TRILYTE WITH FLAVOR PACKS polyethylene glycol 3350 sodium chloride bicarbonate and potassium powder for solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P)

Доступно од:

Alaven Pharmaceutical LLC

INN (Међународно име):

Polyethylene Glycol 3350

Састав:

Polyethylene Glycol 3350 420 g in 4 L

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

TRILYTE WITH FLAVOR PACKS- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE,
SODIUM
BICARBONATE AND POTASSIUM CHLORIDE POWDER, FOR SOLUTION
ALAVEN PHARMACEUTICAL LLC
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TRILYTE WITH FLAVOR PACKS
(PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
for oral solution)
RX ONLY
DESCRIPTION
TRILYTE is a white powder for reconstitution containing 420 g
polyethylene glycol 3350, 5.72 g
sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride.
Flavor packs, each containing
3.22 g of flavoring ingredients, are attached to the 4 liter bottle.
See individual flavor packs for
complete listing of ingredients. When dissolved in water to a volume
of 4 liters, TRILYTE with flavor
packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium
chloride for oral solution) is an
isosmotic solution, for oral administration, having a pleasant mineral
water taste. One flavor pack can be
added before reconstitution to flavor the solution. TRILYTE with
flavor packs is administered orally or
via nasogastric tube as a gastrointestinal lavage. This preparation
can be used without the addition of a
flavor pack.
CLINICAL PHARMACOLOGY
TRILYTE with flavor packs induces a diarrhea which rapidly cleanses
the bowel, usually within four
hours. The osmotic activity of polyethylene glycol 3350 and the
electrolyte concentration result in
virtually no net absorption or excretion of ions or water.
Accordingly, large volumes may be
administered without significant changes in fluid or electrolyte
balance.
INDICATIONS AND USAGE
TRILYTE with flavor packs is indicated for bowel cleansing prior to
colonoscopy.
CONTRAINDICATIONS
TRILYTE with flavor packs is contraindicated in patients known to be
hypersensitive to any of the
components. TRILYTE with flavor packs is contraindicated in patients
with ileus, gastrointestinal
obstruction, gastric retention, bowel perforation, toxic colitis or
toxic megacolon.
WARNINGS
The flavor packs are for use with the accompanying 4 liter bottle. No
additional ingredients, e.g.,
flavorings, sh