近日，美国食品局及药物管理局（FDA）已批准DEXTENZA（地塞米松 dexamethasone）眼用插入物0.4mg,用于眼科手术后眼痛的小管内治疗。
批准日期：2018年12月3日 公司：Ocular Therapeutix, Inc.
DEXTENZA(地塞米松[dexamethasone])滴眼液0.4mg，用于小管内使用
首次美国批准：1958
作用机理
地塞米松是一种皮质类固醇，通过抑制多种炎性细胞因子抑制炎症，导致水肿、纤维蛋白沉积、毛细血管渗漏和炎性细胞迁移增加。
适应症及用法
是一种皮质类固醇，用于眼科手术后的眼部疼痛的治疗。
剂量与给药
DEXTENZA是一种眼科插入物，它被插入泪小管下部。一个Extuntz释放0.4毫克剂量地塞米松在插入后最多30天。
剂型和强度
含0.4毫克地塞米松的眼内腔插入物。
禁忌症
主动眼部感染
警告和注意事项
眼压升高：监测眼内压。
细菌感染：类固醇可能掩盖感染的迹象，并加强现有的感染。
●病毒感染：眼类固醇可延长病程并加重眼病毒感染的严重程度。
真菌感染：考虑任何持续性角膜溃疡的真菌浸润。
延迟愈合：眼部类固醇可能会减缓眼部愈合的速度。
不良反应
最常见的不良反应是前房琥珀色炎症和眼压升高。
这些发生在约5-9%的患者。
包装供应/储存和搬运
DEXTANZA是在泡沫载体中无菌的，在箔层压袋中包含：
NDC 7038 2-204-10纸箱，包含10个袋（10个插入件）
NDC7038 2-204-01纸箱含1袋（1插入）
如果袋破损或破损，请勿使用。
DEXTUNZA仅用于单剂量。
储存：冷藏，在2°C和8°C之间（36μF和46°F）。不要冻僵。保护光线，保持包装直到使用。
完整资料附件：http://www.dextenza.com/wp-content/uploads/2018/12/DEXTENZA-Final-Label-12.1.18.pdf

DEXTENZA(dexamethasone ophthalmic insert)0.4mg,
for intracanalicular use
DEXTENZA is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.
WARNINGS AND PRECAUTIONS
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma and intraocular pressure should be monitored during treatment.
Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.
Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
ADVERSE REACTIONS
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (1%); and conjunctival hyperemia (1%).
The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).
Dextenza, a 0.4mg bioresorbable intracanalicular insert, is designed to deliver a tapered dose of dexamethasone to the ocular surface for up to 30 days.