There have been rare reports of generalized tonic-clonic seizures associated with use of polyethylene glycol colon preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, MoviPrep® should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics or angiotensin converting enzyme (ACE)-inhibitors] or in patients with known or suspected hyponatremia. Consider performing baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

MoviPrep® should be used with caution in patients with severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, or toxic megacolon.

General: Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during the administration of MoviPrep®. If a patient experiences severe bloating, abdominal distention, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate tests should be performed to rule out these conditions before administration of MoviPrep®.

Phenylketonurics: MoviPrep® contains phenylalanine – a maximum of 2.33 mg of phenylalanine per treatment.

No additional ingredients (e.g., flavorings) should be added to the MoviPrep® solution.

Since MoviPrep® contains sodium ascorbate and ascorbic acid, MoviPrep® should be used with caution in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency especially G-6-PD deficiency patients with an active infection, with a history of hemolysis, or taking concomitant medications known to precipitate hemolytic reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate the carcinogenic potential have not been performed with MoviPrep®. Studies to evaluate potential for impairment of fertility or mutagenic potential have not been performed with MoviPrep®.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been performed with MoviPrep®. It is also not known if MoviPrep® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. MoviPrep® should be given to a pregnant woman only if clearly needed.

Nursing Mothers: Because many drugs are excreted in human milk, caution should be exercised when MoviPrep® is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of MoviPrep® in pediatric patients has not been established.

Geriatric Use: Of the 413 patients in clinical studies receiving MoviPrep®, 91 (22%) patients were aged 65 or older, while 25 (6%) patients were over 75 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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