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Prepopik

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Prepopik

Prepopik Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Prepopik is indicated for cleansing of the colon as a preparation for colonoscopy in adults. It is a laxative. The most common side effects from Prepopik were nausea, headache, and vomiting.

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. Other drugs may interact with Preopik. Tell your doctor all medications you use. 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.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prepopik FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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) l/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)

Postmarketing Experience

The following foreign spontaneous reports have been identified during use of formulations similar to PREPOPIK. Because these events 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.

Allergic reactions

Cases of hypersensitivity reactions including rash, urticaria, and purpura have been reported.

Electrolyte abnormalities

There have been reports of hypokalemia, hyponatremia and hypermagnesemia with the use of PREPOPIK for colon preparation prior to Colonoscopy.

Gastrointestinal

Abdominal pain, diarrhea, fecal incontinence, and proctalgia have been reported with the use of PREPOPIK for colon preparation prior to colonoscopy. There have been isolated reports of reversible aphthoid ileal ulcers. Ischemic colitis has been reported with the use of PREPOPIK for colon preparation prior to colonoscopy. However, a causal relationship between these ischemic colitis cases and the use of PREPOPIK has not been established.

Neurologic

There have been reports of generalized tonic-clonic seizures associated with and without hyponatremia in epileptic patients.

Read the entire FDA prescribing information for Prepopik (Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid) for Oral Solution) »

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