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Prepopik (sodium picosulfate, magnesium oxide and anhydrous citric acid) for oral solution is available in 2 flavors, orange and cranberry flavor, and is provided in two packets. The contents of each is to be dissolved in 5 ounces of cold water and consumed.
Each packet for both flavors contains 10 mg sodium picosulfate, 3.5 g magnesium oxide and 12 g anhydrous citric acid. The product also contains the following inactive ingredients: potassium hydrogen carbonate, saccharine sodium and orange or cranberry flavors. The orange flavor contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole, and the cranberry flavor contains maltodextrin, glyceryl triacetate (triacetin) and sodium octenyl succinated starch. The following is a description of the three active ingredients:
Sodium picosulfate is a stimulant laxative.
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Magnesium citrate, which is formed in solution by the combination of magnesium oxide and anhydrous citric acid, is an osmotic laxative.
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Prepopik® is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.
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.
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.
Reconstitute immediately before use. Do not prepare the solution in advance or store the solution for later use. Do not refrigerate or add ice to the solution.
For oral solution: Each of the two packets contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide, and 12.0 g of anhydrous citric acid in 16.1g of powder for orange flavor or 16.2 g of powder for cranberry flavor.
Prepopik is supplied in a carton containing 2 packets, each holding 16.1 grams of powder in orange flavor or 16.2 grams of powder in cranberry flavor for oral solution, along with a pre-marked dosing cup. Each packet for both flavors contains 10 mg sodium picosulfate, 3.5 g magnesium oxide and 12 g anhydrous citric acid. The excipients for both flavors include potassium hydrogen carbonate, sodium saccharin, orange or cranberry flavor. The orange flavor contains acacia gum, lactose, ascorbic acid, and butylated hydroxyanisole, and the cranberry flavor contains maltodextrin, glyceryl triacetate (triacetin) and sodium octenyl succinated starch.
Store at room temperature between 20 to 25°C (68 to 77°F). Excursions permitted between 15° and 30°C (59° and 86° F) [see USP Controlled room temperature].
Orange flavor: NDC# 55566-9300-2 Kit, 2 packets and cup
Cranberry flavor: NDC# 55566-9700-1-Kit, 2 packets and cup
Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054, USA. Revised: Aug 2023
The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
In randomized, multicenter, controlled clinical trials, nausea, headache, and vomiting were the most common adverse reactions (>1%) following Prepopik administration. The patients were not blinded to the study drug. Since abdominal bloating, distension, pain/cramping, and watery diarrhea are known to occur in response to colon cleansing preparations, these effects were documented as adverse events in the clinical trials only if they required medical intervention (such as a change in study drug or led to study discontinuation, therapeutic or diagnostic procedures, met the criteria for a serious adverse event), or showed clinically significant worsening during the study that was not in the frame of the usual clinical course, as determined by the investigator.
Prepopik was compared for colon cleansing effectiveness with a preparation containing two liters (2L) of polyethylene glycol plus electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets, all administered the day before the procedure. Table 1 displays the most common adverse reactions in Study 1 and Study 2 for the Prepopik Split-Dose and Day-Before dosing regimens, respectively, each as compared to the comparator preparation.
Table 1: Treatment-Emergent Adverse Reactions observed in at Least (>1%) of Patients using the Split-Dose Regimen and Day-Before Regimen **
| Adverse Reaction | Study 1: Split-Dose Regimen | Study 2: Day-Before Regimen | ||
| PREPOPIK (N=305) n (% = n/N) |
2L PEG+E* with 2 x 5-mg bisacodyl tablets (N=298) n (% = n/N) |
PREPOPIK (N=296) n (% = n/N) |
2L PEG+E* with 2 x 5-mg bisacodyl tablets (N=302) n (% = n/N) |
|
| Nausea | 8 (2.6) | 11 (3.7) | 9 (3.0) | 13 (4.3) |
| Headache | 5 (1.6) | 5 (1.7) | 8 (2.7) | 5 (1.7) |
| Vomiting | 3 (1.0) | 10 (3.4) | 4 (1.4) | 6 (2.0) |
| * 2L PEG + E = two liters polyethylene glycol plus electrolytes solution. **abdominal bloating, distension, pain/cramping, and watery diarrhea not requiring an intervention were not collected Page |
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In general, Prepopik was associated with numerically higher rates of abnormal electrolyte shifts on the day of colonoscopy compared to the preparation containing 2L of PEG + E plus two x 5-mg bisacodyl tablets (Table 2). These shifts were transient in nature and numerically similar between treatment arms at the Day 30 visit.
Table 2: Shifts from Normal Baseline to Outside the Normal Range at Day 7 and Day 30
| Laboratory Parameter (direction of change) | Visit | Study 1: Split-Dose Regimen | Study 2: Day-Before Regimen | ||
| PREPOPIK | 2L PEG+E with 2x 5 mg bisacodyl tablets | PREPOPIK | 2L PEG+E with 2x 5 mg bisacodyl tablets | ||
| n/N (%) | n/N (%) | ||||
| Potassium (low) | Day of Colonoscopy | 19/260 (7.3) | 11/268 (4.1) | 13/274 (4.7) | 13/271 (4.8) |
| 24-48 hours | 3/302 (1.0) | 2/294 (0.7) | 3/287 (1.0) | 5/292 (1.7) | |
| Day 7 | 11/285 (3.9) | 8/279 (2.9) | 6/276 (2.2) | 14/278 (5.0) | |
| Day 30 | 11/284 (3.9) | 8/278 (2.9) | 7/275 (2.5) | 8/284 (2.8) | |
| Sodium (low) | Day of Colonoscopy | 11/298 (3.7) | 3/295 (1.0) | 3/286 (1.0) | 3/295 (1.0) |
| 24-48 hours | 1/303 (0.3) | 1/295 (0.3) | 1/288 (0.3) | 1/293 (0.3) | |
| Day 7 | 2/300 (0.7) | 1/292 (0.3) | 1/285 (0.4) | 1/291 (0.3) | |
| Day 30 | 2/299( 0.7) | 3/291 (1.0) | 1/284( 0.4) | 1/296 (0.3) | |
| Chloride (low) | Day of Colonoscopy | 11/301 (3.7) | 1/298 (0.3) | 3/287 (1.0) | 0/297 (0.0) |
| 24-48 hours | 1/303 (0.3) | 0/295 (0.0) | 2/288 (0.7) | 0/293 (0.0) | |
| Day 7 | 1/303 (0.3) | 3/295 (1.0) | 0/285 (0.0) | 0/293 (0.0) | |
| Day 30 | 2/302 (0.7) | 3/294 (1.0) | 0/285 (0.0) | 0/298 (0.0) | |
| Magnesium (high) | Day of Colonoscopy | 34/294 (11.6) | 0/294 (0.0) | 25/288 (8.7) | 1/289 (0.3) |
| 24-48 hours | 0/303 (0.0) | 0/295 (0.0) | 0/288 (0.0) | 0/293 (0.0) | |
| Day 7 | 0/297 (0.0) | 1/291 (0.3) | 1/286 (0.3) | 1/285 (0.4) | |
| Day 30 | 1/296 (0.3) | 2/290 (0.7) | 0/286 (0.0) | 0/290 (0.0) | |
| Calcium (low) | Day of Colonoscopy | 2/292 (0.7) | 1/286 (0.3) | 0/276 (0.0) | 2/282 (0.7) |
| 24-48 hours | 0/303 (0.0) | 0/295 (0.0) | 0/288 (0.0) | 0/293 (0.0) | |
| Day 7 | 0/293 (0.0) | 1/283 (0.4) | 0/274 (0.0) | 0/278 (0.0) | |
| Day 30 | 0/292 (0.0) | 1/282 (0.4) | 0/274 (0.0) | 1/283 (0.4) | |
| Creatinine (high) | Day of Colonoscopy | 5/260 (1.9) | 13/268 (4.9) | 12/266 (4.5) | 16/270 (5.9) |
| 24-48 hours | 1/303 (0.3) | 0/295 (0.0) | 0/288 (0.0) | 0/293 (0.0) | |
| Day 7 | 10/264 (0.4) | 13/267 (4.8) | 10/264 (3.8) | 10/265 (3.8) | |
| Day 30 | 11/264 (4.2) | 14/265(5.3) | 18/264 (6.8) | 10/272 (3.7) | |
| eGFR (low) | Day of Colonoscopy | 22/221 (10.0) | 17/214 (7.9) | 26/199 (13.1) | 25/224 (11.2) |
| 24-48 hours | 76/303 (25.1) | 72/295 (24.4) | 82/288 (28.5) | 62/293 (21.2) | |
| Day 7 | 22/223 (10.0) | 17/213 (8.0) | 11/198 (5.6) | 28/219 (12.8) | |
| Day 30 | 24/223(10.8) | 21/211 (10.0) | 21/199 (10.6) | 24/224 (10.7) | |
In the pediatric patients aged 9 to 16 years who received Prepopik, the most common adverse reactions (> 5%) were nausea, vomiting, and abdominal pain [see Clinical Studies]. Electrolytes abnormalities were observed in pediatric patients similar to those seen in adults. Three patients had abnormally low glucose levels (40 to 47 mg/dL). Two patients received Prepopik and one received the comparator (PEG). The abnormal values occurred at the colonoscopy visit for one patient (Prepopik) and at the 5-day follow up visit for the other two patients (Prepopik and PEG). All three patients were asymptomatic.
The following adverse reactions have been identified during post approval use of other oral formulations of sodium picosulfate, magnesium oxide and anhydrous citric acid similar to Prepopik. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity: rash, urticaria, purpura, and anaphylaxis [see CONTRAINDICATIONS]
Gastrointestinal: abdominal pain, diarrhea, fecal incontinence, aphthoid ileal ulcers, ischemic colitis [see WARNINGS AND PRECAUTIONS]
Neurologic: generalized tonic-clonic seizures with and without hyponatremia in epileptic patients, and syncope [see WARNINGS AND PRECAUTIONS].
Use caution when prescribing Prepopik for patients with conditions and/or who are taking other drugs that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, syncope, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities [see WARNINGS AND PRECAUTIONS].
Prepopik can reduce the absorption of other co-administered drugs [see DOSAGE AND ADMINISTRATION]:
Prior or concomitant use of antibiotics with Prepopik may reduce efficacy of Prepopik as conversion of sodium picosulfate to its active metabolite BHPM is mediated by colonic bacteria.
Included as part of the "PRECAUTIONS" Section
Advise patients to hydrate adequately before, during, and after the use of Prepopik. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking Prepopik, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Approximately 20% of adult patients in both arms (Prepopik, 2L of PEG + E plus two x 5-mg bisacodyl tablets) of clinical trials of Prepopik had orthostatic changes (changes in blood pressure and/or heart rate) on the day of colonoscopy. In adult clinical trials orthostatic changes were documented up to seven days post colonoscopy. In a single study of patients 9 to 16 years of age, approximately 20% of patients in Prepopik arms had orthostatic changes (changes in blood pressure and/or heart rate) compared with approximately 7% of those who received the comparator (PEG) [see Clinical Studies]. These changes occurred up to five days post colonoscopy.
Fluid and electrolyte disturbances can lead to serious adverse reactions including cardiac arrhythmias, seizures, renal impairment, and syncope [see Syncope]. Correct fluid and electrolyte abnormalities before treatment with Prepopik [see DOSAGE AND ADMINISTRATION]. Advise patients to consume a variety of clear liquids (e.g., balanced electrolyte solution), not only water after each dose of Prepopik. In addition, use caution when prescribing Prepopik for patients who have conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or that may increase the risk of adverse events of seizure, arrhythmia, and renal impairment [see DRUG INTERACTIONS].
There have been reports of generalized tonic-clonic seizures and/or loss of consciousness with the use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Use caution when prescribing Prepopik for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see ADVERSE REACTIONS].
Prepopik is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), accumulation of magnesium in plasma may occur. Use caution when prescribing Prepopik for patients with mild to moderate renal impairment or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see DRUG INTERACTIONS]. These patients may be at increased risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of Prepopik. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.
There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing Prepopik for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
Syncope has been reported with Prepopik in the postmarketing setting. Some cases were serious events that included falls with associated head injuries or fractures requiring hospitalization. In some cases, electrolyte abnormalities were also present (e.g., hyponatremia and hypokalemia). Cases have been reported after one or two Prepopik doses and many cases occurred within 12 hours of dosing. Patients should be aware of the risk of syncope during treatment and adequately hydrate before, during, and after the use of Prepopik. Advise patients to consume a variety of clear liquids (e.g., balanced electrolyte solution), not only water after each dose of Prepopik and to get up gradually from a lying orsitting position [see Serious Fluid And Electrolyte Abnormalities].
Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with Prepopik may increase this risk. The potential for mucosal ulcerations should be considered when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease [see ADVERSE REACTIONS].
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering Prepopik [see CONTRAINDICATIONS]. Use with caution in patients with severe active ulcerative colitis.
Patients with impaired gag reflex are at risk for regurgitation or aspiration during the administration of Prepopik. Observe these patients during the administration of Prepopik. Use with caution in these patients.
Each packet must be dissolved in 5 ounces of cold water and administered at separate times according to the dosing regimen [see DOSAGE AND ADMINISTRATION]. Ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Instruct patients:
Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with Prepopik. Sodium picosulfate was not mutagenic in the Ames test, the mouse lymphoma assay and the mouse bone marrow micronucleus test.
In an oral fertility study in rats, Prepopik did not cause any significant adverse effect on male or female fertility parameters up to a maximum dose of 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on the body surface area).
There are no data with Prepopik use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In an animal reproduction study, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based on body surface area during organogenesis.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Animal Data
A reproduction study with sodium picosulfate, magnesium oxide, and anhydrous citric acid has been performed in pregnant rats following oral administration of up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area) during the period of organogenesis. There was no evidence of harm to the fetus due to sodium picosulfate, magnesium oxide, and anhydrous citric acid. A reproduction study in rabbits was not adequate, as treatment-related mortalities were observed at all doses. A pre and postnatal development study with sodium picosulfate, magnesium oxide, and anhydrous citric acid in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area).
Published reproduction studies with sodium picosulfate in pregnant rats and rabbits during the period of organogenesis did not show evidence of harm to the fetus at doses up to 100 mg/kg (approximately 49 and 98 times, respectively, the recommended human dose of 10 mg sodium picosulfate based on body surface area).
There are no data on the presence of magnesium oxide or anhydrous citric acid in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Published data on lactating women indicate that the active metabolite of sodium picosulfate, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) remained below the limit of detection (1 ng/mL) in breast milk after both single and multiple doses of 10 mg/day. There are no data on the effects of sodium picosulfate on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Prepopik and any potential adverse effects on the breastfed infant from Prepopik or the underlying maternal condition.
The safety and effectiveness of Prepopik have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years of age and older. Use of Prepopik in this age group is supported by evidence from adequate and well-controlled trials of Prepopik in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age [see Clinical Studies]. The safety profile of Prepopik in this pediatric population was similar to that seen in adults [see ADVERSE REACTIONS]. Monitor for possible hypoglycemia in pediatric patients, as Prepopik has no caloric substrate.
The safety and effectiveness of Prepopik in pediatric patients less than 9 years of age have not been established.
Of the 1201 patients in clinical trials who received Prepopik, 215 (18%) patients were 65 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. However, elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see WARNINGS AND PRECAUTIONS].
Prepopik is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), as accumulation of magnesium in plasma may occur [see CONTRAINDICATIONS]. Patients with mild to moderate renal impairment or patients taking concomitant medications that may affect renal function may be at increased risk for renal injury [see WARNINGS AND PRECAUTIONS. Advise these patients of the importance of adequate hydration before, during and after the use of Prepopik [see DOSAGE AND ADMINISTRATION]. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.
Overdosage of more than the recommended dose of Prepopik may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances [see WARNINGS AND PRECAUTIONS]. Monitor for fluid and electrolyte disturbances and treat symptomatically.
Prepopik is contraindicated in the following conditions:
Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis.
Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.
The stimulant laxative activity of sodium picosulfate together with the osmotic laxative activity of magnesium citrate produces a purgative effect which, when ingested with additional fluids, produces watery diarrhea.
After administration of the first packet of Prepopik in 16 healthy subjects, mean maximum concentration (Cmax) for picosulfate of 2.3 ± 1.4 ng/mL was reached at 2 hours. After administration of 2 packets of Prepopik separated by 6 hours, picosulfate reached the mean Cmax of 3.2 ± 2.6 ng/mL at approximately 7 hours (Tmax). In the same study, baseline uncorrected magnesium reached a Cmax of approximately 1.9 mEq/L, which occurred at 10 hours post first packet administration (Tmax). This represents an approximately 20% increase from the baseline.
The apparent volume of distribution (V/F) for picosulfate was 4199 liters in healthy adults.
Sodium picosulfate, which is a prodrug, is converted to its active metabolite, BHPM, by colonic bacteria. Plasma concentration of the free BHPM were low, and below the lower limit of quantification (0.1 ng/mL) in 13 out of 16 subjects studied. The fraction of the sodium picosulfate dose excreted unchanged in urine was 0.2%. In urine, the majority of excreted BHPM was in the glucuronideconjugated form. The terminal half-life of sodium picosulfate was 7.4 hours. The apparent clearance (CL/F) of picosulfate was 629 L/h.
Pharmacokinetics of picosulfate was studied in pediatric patients aged from 9 to 16 years old.
For picosulfate, the apparent clearance is from 316 to 409 L/h. The corresponding estimates for apparent volume of distribution are from 2457 to 3935 liters. The derived half-life using these model estimates would be 7 hours. The picosulfate reached the mean Cmax of 3.5 ± 2.1 ng/mL at approximately 6 to 7 hours (Tmax)
The baseline uncorrected mean serum magnesium concentration was 2.02 mEq/L at 10 hours after the first dose of Prepopik and ranged from 1.7 to 2.46 mEq/L in pediatric patients from 9 to 16 years of age.
In an in vitro study using human liver microsomes, sodium picosulfate did not inhibit the major CYP enzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5) evaluated. Based on an in vitro study using freshly isolated hepatocyte culture, sodium picosulfate is not an inducer of CYP1A2, CYP2B6 or CYP3A4/5.
The colon cleansing efficacy of Prepopik was evaluated for non-inferiority against a comparator in two randomized, investigator-blinded, active-controlled, multicenter US trials in adult patients scheduled to have an elective colonoscopy. In all, 1195 adult patients were included in the primary efficacy analysis: 601 from Study 1, and 594 from Study 2. Patients ranged in age from 18 to 80 years (mean age 56 years); 61% were female and 39% male. Self-identified race was distributed as follows: 90% White, 10% Black, and less than 1% other. Of these, 3% self-identified their ethnicity as Hispanic or Latino.
Patients randomized to Prepopik in the two studies were treated with one of two dosing regimens:
The comparator was a preparation containing two liters of polyethylene glycol plus electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets, administered the day before the procedure. All patients in both the Prepopik and comparator groups were limited to a clear liquid diet on the day before the procedure (24 hours before).
The primary efficacy endpoint was the proportion of patients with successful colon cleansing, as assessed by blinded colonoscopists using the Aronchick Scale. The Aronchick scale is a tool used to assess overall colon cleansing. Successful colon cleansing was defined as bowel preparations with >90% of the mucosa seen and mostly liquid stool that were graded excellent (minimal suctioning needed for adequate visualization) or good (significant suctioning needed for adequate visualization) by the colonoscopist.
In both studies, Prepopik was non-inferior to the comparator. In addition, Prepopik provided by Split-Dose dosing met the prespecified criteria for superiority to the comparator for colon cleansing in Study 1. The comparator in that study was administered entirely on the day prior to colonoscopy. See Tables 3 and 4 below.
Table 3: Proportion of Patients with Successful Colon Cleansing in Study 1 Split-Dose Regimen
| PREPOPIK Split-Dose Regimen |
2L PEG+E* with 2 x 5-mg bisacodyl tablets |
Difference between treatment groups | |
| % (n/N) | % (n/N) | Difference | 95% CI |
| 84 % (256/304) | 74% (221/297) | 10% | (3.4%, 16.2%)† |
| * 2L PEG + E = two liters polyethylene glycol plus electrolytes solution. † Non-inferior and superior 2L PEG+E with 2 x 5-mg bisacodyl tablets |
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Table 4: Proportion of Patients with Successful Colon Cleansing in Study 2 Day-Before Regimen
| PREPOPIK Day-Before Regimen |
2L PEG+E* with 2 x 5-mg bisacodyl tablets |
Difference between treatment groups | |
| % (n/N) | % (n/N) | Difference | 95% CI |
| 83% (244/294) | 80% (239/300) | 3 % | (-2.9%, 9.6%)‡ |
| * 2L PEG + E = two liters polyethylene glycol plus electrolytes solution. ‡ Non-inferior |
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Prepopik was evaluated for colon cleansing in a randomized, assessor-blind, multicenter, dose-ranging, active-controlled study in 78 pediatric patients 9 years to 16 years of age. The majority of patients were female (68%), white (91%), and of non-Hispanic or non-Latino ethnicity (95%). The mean age was 12 years of age. All 78 patients were included in the primary efficacy analysis.
Patients aged 9 years to 12 years were randomized into 3 arms (1:1:1):
Patients aged 13 years to 16 years were randomized into 2 arms (1:1):
Patients randomized to Prepopik had two options for dosing, as determined by the investigator. The “Split Dose” regimen was the preferred method and the “Day Before” regimen was the alternative method if the “Split Dose” was not appropriate.
“Split-Dose” Regimen: (evening before and day of) dosing, where the first dose was taken the evening before the colonoscopy (between 5:00 and 9:00 PM), followed by five (5) 8-ounce glasses of clear liquid, and the second dose was taken the morning of the colonoscopy (at least 5 hours prior to but no more than 9 hours prior to colonoscopy), followed by three (3) 8-ounce glasses of clear liquid.
“Day-Before” Regimen: (afternoon/evening before only) dosing, where both doses were taken separately on the day before the colonoscopy, with the first dose taken in the afternoon (between 4:00 and 6:00 PM), followed by five (5) 8-ounce glasses of clear liquid, and the second dose taken in the late evening (approximately 6 hours later, between 10:00 PM and 12:00 AM), followed by three (3) 8-ounce glasses of clear liquid.
All patients randomized to Prepopik were limited to a clear liquid diet on the day before the procedure. Those who received the comparator were given dietary instructions per the trial site’s standard of care.
The primary efficacy endpoint was the proportion of patients with successful colon cleansing as defined as a rating of either “Excellent” (> 90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization) or “Good” (> 90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization) using the Aronchick scale, as assessed by blinded colonoscopists.
The Prepopik regimen of one-half packet administered as two doses did not demonstrate comparable efficacy to the comparator, PEG, in patients 9 to 12 years of age and is not a recommended dosage regimen [see DOSAGE AND ADMINISTRATION].
The Prepopik regimen of one packet administered as two doses demonstrated successful colon cleansing in both the 9 to 12 year age group and the 13 to 16 year age group. The efficacy rates were similar to those observed in the PEG groups, as shown in Table 5.
Table 5. Proportion of Patients 9 to 16 Years of Age with Successful Colon Cleansing1
| PREPOPIK One Packet Administered as TwoDoses either as Split Dose or Day Before Regimen2 | PEG Comparator3 | |||
| % (n/N) | 95% CI | % (n/N) | 95% CI | |
| Age 9-12 | 88% (14/16) | (62, 98) | 81% (13/16) | (54, 96) |
| Age 13-16 | 81% (13/16) | (54, 96) | 86% (12/14) | (57, 98) |
| 1 Successful colon cleansing as defined by “Excellent” or “Good” on the Aronchick scale 2 Of the 32 patients, 9 received the Split Dose Regimen and 23 the Day Before Regimen 3 Oral PEG-based preparation was used in the study as per standard of care |
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PREPOPIK®
(prep-o-pik)
(sodium picosulfate, magnesium oxide, and anhydrous citric acid) for oral solution
Read and understand this Medication Guide and the Instructions for Use that come with PREPOPIK at least 2 days before your colonoscopy and again before you start taking Prepopik.
What is the most important information I should know about Prepopik?
Prepopik and other bowel preparations can cause serious side effects, including:Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:
Your chance of having fluid loss and changes in blood salts with Prepopik is higher if you:
Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid(dehydration) while taking Prepopik:
See “What are the possible side effects of Prepopik?” for more information about side effects.
What is Prepopik?
Prepopik is a prescription medicine used by adults and children 9 years of age and older to clean the colon before a colonoscopy. Prepopik cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.
It is not known if Prepopik is safe and effective in children under 9 years of age.
Do not take Prepopik if your healthcare provider has told you that you have:
Before taking Prepopik, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Prepopik may affect how other medicines work, and other medicines may affect how Prepopik works. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of Prepopik.
Especially tell your healthcare provider if you take:
The following medicines should be taken at least 2 hours before starting Prepopik and not less than 6 hours after taking Prepopik:
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking the medicines listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Prepopik?
See the Instructions for Use for dosing instructions. You must read, understand, and follow these instructions to take Prepopik the right way.
Contact your healthcare provider right away if after taking Prepopik you have severe vomiting, signs of dehydration, changes in consciousness such as feeling confused, delirious or fainting (loss of consciousness) or seizures after taking Prepopik.
What are the possible side effects of Prepopik?
Prepopik can cause serious side effects, including:
The most common side effects of Prepopik in adults include:
The most common side effects of Prepopik in children 9 to 16 years of age include:
These are not all the possible side effects of Prepopik.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Prepopik?
Keep Prepopik and all medicines out of the reach of children.
General information about the safe and effective use of Prepopik.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Prepopik for a condition for which it was not prescribed. Do not give Prepopik to other people, even if they are going to have the same procedure you are. It may harm them. You can ask your pharmacist or healthcare provider for information about Prepopik that is written for health professionals.
What are the ingredients in Prepopik?
Prepopik comes in a carton containing 2 packets, each containing 16.1 grams of powder in orange flavor or 16.2 grams of powder in cranberry flavor, along with a pre-marked dosing cup.
Active ingredients: sodium picosulfate, magnesium oxide, and anhydrous citric acid
Inactive ingredients: potassium hydrogen carbonate, saccharin sodium, orange flavor which contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole or the cranberry flavor which contains maltodextrin, glyceryl triacetate (triacetin) and sodium octenyl succinated starch.
This Medication Guide has been approved by the U.S. Food and Drug Administration
INSTRUCTIONS FOR USE
Prepopik®
(prep-o-pik) (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for oral solution
Before Taking Prepopik
There are 2 different methods for taking Prepopik. It is better (preferred) to use the Split-Dose method. If you cannot use the Split-Dose method, you can take Prepopik using the Day-Before method. Talk with your healthcare provider before you start if you have any questions.
Important:
See Table 1 for a list of liquids you can drink for your clear liquid diet.
Table 1: List of liquids for the clear-liquid diet
Important:
See Table 2 for the items you cannot eat or drink before your colonoscopy.
Table 2: Do not eat or drink these items during the clear-liquid diet
Important:
Split-Dose Instructions
Dose 1 – In the evening the day before your colonoscopy (sometime between 5:00 PM to 9:00 PM)
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Note: Prepopik powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.
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Important: See Table 1 for a list of acceptable clear liquids.
Dose 2 -In the morning of colonoscopy (approximately 5 hours prior to colonoscopy)
Note: Do not eat solid food. Drink only clear liquids.
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Note: Prepopik powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.
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Important: See Table 1 for a list of acceptable clear liquids.
Stop drinking clear liquids 2 hours before your colonoscopy, or as advised by your healthcare provider.
Day-Before Instructions
Dose 1 – In the afternoon or early evening the day before your colonoscopy (sometime between 4:00 PM to 6:00 PM)
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Note: Prepopik powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.
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After taking Prepopik if you have any bloating or feeling like your stomach is upset, wait to take your second dose until your stomach feels better.
Important: See Table 1 for a list of acceptable clear liquids.
Dose 2 – In the evening before your colonoscopy (sometime between 10:00 PM to 12:00 AM):
Note: Do not eat solid food. Drink only clear liquids. Do not drink only plain water (see Table 1).
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Note: Prepopik powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.
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Important: See Table 1 for a list of acceptable clear liquids.
Stop drinking clear liquids 2 hours before your colonoscopy, or as advised by your healthcare provider.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
