Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor

1 INDICATIONS AND USAGE 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

6 ADVERSE REACTIONS Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation. (6) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions (5.4)] Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions (5.5)] Patients with significant gastrointestinal disease [see Warnings and Precautions (5.6)] Aspiration [see Warnings and Precautions (5.7)] The following adverse reactions associated with the use of Polyethylene Glycol 3350 and electrolytes for oral solution were identified in clinical t...

8.1 Pregnancy Animal reproduction studies have not been conducted with Polyethylene Glycol 3350 and electrolytes for oral solution. It is also not known whether Polyethylene Glycol 3350 and electrolytes for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Polyethylene Glycol 3350 and electrolytes for oral solution should be given to a pregnant woman only if clearly needed.

5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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) obstruc...