POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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), SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SULFATE ION - UNII:7IS9N8KPMG)

Available from:

Novel Laboratories, Inc.

INN (International Name):

POLYETHYLENE GLYCOL 3350

Composition:

POLYETHYLENE GLYCOL 3350 240 g in 278.26 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. PEG-3350 (240 g) and electrolytes for oral solution with flavor pack is contraindicated in patients known to be hypersensitive to any of the components. PEG-3350 (240 g) and electrolytes for oral solution with flavor pack is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

Product summary:

PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack is supplied in 4 liter bottles with an attached lemon flavor pack. Each 4 liter bottle contains polyethylene glycol-3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution. PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack 4liter: NDC 40032-060-19 Store at 20° to 25°C (68° to 77°F): excursions permitted between 15° to 30°C (59° to 86°F). KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION. Manufactured by: Novel Laboratories, Inc. 400 Campus Drive Somerset, NJ 08873, USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK -
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR
SOLUTION
NOVEL LABORATORIES, INC.
----------
PEG-3350 (240 G) AND ELECTROLYTES FOR ORAL SOLUTION, USP WITH FLAVOR
PACK
RX ONLY
4 LITERS
FOR GASTROINTESTINAL LAVAGE
DESCRIPTION
PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor
pack is a white, colon lavage
preparation provided as water-soluble components for solution. In
solution this preparation with lemon
flavor pack added 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 0.500
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 an isosmotic
solution, for oral administration,
having mild salty taste. This preparation can be used without the
lemon flavor pack and is administered
orally or via nasogastric tube.
Each lemon flavor pack (2 g) contains natural lemon flavor powder,
saccharin sodium, maltodextrin.
CLINICAL PHARMACOLOGY
PEG-3350 (240 g) and electrolytes for oral solution with flavor pack
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. Accordingly, large
volumes may be administered without significant changes in fluid and
electrolyte balance.
INDICATIONS AND USAGE
PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor
pack is indicated for bowel
cleansing prior to colonoscopy or barium enema X-ray examination.
CONTRAINDICATIONS
PEG-3350 (240 g) and electrolytes for oral solution with flavor pack
is contraindicated in patients
known to be hypersensitive to any of the components. PEG-3350 (240 g)
and electrol