INDICATIONS
Durezol (difuprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.

DOSAGE AND ADMINISTRATION
Instill one drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hoursafter surgery and continuing throughout the frst 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.

HOW SUPPLIED
Dosage Forms And Strengths
Durezol contains 0.05% difuprednate as a sterile preserved emulsion for topical ophthalmic administration.
Durezol (difuprednate ophthalmic emulsion) 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following size:
5 mL in a 5 mL bottle (NDC 42826-601-05)

SIDE EFFECTS
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and feld defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in 5–15% of subjects in clinical studies with Durezol included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacifcation, anterior chamber cells, anterior chamber fare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1–5% of subjects included reduced visual acuity, punctate keratitis, eye infammation, and iritis. Ocular adverse events occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, scleral hyperemia, and uveitis. Most of these events may have been the consequence of the surgical procedure.

Storage
Store at 15-25°C (59-77°F). Do not freeze. Protect from light. When not in use keep the bottles in the protective carton.

　    DUREZOL是由 Sirion Theraeutics公司研制开发的糖皮质激素受体激动剂,是泼尼松龙的氟化衍生物,具有抗炎活性,主要用于治疗手术后眼部感染和疼痛。DUREZOL已于2008年6月由美国食品药品管理局(FDA)批准上市,商品名为DUREZOL。
        DUREZOL的结构与其他糖皮质激素的结构类似,其抗炎作用机制也相似。糖皮质激素的抗炎作用在于能够延缓愈合过程,抑制水肿、纤维细胞的增生和瘢痕的形成。局部糖皮质激素的作用机制尚不确切,一般认为是通过抑制磷酸酯酶 A2而发挥抗炎作用。抑制磷酸酯酶A2可以抑制炎症因子的生物前体花生四烯酸的释放,从而减少炎症因子 (如前列腺素)的生物合成。在随机双盲安慰剂对照的临床试验中,DUREZOL的结构与其他糖皮质激素的结构类似,其抗炎作用机制也相似。糖皮质激素的抗炎作用在于能够延缓愈合过程,抑制水肿、纤维细胞的增生和瘢痕的形成。局部糖皮质激素的作用机制尚不确切,一般认为是通过抑制磷酸酯酶 A2而发挥抗炎作用。抑制磷酸酯酶A2可以抑制炎症因子的生物前体花生四烯酸的释放,从而减少炎症因子 (如前列腺素)的生物合成。在随机双盲安慰剂对照的临床试验中,DUREZOL表现出显著的临床应用价值。
        该药于患者术后24h给药,一日4次,一次1滴,持续给药两周后,改为一日2次,持续一周后,根据病情逐渐减少剂量。DUREZOL与其他糖皮质激素的不良反应类似,一些角膜及巩膜变薄的患者长期使用时,可导致眼球穿孔;有单纯疱疹病毒性角膜炎病史的患者以及急性化脓性感染患者应慎用;长期应用本品可能导致非敏感菌过度生长或大剂量眼部使用本品可导致后囊膜下白内障 ,同时可引起眼内压升高,从而导致视神经的损害和视野的缺损。表现出显著的临床应用价值。该药于患者术后24h给药,一日4次,一次1滴,持续给药两周后,改为一日2次,持续一周后,根据病情逐渐减少剂量。
        DUREZOL与其他糖皮质激素的不良反应类似,一些角膜及巩膜变薄的患者长期使用时,可导致眼球穿孔;有单纯疱疹病毒性角膜炎病史的患者以及急性化脓性感染患者应慎用;长期应用本品可能导致非敏感菌过度生长或大剂量眼部使用本品可导致后囊膜下白内障 ,同时可引起眼内压升高 ,从而导致视神经的损害和视野的缺损。的结构与其他糖皮质激素的结构类似 ,其抗炎作用机制也相似。糖皮质激素的抗炎作用在于能够延缓愈合过程,抑制水肿、纤维细胞的增生和瘢痕的形成。局部糖皮质激素的作用机制尚不确切,一般认为是通过抑制磷酸酯酶 A2而发挥抗炎作用。抑制磷酸酯酶A2可以抑制炎症因子的生物前体花生四烯酸的释放,从而减少炎症因子 (如前列腺素)的生物合成。在随机双盲安慰剂对照的临床试验中, DUREZOL表现出显著的临床应用价值。

        该药于患者术后24 h给药 ,一日4次,一次1滴,持续给药两周后 改为一日2次,持续一周后,根据病情逐渐减少剂量。DUREZOL与其他糖皮质激素的不良反应类似,一些角膜及巩膜变薄的患者长期使用时 可导致眼球穿孔;有单纯疱疹病毒性角膜炎病史的患者以及急性化脓性感染患者应慎用;长期应用本品可能导致非敏感菌过度生长或大剂量眼部使用本品可导致后囊膜下白内障,同时可引起眼内压升高。从而导致视神经的损害和视野的缺损。

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