MOVIPREP- polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate
Salix Pharmaceuticals, Inc.
MoviPrep (polyethylene glycol electrolyte solution) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.
1 INDICATIONS AND USAGE
MoviPrep is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Overview
There are two possible dosing regimens. Each regimen requires different dosing times:
Split-dose (2-Day) [see Dosage and Administration (2.2)]
Evening only (1-Day) [see Dosage and Administration (2.3)]
Both MoviPrep dosing regimens require administration of MoviPrep using the mixing container provided to dilute powder for oral solution (contents of Pouch A and B) with water to the Fill Line. Preparation of MoviPrep solution (the contents of one Pouch A and one Pouch B) occurs twice in each dosing regimen. Additional fluids must be consumed in both dosing regimens [see Dosage and Administration (2.2, 2.3)]. Instruct patients to consume only clear liquids (no solid food) from the start of MoviPrep treatment until after the colonoscopy [see Warnings and Precautions (5.1)]. Additionally, instruct patients to not consume any clear liquids at least 2 hours before the colonoscopy.
2.2 Split-Dose (2-Day) Regimen (Preferred Method)
The Split-Dose regimen is the preferred dosing method. Instruct patients to take two separate doses in conjunction with fluids, as follows:
Dose 1 � Take this dose the evening before the colonoscopy (10 to 12 hours before Dose 2)
1. Empty the contents of 1 Pouch A and 1 Pouch B into the container that comes with MoviPrep.
2. Add lukewarm water to the Fill Line on the container.
3. Mix to completely dissolve the contents of Pouch A and B into the lukewarm water.
4. Drink one 8 oz. (ounce) glass (240 mL) every 15 minutes. Be sure to drink all of the solution. This should take about 1 hour.
5. Fill the container with 16 oz. (two 8 oz. glasses) of clear liquid and drink all of this liquid before going to bed.
Dose 2 � Take this dose the next morning, on the day of the colonoscopy (start at least 3 � hours prior to colonoscopy)
1. Repeat steps 1 through 4 from Dose 1 of the Split-dose (2-Day) instructions.
2. Fill the container with 16 oz. (two 8 oz. glasses) of clear liquid and drink all of this liquid at least 2 hours before the colonoscopy.
3. Drink only clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.
2.3 Evening Only (1-Day) Regimen (Alternative Method)
The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing regimen is inappropriate. Instruct patients to take two separate doses in conjunction with fluids as follows:
Dose 1 � Take this dose at least 3 � hours before bedtime the evening before the colonoscopy:
1. Empty the contents of 1 Pouch A and 1 Pouch B into the container that comes with MoviPrep.
2. Add lukewarm water to the Fill Line on the container.
3. Mix to completely dissolve the contents of Pouch A and B into the lukewarm water.
4. Drink one 8 oz. (ounce) glass (240 mL) every 15 minutes. Be sure to drink all of the solution. This should take about 1 hour.
Dose 2 � Take Dose 2 about 1 � hours after starting Dose 1 on the evening before the colonoscopy:
1. Repeat steps 1 through 4 from Dose 1 of the Evening only (1-Day) instructions.
2. After you complete steps 1 through 4, fill the container again to the Fill Line with clear liquid and drink all of this liquid before going to bed.
3. Drink only clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.
Additional Information: MoviPrep solution may be refrigerated before drinking. Keep the mixed solution in an upright position and store in the refrigerator. MoviPrep should be taken within 24 hours after it is mixed in water. Do not add other ingredients to the MoviPrep solution .
3 DOSAGE FORMS AND STRENGTHS
Powder for Oral Solution: MoviPrep is available in a carton that contains 2 pouches labeled Pouch A and 2 pouches labeled Pouch B. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP, plus the following excipients: aspartame, NF (sweetener), acesulfame potassium, NF (sweetener), and lemon flavoring. Each Pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams of sodium ascorbate, USP.
