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          2.  | EN

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            Mesalazine Enteric-coated Tablets

            【Properties】

            This product is reddish brown enteric-coated tablets, remove the coating after the core is light brown.

            【Indications】

            For colon ulcer, colitis treatment.

            【Pharmacology and Toxicology】

            Pharmacological effects

            Mesalazine, the major active ingredient of sulfasalazine, is used to treat ulcerative colitis. Sulphasalazine is converted to an equivalent molecular weight of sulfapyridine and mesalazine by the bacteria in the colon. The mechanism of action of mesalamine (and sulfasalazine) is not clear, and pharmacodynamics may occur primarily through local rather than systemic effects. In patients with chronic inflammatory bowel disease, the cyclooxygenase pathway (producing prostaglandins) and the lipoxygenase pathway (producing leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs) ), Which increased the production of arachidonic acid (AA) metabolites in the local mucosa. Mesalazine may reduce its local inflammation by inhibiting the production of cyclooxygenase and prostaglandin (PG) in the colon.

            Toxicological research

            Genotoxicity: Ames test, sister chromosome exchange induction (SCE) test, Chinese hamster ovary cells in vitro chromosome aberration test, mouse bone marrow multi-staining cell micronucleus test results were negative.

            Life and death toxicity: The rat oral dose of 480mg / kg / day, never seen male and female animal fertility and reproductive function. Rats and rabbits dosed 480mg / kg / day, did not show mesalamine-induced teratogenic and fetal toxicity. However, there is no adequate and rigorous clinical study data on pregnant women. Because animal reproductive research often does not always predict the effects of drugs on humans, this product should only be used in pregnant women if it is clearly needed. The low-concentration and high-concentration Mesalazine N-acetyl metabolites were detected in human milk, and its clinical significance was not clear. Mesalazine given to breast-feeding women should be careful.

            Carcinogenicity: Rats and mice were given mesalazine doses up to 480 mg / kg / day and 2000 mg / kg / day, respectively, for the recommended maintenance dose (mesalazine 1.6 g / day in terms of body surface area) 2.4-fold and 5.1-fold, did not show carcinogenic effects.

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