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ETHAMOLIN (ethanolamine oleate) Injection should be used in pregnant women only when clearly needed (see 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.
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.
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.
Safety and effectiveness in pediatric patients have not been established.
Last reviewed on RxList: 10/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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