Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl Delayed-release Tablet

1 INDICATIONS & USAGE GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults. GaviLyte - H and bisacodyl delayed-release tablet, USP is a combination of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults ( 1 )

6 ADVERSE REACTIONS Most common adverse reactions (>3%) are overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting, ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 908-603-6000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a clinical study of GaviLyte - H and (5 mg vs.

5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment – assess concurrent medications and consider testing in some patients ( 5.1 , 5.2 , 5.3 , 5.4 ) Patients with renal impairment – use caution, ensure adequate hydration and consider testing ( 5.3 ) Ischemic colitis has been reported ( 5.5 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration ( 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 ) 5.1 Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of GaviLyte - H and bisacodyl delayed-release tablet, USP. 4 CONTRAINDICATIONS The GaviLyte - H and bisacodyl delayed-release tablet, USP is contraindicated in the following conditions: Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis and toxic megacolon Gastric retention Ileus Gastrointestinal (GI) obstruction ( 4 ) Bowel perforation ( 4 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 )