Polyethylene glycol 3350, Potassium chloride, Sodium bicarbonate and Sodium chloride

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater

The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, supplied as a powder, must be reconstituted with water before its use. On day prior to colonoscopy, instruct patients to: Eat a light breakfast or have clear liquids (avoid red and purple liquids). Early in the evening prior to colonoscopy, fill container containing PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution powder with lukewarm water to 4 liter fill line. After capping container, shake vigorously several times. Instruct patients to consume water or clear liquids during and after bowel preparation up until 2 hours before time of colonoscopy. Adults: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear. For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour.

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is contraindicated in the following conditions: Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Known allergy or hypersensitivity to any component of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution Gastrointestinal (GI) obstruction, ileus, or gastric retention. Bowel perforation. Toxic colitis or toxic megacolon. Known allergy or hypersensitivity to components of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution

Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment– assess concurrent medications and consider testing in some patients. Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing. Suspected GI obstruction or perforation – rule out the diagnosis before administration. Patients at risk for aspiration – observe during administration. Not for direct ingestion – dilute and take with additional water

The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities. Cardiac Arrhythmias. Seizures. Renal Impairment Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative Colitis Patients with Significant Gastrointestinal Disease Aspiration Direct Ingestion. The following adverse reactions have been identified during post-approval use of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Some drugs increase risks due to fluid and electrolyte changes. Oral medication taken within 1 hour of start of each dose may not be absorbed properly

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). When reconstituted, keep solution refrigerated.