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Loperamide is not recommended for children under 6 years of age. Its use has been associated with fatal episodes of paralytic ileus in infants and young children.
The use of higher than the recommended doses for control of the diarrhea may lead to abnormal heart rhythms and serious cardiac events leading to death. Cases of syncope and ventricular tachycardia have been reported in adult patients receiving the recommended dosage of IMODIUM. Some of these patients were taking other drugs or had other risk factors that may have increased their risk of cardiac adverse reactions.
Abuse and misuse of loperamide, as an opioid substitute, have been described in individuals with opioid addiction (see Overdosage).
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