Sodium Picosulfate — Active Pharmaceutical Ingredient

Sodium Picosulfate is an active pharmaceutical ingredient found in 4 FDA-approved drug products. Forms: FOR SOLUTION, SOLUTION. Routes: ORAL.

This content is for informational purposes only. Always consult a healthcare professional.

Sodium Picosulfate (4 brand names, 2 dosage forms, 1 route)

Available dosage forms: FOR SOLUTION, SOLUTION.

Routes of administration: ORAL.

Brand Names

  • CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
  • CLENPIQ
  • PREPOPIK
  • SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Indications and Usage

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

Contraindications

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 [see Warnings and Precautions (5.3)]. Gastrointestinal obstruction or ileus [see Warnings and Precautions (5.6)]. Bowel perforation [see Warnings and Precautions (5.6)]. Toxic colitis or toxic megacolon. Gastric retention. Hypersensitivity to any of the ingredients in CLENPIQ [see Adverse Reactions (6.2)].

Adverse Reactions

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 (5.1)] Seizures [see Warnings and Precautions (5.2)] Use in Patients with Renal Impairment [see Warnings and Precautions (5.3)] Cardiac Arrhythmias [see Warnings and Precautions (5.4)] Syncope [see Warnings and Precautions (5.5)] Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions (5.6)] Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.7)] Aspiration [see Warnings and Precautions (5.8)]

Mechanism of Action

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.

Overdosage

Overdosage of more than the recommended dose of CLENPIQ may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances [see Warnings and Precautions (5.1)]. Monitor for fluid and electrolyte disturbances and treat symptomatically.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.