Is polyethylene glycol (Miralax) safe for use in a 4-month-old infant?

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From the Guidelines

Miralax (polyethylene glycol 3350) is not recommended for infants as young as 4 months old without specific medical supervision. The safety and efficacy of bowel preparations, including Miralax, have not been well studied in infants, and there is limited data on its use in this age group 1. The American Gastroenterological Association and the American Society of Gastrointestinal Endoscopy have expressed concerns about the use of sodium phosphate (NaP) preparations in children, and similar concerns may apply to Miralax due to the potential for fluid and electrolyte abnormalities 1.

For infants, doctors typically recommend gentler interventions first, such as:

  • Adjusting formula if formula-fed
  • Ensuring proper hydration
  • Giving small amounts of prune or pear juice (1-2 ounces) diluted with water
  • Using glycerin suppositories specifically designed for infants These methods are often effective in managing infant constipation and are considered safer than using Miralax or other laxatives.

It is essential to consult with a pediatrician before using any medication, including Miralax, in a 4-month-old infant, as persistent constipation could indicate an underlying issue that needs proper evaluation. The Israeli Society of Pediatric Gastroenterology and Nutrition has recommended that certain medications, including NaP, should not be used in children younger than 12 years of age or with certain comorbidities, highlighting the need for caution when considering laxative use in infants 1.

In the case of a 4-month-old infant experiencing constipation, it is crucial to seek medical advice to determine the best course of treatment and rule out any underlying conditions that may require medical attention. Always prioritize medical supervision when considering the use of any medication, including Miralax, in infants.

From the FDA Drug Label

children 16 years of age or under: ask a doctor The FDA drug label does not answer the question for a 4-month-old, as it only provides guidance for children 16 years of age or under, without specifying dosage or usage for infants.

  • Key point: The label advises to ask a doctor for children under 16, implying that medical consultation is necessary for this age group.
  • For a 4-month-old, caution is warranted, and the label does not provide sufficient information to make a decision. 2

From the Research

Miralax in a 4-Month-Old

  • The use of Miralax (polyethylene glycol 3350) in infants is a topic of interest, particularly for treating constipation.
  • According to 3, osmotic laxatives like polyethylene glycol 3350 are considered effective and safe for both long and short-term treatment of pediatric functional constipation.
  • A study published in 4 found that treatment with polyethylene glycol 3350 plus electrolytes was effective in critically ill children, including those under 2 years old, with few adverse events.
  • Another study 5 evaluated the use of polyethylene glycol in functional constipation and fecal impaction, concluding that it is more efficacious than placebo and lactulose, with great safety and tolerability.
  • However, it is essential to note that the studies do not specifically address the use of Miralax in 4-month-old infants, and the safety and efficacy of its use in this age group may require further evaluation.
  • The administration of suppositories, as discussed in 6, may not be directly relevant to the use of Miralax in infants, but it highlights the importance of a professional and sensitive approach when treating constipation in patients.
  • The introduction of solids to infants, as discussed in 7, may be related to the development of constipation, but the optimal timing for solids introduction is still a topic of debate, and more research is needed to provide a clear evidence base for infant feeding guidelines.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Use of polyethylene glycol in functional constipation and fecal impaction.

Revista espanola de enfermedades digestivas, 2016

Research

How to administer suppositories in adults with constipation.

Nursing standard (Royal College of Nursing (Great Britain) : 1987), 2025

Research

Optimal timing for solids introduction - why are the guidelines always changing?

Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2013

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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