Wednesday, April 23, 2014
Loperamide use in children
I have a question with regards to the use of Loperamide in children less than 8 years. According to the package insert of Loperamide 2 mg, it is not for children less than 8 years but according to the Springhouse Nurse`s Drug Guide, it can be used in children aged 12, and the dose for 12-year-old children is the same as that of the adult. Can you explain to me why the recommendation of the manufacturer is different from that in the book?
The package insert is a document created by the company that manufactures the loperamide and is approved by the Food and Drug Administration. If the insert says the drug is not for use in children less than 8 years of age, then it relates to testing which showed it did not work sufficiently well enough or absence of testing that would not allow the FDA to approve its use in children under 8. If testing were available to show that the drug was safe and effective in younger children, the package insert would be quickly changed.
Michael Spigarelli, MD, PhD
Formerly, Associate Professor of Pediatrics and Internal Medicine
College of Medicine
University of Cincinnati