英文药名: Restasis(Cyclosporine Eye Drops) 中文药名: 环孢素滴眼液 生产厂家: Allergan 药品介绍 通用名称：环孢素滴眼液 英文名称：Cyclosporin Eye Drops 性 状：本品为淡黄色的澄明油状液体。 药品简介 2010年11月,加拿大卫生部批准了Allergan有限公司开发的环孢素(cyclosporin)0.05%眼用乳剂Restasis,用于治疗中至中重度干眼病。干眼病的发病率随年龄增长而提高,实际影响到5%～30%的50岁以上人群。 干眼病是因眼组织不能生产适量和(或)高质量的泪液以维持眼部湿润所致,而Restasis能够减少干眼病相关炎症,帮助提高眼组织生产泪液。 干眼病患者的症状的严重程度并不相同,具体包括疼痛、瘙痒、刺激感、光敏反应和含沙或多沙感,会引起视力波动和下降,损害患者的工作、学习和驾车等能力。干眼病若不治疗,还可能导致更严重的问题,如角膜瘢痕或溃疡和提高眼感染风险。 临床试验结果显示,使用Restasis治疗能使干眼病患者的眼部炎症减少和泪液生产提高,由此改善他们的眼部不适症状,提高生活质量。 适 应 症 用于预防和治疗眼角膜移植术后的免疫排斥反应。 用法用量 本品仅进行了与糖皮质激素联合应用预防角膜移植术后免疫排斥反应的临床试验，对本品单独应用预防角膜移植术后免疫排斥反应尚无临床数据支持。 在与糖皮质激素联合应用时本品的用法用量为：将药物滴入结膜囊内，每日4-6次，每次1-2滴。 本品临床应用根据治疗疾病的种类不同, 用量有一定差异, 必须在专业医师的指导下或遵医嘱用药。 使用方法：因本品为油溶液，使用时旋开瓶盖，将滴眼瓶与眼部垂直，轻轻挤压滴眼瓶，使药液滴入眼内，避免药液挂流瓶口造成污染，用完后立即盖好瓶盖。 不良反应 本品的临床试验过程中有部分患者出现眼部轻微刺激症或结膜轻度充血，有报道偶见睫毛脱落、角膜上皮缺损、眼周皮炎、过敏症、角膜上皮点状病变等症状，但停药后可自愈。 禁 忌 对环孢素过敏者、对滴眼液中其他成份过敏者。 注意事项 1. 角膜移植术后如发生植片排斥反应，临床医生可视排斥反应的轻重不同适当增加本品滴眼次数。 2. 与糖皮质激素联合应用时请注意逐渐调整糖皮质激素的给药剂量。 3．本品不具有抗感染功效，若发生感染，应立即用抗生素治疗。 4．本品放置儿童不易拿到的地方。儿童用药须在成人的监护下使用。 5．本品低温贮存时，有凝固倾向，可呈轻微凝固状或有轻微烟雾状或见少量絮状物，如果出现这些情况，使用时将本品放置在室温下（25-30℃），并轻微振摇直至其消失成溶液状。本品发生凝固状或烟雾状或少量絮状物并不影响药物质量。 孕妇及哺乳期妇女用药 本品口服可以通过胎盘，也可进入乳汁，对哺乳的婴儿可产生高血压、肾毒性、恶性肿瘤等不良作用的潜在危险性。眼局部用药仍有全身吸收，虽然浓度很低（＜50ng/ml），但尚不清楚是否可通过胎盘和通过人乳分泌, 所以孕妇及哺乳妇女避免使用。如必须使用，应在使用前排除妊娠的可能性，哺乳妇女不应哺乳。 包装规格： 0.05%眼药乳液：0.4mlx30个  32个 0.05%眼药水：3mlx1支  Restasis Eye Drops 0.05% contain cyclosporine, an immunomodulator that is used to increase natural tear production in dry eye disease. Restasis - Prescription Eye Drops for Dry Eyes Restasis is One Treatment for Dry Eyes but has Limitations Due to Side Effects and Cost Restasis Ophthalmic Emulsion (cyclosporine ophthalmic emulsion 0.05%) by Allergan Pharmaceuticals is a prescription eye drop used for the treatment of chronic dry eye (keratoconjunctivitis sicca). Restasis is the only prescription eye drop medicine that is prescribed for long-term use to increase the eye’s ability to produce tears for patients whose tear production is suppressed due to ocular inflammation. Dry eye syndrome is an ongoing condition and depending on its cause, it may not be curable but it can definitely be managed. There are different causes of dry eye. One cause in particular is ocular inflammation that suppresses the production of tears. How Restasis Works Patients with chronic dry eye have more inflammatory T-cells that produce by-products, which decrease the nerve signals to the lacrimal gland resulting in dryness.  Restasis inhibits the activation of T-cells, which results in increased tear production by the lacrimal gland.  Restasis does not improve tear flow in patients on anti-inflammatory eye drops or those with punctal plugs. Recommended Dosage of Restasis The recommended dosage of Restasis is one drop twice a day (1 drop in the morning and another drop in the evening approximately 12 hours apart).  The medication comes in a package of 30 (thirty) single use vials.  Some patients may begin to experience the benefit of increased tear production in as early as one month, but for others, it may take a few months longer since no two people react to the medication exactly the same. It is essential that Restasis be used consistently, twice a day, every day to achieve maximum effectiveness. Since there currently is no cure for chronic dry eye, Restasis is a long-term treatment and its benefits will cease if the product is discontinued. Side Effects of Restasis The most common side effect following the use of Restasis is ocular burning (17% of patients).  Other possible side effects (1-5% of patients) of Restasis include conjunctival redness, stinging, pain, foreign body sensation, itching and blurred vision. The use is contradicted with patients who have an active eye infection or for those who have a known or suspected hypersensitivity to any one of its ingredients. The safety and efficacy has not been established for patients under the age of sixteen.  There are also no well controlled or adequate studies for Restasis in pregnant women and caution should be exercised in nursing mothers.  Restasis should not be used while wearing contact lenses. Cost of Restasis Most patients with commercial health insurance have plans that cover most of the cost of RESTASIS® prescriptions. Most patient co-pays for a RESTASIS® prescription ranges from $20 to $50 for a monthly supply (2 trays). Alternative Dry Eye Treatments There are many solutions to improving chronic dry eye syndrome including therapy with Lotemax, Omega 3’s, punctal occlusion, artificial tears and doxycycline to name a few.  Restasis is one medical treatment that may be prescribed by your eye care doctor at Master Eye Associates. ------------------------------------ Restasis general information What is Restasis used for? Restasis Eye Drops 0.05% are used to increase natural tear production by the eye. Tear production is reduced due to inflammation associated with a chronic eye disease called keratoconjunctivitis sicca, more commonly known as dry eye disease, in which the eye does not produce sufficient tears to cover the cornea and protect the surface of the eye. This condition can be caused as a side effect of certain drugs, such as isotretinoin; as a symptom of certain diseases, such as rheumatoid arthritis; abnormal composition of tears causing them to evaporate rapidly; the aging process. Often there is no known cause (idiopathic). Chronic dry eyes results in inflammation and damage to the structures of the eye surface. Restasis Eye Drops 0.05% help prevent inflammation on the surface of the eye and this in turn helps increase natural tear production. Restasis Eye Drops 0.05% can also be used in conjunction with artificial tears. How does Restasis work? Restasis Eye Drops 0.05% contain cyclosporine, which is an immunosuppressive drug usually taken orally for suppressing the immune system and preventing rejection of organ transplants or for treatment of certain autoimmune diseases. When used for treating dry eye disease caused by reduced normal tear production, cyclosporine in Restasis Eye Drops 0.05% is thought to act as an immunomodulator by inhibiting the production of certain inflammatory chemicals called cytokines produced by lymphocytes at sites of inflammation. By damping down the effect of inflammatory cytokines in the eye, cyclosporine in Restasis Eye Drops 0.05% reduces local inflammation and helps the eyes resume normal tear production, which is important to protect and lubricate the eyes. What does Restasis contain? Restasis Eye Drops 0.05% are an ophthalmic emulsion containing the active ingredient cyclosporine, an immunosuppressant and immunomodulator, used to increase tear production in dry eye disease. They also contain: glycerine, castor oil, polysorbate 80, carbomer copolymer type A, purified water; and sodium hydroxide to adjust pH. Treating dry eyes with Restasis Restasis Eye Drops 0.05% contain cyclosporine, an immunomodulator that is used to increase natural tear production in dry eye disease. Dry eye disease is a chronic eye disease called keratoconjunctivitis sicca, in which the eye does not produce sufficient tears to cover the cornea and protect the surface of the eye. This condition can be caused as a side effect of certain drugs, such as isotretinoin; as a symptom of certain diseases, such as rheumatoid arthritis conditions; abnormal composition of teats causing them to evaporate rapidly; the aging process. Often there is no known cause (idiopathic). Chronic dry eyes results in inflammation which blocks normal tear production and causes damage to the structures of the eye surface. Cyclosporine in Restasis Eye Drops 0.05% is thought to work by inhibiting the production of certain inflammatory chemicals called cytokines produced by lymphocytes at sites of inflammation. Reducing inflammation locally helps the increase normal tear production, which is important to protect and lubricate the eyes. What are the side effects of Restasis? The most commonly reported side effects when taking Restasis include: burning sensation in the eye, eye redness and discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision. When should Restasis not be used? You should not use Restasis Eye Drops 0.05% if you: •are allergic to cyclosporine or any ingredients in Restasis eye drops •have an active eye infection •are pregnant or are breastfeeding, without discussion with your doctor How should Restasis be used? Before using your Restasis Eye Drops 0.05%, gently invert the vial a few times to ensure it is well mixed and the white emulsion is uniform and opaque. Add one drop into each eye twice daily, 12 hours apart. If you are also using artificial tears, you should wait for 15 minutes after applying your Restasis Eye Drops 0.05%. You should continue to use your Restasis Eye Drops 0.05% continually for as long as recommended by your doctor, usually for at least 30 days. How long should you take Restasis? You should continue to use your Restasis Eye Drops 0.05% continually for as long as recommended by your doctor, usually for at least 30 days. Missed dose of Restasis If you miss a dose of Restasis take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose. Do not take a double dose. How should Restasis be stored? You should store your Restasis below 15-25°C in a cool dry place.