Colprep Dosage

Dosage Regimen

The recommended dosage of ColPrep Kit is one bottle administered in the evening before colonoscopy and the second bottle administered the morning of colonoscopy as follows:
Dose 1: Early in the evening prior to colonoscopy, 10 to 12 hours before the second dose.
Dose 2: The morning of colonoscopy, at least 3 ½ hours before colonoscopy.

Important Dosing Instructions

• ColPrep Kit must be reconstituted and diluted in water prior to ingestion. Direct ingestion of the undiluted reconstituted solution may increase the risk of nausea, vomiting, and dehydration [See Warnings and Precautions (5.8)].
• The ColPrep Kit is comprised of two bottles of ColPrep administered as a two-day regimen. Both doses of ColPrep Kit are required for a complete preparation for colonoscopy.
• Additional fluids must be consumed after each dose of ColPrep [See Dosage and Administration (2.4)].
• Do not take other laxatives while taking ColPrep Kit.

Instructions for Use

Dose 1 - On the day before colonoscopy (start 10 to 12 hours prior to Dose 2):

• A light breakfast may be consumed in the morning.
• Only clear liquids may be consumed for the rest of the day after a light breakfast. Do not drink milk.
• Do not eat solid foods for the rest of the day after breakfast until the next day after colonoscopy.
• Do not eat or drink anything colored red or purple.
• Do not drink alcohol.
• Do not take oral medications within one hour of starting the first dose of ColPrep Kit.

Dose 2 - Next morning on the day of colonoscopy (start at least 3 ½ hours prior to colonoscopy):

• Continue to abstain from all solid food and anything to drink other than clear liquids.
• Do not take oral medications within one hour of starting the second dose of ColPrep Kit.
• Complete all ColPrep Kit and required water at least 2 hours prior to colonoscopy or as directed by physician.
• Stop drinking clear liquids at least 2 hours before colonoscopy.

Preparation and Administration

Two doses of ColPrep Kit are required for a complete preparation for colonoscopy as a split-dose (two-day regimen). The total volume of liquid required is approximately 2.8 L taken orally prior to the colonoscopy, as described below.
Dose 1: Early in the evening prior to colonoscopy, 10 to 12 hours before Dose 2:

1. Open ONE (1) bottle from the ColPrep Kit.
2. Fill the bottle with water up to the neck of the bottle. Shake well and mix thoroughly.
3. Pour the reconstituted solution from the bottle into the mixing container provided.
4. Fill the mixing container with water to the 16 ounce fill line.
5. Drink the entire amount.
6. Important: Drink two additional mixing containers filled to the 16 ounce fill line with water over the next hour (32 ounces of additional water).

Dose 2: The morning of colonoscopy, at least 3 ½ hours before colonoscopy:

1. Repeat Steps 1 through 6 from Dose 1 of the Split-Dose (2-Day Regimen).
2. Complete all ColPrep Kit solution and required water at least two hours prior to colonoscopy.