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Ethamolin (Ethanolamine Oleate) - Warnings and Precautions

 
 



WARNINGS

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.

PRECAUTIONS

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

Page last updated: 2013-04-23

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