MOVIPREP

The colon cleansing efficacy and safety of MoviPrep was evaluated in two randomized, actively-controlled, multi-center, investigator-blinded trials in adult patients scheduled to have an elective colonoscopy. In Study 1, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of MoviPrep with 1 additional liter of clear liquid split into two doses (during the evening before and the morning of the colonoscopy) and 2) 4 liters of polyethylene glycol plus electrolytes solution (4L PEG + E) split into two doses (during the evening before and the morning of th...

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)]
• Pa...

MoviPrep 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 ingredient in MoviPrep [see Warnings and Precautions (5.10) and Description (11) ]
• Gastrointestinal (GI) obstruction ( 4...

• 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...

7 DRUG INTERACTIONS Drugs that increase risk for fluid and electrolyte imbalance. ( 7.1 ) 7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities Use caution when prescribing MoviPrep for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or...