Ethanolamine Oleate

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

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 (see PRECAUTIONS). 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.

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 A and 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%), 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 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.

(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.

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