Loperamide, also known as imodium or diamide, belongs to the class of organic compounds known as diphenylmethanes.Diphenylmethanes are compounds containing a diphenylmethane moiety, which consists of a methane wherein two hydrogen atoms are replaced by two phenyl groups. [Specific package insert requirement for Loperamide] WARNING: Not recommended for children under 6 years of age. In a double blind randomised clinical trial in 56 patients with acute diarrhoea receiving loperamide, onset of anti-diarrhoeal action was observed within one hour following a single 4 mg dose. FDA reported that the majority of serious cardiac events happened when individuals were misusing or abusing high doses of loperamide because of an opioid use disorder or to self-treat withdrawal symptoms from opioids.Steven Dudley, PharmD, DABAT, a clinical toxicologist and director of the Arizona Poison and Drug Information Center, said loperamide abuse has been a growing problem for a while now. Available for Android and iOS devices. Drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea.Take 4 teaspoonfuls (20 mL) after the first loose bowel movement and 2 teaspoonfuls (10 mL) after each subsequent loose bowel movement but no more than 8 teaspoonfuls (40 mL) a day for no more than 2 days.Take 2 teaspoonfuls (10 mL) after the first loose bowel movement and 1 teaspoonful (5 mL) after each subsequent loose bowel movement but no more than 6 teaspoonfuls (30 mL) a day for no more than 2 days.Take 2 teaspoonfuls (10 mL) after the first loose bowel movement and 1 teaspoonful (5 mL) after each subsequent loose bowel movement but no more than 4 teaspoonfuls (20 mL) a day for no more than 2 days.Children under 6 years old (up to 47 lbs): Consult a physician. Warnings appear on the package label and instruct the user not to take the drug for more than 2 days unless directed by a physician. Clinical comparisons with other antidiarrhoeal drugs confirmed this exceptionally rapid onset of action of loperamide. Roxane Laboratories, Inc. LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride solution: Product Information: Product Type: HUMAN PRESCRIPTION DRUG LABEL: Item Code (Source) NDC:0054-8534: … FDA said it has warned online retailers, but any actions on their part would be voluntary.Loperamide was approved by FDA in 1976 and considered a Schedule V drug until 1982, when it was decontrolled. The agency announced that it is working with manufacturers to limit the number of doses in a package.The changes apply to the packaging for tablet and capsule forms of the brand-name OTC antidiarrheal medications Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCI Capsules, according to an FDA safety communication.Each pack will now contain no more than 48 mg of loperamide, and tablets or capsules will have to be packaged in individual, unit-dose blister packs. PLEASE SAVE THIS FOR FUTURE REFERENCE.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.DO NOT USE IF DIARRHEA IS ACCOMPANIED BY HIGH FEVER (GREATER THAN 101°F), OR IF BLOOD OR MUCUS IS PRESENT IN THE STOOL, OR IF YOU HAVE HAD A RASH OR OTHER ALLERGIC REACTION TO LOPERAMIDE HYDROCHLORIDE.We comply with the HONcode standard for trustworthy health information - In its 2017 annual report, the American Association of Poison Control Centers reported more than 1,500 loperamide overdoses, with a few resulting in death.“We see people taking 100 mg to 400 mg a day—that’s about 50 to 200 tablets,” said Dudley. In the years since the approval and up until 2015, when data were last available, FDA has received reports of 48 cases of serious heart problems associated with loperamide use, with more than one-half of those cases reported after 2010.FDA warned the public starting in 2016 about loperamide’s cardiac risks, including Torsades de pointes, cardiac arrest, ventricular tachycardia, syncope, and even death.