MiraLAX Dosing for Children
For children 17 years and older, the FDA-approved dose is 17 grams (one capful or packet) dissolved in 4-8 ounces of any beverage once daily for up to 7 days; for children 16 years and younger, the FDA label states to "ask a doctor" as there is no FDA-approved pediatric dose, though clinical evidence supports weight-based dosing of approximately 0.5-1.5 g/kg/day. 1
FDA-Approved Dosing
- Adults and children ≥17 years: 17 grams (one capful or packet) dissolved in 4-8 ounces of beverage once daily, maximum 7 days 1
- Children ≤16 years: No FDA-approved dose; label directs to consult a physician 1
- The powder must be fully dissolved before drinking, and should not be consumed if clumps remain 1
- Can be mixed with cold, hot, or room temperature beverages 1
- Should not be combined with starch-based thickeners 1
Evidence-Based Pediatric Dosing (Off-Label)
While not FDA-approved for children under 17, substantial clinical evidence supports weight-based dosing:
Weight-Based Dosing Strategy
- Average effective dose: 0.63 g/kg/day based on clinical studies in children with dysfunctional elimination 2
- Typical dosing range: 0.5-1.5 g/kg/day, with most children responding to doses in this range 2, 3
- Colonoscopy preparation: 1.5 g/kg divided twice daily for 2 days has proven effective and safe 3
Practical Application
- For a child weighing 20 kg, this translates to approximately 10-30 grams daily (roughly 0.6-1.8 capfuls of the 17-gram dose) 2
- Dosing can be adjusted based on response, with the goal of achieving regular, soft bowel movements without diarrhea 2
- The medication can be titrated upward if constipation persists, though some children may remain constipated even at higher doses 2
Safety Profile in Children
PEG 3350 demonstrates excellent safety and tolerability in pediatric populations:
- Most common adverse effect: Diarrhea, reported in approximately 20% of patients (9 of 46 in one study) 2
- No serious adverse events reported in clinical trials 3
- Non-addictive and tasteless, improving compliance compared to other laxatives 2, 4
- Laboratory values (serum chemistry panels) remain stable during treatment 3
Clinical Efficacy
- Significant increase in bowel movement frequency (p = 0.0001) 2
- 88% of children achieved excellent/good bowel preparation for colonoscopy compared to 29% with senna (p = 0.0022) 3
- In children with dysfunctional elimination: 39% became completely dry, 57% had decreased wetting, and only 4% showed no improvement 2
- Improved voiding parameters: increased voided volume (146 vs 210 mL, p <0.0001) and decreased post-void residual (92 vs 48 mL, p <0.0001) 2
Important Clinical Considerations
Common pitfalls to avoid:
- Duration limitation: The FDA label specifies maximum 7 days for over-the-counter use, though clinical practice often involves longer-term maintenance therapy under physician supervision 1, 4
- Persistent constipation: Children who remain constipated despite treatment have significantly higher post-void residuals and less improvement in symptoms 2
- Dose inadequacy: If constipation persists, the dose may need adjustment rather than switching medications, as the average dose in treatment failures (0.69 g/kg) did not differ significantly from successes (0.61 g/kg), suggesting individual variation 2
Role in Treatment Guidelines
- Consensus guidelines recommend osmotic laxatives like PEG 3350 as first-line maintenance treatment for pediatric functional constipation 4
- Should be used in conjunction with patient and parental education and behavioral training 4
- Particularly valuable for children who have failed or are intolerant of other pharmacotherapies 4