From the FDA Drug Label
Pediatric: ...the recommended initial daily oral dose in infants is 2.5 mL to 10 mL in divided doses. The recommended dose of lactulose for infants is 2.5 mL to 10 mL in divided doses 1.
- The dose may be adjusted to produce 2 or 3 soft stools daily.
- If the initial dose causes diarrhea, the dose should be reduced immediately.
- If diarrhea persists, lactulose should be discontinued.
From the Research
The recommended dose of lactulose for infants is 1-3 mL per day for newborns and young infants, divided into multiple doses, with a higher dose of 4-6 ml/kg/day (max. 120 ml/day) for disimpaction therapy, as supported by the most recent study 2.
Key Considerations
- Lactulose should be administered orally and can be mixed with formula, breast milk, or water if needed to improve palatability.
- The medication typically takes 24-48 hours to show effect, and its efficacy can be assessed by monitoring stool consistency and frequency.
- Lactulose works by drawing water into the intestine and softening stool through its osmotic properties, making it an effective treatment for constipation in infants.
Age-Based Dosing
- For newborns and young infants, the dose typically ranges from 1-3 mL per day, divided into multiple doses.
- For older infants (6-12 months), the dose may increase to 5-10 mL per day, but this should be determined on a case-by-case basis, considering the infant's weight and response to treatment.
Important Notes
- Always consult with a pediatrician before administering lactulose to infants, as individual dosing may vary based on the specific condition being treated, the infant's weight, and their response to treatment.
- The most recent study 2 provides evidence for the safety and efficacy of lactulose in infants, and its findings should be considered when determining the optimal dose for a given patient.