COLYTE polyethylene glycol 3350 sodium chloride potassium bicarbonate and sulfate anhydrous 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 227.1 g in 3.785 L

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

New Drug Application

Карактеристике производа

COLYTE- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE,
SODIUM BICARBONATE,
AND SODIUM SULFATE ANHYDROUS POWDER, FOR SOLUTION
ALAVEN PHARMACEUTICAL LLC
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COLYTE WITH FLAVOR PACKS (PEG-3350 & ELECTROLYTES FOR ORAL SOLUTION)
ONE GALLON
FOR GASTROINTESTINAL LAVAGE RX ONLY
DESCRIPTION: Colyte
with flavor packs is a colon lavage preparation provided as
water-soluble
components for solution. In solution this preparation with one flavor
pack delivers the following, in
grams per liter.
Polyethylene glycol
3350
60.00
Sodium chloride
1.46
Potassium chloride
0.745
Sodium bicarbonate
1.68
Sodium sulfate
5.68
Flavor ingredients
0.851
When dissolved in sufficient water to make 1 gallon, the final
solution contains 125 mEq/L sodium, 10
mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L
chloride and 18 mEq/L
polyethylene glycol 3350. The reconstituted solution is isosmotic and
has a mildly salty taste. This
preparation can be used without the flavor packs and is administered
orally or via nasogastric tube.
Each orange flavor pack (3.22 g) contains hypromellose, natural and
artifical orange powder, saccharin
sodium, colloidal silicon dioxide. Each lemon lime flavor pack (3.22
g) contains, hypromellose, natural
and artifical lemon lime powder, Prosweet
Powder Natural, saccharin sodium, colloidal silicon
dioxide. Each cherry flavor pack (3.22 g) contains hypromellose,
artifical cherry powder, saccharin
sodium, colloidal silicon dioxide.
CLINICAL PHARMACOLOGY: Colyte
with flavor packs cleanses the bowel by induction of
diarrhea. The osmotic activity of polyethylene glycol 3350, in
combination with the electrolyte
concentration, results in virtually no net absorption or excretion of
ions or water.
INDICATIONS AND USAGE: Colyte with flavor packs is indicated for bowel
cleansing prior to
colonoscopy or barium enema X-ray examination.
CONTRAINDICATIONS:
Colyte is contraindicated in the following conditions:
Gastrointestinal (GI) obstruction
Bowel perforation
Gastric retention
Ileus
Toxic colitis or