Rebamipide Dosing in Children
There are no established pediatric dosing guidelines for rebamipide, and the medication has not been studied or approved for use in children.
Absence of Pediatric Data
- Rebamipide lacks any published pediatric dosing regimens, safety data, or efficacy studies in children 1, 2, 3.
- The drug has only been studied and approved for adult use, primarily in Japan and other Asian countries, with standard adult dosing of 100 mg three times daily 1, 3.
- Extrapolating adult doses to pediatric patients is contraindicated due to the absence of pediatric formulations, pharmacokinetic data, and safety profiles in children 4, 5.
Clinical Implications
- For children requiring gastric mucosal protection, clinicians must select alternative medications with documented pediatric safety profiles and established weight-based dosing 4, 5.
- The lack of pediatric studies means that both efficacy and safety remain completely unknown in children, making rebamipide use in this population experimental at best 5.
Recommended Alternatives
- For NSAID-induced gastropathy prevention in children, consider proton pump inhibitors which have established pediatric dosing guidelines 1.
- If mucosal protection is essential in a pediatric patient, referral to a pediatric gastroenterology specialist is advised to identify evidence-based alternatives 4.
Key Pitfall to Avoid
- Do not attempt to calculate pediatric doses using weight-based extrapolation from adult dosing (100 mg TID), as this approach lacks any scientific validation and poses unknown safety risks in children 4, 5.
- The 50-90% of drugs used off-label in children contribute to adverse events and treatment failures; rebamipide should not be added to this problematic practice without proper pediatric trials 5.