Generic Name: SODIUM PICOSULFATE 10mg in 16.1g, MAGNESIUM OXIDE 3.5g in 16.1g, ANHYDROUS CITRIC ACID 12g in 16.1g
Dosage Form: powder for oral solution
Drug Class: Laxatives
Important Preparation and Administration Instructions
- Correct fluid and electrolyte abnormalities before administration of Prepopik [see Warnings and Precautions (5.1)].
- Two doses (one packet per dose) of Prepopik are required for a complete preparation for colonoscopy either as a Split-Dose (preferred) or Day-Before dosing regimen.
- The preferred method is the "Split-Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, the morning of the day of the colonoscopy [see Dosage and Administration (2.2)].
- The alternative method is the "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy [see Dosage and Administration (2.3)].
- Each packet of Prepopik must be dissolved in 5 ounces of cold water prior to ingestion and administered according to the dosing regimen. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration and electrolyte disturbances [see Warnings and Precautions (5.8)].
- Additional fluids must be consumed after every dose of Prepopik in both dosing regimens [see Dosage and Administration (2.2), Warnings and Precautions (5.1)].
- Consume only clear fluids (no solid food) from the start of Prepopik treatment until after the colonoscopy.
- Do not eat solid food or dairy and do not drink anything colored red or purple.
- Do not drink alcohol.
- Do not take other laxatives while taking Prepopik
- Do not take oral medications within one hour before or after starting Prepopik.
- If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of Prepopik [see Drug Interactions (7.2)].
- Stop consumption of all fluids at least 2 hours before the colonoscopy.
Reconstitution of Prepopik Powder
- Reconstitute the Prepopik powder immediately before each administration. Do not prepare the solution in advance.
- Fill the supplied dosing cup with cold water up to the lower (5-ounce) line on the cup and pour in the contents of one packet of Prepopik powder.
- Stir for 2 to 3 minutes. The reconstituted Prepopik solution may become slightly warm as the powder dissolves.
Split-Dose Dosing Regimen (Preferred Method)
The Split-Dose regimen is the preferred dosing method. The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses (one packet per dose) in conjunction with fluids.
Dose 1 – On the day before colonoscopy:
- Instruct patients to consume only clear liquids (no solid food or dairy) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy.
- Take the first dose of Prepopik during the evening before the colonoscopy (e.g., 5:00 to 9:00 PM).
- Follow Prepopik by drinking at least five 8-ounce cups of clear liquids (40 ounces total), using the upper line on the cup, within 5 hours and before bed.
- If severe bloating, distention, or abdominal pain occurs, following the first dose, delay the second dose until the symptoms resolve.
Dose 2 – Next morning on the day of colonoscopy (start approximately 5 hours prior to colonoscopy):
- Continue to consume only clear liquids (no solid food or dairy).
- Take the second dose of Prepopik.
- Following the Prepopik dose, drink at least three 8-ounce cups of clear liquids (24 ounces), using the upper line on the cup, at least 2 hours before the colonoscopy.
Day-Before Dosing Regimen (Alternative Method)
The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses (one packet per dose) in conjunction with fluids
Dose 1 – On the day before colonoscopy:
- Instruct patients to consume only clear liquids (no solid food or dairy) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy.
- Take the first dose of Prepopik in the afternoon or early evening before the colonoscopy (e.g., 4:00 to 6:00 PM).
- Following the Prepopik dose, drink at least five 8-ounce cups of clear liquids (40 ounces total), using the upper line on the cup, within 5 hours and before the next dose.
- If severe bloating, distention, or abdominal pain occurs, following the first dose, delay the second dose until the symptoms resolve.
Dose 2 – Approximately 6 hours later in the evening the night before the colonoscopy (e.g., 10:00 PM to 12:00 AM):
- Take the second dose of Prepopik.
- Following the Prepopik dose, drink at least three 8-ounce cups (24 ounces), using the upper line on the cup, of clear liquids within 5 hours and before bed.