Lactulose for Infant Constipation
Lactulose is safe and effective for treating constipation in infants, with the FDA-approved dosing of 2.5-10 mL daily in divided doses for infants under 6 months, and can be used as first-line therapy alongside dietary measures like prune, pear, or apple juice. 1
Age-Specific Dosing Algorithm
Infants Under 6 Months
- Start with 2.5-10 mL daily in divided doses as the FDA-approved initial dosing range 1
- Lactulose and lactitol-based medications are specifically authorized and effective before 6 months of age 2
- The goal is to produce 2-3 soft stools daily, adjusting the dose every 1-2 days based on response 1
Infants 6-12 Months
- Begin with 2.5-10 mL daily in divided doses, which can be increased as needed 1
- For older infants approaching 12 months, the total daily dose range extends to 40-90 mL as tolerated 1
- Polyethylene glycol (PEG) becomes an additional option after 6 months of age, though lactulose remains effective 2
Treatment Strategy and Positioning
First-Line Approach
- Dietary interventions should be attempted first using fruit juices high in sorbitol and fructose (prune, pear, apple juice at 10 mL/kg body weight) to increase stool frequency and water content 3
- If dietary measures fail after 1-2 weeks, initiate lactulose at the lower end of the dosing range 1, 2
Dose Titration Protocol
- If the initial dose causes diarrhea, reduce the dose immediately 1
- If diarrhea persists despite dose reduction, discontinue lactulose 1
- Increase the dose gradually every 1-2 days if constipation persists, targeting 2-3 soft, non-forced bowel movements daily 1
Safety Profile in Infants
Common Side Effects
- Bloating and flatulence occur in approximately 20% of patients and are dose-dependent 4, 5
- Abdominal cramping and gas distension may occur but are generally mild 5
Serious Adverse Effects to Monitor
- Excessive dosing can lead to diarrhea with potential complications including hypokalemia (low potassium) and hypernatremia (high sodium) 4
- Monitor for signs of dehydration if diarrhea develops, particularly in young infants 5
Clinical Pitfalls to Avoid
Dosing Errors
- Do not assume that lack of effect with smaller doses can be remedied with much larger doses - this can lead to electrolyte complications 5
- Very little information exists on lactulose use in young children, so careful monitoring is essential 1
Treatment Duration
- Lactulose requires sufficient dosing for a long enough duration - underdosing and premature discontinuation are common causes of treatment failure 2
- Continue therapy until regular bowel patterns are established, which may take weeks to months 2
When to Escalate Care
- If constipation persists despite adequate lactulose dosing at maximum tolerated doses for 2-4 weeks, investigate for underlying causes rather than simply increasing the dose further 5
- Consider referral to pediatric gastroenterology if symptoms suggest Hirschsprung's disease (constipation from birth, failure to pass meconium within 48 hours, explosive stools with rectal exam) 6
Mechanism and Expected Response
- Lactulose is a synthetic disaccharide that exerts an osmotic laxative effect in the colon by retaining water and promoting peristalsis 4
- Clinical improvement may occur within 24 hours but may not begin before 48 hours or even later 1
- The malabsorption of carbohydrates in lactulose creates an osmotic load that increases stool frequency and water content 3