Surveillance of Loperamide Ingestions: An Analysis of 216 Poison Center Reports

Abstract

Background: Loperamide was approved for nonprescription use in 1988. While efficacy is well documented, there are few data on loperamide overdose and management. Methods: Eight poison centers participated in a prospective study enrolling 216 patients. Results: Where the amount ingested was known it ranged from 0.03 to 0.94 mg/kg. One-to 3-year-olds were involved in 57.9% of ingestions. Ingestion was unintentional in 182 cases (84.3%), including 59 patients with therapeutic errors (27.3% of all cases). Dispensing cup errors were implicated in 23 cases; 15 patients assumed the dispensing cup was the unit of measure. No symptoms developed in 63.0%; 27.8% had related symptoms. No related symptoms were life-threatening, and no fatalities occurred. The most frequent symptoms were drowsiness (15.7%), vomiting (4.2%), and abdominal pain or burning (3.7%). The frequency of related symptoms was compared in patients receiving the most frequently utilized decontamination modalities: ipecae alone, activated charcoal alone, lavage and activate charcoal, and ipecac and activated charcoal. Compared to the 112 patients who received no decontamination, only the ipecac-treated group demonstrated a significant reduction in the frequency of related symptoms; 13.9% of patients given ipecac alone (without other gastric decontamination) had related symptoms compared to 33.0% of patients who received no decontamination. There patients received naloxone for CNS symptoms related to loperamide; two responded and the response of the third was unknown. Conclusion: Within the range of doses implicated in this study (up to 0.94 mg/kg), there were no life threatening clinical effects and no fatalities. Development of a management protocol is complicated by the absence of a predictable clinical responses in each dose range. The data suggest that children over six months with single acute ingestions up to 0.4 mg/kg, and possibly higher, can be safely managed at home, without gastric decontamination