Anhydrous citric acid, Magnesium oxide and Sodium picosulfate

CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. 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 and pediatric patients ages 9 years and older.

Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.

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. Two doses of CLENPIQ are required for a complete preparation for colonoscopy as a Split-Dose regimen. Consume five or more 8-ounce cups of clear liquids after the first dose and four or more 8-ounce cups of clear liquids after the second dose. Consume a variety of clear liquids after each dose of CLENPIQ. Ensure inclusion of balanced electrolyte solution along with other clear liquids. Administer oral medications at least 1 hour before starting CLENPIQ. 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.

CLENPIQ is contraindicated in the following conditions: Patients with severe renal impairment (creatinine clearance less than 30 mL/minute), which may result in accumulation of magnesium. Gastrointestinal obstruction or ileus. Bowel perforation. Toxic colitis or toxic megacolon. Gastric retention. Hypersensitivity to any of the ingredients in CLENPIQ. Severe renal impairment (creatinine clearance less than 30 mL/minute). Gastrointestinal (GI) obstruction or ileus. Bowel perforation. Gastric retention.

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. Use in patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration, and consider testing. Syncope: Resulted in serious outcomes including falls, head injuries, and fractures, encourage adequate hydration. Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. Suspected GI obstruction or perforation: Rule out diagnosis before administration. Patients at risk for aspiration: Observe during administration.

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities Seizures Use in Patients with Renal Impairment Cardiac Arrhythmias Syncope Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis Use in Patients with Significant Gastrointestinal Disease Aspiration Most common adverse reactions are: Adults (≥2%): nausea, headache, hypermagnesemia, abdominal pain and dehydration or dizziness. Pediatrics 9 to 16 years (>5%): nausea, vomiting, and abdominal pain.

Drugs that increase risks due to fluid and electrolyte changes. Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing CLENPIQ for patients with conditions or who are taking other drugs, that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, syncope, arrhythmias or QT prolongation in the setting of fluid and electrolyte abnormalities.

Store CLENPIQ at 25°C (77°F). Excursions permitted at 15°C to 30°C (59°F to 86°F). Do not refrigerate or freeze.