Recommended Topic Related To:

Prepopik

"Oct. 17, 2012 -- A drug used to treat psoriasis may provide a much-needed option for people with bad cases of Crohn's disease.

In the new study, some people with moderate to severe Crohn's given Stelara (ustekinumab) began to see imp"...

Prepopik

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 Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for oral solution) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities

Use caution when prescribing PREPOPIK for patients with conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids, or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when PREPOPIK is used in patients on nonsteroidal anti-inflammatory drugs (NSAIDS) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance. Consider additional patient evaluations as appropriate, [see ADVERSE REACTIONS]

Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of administration of PREPOPIK solution may be flushed from the GI tract and the medication may not be absorbed.

Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of PREPOPIK to avoid chelation with magnesium.

Antibiotics

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.

Read the Prepopik Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/27/2012
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


GI Disorders

Get the latest treatment options.