"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
When injected intravenously, ETHAMOLIN (ethanolamine oleate) Injection acts primarily by irritation of the intimal endothelium of the vein and produces a sterile dose-related inflammatory response. This results in fibrosis and possible occlusion of the vein.
ETHAMOLIN (ethanolamine oleate) Injection also rapidly diffuses through the venous wall and produces a dose-related extravascular inflammatory reaction.
The oleic acid component of the ETHAMOLIN (ethanolamine oleate) Injection is responsible for the inflammatory response, and may also activate coagulation in vivo by release of tissue factor and activation of Hageman factor. The ethanolamine component, however, may inhibit fibrin clot formation by chelating calcium, so that a procoagulant action of ETHAMOLIN (ethanolamine oleate) has not been demonstrated.
After injection, ETHAMOLIN (ethanolamine oleate) disappears from the injection site within five minutes via the portal vein. When volumes larger than 20 mL are injected, some ETHAMOLIN (ethanolamine oleate) also flows into the azygos vein through the periesophageal vein. In human autopsy studies it was found that within four days after injection there is neutrophil infiltration of the esophageal wall and hemorrhage within six days. Granulation tissue is first seen at ten days, red thrombi obliterating the varices by twenty days, and sclerosis of the varices by two and a half months. The time course of these findings suggests that sclerosis of esophageal varices will be a delayed rather than an immediate effect of the drug.
The minimum lethal dose of ETHAMOLIN (ethanolamine oleate) Injection administered intravenously to rabbits is 130 mg/kg.
In dogs, ETHAMOLIN (ethanolamine oleate) injected into the right atrium at a dose of 1 mL/kg over one minute has been shown to increase extravascular lung water. The maximum recommended human dose is 20 mL, or 0.4 mL/kg for a 50-kg person. The
concentration of ETHAMOLIN (ethanolamine oleate) reaching the lung in human treatment will be less than in the dog studies, but pleural effusions, pulmonary edema, pulmonary infiltration and pneumonitis have been reported in clinical trials, and minimizing the total per session dose, especially in patients with concomitant cardiopulmonary disease, is recommended (see PRECAUTIONS).
Last reviewed on RxList: 10/29/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Ethamolin Information
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