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Country of origin : Switzerland

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racecadotril

Capsules 100 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Switzerland
GMP approvals
EU GMP
Unavailable markets
France , Germany , Poland , United Kingdom , Vietnam
Available for
Distribution only
Comments
Ref. Tiorfan RX/OTC
Manufacturer #269

A pharmaceutical manufacturer based in the EU that is active in 100+ countries selling its products in Europe, North America, Africa, the Middle East, and Asia for 40+ years. Main therapeutic areas include CNS, cardiovascular medication, and anti-infectives. The company's production lines are EU GMP-compliant. Key production lines are Rx and OTC. The company owns 20+ branches in Europe, Africa, and Asia.

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RACECADOTRIL

Racecadotril also called acetorphan is an oral enkephalinase inhibitor. It is used treatment of acute diarrhea. Its actions prevent the degradation of endogenous enkephalins and also reducing hypersecretion of water and electrolytes into the intestinal lumen. Racecadotril therapy reduces both the incidence and duration of acute diarrhea and diarrhea-associated symptoms. It significantly reduces stool output in infants and young children aged 2 months to 4 years with acute diarrhea. It is effective against both rotavirus-negative and rotavirus-positive infections in the children. Racecadotril is a widely used medicine and made by several companies under brand names like Hidrasec, Racedot, Redotil, Acquasec among 65 others.
Racecadotril is not available in the United States. Racecadotril was first introduced in 1990. Initially, it was available in France and other European countries including Germany, Italy, the United Kingdom, Spain, Portugal, Russia and the Czech Republic as well as most of South America and some South East Asian countries including China, India and Thailand.

Dosage:

In treating acute cases in Infants and Children, the usual dose is 1.5 mg per kilogram of body weight, 3 times daily. This is to be given as an adjuvant therapy to oral rehydration solution. The combination should significantly reduce mean stool output

The cost

This is a relatively inexpensive medicine, especially in the developing and the poorer parts of the world. In India, for a supply of 100 capsules of 100 mg strength, the consumers have to pay only US$0.70. The wholesale price of 1gm in the international market is USD 106 for a supply of 1 gram and USD60 for a supply of 200mg.

How does it work?

Racecadotril is an antidiarrheal drug, they act as a peripheral enkephalinase inhibitor. It results in a reduction in the secretion of water and electrolytes into the intestine. Thiorphan, the active metabolite in Racecadotril, exerts bulk of its inhibitory actions on enkephalinases. It also has an antisecretory property to reduce intestinal motility effect, unlike other opioid medications used to treat diarrhea. It reduces the secretion of water and electrolytes into the intestine.

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