itopride Tablets 50 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Bolivia , Chile , Colombia , Costa Rica , Dominican Republic , El Salvador , Guatemala , Honduras , Nicaragua , Panama , Paraguay , Peru , Ukraine , Uruguay , Venezuela
Comments
DCP successful, RMS EE
Manufacturer #422

A pharmaceutical manufacturer based in the EU that has been 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.

Manufacturer usually replies in 5 days

Itopride

Itopride is a prokinetic benzamide derivative. Its actions inhibit dopamine and acetylcholine esterase enzyme and have a gastro kinetic effect, unlike domperidone, another benzamide derivative. Itopride used to treat functional dyspepsia and other gastrointestinal conditions. Typically, it is recommended in the treatment of GI symptoms caused by reduced GI motility like Dyspepsia of a non-ulcer, gastric discomfort, and associated pain, Gastroparesis, anorexia, heartburn, regurgitation, bloating, nausea and vomiting. It has also been found effective in relieving symptoms of other possible gastric, prolactin, or dopamine-related conditions Itopride is sold under the brand name Ganaton amongst others. Abbott, Takeda, Zentiva are amongst top three selling Itopride in countries like Japan, Czech Republic, Russian Federation, Moldova, Bangladesh and other eastern European countries. However, it is not yet approved for sales in the USA or UK as does not have the approvals from U.S. FDA for use in the USA, nor is it approved for use in the United Kingdom.

Dosage and Forms

This medicine is sold in the tablet form. The recommended daily dosage for adults is 50mg taken 3 times a day orally. It is recommended to take this medicine before meals.

The Cost of Itopride

In India, the consumers have to pay about $0.5 to $2usd per pill of 50 mg strength. Whereas in Japan a sheet of 10 pills of 50 mg strength cost US$38.79.

How does Itopride work?

Itopride’s actions ease the movement of food through the stomach and intestine thus facilitating bowel movement. It increases the secretion acetylcholine, which stimulates rapid stomach movement, empties the stomach. It also improves coordination between the stomach and the small intestine. Itopride’s dopamine D2 antagonizing and Acetylcholinesterase inhibitory activity activates gastrointestinal propulsive motility. This in turn activates acetylcholine release and inhibits its degradation. Itopride also has shown antiemetic properties through interaction with D2 receptors located in the chemoreceptor trigger zone. However, Its actions are highly specific for the upper gastrointestinal tract. In other studies conducted on Itopride, the same properties have been shown to be increasing levels of motilin, somatostatin, and lowers levels of cholecystokinin, as well as adrenocorticotropic hormone.

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