POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE powder, for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

제공처:

Novel Laboratories, Inc.

INN (International Name):

POLYETHYLENE GLYCOL 3350

구성:

POLYETHYLENE GLYCOL 3350 420 g in 438.4 g

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is contraindicated in patients known to be hypersensitive to any of the components. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

제품 요약:

PEG 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE with Flavor Pack is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has an attached lemon flavor pack, in powdered form, for the addition of the flavor pack by the pharmacist prior to dispensing. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND SODIUM BICARBONATE FOR ORAL SOLUTION with Flavor Pack : PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and lemon flavor pack 2 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. STORAGE : Store in sealed container at 25°C. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. NDC 40032-050-19 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND
SODIUM BICARBONATE - POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE,
POTASSIUM CHLORIDE AND
SODIUM BICARBONATE POWDER, FOR SOLUTION
NOVEL LABORATORIES, INC.
----------
PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE
FOR ORAL SOLUTION WITH
FLAVOR PACK
RX ONLY
DESCRIPTION
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE 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 and one 2 g flavor pack
(optional). When dissolved in
water to a volume of 4 liters, PEG-3350, SODIUM CHLORIDE, POTASSIUM
CHLORIDE, SODIUM
BICARBONATE (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. PEG-
3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is
administered
orally or via nasogastric tube as a gastrointestinal lavage. PEG-3350,
SODIUM CHLORIDE,
POTASSIUM CHLORIDE, SODIUM BICARBONATE Flavor Pack is available in
lemon flavor. This
preparation can be used without the addition of a PEG-3350, SODIUM
CHLORIDE, POTASSIUM
CHLORIDE, SODIUM BICARBONATE Flavor Pack.
CLINICAL PHARMACOLOGY
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE
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
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for
Oral
Solution is indicated for bowel cleansing prior to colonoscopy.
CONTRAINDICATIONS
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is
contraindicated in patients known to be hypersensitive to any of the
components.