For a discussion of loperamide, its abuse potential, and the potentially serious consequences of such abuse, see Loperamide (Immodium®) abuse.
The U.S. Food and Drug Administration (FDA) announced on January 30, 2018, that it is working with manufacturers to promote safe use of over-the-counter (OTC) loperamide. The FDA has recommended that manufacturers use blisters packs or other single dose packaging and limit the number of doses in a package.
1. What is loperamide?
Loperamide (generic and brand name Imodium A-D®) is a weak opioid agonist and used as an antidiarrheal medication. It acts on opioid receptors in the gut to decrease the number of bowel movements and provide symptomatic relief from diarrhea. The maximum recommended dosage for OTC and prescription use is 8 mg per day and 16 mg per day respectively.
2. Why is the FDA concerned about loperamide?
Loperamide does not have any significant systemic side effects and it is a safe medication when used in recommended doses.
However, some people abuse the drug and combine the drug with other drugs to increase its intestinal absorption, reduce its metabolism, increase the drug crossing the blood-brain-barrier, and increase its euphoric effects.
Also, some people consume it in large doses to treat symptoms of opioid withdrawal. When taken in such large doses, it can result in serious cardiac effects such as QTc prolongation, arrhythmias, syncope, and cardiac arrest. So, to encourage safer use of loperamide, the FDA is promoting this change in packing.
3. What should clinicians do with regard to loperamide?
– Avoid loperamide whenever possible and consider an alternative drug.
– Educate patients to not to use loperamide in more than the prescribed dosages or above those mentioned on OTC drug labels.
– Check for possible drug interactions with loperamide and educate their patients about this.
– If any patient specifically requests a prescription for loperamide, screened the patient for possible abuse of loperamide.
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