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loperamide hydrochloride

Capsules 2mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #16206

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Loperamide hydrochloride

Loperamide hydrochloride is a medication used to decrease the frequency of diarrhea and sudden diarrhea including traveler's diarrhea. It is often prescribed for treating inflammatory bowel disease and short bowel syndrome but not in those with blood in the stool, mucus in the stool, or fevers. It also reduces the discharge quantity in patients who have undergone an ileostomy. It only treats the symptoms, but cannot treat the cause of diarrhea, so only a doctor normally decides on the use of this medicine. Loperamide hydrochloride is sold under the brand name Imodium & Diamond among others. Paul Janssen from Janssen Pharmaceutica in Beerse, Belgium, first synthesized Loperamide hydrochloride in 1969 and started selling Loperamide in 1973. US FDA approval gave the approval for selling it in 1976. During the 1980s, it was the best-selling prescription antidiarrheal in the USA.

Dosages and administration

Loperamide hydrochloride is sold in capsules of 2mg and taken orally. the recommended usual adult Dose for treating Acute Diarrhea is 4 mg, to be taken orally after the first loose stool. This is followed by a 2 mg dose, post each unformed stool, with a maximum dose not exceeding 16 mg per day. the patient should see improvement in condition in 2 days. The dose for Acute Diarrhea for kids age 2 to 5 years between 13 to 20 kg, is 1 mg orally 3 times a day (3 mg total daily dose) on the First day, followed by a Subsequent daily dosage of 1 mg only after a loose stool, but not to exceed 3 mg per day. for kids aged 6 to 8 years or 20 to 30 kg, the dose is 2 mg, taken orally twice a day 2, a total of 4 mg on the First day, followed by a subsequent daily dosage of 2 mg only after a loose stool, total dose per day not exceeding 4 mg. For kids aged 9 to 12 years or over 30 kg, the dose on the First day is 2 mg, taken orally, 3 times a day, totaling 6 mg, followed by a subsequent daily dose of 2 mg only after a loose stool, totaling no more than 6mg a day. the dose for 13 years and older is 4 mg, taken orally, after the first loose stool, followed by 2, taken mg orally, after each unformed stool, not exceeding 16 mg per day.

The price of Loperamide hydrochloride

In the UK, the consumer has to pay an average retail price as indicated by NHS of £1.11 for a supply of 10, 2mg capsules. In India, the 10 capsules cost between USD 0.22 and USD 0.35

How does it work? Loperamide hydrochloride slows down the movement of the gut resulting in a decrease in the number of bowel movements in addition to making the stool less watery. As an opioid-receptor agonist, its acts on the μ-opioid receptors in the myenteric plexus of the large intestine. There is decreasing the myenteric plexus activity, which in turn decreases the tone of the longitudinal and circular smooth muscles of the intestinal wall. The resulting benefit is an increase in the time material stays in the intestine, during which more water is absorbed from the fecal matter in addition to decreasing the colonic mass movements and suppressing the gastrocolic reflex.

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