MoviPrep® is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

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 prior to the colonoscopy in one of the following ways:

1. Split-dose MoviPrep® regimen: The evening before the colonoscopy, take the first liter of MoviPrep® solution over one 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 one hour and then drink 0.5 liters of clear liquid at least one hour prior to the start of the colonoscopy; or
2. Evening-only (Full-dose) MoviPrep® regimen: Around 6 PM in the evening before the colonoscopy, take the first liter of MoviPrep® solution over one hour (one 8 ounce glass every 15 minutes) and then about 1.5 hours later take the second liter of MoviPrep® solution over one hour. In addition, take 1 liter (approximately 32 ounces) of additional clear liquid during the evening before the colonoscopy.

Preparation of the MoviPrep® solution: 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 prior to drinking. The reconstituted solution should be used within 24 hours. After consumption of the first liter of MoviPrep® solution, the above mixing procedure should be repeated with the second pouch A and pouch B to reconstitute the second liter of the MoviPrep® solution.

MoviPrep® is supplied in powdered form. MoviPrep® is administered as an oral solution after reconstitution.

MoviPrep® is available in the following presentations:

Carton: 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 wth 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

Storage

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.

Manufactured by: Norgine B.V., Hogehilweg 7,1101 CA Amsterdam Zuidoost, Netherlands, VENART 53-2 / January 2008, For: Salix Pharmaceuticals, Inc., Morrisville, NC 27560, FDA revision date: 2/5/2008

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