From the Guidelines
Loperamide should not be given to children under 18 years of age with acute diarrhea. The primary concern with using loperamide in children is the risk of central nervous system effects, such as respiratory depression, sedation, and paradoxical agitation, especially in young children who are more susceptible due to immature hepatic function and blood-brain barrier development 1.
Key Considerations
- The age restriction is in place to protect children from potential complications associated with loperamide use, emphasizing the importance of prioritizing fluid replacement and oral rehydration solutions as the first line of treatment for diarrhea in this age group.
- For children under 2 years, loperamide is contraindicated due to the high risk of adverse effects, including severe central and peripheral side effects like ileus 1.
- While loperamide may be beneficial for children between 2 and 11 years of age without causing severe adverse events, its use should be approached with caution and under medical supervision if necessary 1.
Recommendations for Practice
- Parents should always try oral rehydration solutions first for children with diarrhea.
- Medical attention should be sought if a child has severe diarrhea, especially if accompanied by fever, blood in stool, or signs of dehydration.
- The use of loperamide in children aged 2-12 years should be carefully considered, with a preference for medical supervision for those aged 2-5 years and consultation with a healthcare provider for those aged 6-12 years to ensure appropriate dosing based on weight.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION Loperamide hydrochloride capsules are contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions Pediatric Patients 2 Years to 12 Years of Age: In pediatric patients 2 years to 5 years of age (20 kg or less), the non-prescription liquid formulation (Imodium A-D 1 mg/5 mL) should be used; for ages 6 to 12, either loperamide hydrochloride capsules or Imodium A-D liquid may be used
The age limit for using Loperamide in children is:
- Contraindicated in children less than 2 years of age
- Approved for use in children 2 years and older 2
From the Research
Age Limit for Loperamide Use in Children
The age limit for using Loperamide in children is a topic of discussion among medical professionals.
- According to a study published in 2007 3, Loperamide may be a useful adjunct to oral rehydration and early refeeding in children older than 3 years with no or minimal dehydration.
- However, the same study found that in children younger than 3 years, malnourished, moderately or severely dehydrated, systemically ill, or have bloody diarrhea, adverse events outweigh benefits even at doses ≤0.25 mg/kg/d.
- Another study published in 1995 4 found that the use of Loperamide is not recommended in the treatment of infants and young children with acute diarrhea.
Safety and Efficacy
- A systematic review and meta-analysis of randomized controlled trials 3 found that Loperamide was effective in reducing the duration and severity of diarrhea in children, but also found that serious adverse events were reported in 0.9% of children allocated to Loperamide.
- The study also found that serious adverse events were only reported in children younger than 3 years.
- A double-blind placebo-controlled trial 4 found that high-dose Loperamide may cause potentially harmful side-effects in a small number of patients.
Recommendations
- Based on the available evidence, it is recommended that Loperamide should not be used in children under 3 years of age, except in cases where the benefits outweigh the risks and under close medical supervision 3, 4.
- For children over 3 years of age, Loperamide may be used as an adjunct to oral rehydration and early refeeding, but with careful monitoring for adverse events 3.