眼科新药Zylet(loteprednol etabonate0.5%/tobramycin 0.3％，氯替泼诺0.5％/托布霉素0.3％眼科用混悬剂)获美国FDA批准上市，用于治疗类固醇应答性炎性眼科病。 Zylet（氯替泼诺/托布霉素 loteprednol etabonate/tobramycin）眼用悬浮液0.5％/0.3％ 初始美国批准：2004 作用机制 皮质类固醇抑制对多种呕吐剂的炎症反应，并且可能延迟或缓慢愈合。它们抑制水肿，纤维蛋白沉积，毛细血管扩张，白细胞迁移，毛细血管增生，成纤维细胞增殖，胶原沉积和与炎症相关的瘢痕形成。对于眼用皮质类固醇的作用机制没有普遍接受的解释。然而，皮质类固醇被认为通过诱导磷脂酶A2抑制蛋白（统称为脂质体）起作用。 假定这些蛋白质通过抑制其共同的前体花生四烯酸的释放来控制炎症的有效介质如前列腺素和白三烯的生物合成。 花生四烯酸通过磷脂酶A2从膜磷脂释放。皮质类固醇能够产生眼内压的上升。 氯替泼诺乙磺酸盐在结构上类似于其他皮质类固醇。然而，不存在20位的酮基。 包括组合中的抗感染组分（妥布霉素）以提供对敏感生物体的作用。体外研究已经证明妥布霉素对下列微生物的易感菌株有活性： 葡萄球菌，包括金黄色葡萄球菌和表皮葡萄球菌（凝固酶阳性和凝固酶阴性），包括耐青霉素菌株。 链球菌，包括一些A-β-溶血性物质，一些非溶血性物种和一些肺炎链球菌。铜绿假单胞菌，大肠杆菌，肺炎克雷伯杆菌，产气肠杆菌，奇异变形杆菌，摩氏摩根氏菌，大多数普通变形杆菌菌株，流感嗜血杆菌和埃及伊蚊，流感莫卡氏菌，醋酸钙不动杆菌和一些奈瑟氏菌属物种。 适应症和用法 Zylet是用于类固醇-反应性炎症性眼部病症的局部抗感染和类固醇组合，其中指示皮质类固醇，并且存在浅表性细菌性眼部感染或细菌性眼部感染的风险。 剂量和给药 每四至六小时，将一滴或两滴Zylet滴入受累眼睛的结膜囊。 剂量形式和强度 Zylet含有5mg/mL氯替泼酸乙酯和3mg/mL妥布霉素。 禁忌症 与其它类固醇抗感染性眼用组合药物一样，Zylet在角膜和结膜的大多数病毒性疾病中是禁忌的，包括上皮性单纯疱疹性角膜炎（树突状角膜炎），牛痘和水痘，以及眼部的分枝杆菌感染和真菌性疾病的眼结构。 警告和注意事项 •眼内压（IOP）-长期使用皮质类固醇可导致青光眼，损伤视神经，视力缺陷和视野。如果本产品使用10天或更长时间，应监测IOP。 •白内障-使用皮质类固醇可能导致后囊膜性白内障形成。 •延迟愈合-白内障手术后类固醇的使用可能延迟愈合并增加气泡形成的发生率。在导致角膜或巩膜变薄的那些疾病中，已知使用局部类固醇会发生穿孔。药物医嘱的初始处方和更新应当由医生在借助于诸如裂隙灯活组织显微镜和适当时荧光素染色的放大率检查患者之后进行。 •细菌感染 - 长期使用皮质类固醇可抑制宿主反应，从而增加继发性眼部感染的危险。在急性化脓性条件下，类固醇可以掩盖感染或增强现有感染。如果体征和症状在2天后不能改善，应重新评估患者。 •病毒感染-使用皮质类固醇药物治疗单纯疱疹病史的患者需要非常小心。眼用类固醇的使用可能延长病程，并可能加剧眼睛的许多病毒感染（包括单纯疱疹）的严重性。 •真菌感染-角膜的真菌感染特别容易与长期的局部类固醇应用发展。真菌侵袭必须考虑在任何持续性角膜溃疡中使用或正在使用类固醇。 不良反应 在患者中报告的最常见的不良反应是注射和浅表点状角膜炎，眼内压升高，滴注时灼伤和刺痛。 完整处方资料附件： 1）https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3dd9b060-5355-404d-bdf1-09ee8b52a9f5 2）：https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=19802 ZYLET (loteprednol etabonate/tobramycin ophthalmic suspension, 0.5%/0.3%). INDICATIONS AND USAGE ZYLET (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) is a topical anti‑infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. IMPORTANT SAFETY INFORMATION •ZYLET is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infections of the eye and fungal diseases of ocular structures. •Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, and defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. •Use of corticosteroids may result in posterior subcapsular cataract formation. •The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining. •Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections. If signs and symptoms fail to improve after 2 days, the patient should be re-eva luated. •Employment of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye (including herpes simplex). •Fungal infections of the cornea are particularly prone to develop coincidentally with long-term, local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. •Most common adverse reactions reported in patients were injection and superficial punctate keratitis, increased intraocular pressure, and burning and stinging upon instillation. ----------------------------------------------------------------- 产地国家：美国 原产地英文商品名: ZYLET EYE DROPS 5mls/bottle 原产地英文药品名: TOBRAMYCIN/LOTEPREDNOL ETABONATE 中文参考商品译名: ZYLET滴眼液 5毫升/瓶 中文参考药品译名: 托布霉素/氯替泼诺 ETABONATE 生产厂家中文参考译名: BAUSCH AND LOMB 生产厂家英文名: BAUSCH AND LOMB ----------------------------------------------------------------- 产地国家：美国 原产地英文商品名: ZYLET EYE DROPS 10mls/bottle 原产地英文药品名: TOBRAMYCIN/LOTEPREDNOL ETABONATE 中文参考商品译名: ZYLET滴眼液 10毫升/瓶 中文参考药品译名: 托布霉素/氯替泼诺 ETABONATE 生产厂家中文参考译名: BAUSCH AND LOMB 生产厂家英文名: BAUSCH AND LOMB ----------------------------------------------------------------- 产地国家：美国 原产地英文商品名: ZYLET EYE DROPS 2.5mls/bottle 原产地英文药品名: TOBRAMYCIN/LOTEPREDNOL ETABONATE 中文参考商品译名: ZYLET滴眼液 2.5毫升/瓶 中文参考药品译名: 托布霉素/氯替泼诺 ETABONATE 生产厂家中文参考译名: BAUSCH AND LOMB 生产厂家英文名: BAUSCH AND LOMB