Clinical Information
Gen. Code and Des.
62659 peg3350/sod sulf,bicarb,Cl/KCl ORAL SOLN RECON 240-22.72G
GCN and Des.
98433 peg3350/sod sulf,bicarb,Cl/KCl ORAL SOLN RECON 240-22.72G
Strength
Dose Form
SOLUTION, RECONSTITUTED, ORAL
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
56120000 CATHARTICS AND LAXATIVES
Active Ingredients
11039 sodium bicarbonate 144558
6177 sodium sulfate anhydrous 7757826
6552 polyethylene glycol 3350
7231 potassium chloride 7447407
759 sodium chloride 7647145
Inactive Ingredients
2600 saccharin 81072
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES - polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and sodium sulfate anhydrous powder, for solution
Novel Laboratories, Inc.
Rx only
DESCRIPTION
PEG-3350 (236 g) and Electrolytes is a white powder in a 4 liter jug for reconstitution, containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride. When dissolved in water to a volume of 4 liters, PEG-3350 (236 g) and Electrolytes for Oral Solution, USP is an isosmotic solution, for oral administration, having a mildly salty taste. PEG-3350 and Electrolytes for Oral Solution, USP is administered orally or via nasogastric tube as a gastrointestinal lavage.
CLINICAL PHARMACOLOGY
PEG-3350 (236 g) and Electrolytes for Oral Solution 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 (236 g) and Electrolytes for Oral Solution, USP is indicated for bowel cleansing prior colonoscopy and barium enema X-ray examination.
DOSAGE AND ADMINISTRATION
The recommended dose for adults is 4 liters of PEG-3350 (236 g) and Electrolytes for Oral Solution prior to gastrointestinal examination, as ingestion of this dose produces a satisfactory preparation in over 95% of patients. Ideally, the patients should fast for approximately three or four hours prior to PEG-3350 (236 g) and Electrolytes for Oral Solution administration, but in no case should solid food be given for at least two hours before the solution is given.
PEG-3350 (236 g) and Electrolytes for Oral Solution is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Oral administration is at a rate of 240 mL (8 oz.) every 10 Minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously.
