What is the use of Picosulfate (laxative) in pediatrics?

From the Guidelines

Sodium picosulfate is a recommended stimulant laxative for short-term use in pediatric patients with constipation, as stated in the 2023 clinical practice guideline by the American Gastroenterological Association and American College of Gastroenterology 1.

Key Considerations

• The guideline suggests the use of bisacodyl or sodium picosulphate short term or as rescue therapy over management without these agents, with a strong recommendation and moderate certainty of evidence 1.
• For children, the recommended dosing of sodium picosulfate is age-dependent, typically ranging from 2.5-10 mg (¼-1 sachet) administered once daily.
• Picosulfate works as a stimulant laxative by increasing intestinal motility and water retention in the colon, typically producing a bowel movement within 6-12 hours.
• Common side effects include abdominal cramps and diarrhea, and adequate hydration is essential during treatment to prevent electrolyte imbalances.

Important Precautions

• Picosulfate should not be used in children with intestinal obstruction, acute inflammatory bowel conditions, or severe dehydration.
• For chronic constipation, it should be used as a short-term solution while addressing underlying causes through dietary changes, increased fluid intake, and regular physical activity.

Additional Guidance

• A study from 2014 provides guidance on bowel preparation regimens for pediatric patients, including the use of sodium picosulfate, and highlights the importance of individualizing the selection of bowel preparation regimens according to the patient's age, clinical state, and anticipated willingness or ability to comply with the specific medications 1.
• The study also notes that maintenance of adequate hydration during colonoscopy preparation is important, especially in children.

From the FDA Drug Label

The safety and effectiveness of sodium picosulfate, magnesium oxide and anhydrous citric acid have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years of age and older Use of sodium picosulfate, magnesium oxide and anhydrous citric acid in this age group is supported by evidence from adequate and well-controlled trials of sodium picosulfate, magnesium oxide and anhydrous citric acid in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age The safety profile of sodium picosulfate, magnesium oxide and anhydrous citric acid in this pediatric population was similar to that seen in adults Monitor for possible hypoglycemia in pediatric patients, as sodium picosulfate, magnesium oxide and anhydrous citric acid has no caloric substrate. The safety and effectiveness of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution in pediatric patients less than 9 years of age have not been established.

Key Points:

• Sodium picosulfate is approved for use in pediatric patients 9 years of age and older.
• The safety profile in pediatric patients is similar to that in adults.
• Monitoring for hypoglycemia is recommended in pediatric patients.
• The safety and effectiveness in pediatric patients less than 9 years of age have not been established 2.

From the Research

Efficacy of Picosulfate in Pediatrics

• Sodium picosulfate/magnesium citrate is an effective colorectal cleansing agent in children and adolescents, as shown in a study published in 2009 3.
• The preparation was more effective than oral bisacodyl 0.01 or 0.02 g plus a sodium phosphate enema preparation in this population 3.
• A study published in 2004 found that bowel preparation with picosulphate sodium and clear fluids provides an effective, practical method of preparing the bowel for colonoscopy in children and adolescents 4.
• Another study published in 2018 found that sodium picosulphate-magnesium citrate is an effective, safe, and well-tolerated option for bowel preparation in pediatric patients undergoing colonoscopy 5.

Safety and Tolerability

• Sodium picosulfate/magnesium citrate is generally well tolerated in pediatric patients, with adverse events being mild to moderate in intensity and mainly gastrointestinal in nature 3, 5.
• The most common adverse events reported in pediatric patients include nausea, abdominal pain, and vomiting 5.
• A study published in 2004 found that 47.8% of pediatric patients experienced side effects, including abdominal pain and nausea, but the preparation was still considered effective and well tolerated 4.

Comparison with Other Laxatives

• Sodium picosulfate/magnesium citrate has been compared to other laxatives, such as polyethylene glycol, and has been found to be at least as effective and well tolerated 3, 6.
• A study published in 2016 found that polyethylene glycol is more efficacious than placebo for the treatment of functional constipation in pediatric patients, but sodium picosulfate/magnesium citrate may be a more convenient and palatable option 6.

Usage Patterns

• A study published in 2008 found that patients using sodium picosulfate for self-treatment of constipation reported high efficacy and safety, with 90% rating the efficacy as "very good" to "good" 7.
• The study also found that patients were generally compliant with the recommended dosage and indication, and that adverse events were mild to moderate in intensity 7.