适利达xalatan(拉坦前列素滴眼液)主要适用于青光眼和高眼压症,在全球各主要用于青光眼药物治疗的领先地位。该药每日一 次,平均降眼压幅度达到35%,降眼压作用持续稳定效果。 批准日期:公司:辉瑞 XALATAN(拉坦前列素latanoprost ophthalmic solution)滴眼液0.005% 最初美国批准:1996年 作用机理 拉坦前列素是被认为是通过增加房水的流出,降低眼内压(IOP)一类前列腺素的选择性FP受体激动剂。在动物和人的研究表明,采取行动的主要机制是增加葡萄膜巩膜外流。高眼压代表青光眼性视野丧失的主要危险因素。眼压的水平越高,视神经损伤和视野损失的可能性就越大。 适应症和用法 适利为升高的眼内压在患者的降低具有开角型青光眼或高眼压症表示的前列腺素F2α类似物。 用法用量 在受影响的眼睛(S)每天晚上一次一滴。 剂型和规格 含50微克/毫升的拉坦前列素(0.005%)的眼用溶液。 禁忌症 已知过敏拉坦前列素,苯扎氯铵,或本产品的任何其它成分。 警告和注意事项 色素沉着:虹膜色素沉着,可出现眶周组织(眼皮)和睫毛。虹膜色素沉着可能是永久性的。 睫毛的变化:渐变睫毛,包括增加的长度,厚度和睫毛的数量。通常是可逆的。 不良反应 从临床试验中最常见的不良反应(≥4%)是视力模糊,烧灼和刺痛,眼结膜充血,异物感,发痒,增加了虹膜色素沉着,点状上皮角膜病变,和上呼吸道感染/感冒/流感。 要报告疑似不良反应,请在辉瑞或1-800-438-1985 FDA电话1-800-FDA-1088或www.fda.gov/medwatch。 药物相互作用 体外研究已经表明,当含有硫柳汞滴眼剂与适利混合发生析出。如果使用这样的药物,它们应该至少5分钟间隔给药。
XALATAN ® (latanoprost ophthalmic solution) 0.005% XALATAN safety information XALATAN® (latanoprost ophthalmic solution) is contraindicated in patients with known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. XALATAN may cause changes to pigmented tissues. Most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as XALATAN is administered. Iris pigmentation is likely to be permanent. Eyelid skin darkening and eyelash changes may be reversible. The effects beyond 5 years are unknown. XALATAN should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation. XALATAN should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. XALATAN should be used with caution in patients with a history of herpetic keratitis. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. The preservative in XALATAN, benzalkonium chloride, may be absorbed by contact lenses. Contact lenses should be removed prior to administration of XALATAN. Contact lenses should be reinserted 15 minutes following administration. The most common reported adverse events (5%-15%) in XALATAN clinical trials included blurred vision, burning and stinging, conjunctival hyperemia, foreign-body sensation, itching, increased iris pigmentation, and punctate epithelial keratopathy. The combined use of 2 or more prostaglandins or prostaglandin analogs, including XALATAN, is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the intraocular–pressure lowering effect or cause paradoxical elevations in IOP. Indication XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Please see Full Prescribing Information. ----------------------------------------- 产地国家:美国 原产地英文商品名: Xalacom 0.005% 2.5ml/VIAL 原产地英文药品名: LATANOPROST 中文参考商品译名: 适利达滴眼液0.005 2.5毫升/瓶 中文参考药品译名: 拉坦前列素 生产厂家中文参考译名: PFIZER INC 生产厂家英文名: PFIZER INC ----------------------------------------- 产地国家:美国 原产地英文商品名: XALATAN 0.005% 2.5ml/VIAL 3VIAL/box 原产地英文药品名: LATANOPROST 中文参考商品译名: 适利达滴眼液 0.005% 2.5毫升/瓶 3瓶/盒 中文参考药品译名: 拉坦前列素 生产厂家中文参考译名: 辉瑞 生产厂家英文名: PFIZER INC
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