Ethamolin

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.

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.

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 (dilated blood vessels inside the tissues lining the esophagus or upper part of the stomach). Esophageal varices is a life-threatening condition that causes 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. This medication is not for treating varicose veins in the legs.

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

Since ethanolamine oleate is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

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. 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 (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 sclerotherapy.

Drug Abuse And Dependence

There is no potential for drug abuse or drug dependence.

Read the entire FDA prescribing information for Ethamolin (Ethanolamine Oleate)

Since ethanolamine oleate is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

Fatal anaphylactic shock was reported following injection of a larger than normal volume of ETHAMOLlN 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 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 Aand B. Complications of ulceration, necrosis, and delayed esophageal perforation appear to occur more frequently when Ethamolin 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 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 elderly and critically-ill subjects.

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.

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 ETHAMOLlN Injection is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established

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 (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 sclerotherapy.

Ethamolin® (Ethanolamine Oleate) Injection, 5% is available in 2 mL, sterile, single-use glass ampules supplied as boxes of 10 ampules.

Storage

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

Distributed by:

QOL Medical, LLC

Vero Beach, FL 32963

www.Ethamolin.net

phone 1-866-528-4750

fax 1-866-528-4749

213250 / Rev. 08/12

Applies to ethanolamine oleate: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking ethanolamine oleate (the active ingredient contained in Ethamolin) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• 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 of ethanolamine oleate 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.