Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2798
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Ethamolin (Injection)
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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. Note:
Parenteral drug products should be inspected visually for particulate matter
and discoloration before administration whenever solution and container permit.
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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. The
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
demonstrated. 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 thereis 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 Injection administered intravenously to rabbits is
130 mg/kg. 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 .
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ETHAMOLIN (Ethanolamine Oleate) Injection,
5% is available in 2 mL ampules supplied as boxes of 10 ampules.<br/>Storage: Store at controlled room temperature, 15�����30��C
(59�����86��F). Protect from light. CAUTION:
Federal law prohibits dispensing without prescription. Manufactured for QOL Medical, LLC. QOL Medical, LLC 5400 Carillon PointKirkland, WA 98033www.ethamolin.netphone 1-866-528-4750fax 1-866-528-4749 PL041/Rev. 05
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ethanolamine oleate
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Ethamolin (Injection)
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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%). Other
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 .
These complications appear to be dependent upon the dose and the patient's
clinical state. 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 .
Anaphylactic shock and acute renal failure with spontaneous recovery have
occurred . A case
of disseminated intravascular coagulation has been reported. Spinal
cord paralysis due to occlusion of the anterior spinal artery has been reported
in one child eight hours after ETHAMOLIN sclerotherapy.
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| dailymed-instance:indicatio... |
ETHAMOLIN Injection is indicated for the treatment of patients
with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN
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
reinjection.
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Ethamolin
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