FAQs

How does MoviPrep® (PEG–3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) work?

MoviPrep produces a watery stool leading to cleansing of the colon. The osmotic activity of polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, when taken with 1 liter of additional clear fluid, usually results in no net absorption or excretion of ions or water. The pharmacokinetics of MoviPrep have not been studied in patients with renal or hepatic insufficiency.

back to top

What is the dosing for MoviPrep?

The MoviPrep dose for colon cleansing for adult patients is 2 liters (approximately 64 ounces) of MoviPrep solution (with 1 additional liter of clear fluids) taken orally before the colonoscopy in one of the following ways:

PM/AM Split Dosing^TM MoviPrep regimen: The evening before the colonoscopy, take the first liter of MoviPrep solution over 1 hour (one 8–ounce glass every 15 minutes) and then drink 0.5 liters (approximately 16 ounces) of clear fluid. Then, on the morning of the colonoscopy, take the second liter of MoviPrep solution over 1 hour and then drink 0.5 liters of clear liquid at least one hour before the start of the colonoscopy.

Evening–only (full–dose) MoviPrep regimen: Approximately 6 PM in the evening before the colonoscopy, take the first liter of MoviPrep solution over 1 hour (one 8–ounce glass every 15 minutes). Then, approximately 1.5 hours later, take the second liter of MoviPrep solution over 1 hour. In addition, take 1 liter (approximately 32 ounces) of additional clear liquid during the evening before the colonoscopy.

back to top

How should the MoviPrep solution be prepared?

MoviPrep solution is prepared by emptying the contents of 1 pouch A and 1 pouch B into a suitable glass container (or the container provided) and adding to the container 1 liter of lukewarm water. Mix the solution to ensure that the ingredients are completely dissolved. If the patient prefers, the MoviPrep solution can be refrigerated before drinking. The reconstituted solution should be used within 24 hours.

back to top

How is MoviPrep supplied?

MoviPrep is packaged in a carton and supplied in powdered form. After reconstitution, MoviPrep is administered as an oral solution.

The MoviPrep carton contains a disposable container for reconstitution of MoviPrep and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B). Pouch A contains polyethylene glycol (PEG) 3350 100 grams, sodium sulfate 7.5 grams, sodium chloride 2.69 grams, and potassium chloride 1.015 grams. Pouch B contains ascorbic acid 4.7 grams and sodium ascorbate 5.9 grams. 1 pouch A and 1 pouch B should be dissolved together in 1 liter of lukewarm water. When reconstituted to 1 liter volume with water, the solution contains PEG–3350 29.6 mmol/L, sodium 181.6 mmol/L (of which not more than 56.2 mmol is absorbable), sulfate 52.8 mmol/L, chloride 59.8 mmol/L, potassium 14.2 mmol/L, and ascorbate 29.8 mmol/L.

NDC 65649–201–75

back to top

How should MoviPrep be stored?

Store carton/container at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). When reconstituted, store upright and keep solution refrigerated. Use within 24 hours.

back to top

Can MoviPrep be used during pregnancy?

Pregnancy Category C: MoviPrep should be given to a pregnant woman only if clearly needed.

back to top

What are the contraindications and warnings for MoviPrep?

MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction to any of its components.

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.

back to top

What general precautions should be taken with MoviPrep administration?

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 (eg, 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), a history of hemolysis, or who are taking concomitant medications known to precipitate hemolytic reactions.

Studies assessing the effects of MoviPrep on fetal health or reproductive capacity have not been performed. MoviPrep should be given to a pregnant woman only if clearly needed. Caution should be exercised when MoviPrep is administered to a nursing woman because many drugs are excreted in human milk.

The safety and effectiveness of MoviPrep in pediatric patients has not been established.

No overall differences in safety or effectiveness were observed between geriatric patients and younger patients with MoviPrep, but greater sensitivity of some older individuals cannot be ruled out.

For a complete list of precautions, please see full prescribing information.

back to top

What are the most common adverse events for MoviPrep?

In the MoviPrep trials, abdominal distension, anal discomfort, thirst, nausea, and abdominal pain were some of the most common adverse reactions to MoviPrep administration.

For a complete list of adverse events, please see full prescribing information.

back to top

---