dioctahedral smectite Oral solution 3g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
Manufacturer #860

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Dioctahedral Smectite

Dioctahedral smectite is a natural adsorbent clay and belongs to the class of other intestinal adsorbents. It is made up of fine sheets of aluminomagnesium silicate. Smectite adsorbs viruses, bacteria, and bacterial toxins. Its action protects the intestinal mucosa. It has shown high efficacy in reducing the duration of diarrhoea. It is used in the symptomatic treatment of irritable Bowel Syndrome in adults and gastroesophageal reflux in infant caused by mucoprotective effects, and in the Treatment of acute and chronic diarrhoea. In children with acute diarrhea rehydrated with oral rehydration solution, it shortens the duration by about 20–50%. However, this is yet to be approved by authorities as it passes through the blood. It is also not for use by pregnant women or breastfeeding mothers. Dioctahedral smectite is sold under the brand name Smecta, made by Ipsen Pharma. It is approved for sales in Asia, parts of Europe. Ipsen Pharma SAS from France filed for the patent of Dioctahedral smectite, under their brand name Smecta in 2011in the European Union and was granted approval in 2017. It is now sold in several countries as an OTC drug.

Dosage and Administration

Dioctahedral smectite is supplied as power in 3g sachets and is normally flavored. For use in children under the age of 1 year, the recommended dose is 1 sachet per day, for kids between 1 to 2 years, the dose is 1 to 2 sachets per day and for kids over the age of 2 years, the dose is 2 to 3 sachets per day, administered in 2-3 divided doses. The sachet contents are mixed in a bottle with 50 ml of water or or a semi-liquid like broth, stewed fruit, mashed vegetables or baby food. For treating adults, the dose is an average of 3 sachets, take in 2-3 divided doses after being mixed in half a glass of water. In patients suffering from acute diarrhea, the dosage is doubled at the beginning of treatment. It is normally taken after meals.

The price of Dioctahedral smectite

In Asia countries, when bought online, the price of 30 sachets of 3g costs the consumer around $24.99. In Malaysia, the price of each sachet is around USD4.

How does it work?

Dioctahedral smectite has a leaflet structure and high plastic viscosity. It has a powerful coating property on the mucosa in the gastrointestinal tract. It improves the resistance of the mucosal gel in response to aggressive agents by By interacting with glycoproteins of mucus, by exerting its effects on the gastrointestinal mucous barrier and its high binding capacity. Its key role is to protect the gastrointestinal mucosa. It is radiolucent, does not color the stools and, will not change physiological intestinal transit time, at normal doses.

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