rebamipide Tablets 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Vietnam
GMP approvals
EU GMP, PICS, Japan
Manufacturer #20843

This CTD dossier owner and manufacturer in Southeast Asia is actively supporting healthcare and education through numerous initiatives. They have donated their innovative Bioskin hand sanitizer, featuring antibacterial Nano Silver and natural oils, to teachers and staff in education sectors, and frontline workers across the region. Their contributions include nearly 10 billion VND in support, encompassing essential medical supplies, equipment, and monetary donations for epidemic prevention. With a focus on community well-being, they continue to provide widespread access to Bioskin in over 10,000 pharmacies, enhancing public health during challenging times.

Rebamipide

Rebamipide is an amino acid derivative of 2-(1H)-quinolinone. It is used for mucosal protection, healing of gastroduodenal ulcers, treatment of gastritis, Gastrointestinal ulcers, Dry eyes, peptic ulcer disease, and mouth ulcers. It is a mucosal protective agent. Rebamipide can also limit the damaging effects of NSAIDs on the GIT mucosa, the small intestine, however, it is not used for naproxen-induced gastric damage. Rebamipide accelerates and improves the quality of ulcer healing and reduces ulcer recurrence rate. Rebamipide is sold in Asian countries including Japan, South Korea, China, India, and Russia under the brand names Mucosta, Rebagen, Rebagit among others. Otsuka Pharmaceutical Co Ltd filed for the first patent for Rebamipide in 1983 and later renewed it in 2005, granted in 2010. In 2002, Hanmi Pharm Co Ltd filed for a different patent for an improved method for the preparation of Rebamipide. It is yet to approved by USFDA for sales in the USA.

Dosage and administration

Rebamipide is sold as a tablet. In the treatment of Gastric Mucosal Lesions, which includes Erosion, Bleeding, Redness, and Edema in Acute Gastritis and Acute Exacerbation of Chronic Gastritis among adults, the recommended Usual Dose is 1 tab, taken orally, three times a day. In the treatment of Gastric Ulcers, the recommended Usual adult Dose is one tablet, taken orally, three times a day.

The Price of Rebamipide

In Japan, the consumers have to pay USD 39, for a supply of 14 tablets of 100mg strength. In India, the consumer pays USD 1 for a supply of 10 tablets of 100mg.

How does it work?

Rebamipide actions increase prostaglandin synthesis, which improves the healing of the ulcer. In actions enhance mucosal defense, scavenge free radicals, and temporarily activate genes encoding cyclooxygenase-2. In the replacement of lost tissue, it works by increasing the expression of EGF and its receptors, through which it exerts angiogenesis. This increases the production of granulation tissue and epithelization of ulcer healing. Its key properties include stimulating the prostaglandin and mucus glycoprotein synthesis, inhibiting reactive oxygen species, inflammatory cytokines and chemokines, and inhibition of neutrophils activation. It has also been shown effective against gastric cancer growth, slowing it down.

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