Transcription of Ethamolin
1 The minimum lethal dose of Ethamolin Injectionadministered intravenously to rabbits is 130 dogs, Ethamolin injected into the right atrium at adose of 1 mL/kg over one minute has been shown to increaseextravascular lung water. The maximum recommendedhuman dose is 20 mL, or mL/kg for a 50-kg person. Theconcentration of Ethamolin reaching the lung in humantreatment will be less than in the dog studies, but pleuraleffusions, pulmonary edema, pulmonary infiltration andpneumonitis have been reported in clinical trials, andminimizing the total per-session dose, especially in patientswith concomitant cardiopulmonary disease, is recommended(see PRECAUTIONS).
2 INDICATIONS AND USAGEETHAMOLIN Injection is indicated for the treatment ofpatients with esophageal varices that have recently bled, toprevent is not indicated for the treatment of patientswith esophageal varices that have not bled. There is noevidence that treatment of this population decreases thelikelihood of with Ethamolin has no beneficial effectupon portal hypertension, the cause of esophageal varices, sothat recanalization and collateralization may occur,necessitating Injection should not be administered to subjectswith a known hypersensitivity to ethanolamine, oleic acid, orethanolamine Injection should be used in pregnant women onlywhen clearly needed (see PRECAUTIONS).
3 The practice of injecting varicosities of the leg withETHAMOLIN Injection is not supported by adequatelycontrolled clinical trials. Therefore, such use is anaphylactic shock was reported following injection of alarger than normal volume of Ethamolin Injection into amale who had a known allergic disposition. Although thereare only three known reports of anaphylaxis, the possibility ofan anaphylactic reaction should be kept in mind, and thephysician should be prepared to treat it appropriately. Inextreme emergencies, mL of a 1:1,000 intravenoussolution of epinephrine ( mg) should be used, andallergic reactions should be controlled with renal failure with spontaneous recovery followed injection of 15 to 20 mL of Ethamolin Injectioninto two physician should bear in mind that severe injection necrosis may result from direct injection ofsclerosing agents, especially if excessive volumes are used.
4 Atleast one fatal case of extensive esophageal necrosis and deathhas been reported. The drug should be administered byDESCRIPTIONETHAMOLIN (Ethanolamine Oleate) Injection is a mildsclerosing agent. Chemically it is C17H33 COOH . has the following structure:The empirical formula is C20H41NO3, representing amolecular weight of Injection consists of ethanolamine, a basicsubstance, which when combined with oleic acid, forms aclear pale-yellow to straw-colored, deliquescent oleate. ThepH ranges from to Injection is a sterile, apyrogenic, aqueoussolution containing in each mL approximately 50 mg ofethanolamine oleate with benzyl alcohol 2% by volume PHARMACOLOGYWhen injected intravenously, Ethamolin Injection actsprimarily by irritation of the intimal endothelium of the veinand produces a sterile dose-related inflammatory results in fibrosis and possible occlusion of the Injection also rapidly diffuses through the venouswall and produces a dose-related extravascular oleic acid component of Ethamolin Injection isresponsible for the inflammatory response.
5 And may alsoactivate coagulation in vivoby release of tissue factor andactivation of Hageman factor. The ethanolamine component,however, may inhibit fibrin clot formation by chelatingcalcium, so that a procoagulant action of Ethamolin has notbeen injection, Ethamolin disappears from the injectionsite within five minutes via the portal vein. When volumeslarger than 20 mL are injected, some Ethamolin also flowsinto the azygos vein through the periesophageal vein. Inhuman autopsy studies it was found that within four days afterinjection there is neutrophil infiltration of the esophageal walland hemorrhage within six days. Granulation tissue is firstseen at ten days, red thrombi obliterating the varices bytwenty days, and sclerosis of the varices by two and a halfmonths.
6 The time course of these findings suggests thatsclerosis of esophageal varices will be a delayed rather thanan immediate effect of the (Ethanolamine Oleate) Injection, 5%CH2CH2 OHCH3 (CH2)7(CH2)7 C O-NH2 HHHOC=Cl +=For Local Intravenous Use Only Rx only213250213250 (1) insert_PL041 12-09-25 4:05 PM Page 1physicians who are familiar with an acceptable in Child Class C are more likely to developesophageal ulceration than those in Classes A and of ulceration, necrosis, and delayed esophagealperforation appear to occur more frequently whenETHAMOLIN Injection is injected submucosally. This route isnot patients with concomitant cardiorespiratory disease,careful monitoring and minimization of the total dose persession is aspiration pneumonia has occurred in elderly patientsundergoing esophageal variceal sclerotherapy withETHAMOLIN Injection.
7 This adverse event appears to beprocedure-related, rather than drug-related; but as aspirationof blood and/or stomach contents is not uncommon inpatients with bleeding esophageal varices, special precautionsshould be taken to prevent its occurrence, especially in elderlyand critically-ill : (Teratogenic Effects: Pregnancy Category C)Animal reproduction studies have not been conducted withETHAMOLIN Injection. It is also not known whetherETHAMOLIN Injection can cause fetal harm whenadministered to a pregnant woman or can affect reproductioncapacity. Ethamolin Injection should be given to a pregnantwoman only if clearly MothersIt is not known whether this drug is excreted in human many drugs are excreted in human milk, cautionshould be exercised when Ethamolin Injection isadministered to a nursing UseSafety and effectiveness in pediatric patients have not been REACTIONSThe reported frequency of complications/adverse events perinjection session was 13%.
8 The most common complicationswere pleural effusion/infiltration ( ), esophageal ulcer( ), pyrexia ( ), retrosternal pain ( ), esophagealstricture ( ), and pneumonia ( ).Other adverse local esophageal reactions have also beenreported at rates of to , including esophagitis, tearingof the esophagus, sloughing of the mucosa overlying theinjected varix, ulceration, stricture, necrosis, periesophagealabscess and perforation (see PRECAUTIONS). Thesecomplications appear to be dependent upon the dose and thepatient s clinical has been observed in patients followinginjection of esophageal varices with Ethamolin . Pyrexia andretrosternal pain are not infrequently observed during thepost-injection period.
9 Fatal aspiration pneumonia hasoccurred in patients with esophageal varices who underwentETHAMOLIN Injection Sclerotherapy (see PRECAUTIONS).Anaphylactic shock and acute renal failure with spontaneousrecovery have occurred (see PRECAUTIONS). A case ofdisseminated intravascular coagulation has been cord paralysis due to occlusion of the anteriorspinal artery has been reported in one child eight hours afterETHAMOLIN ABUSE AND DEPENDENCET here is no potential for drug abuse or drug of Ethamolin Injection can result in severeintramural necrosis of the esophagus. Complications resultingfrom such overdosage have resulted in AND ADMINISTRATIONL ocal Ethamolin Injection sclerotherapy of esophagealvarices should be performed by physicians who are familiarwith an acceptable technique.
10 The usual intravenous dose to mL per varix. The maximum dose per treatmentsession should not exceed 20 mL. Patients with significantliver dysfunction (Child Class C) or concomitantcardiopulmonary disease should usually receive less than therecommended maximum dose. Submucosal injections are notrecommended as they reportedly are morelikely toresult inulceration at the site of obliterate the varix, injections may be made at the timeof the acute bleeding episode and then after one week, sixweeks, three months, and six months, as : Parenteral drug products should be inspected visuallyfor particulate matter and discoloration before administrationwhenever solution and container SUPPLIEDETHAMOLIN (Ethanolamine Oleate) Injection, 5% isavailable in 2 mL, sterile, single-use glass ampules supplied asboxes of 10 ampules.
