Ethamolin®(Ethanolamine Oleate)Injection, 5%For
Local Intravenous Use Only
ethanolamine oleate injection QOL Medical, LLC.
Ethamolin® (Ethanolamine Oleate) Injection, 5% For
Local Intravenous Use Only
ETHAMOLIN® (Ethanolamine Oleate) Injection
is a mild sclerosing agent. Chemically it is C17H33COOH•NH2CH2CH2OH. It has the following
The empirical formula is C20H41NO3,
representing a molecular weight of 343.55.
Injection consists of ethanolamine, a basic substance, which when combined
with oleic acid forms a clear, straw to pale yellow colored, deliquescent
oleate. The pH ranges from 8.0 to 9.0.
is a sterile, apyrogenic, aqueous solution containing in each mL approximately
50 mg of ethanolamine oleate with benzyl alcohol 2% by volume as preservative.
When injected intravenously, ETHAMOLIN 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 Injection also rapidly diffuses through the
venous wall and produces a dose-related extravascular inflammatory reaction.
oleic acid component of the ETHAMOLIN 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 has not been
After injection, ETHAMOLIN disappears
from the injection site within five minutes via the portal vein. When volumes
larger than 20 mL are injected, some ETHAMOLIN 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.
lethal dose of ETHAMOLIN Injection administered intravenously to rabbits is
In dogs, ETHAMOLIN 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 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).
INDICATIONS AND USAGE
ETHAMOLIN Injection is indicated for the treatment of patients
with esophageal varices that have recently bled, to prevent rebleeding.
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
ETHAMOLIN Injection should not be administered to subjects
with a known hypersensitivity to ethanolamine, oleic acid, or ethanolamine
ETHAMOLIN Injection should be used in pregnant women only
when clearly needed (see PRECAUTIONS).
practice of injecting varicosities of the leg with ETHAMOLIN Injection is
not supported by adequately controlled clinical trials. Therefore, such use
is not recommended.
Fatal anaphylactic shock was reported following injection
of a larger than normal volume of ETHAMOLIN 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
Acute renal failure with spontaneous
recovery followed injection of 15 to 20 mL of ETHAMOLIN Injection into two
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.
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 Injection is injected
submucosally. This route is not recommended.
with concomitant cardiorespiratory disease, careful monitoring and minimization
of the total dose per session is recommended.
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 the elderly and critically ill subjects.
Teratogenic Effects: Pregnancy Category C
Animal reproduction studies have not been conducted with
ETHAMOLIN 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
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 Injection is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not
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%).
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
Bacteremia has been observed in patients
following injection of esophageal varices with ETHAMOLIN. Pyrexia and retrosternal
pain are not infrequently observed during the post-injection period. Fatal
aspiration pneumonia has occurred in patients with esophageal varices who
underwent ETHAMOLIN Injection Sclerotherapy (see PRECAUTIONS).
Anaphylactic shock and acute renal failure with spontaneous recovery have
occurred (see PRECAUTIONS). A case
of disseminated intravascular coagulation has been reported.
cord paralysis due to occlusion of the anterior spinal artery has been reported
in one child eight hours after ETHAMOLIN sclerotherapy.
Overdosage of ETHAMOLIN Injection can result in severe intramural
necrosis of the esophagus. Complications resulting from such overdosage have
resulted in death.
DOSAGE AND ADMINISTRATION
Local ETHAMOLIN Injection sclerotherapy of esophageal varices
should be performed by physicians who are familiar 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 are reportedly 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.
Parenteral drug products should be inspected visually for particulate matter
and discoloration before administration whenever solution and container permit.
ETHAMOLIN® (Ethanolamine Oleate) Injection,
5% is available in 2 mL ampules supplied as boxes of 10 ampules.
Store at controlled room temperature, 15°− 30°C
(59°− 86°F). Protect from light.
Federal law prohibits dispensing without prescription.