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Clenpiq

Last reviewed on RxList: 8/19/2019
Clenpiq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/19/2019

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution is a combination of a stimulant laxative and an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Common side effects of Clenpiq:

Clenpiq is ready to drink. It does not need to be diluted prior to administration. One bottle of Clenpiq is equivalent to one dose. Two doses of Clenpiq are required for a complete preparation for colonoscopy. The preferred method is the “Split-Dose” method. The alternative is the “Day Before” method. Additional fluids must be consumed after every dose of Clenpiq in both dosing regimens. Clenpiq may interact with other drugs that increase the risk for fluid and electrolyte disturbances and antibiotics. Clenpiq can reduce the absorption of other co-administered drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Clenpiq; it is unknown how it would affect a fetus. It is unknown if Clenpiq passes into breast milk. Consult your doctor before breastfeeding.

Our Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution 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.

QUESTION

What are risk factors for developing colon cancer? See Answer
Clenpiq Consumer Information

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.

Read the entire detailed patient monograph for Clenpiq (Sodium Picosulfate Oral Solution)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Clenpiq Professional Information

SIDE 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]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Use in Patients with Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Cardiac Arrhythmias [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]

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.

The safety of CLENPIQ has been established from adequate and well-controlled trials of another orally administered product of sodium picosulfate, magnesium oxide and anhydrous citric acid [see Clinical Studies]. Adverse reactions reported in these adequate and well-controlled studies are described below.

In two randomized, multicenter, investigator-blinded, active-controlled clinical trials for colon cleansing, another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid was compared with a regimen of two liters (2 L) of polyethylene glycol plus electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets, all administered the day before the procedure [see Clinical Studies]. Patients were not blinded to study treatment. Table 1 displays the most common adverse reactions for the Split-Dose and Day-Before dosing regimens in Studies 1 and Study 2, respectively.

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 reactions 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 reaction), or showed clinically significant worsening during the study that was not in the frame of the usual clinical course, as determined by the investigator.

Table 1: Adverse Reactions1 observed in at Least 1% of Patients using the Split-Dose Regimen or Day-Before Regimen for Colon Cleansing2

Adverse Reaction Study 1: Split-Dose Regimen Study 2: Day-Before Regimen
Sodium picosulfate, magnesium oxide, and anhydrous citric acid
(N=305)
n (% = n/N)
2 L PEG+E3 with 2 x 5-mg bisacodyl tablets
(N=298)
n (% = n/N)
Sodium picosulfate, magnesium oxide, and anhydrous citric acid
(N=296)
n (% = n/N)
2 L PEG+E3 with 2 x 5-mg bisacodyl tablets
(N=302)
n (% = n/N)
Nausea 8 (3) 11 (4) 9 (3) 13 (4)
Headache 5 (2) 5 (2) 8 (3) 5 (2)
Vomiting 3 (1) 10 (3) 4 (1) 6 (2)
1 2abdominal bloating, distension, pain/cramping, and watery diarrhea not requiring an intervention were not collected
3 2 L PEG + E = two liters polyethylene glycol plus electrolytes solution.

Electrolyte Abnormalities

In general, sodium picosulfate, magnesium oxide, and anhydrous citric acid was associated with numerically higher rates of abnormal electrolyte shifts on the day of colonoscopy compared to the control regimen (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 Visit Study 1: Split-Dose Regimen Study 2: Day-Before Regimen
Parameter (direction of change) Sodium picosulfate, magnesium oxide, and anhydrous citric acid 2 L PEG+E with 2x 5 mg bisacodyl tablets Sodium picosulfate, magnesium oxide, and anhydrous citric acid 2 L 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)
eGFR = estimated glomerular filtration rate

Pediatrics

In the pediatric patients aged 9 to 16 years who received another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid, 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 sodium picosulfate, magnesium oxide, and anhydrous citric acid and one received the comparator (PEG). The abnormal values occurred at the colonoscopy visit for one patient (sodium picosulfate, magnesium oxide, and anhydrous citric acid) and at the 5-day follow up visit for the other two patients (sodium picosulfate, magnesium oxide, and anhydrous citric acid and PEG). All three patients were asymptomatic.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of another oral product of sodium picosulfate (10 mg), magnesium oxide (3.5 mg) and anhydrous citric acid (12 g). 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, and purpura

Gastrointestinal: abdominal pain, diarrhea, fecal incontinence, proctalgia, reversible 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 Clenpiq (Sodium Picosulfate Oral Solution)

Related Resources for Clenpiq

© Clenpiq Patient Information is supplied by Cerner Multum, Inc. and Clenpiq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

What are risk factors for developing colon cancer? See Answer

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