Polyethylene Glycol 3350 and Electrolytes

Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1) Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults

Gastrointestinal (GI) obstruction (4, 5.6) Bowel perforation (4, 5.6) Toxic colitis or toxic megacolon (4) Gastric retention (4) Ileus (4) Hypersensitivity to components of Polyethylene Glycol 3350 and electrolytes for oral solution (4, 5.8) Polyethylene Glycol 3350 and electrolytes for oral solution, is contraindicated in the following conditions: Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.6)] Bowel perforation [see Warnings and Precautions (5.6)] Toxic colitis or toxic megacolon Gastric retention Ileus Hypersensitivity to any component of Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.8)]

Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. (5.1, 5.2, 7.1) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. (5.2) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold.

(5.3, 7.1) Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. (5.4, 7.1, 8.6) Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. (5.5, 7.3) Patients at risk for aspiration: Observe during administration.

(5.7) Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. (5.8)