ETHAMOLIN- ethanolamine oleate injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

ETHANOLAMINE OLEATE (UNII: U4RY8MRX7C) (MONOETHANOLAMINE - UNII:5KV86114PT)

Dostępny od:

QOL Medical, LLC.

INN (International Nazwa):

Ethanolamine Oleate

Skład:

Ethanolamine Oleate 50 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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. ETHAMOLIN Injection should not be administered to subjects with a known hypersensitivity to ethanolamine, oleic acid, or ethanolamine oleate. There is no potential for drug abuse or drug dependence.

Podsumowanie produktu:

ETHAMOLIN® (Ethanolamine Oleate) Injection, 5% is available in 2 mL, sterile, single-use glass ampules supplied as boxes of 10 ampules. Store at controlled room temperature, 15°- 30°C (59°- 86°F). Protect from light.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

ETHAMOLIN- ETHANOLAMINE OLEATE INJECTION, SOLUTION
QOL MEDICAL, LLC.
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ETHAMOLIN® (ETHANOLAMINE OLEATE) INJECTION, 5%. FOR LOCAL INTRAVENOUS
USE
ONLY
RX ONLY
DESCRIPTION
ETHAMOLIN
(Ethanolamine Oleate) Injection is a mild sclerosing agent. Chemically
it is C
H
COOH•NH
CH
CH
OH. It has the following structure:
The empirical formula is C
H
NO
, representing a molecular weight of 343.55.
ETHAMOLIN Injection consists of ethanolamine, a basic substance, which
when
combined with oleic acid, forms a clear pale-yellow to straw-colored,
deliquescent oleate.
The pH ranges from 8.0 to 9.0.
ETHAMOLIN Injection is a sterile, apyrogenic, aqueous solution
containing in each mL
approximately 50 mg of ethanolamine oleate with benzyl alcohol 2% by
volume as
preservative.
CLINICAL PHARMACOLOGY
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 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
®
17
33
2
2
2
20
41
3
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
sc