related, but as aspiration of blood and/or stomach contents is not uncommon in patients with bleeding esophageal varices, special precautions should be taken to prevent its occurrence, especially in the elderly and critically ill subjects.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with ETHAMOLIN (ethanolamine oleate) Injection. It is also not known whether ETHAMOLIN (ethanolamine oleate) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ETHAMOLIN (ethanolamine oleate) Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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 ETHAMOLIN (ethanolamine oleate) Injection is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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

CONTRAINDICATIONS

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

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

When injected intravenously, ETHAMOLIN (ethanolamine oleate) 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 (ethanolamine oleate) Injection also rapidly diffuses through the venous wall and produces a dose-related extravascular inflammatory reaction.

The oleic acid component of the ETHAMOLIN (ethanolamine oleate) 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 (ethanolamine oleate) has not been demonstrated.

After injection, ETHAMOLIN (ethanolamine oleate) disappears from the injection site within five minutes via the portal vein. When volumes larger than 20 mL are injected, some ETHAMOLIN (ethanolamine oleate) 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 (ethanolamine oleate) Injection administered intravenously to rabbits is 130 mg/kg.

In dogs, ETHAMOLIN (ethanolamine oleate) injected into the right atrium at a dose of 1 mL/kg over one minute has been shown to increase extravascular lung water. The maximum recommended human dose is 20 mL, or 0.4 mL/kg for a 50-kg person. The

concentration of ETHAMOLIN (ethanolamine oleate) reaching the lung in human treatment will be less than in the dog studies, but pleural effusions, pulmonary edema, pulmonary infiltration and pneumonitis have been reported in clinical trials, and minimizing the total per session dose, especially in patients with concomitant cardiopulmonary disease, is recommended (see PRECAUTIONS).

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Ethamolin®
(ethanolamine oleate) Injection, 5%

For Local Intravenous Use Only

DRUG DESCRIPTION

ETHAMOLIN® (Ethanolamine Oleate) Injection is a mild sclerosing agent. Chemically it is C17H33COOH•NH20H2CH2OH.

It has the following structure:

The empirical formula is C20H41N03, representing a molecular weight of 343.55.

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

ETHAMOLIN (ethanolamine oleate) 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.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Ethamolin®
(ethanolamine oleate) Injection, 5%

For Local Intravenous Use Only

DRUG DESCRIPTION

ETHAMOLIN® (Ethanolamine Oleate) Injection is a mild sclerosing agent. Chemically it is C17H33COOH•NH20H2CH2OH.

It has the following structure:

The empirical formula is C20H41N03, representing a molecular weight of 343.55.

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

ETHAMOLIN (ethanolamine oleate) 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.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Ethamolin®
(ethanolamine oleate) Injection, 5%

For Local Intravenous Use Only

DRUG DESCRIPTION

ETHAMOLIN® (Ethanolamine Oleate) Injection is a mild sclerosing agent. Chemically it is C17H33COOH•NH20H2CH2OH.

It has the following structure:

The empirical formula is C20H41N03, representing a molecular weight of 343.55.

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

ETHAMOLIN (ethanolamine oleate) 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.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Ethamolin Patient Information Including Side Effects

Brand Names: Ethamolin

Generic Name: ethanolamine oleate (Pronunciation: ETH a NOLE a meen)

What is ethanolamine oleate (Ethamolin)?

Ethanolamine oleate is a sclerosing (skler-OS-ing) agent. It works by creating scar tissue inside a swollen or dilated (wider than normal) vein to prevent bleeding.

Ethanolamine oleate is used to treat esophageal varices. This is a life-threatening condition that causes dilated blood vessels inside the tissues lining the esophagus or upper part of the stomach. The result is severe bleeding from the esophagus into the throat or intestines. Esophageal varices is caused by liver disease.

Ethanolamine oleate is only for treating esophageal varices that have recently bled.

Ethanolamine oleate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ethanolamine oleate (Ethamolin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • cough or hiccups (may be a sign of fluid buildup around the lungs);
  • fever, chills, cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath; or
  • severe pain or burning in your upper stomach.

Less serious side effects may include:

  • low fever; or
  • trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ethamolin (ethanolamine oleate) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ethanolamine oleate (Ethamolin)?

You should not use this medication if you are allergic to ethanolamine oleate or oleic acid (oleo).

Ethanolamine oleate will not treat any underlying liver disease.

Before receiving this medication, tell your doctor if you have kidney disease, or heart disease, or lung disease. If you have any of these conditions, you may need dose adjustments or special tests during treatment.

In an emergency situation, it may not be possible before you are treated with ethanolamine oleate to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for your pregnancy or your baby knows that you have received this medication.

Serious side effects of ethanolamine oleate include severe pain or burning in your upper stomach, stabbing chest pain, feeling short of breath, fever, chills, cough with yellow or green mucus, or cough or hiccups (may be a sign of fluid buildup around the lungs).

Side Effects Centers

Ethamolin Patient Information including How Should I Take

What should I discuss with my health care provider before receiving ethanolamine oleate (Ethamolin)?

You should not use this medication if you are allergic to ethanolamine oleate or oleic acid (oleo).

Ethanolamine oleate will not treat any underlying liver disease.

If possible, before you receive ethanolamine oleate, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney disease;
  • heart disease; or
  • lung disease.

If you have any of these conditions, you may need dose adjustments or special tests during treatment.

FDA pregnancy category C. It is not known whether ethanolamine oleate is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ethanolamine oleate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

In an emergency situation, it may not be possible before you are treated with ethanolamine oleate to tell your caregivers if you are pregnant or breast-feeding. However, make sure any doctor caring for your pregnancy or your baby knows that you have received this medication.

How is ethanolamine oleate given (Ethamolin)?

Ethanolamine oleate is given as an injection through a needle placed directly into the vein. You will receive this injection in a hospital or emergency setting.

This medication is usually given during a bleeding episode and again at 1 week, 6 weeks, 3 months, and 6 months afterward.

Side Effects Centers

Ethamolin Patient Information including If I Miss a Dose

What happens if I miss a dose (Ethamolin)?

Since ethanolamine oleate is given by a healthcare professional in a hospital setting, it is not likely that you will miss a dose.

What happens if I overdose (Ethamolin)?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include chest pain, or coughing up blood or dark tissue.

What should I avoid while receiving ethanolamine oleate (Ethamolin)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving this medication.

What other drugs will affect ethanolamine oleate (Ethamolin)?

There may be other drugs that can interact with ethanolamine oleate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ethanolamine oleate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Side Effects Centers

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