Medical Editor: John P. Cunha, DO, FACOEP
What Is Prepopik?
Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for Oral Solution is a stimulant laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.
What Are Side Effects of Prepopik?
The most common side effects from Prepopik were:
- nausea,
- headache, and
- vomiting
Tell your doctor if you have symptoms of loss of too much body fluid (dehydration) while taking Prepopik including vomiting that prevents you from keeping down the additional prescribed amounts of clear liquids that you must drink after taking Prepopik, dizziness, or urinating less often than normal.
Prepopik may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- lightheadedness,
- confusion,
- irregular heartbeats,
- seizure,
- little or no urination,
- severe nausea,
- vomiting,
- painful bloating,
- severe stomach cramps,
- rectal bleeding,
- trouble swallowing, and
- trouble drinking liquids
Get medical help right away, if you have any of the symptoms listed above.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Prepopik
Prepopik is supplied as a powder, and is reconstituted with cold water right before use. Each of 2 packets contains 16.1 g of powder: 10 mg sodium picosulfate, 3.5 g magnesium oxide, and 12 g anhydrous citric acid. The first dose is administered in the evening before the colonoscopy, and the second dose is administered the next morning prior to the colonoscopy.
What Drugs, Substances, or Supplements Interact with Prepopik?
Other drugs may interact with Preopik. Tell your doctor all medications you use.
Prepopik During Pregnancy or Breastfeeding
Prepopik should be used during pregnancy only if clearly needed. It is not known if Prepopik passes into breast milk. Women should talk with their doctors about taking Prepopik before breastfeeding.
Additional Information
Our Prepopik Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor right away if you have:
- a light-headed feeling, like you might pass out;
- confusion;
- irregular heartbeats;
- a seizure;
- little or no urination;
- severe nausea or vomiting;
- painful bloating, severe stomach cramps;
- rectal bleeding; or
- trouble swallowing, trouble drinking liquids.
Common side effects may include:
- stomach pain;
- nausea, vomiting; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Pancreatitis is inflammation of an organ in the abdomen called the pancreas. See AnswerSIDE EFFECTS
The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:
- Serious Fluid and Electrolyte Abnormalities [see WARNINGS AND PRECAUTIONS]
- Cardiac Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Use in Patients with Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see WARNINGS AND PRECAUTIONS]
- Use in Patients with Significant Gastrointestinal Disease [see WARNINGS AND PRECAUTIONS]
- Aspiration [see WARNINGS AND PRECAUTIONS]
- Risk of Vomiting and Other Gastrointestinal Complications with Ingestion of Undissolved Powder [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
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 |
||||
Electrolyte Abnormalities
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) | |
Pediatrics
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 Trials]. 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.
Postmarketing Experience
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 [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Prepopik (Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid) for Oral Solution)
© Prepopik Patient Information is supplied by Cerner Multum, Inc. and Prepopik Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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