Indication and Important Safety Information

PREPOPIK^® for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

• PREPOPIK^® is contraindicated in the following conditions: patients with severely reduced renal function, gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, or in patients with a known allergy to any of the ingredients in PREPOPIK^®.
• Patients should be advised on the importance of adequate hydration, and post-colonoscopy lab tests should be considered if a patient develops significant vomiting or signs of dehydration after taking PREPOPIK^®. Patients with electrolyte abnormalities should have them corrected before treatment. Use caution when prescribing for patients who are at risk for seizures, or arrhythmias, including those patients with a history of prolonged QT, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy.
• Caution should be used in patients with impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function, electrolyte imbalance and/or water retention.
• Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with PREPOPIK^® may increase this risk.
• PREPOPIK^® should not be used if gastrointestinal obstruction or perforation is suspected.
• PREPOPIK^® is not for direct ingestion. Each packet must be dissolved in 5 ounces of cold water and administered at separate times, in addition to additional clear fluids, according to the dosing regimen.
• In randomized, multicenter, controlled clinical trials, nausea, headache, and vomiting were the most common treatment-emergent adverse reactions (>1%) following PREPOPIK^® administration.
• Oral medication administered within one hour of the start of administration of PREPOPIK^® solution may be flushed from the GI tract and the medication may not be absorbed. Prior or concomitant use of antibiotics with PREPOPIK^® may reduce its efficacy. Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of PREPOPIK^® to avoid chelation with magnesium.