Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid

1 INDICATIONS AND USAGE PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [ see Warnings and Precautions (5.1) ] Cardiac Arrhythmias [ see Warnings and Precautions (5.2) ] Seizures [ see Warnings and Precautions (5.3) ] Patients with Renal Impairment [ see Warnings and Precautions (5.4) ] Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative 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) ] Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [ see Warnings and Precautions (5.8) ] Hypersensitivity Reactions [ see Warnings and Precautio...

8.1 Pregnancy Risk Summary There are no available data on PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. (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 laboratory testing. 4 CONTRAINDICATIONS PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid 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) ] Gastric retention Ileus Toxic colitis or toxic megacolon Hypersensitivity to any ingr...