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

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)

Mevcut itibaren:

Alaven Pharmaceutical LLC

INN (International Adı):

POLYETHYLENE GLYCOL 3350

Kompozisyon:

POLYETHYLENE GLYCOL 3350 240 g in 4 L

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

COLYTE WITH FLAVOR PACKS- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE,
POTASSIUM
CHLORIDE, SODIUM BICARBONATE, AND SODIUM SULFATE POWDER, FOR SOLUTION
ALAVEN PHARMACEUTICAL LLC
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COLYTE WITH FLAVOR PACKS (PEG-3350 & ELECTROLYTES FOR ORAL SOLUTION)
4 LITERS
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 added delivers the following,
in grams per liter.
When dissolved in sufficient water to make 4 liters, 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 mild 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
artificial orange powder, saccharin
sodium, colloidal silicon dioxide. Each citrus berry flavor pack (3.22
g) contains hypromellose,
artificial citrus berry powder, saccharin sodium, colloidal silicon
dioxide. Each lemon lime flavor pack
(3.22 g) contains hypromellose, natural and artificial lemon lime
powder, Prosweet
Powder Natural,
saccharin sodium, colloidal silicon dioxide. Each cherry flavor pack
(3.22 g) contains hypromellose,
artificial cherry powder, saccharin sodium, colloidal silicon dioxide.
Each pineapple flavor pack (3.22
g) contains hypromellose, artificial pineapple flavor powder, Magna
Sweet™, 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.
CONTR