0.05%二氟泼尼酯眼用乳液
美国FDA批准Sirion Therapeutics公司的0.05%二氟泼尼酯眼用乳液（difluprednate,Durezol）上市，用于治疗术后炎症和疼痛。本品辅料：硼酸、蓖麻油、吐温80、醋酸钠、EDTA钠、氢氧化钠（调节pH值至5.2～5.8）和纯水。
眼科术后快速解决炎症和疼痛非常重要，本品可快速减轻炎症和疼痛。所有研究组患者的平均眼内压在整个研究中始终保持在正常范围内。
在2项Ⅲ期临床研究中，以安慰剂为对照品评价了本品对眼科术后24小时后一日2次和一日4次用药的安全性和疗效，研究纳入438例存在明显炎症、表现为术后当日前眼房细胞2级（>10个细胞）的患者。
2种给药方案（一日2次和一日4次）在减少术后2周前房细胞总的疗效相似（一日2次为86％，一日4次为87％）。然而，一日4次用药在1周时少数患者完全消除了炎症和疼痛。故医生推荐一日4次的给药方案。
DUREZOL Rx
Generic Name and Formulations:
Difluprednate 0.05%; oph emulsion.
Company:
Alcon Laboratories, Inc.
Indications for DUREZOL:
Post-op inflammation and pain associated with ocular surgery.
Adult Dose for DUREZOL:
1 drop into affected eye(s) 4 times daily beginning 24hrs after surgery, continue for 2 weeks post-op, followed by 2 times daily for a week, then taper until resolved.
Children's Dose for DUREZOL:
Not recommended.
Pharmacological Class:
Steroid.
Contraindications:
Ocular fungal, viral, or mycobacterial infections.
Warnings/Precautions:
Do not administer while wearing contacts. Corneal or scleral thinning. Glaucoma. History of herpes simplex. Monitor IOP and for secondary infections in prolonged therapy (>10 days). Pregnancy (Cat.C). Nursing mothers.
Adverse Reactions:
Corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells and flare, conjunctival edema, blepharitis. May mask or exacerbate ocular infections. Prolonged use may increase: IOP, optic nerve damage, visual acuity and field defects, cataract formation, corneal perforation. May delay healing and increase bleb formation after cataract surgery.
How Supplied:
Emulsion—5mL
Durezol(Difluprednate)Ophthalmic Emulsion
Company: Sirion Therapeutics, Inc.
Application No.: 022212
Approval Date: 06/23/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
Approval Letter(s) (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Office Director Memo (PDF)
Cross Discipline Team Leader Reviews (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Microbiology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)