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.

• 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 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

• Safety and effectiveness
• In pediatric patients have not been established

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.

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. …

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.

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

There is no potential for drug abuse or drug dependence.

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

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.