Data from FDA - Curated by EPG Health - Last updated 15 January 2017

Indication(s)

1 INDICATIONS AND USAGE ColPrep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults. ColPrep Kit is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.

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Advisory information

contraindications
4 CONTRAINDICATIONS Gastrointestinal obstruction Bowel perforation Gastric retention Ileus Toxic colitis or toxic megacolon Known allergies to components of the kit [See Description (11)] Gastrointestinal obstruction. (4, 5.6) Bowel perforation. (4, 5.6) Gastric retention. (4) Ileus. (4) Toxic colitis or toxic megacolon. (4) Known allergies to components of the kit. (4, 11)
Adverse reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: overall discomfort, abdominal fullness, nausea, abdominal cramping, and vomiting. To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc. at 1-215-579-1842 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. The safety of ColPrep Kit has been established from adequate and well-controlled trials of another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) [See Clinical Studies (14)]. Below is a display of the adverse reactions of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) in these adequate and well-controlled studies. In a multicenter, controlled clinical trial comparing another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) that were administered in a split-dose (2-day) regimen, the most common adverse reactions after administration of another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache; See Table 1, below. Less common adverse reactions occurring were atrioventricular (AV) block (1 case) and creatine kinase (CK) increase. In this study, patients receiving another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) were limited to a light breakfast followed by clear liquids; patients receiving the PEG + E bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids. Table 2 shows the percentages of patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g)or PEG+E administered as a split-dose (2-day) regimen. There were also 408 patients who participated in a study in which another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) or PEG+E were administered in an evening-only (1-day) regimen. Higher rates of overall discomfort, abdominal distention, and nausea were observed with the evening-only (1- day) regimen compared to the split-dose (2-day) regimen for both preparations. Patients treated with another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) had increased rates of vomiting with the evening-only (1- day) regimen. An evening-only (1-day) dosing regimen was associated with higher rates of abnormal values for some electrolytes when compared to the split-dose (2-day) regimen for both preparations. For another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g), the evening only (1-day) regimen was associated with higher rates of total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) than the split dose (2-day) regimen. Administration of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) in an evening-only (1-day) dosing regimen is not recommended. table 1 table 2

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of ColPrep Kit is a split-dose (2-Day) oral regimen. (2.1): o Dose 1: administered in the evening before colonoscopy, 10 to 12 hours before the second dose o Dose 2: administered the morning of colonoscopy, at least 3 ½ hours before colonoscopy 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. (2.2, 5.8) Additional fluids must be consumed after each dose of ColPrep. (2.2, 2.4) For complete information on dosing, instructions for use, preparation and administration, see full prescribing information. (2.1, 2.2, 2.3, 2.4). Do not take oral medications within 1 hour of start of each dose. (2.3, 7.2) Complete preparation at least 2 hours before colonoscopy or as directed by physician. (2.3) 2.1 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. 2.2 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. 2.3 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. 2.4 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: Open ONE (1) bottle from the ColPrep Kit. Fill the bottle with water up to the neck of the bottle. Shake well and mix thoroughly. Pour the reconstituted solution from the bottle into the mixing container provided. Fill the mixing container with water to the 16 ounce fill line. Drink the entire amount. 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: Repeat Steps 1 through 6 from Dose 1 of the Split-Dose (2-Day Regimen). Complete all ColPrep Kit solution and required water at least two hours prior to colonoscopy.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with ColPrep Kit. It is also not known whether ColPrep Kit can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ColPrep Kit should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ColPrep Kit is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of ColPrep Kit have not been established in pediatric patients. 8.5 Geriatric Use Of the 375 patients who received another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) was given as a one- day preparation.

Interactions

7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes. (7.1) 7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing ColPrep Kit for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [See Warnings (5)] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of each ColPrep Kit dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.

More information

Category Value
Authorisation number NDA204553
Orphan designation No
Product NDC 10702-283
Date Last Revised 10-01-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder KVK-Tech, Inc.