ADVERSE REACTIONS
The adverse effects reported during clinical investigations of IMODIUM® (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with IMODIUM® were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.
The following adverse events have been reported: hypersensitivity reactions such as skin rash and urticaria, and extremely rare cases of anaphylactic shock and bullous eruption including Toxic Epidermal Necrolysis. In the majority of these cases, the patients were on other medications which may have caused or contributed to the events.
The following patient complaints have also been reported: abdominal pain, distention or discomfort, nausea, vomiting, constipation, tiredness, drowsiness or dizziness and dry mouth.
There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children of less than two years of age.
DRUG ABUSE AND DEPENDENCE
ABUSE
A specific clinical study designed to assess the abuse potential of loperamide at high doses resulted in a finding of extremely low abuse potential.
DEPENDENCE
Studies in morphine-dependent monkeys demonstrated that loperamide hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal. However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects, performed after a single high dose, or after more than two years of therapeutic use of IMODIUM® (loperamide hydrochloride), was negative. Orally administered IMODIUM® (loperamide formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.
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