T. Litovitz et al., SURVEILLANCE OF LOPERAMIDE INGESTIONS - AN ANALYSIS OF 216 POISON CENTER REPORTS, Journal of toxicology. Clinical toxicology, 35(1), 1997, pp. 11-19
Background: Loperamide was approved for nonprescription use in 1988, W
hile efficacy is well documented, there are few data on loperamide ove
rdose and management. Methods: Eight poison centers participated in a
prospective study enrolling 216 patients. Results: Where the amount in
gested was known, it ranged from 0.03 to 0.94 mg/kg. One- to 3-year-ol
ds were involved in 57.9% of ingestions. Ingestion was unintentional i
n 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 sym
ptoms developed in 63.0%; 27.8% had related symptoms. No related sympt
oms were life-threatening, and no fatalities occurred. The most freque
nt symptoms were drowsiness (15.7%), vomiting (4.2%), and abdominal pa
in or burning (3.7%). The frequency of related symptoms was compared i
n patients receiving the most frequently utilized decontamination moda
lities: ipecac alone, activated charcoal alone, lavage and activated c
harcoal, and ipecac and activated charcoal. Compared to the 112 patien
ts who received no decontamination, only the ipecac-treated group demo
nstrated a significant reduction in the frequency of related symptoms;
13.9% of patients given ipecac alone (without other gastric decontami
nation) had related symptoms compared to 33.0% of patients who receive
d no decontamination. Three patients received naloxone for CNS symptom
s related to loperamide; two responded and the response of the third w
as unknown. Conclusion: Within the range of doses implicated in this s
tudy (up to 0.94 mg/kg), there were no life threatening clinical effec
ts and no fatalities. Development of a management protocol is complica
ted by the absence of a predictable clinical response in each dose ran
ge. The data suggest that children over six months with single acute i
ngestions up to 0.4 mg/kg, and possibly higher, can be safely managed
at home, without gastric decontamination.