For: Bowel Preparation
Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) is a stimulant laxative and osmotic laxative combination indicated for cleansing of the colon as a preparation for colonoscopy.Generic Name : sod picosulf/mag ox/citric ac
Route : ORAL
Dose Form : SOLUTION, ORAL
Strength : 10 mg-3.5 gram-12 gram/160 mL
AHFS Therapeutic Classifications
56120000 CATHARTICS AND LAXATIVES
Active Ingredients
000788 magnesium oxide 001309484
002487 citric acid 000077929
003762 sodium picosulfate 010040456
Inactive Ingredients
003785 edetic acid 000060004
006300 sulfite 014265453
These highlights do not include all the information needed to use CLENPIQ� safely and effectively. See full prescribing information for CLENPIQ.
CLENPIQ� (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution
Initial U.S. Approval: 2012
INDICATIONS AND USAGE
CLENPIQ� is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid, which form magnesium citrate, an osmotic laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults. ( 1)
DOSAGE AND ADMINISTRATION
Administration:
CLENPIQ is ready to drink. It does not need to be diluted prior to administration. One bottle of CLENPIQ is equivalent to one dose. ( 2.1)
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. ( 2.1)
Additional fluids must be consumed after every dose of CLENPIQ in both dosing regimens. ( 2.1, 5.1)
Do not take oral medications within 1 hour of start of each dose. ( 2.1, 7.2)
If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of CLENPIQ. ( 2.1, 7.3)
For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. ( 2.1, 2.2, 2.3)
Split-Dose Dosage Regimen (Preferred Method) ( 2.2)
First dose: administer during evening before the colonoscopy
Second dose: administer the next day, during the morning prior to the colonoscopy.
Day-Before Dosage Regimen (Alternative Method), if Split-Dosing is inappropriate ( 2.3)
First dose: administer during afternoon or early evening before the colonoscopy.
Second dose: administer 6 hours later during evening before colonoscopy.
DOSAGE FORMS AND STRENGTHS
CLENPIQ oral solution : Each bottle contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide, and 12 g of anhydrous citric acid in 160 mL of solution ( 3)
CONTRAINDICATIONS
Patients with severely reduced renal function (creatinine clearance less than 30 mL/minute) ( 4, 5.3, 8.6)
Gastrointestinal (GI) obstruction or ileus ( 4)
Bowel perforation ( 4)
Toxic colitis or toxic megacolon ( 4)
Gastric retention ( 4)
An allergy to any of the ingredients in CLENPIQ ( 4)
WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities, arrhythmia, seizures, and renal impairment: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. ( 5.1, 5.2, 5.3, 5.4, 7.1)
Use in patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration, and consider testing. ( 4, 5.3, 7.1)
Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5)
Suspected GI obstruction or perforation: Rule out diagnosis before administration. ( 4, 5.6)
Patients at risk for aspiration: Observe during administration. ( 5.7)
ADVERSE REACTIONS
Most common adverse reactions (>1%) are nausea, headache, and vomiting. ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that increase risks due to fluid and electrolyte changes. ( 7.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2017
