1、 Product introduction

【Indication】

      Used for ocular inflammation and treatment of postoperative inflammation and pain.

【Reportable Dosage Form and Strength】
       Ophthalmic emulsion： 0.05%

【Usage and Dosage】

        4 times a day.

【Mechanism of Action】

       Many kinds of stimulants can delay wound healing. Corticosteroids can inhibit these inflammatory reactions, reduce inflammation related swelling, cellulose deposition, capillary expansion, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition and scar formation. At present, the mechanism of action of corticosteroids for eyes is not obvious. However, it is generally believed that corticosteroids act by inducing phospholipase A2 inhibitors. Arachidonic acid is released from membrane phospholipids by phospholipase A2. The hypothesis is that these proteins control the biosynthesis of active inflammatory mediators such as prostaglandins and interleukin by blocking the release of arachidonic acid, a common precursor of inflammatory mediators. The drug was initially used on the skin, and as an ophthalmic drug, it can quickly and effectively penetrate the corneal epithelium. Then it was rapidly deacetylated and transformed into an active metabolite, difluoropropisone butyrate (DFB), which is a highly active corticosteroid receptor agonist. This active ingredient will be converted into inactive metabolites. Difluoropropanilide, unlike other commonly used steroids, does not use benzalklor as a preservative. This tetravalent ammonium is a kind of detergent, which destroys cell wall by emulsifying cell membrane liposome. Benzalkonium chloride can destroy the stability of tear film, have toxic effect on cornea and conjunctival epithelium, and lead to immune allergic reaction. In order to avoid these adverse reactions, difluoropropanyl ester uses sorbic acid as preservative, which has little stimulation and damage to eye tissue.

【Declaration Progress 】
         Prepare for declaration

2. Domestic Declaration