药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201141719180738.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文卢美根处方资料(仅供参考)
Lumigan0.01%,卢美根滴眼液 (FDA)美国食品药物管理局Lumigan (bimatoprost ophthalmic solution); 目前最能降低眼内压力的抗青光眼药物; 由Allergan开发生产; 2001年3月批准上市。治疗眼内压升高新药--0.03%的Lumigan (bimatoprost滴眼液),和0.004%的Travatan(travoprost滴眼液)将为对其它降低眼内压药不敏感或不耐受的病人 提供新的选择。否则这些青光眼患者往往得需手术治疗。在各别的临床试验中, Lumignan和Travatan在降低眼内压上有相似的效果。高眼内压极度地增加了视神 经损伤和视力减退的风险。Lumignan和Travatan可能会引起的副作用包括:眼睛颜色变深和眼睑皮肤逐渐变暗,以及睫毛变浓、变黑和变密。
Allergan公司宣布,FDA已批准其0.03%滴眼液Lumigan作为一线治疗药用于降低开角型青光眼/高眼压症患者的眼压,该药每日用药一次。此前,该药已被广泛作为治疗该病的二线治疗药。 眼压高是导致开角型青光眼患者视力减退的主要原因,眼压越高,患者视神经越有可能受到损害,最后有可能导致视力减退甚至失明。单独采用Lumigan治疗可以持续有效地降低眼压。目前,美国有300万人受到青光眼的困扰,而全世界的青光眼患者人数达6700万名。 有报道称,使用Lumigan治疗之后,虹膜、眼睑和睫毛等部位的颜色会加深,并且睫毛会增生。使用该药的患者应被告知会出现上述情况。
LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) LUMIGAN® 0.01%, approved by the U.S. Food and Drug Administration (FDA) in 2010, is used to lower elevated eye pressure, also called intraocular pressure (IOP), in people with open-angle glaucoma or ocular hypertension. LUMIGAN® 0.03%, initially approved by the FDA in 2001, is also indicated to reduce elevated (IOP) in patients with open-angle glaucoma or ocular hypertension. LUMIGAN® 0.01% is an optimized formulation with a reduced concentration of bimatoprost.
LUMIGAN® 0.01% and LUMIGAN® 0.03% are approved for use as initial treatments for patients to lower elevated IOP, and both formulations of LUMIGAN® also offer convenience with once-a-day dosing and three bottle sizes.
Glaucoma is one of the leading causes of preventable blindness in the United States2 and affects approximately 3 million people nationally and an estimated 65 million people worldwide.3 Elevated IOP represents a major risk factor for vision loss associated with open-angle glaucoma and is the only risk factor that can currently be treated; the higher the IOP, the greater the likelihood of optic nerve damage, which can lead to vision loss and potential blindness. In fact, an estimated 3 million to 6 million people in the United States have elevated IOP.4 Talk with your eye care professional about whether LUMIGAN® is right for you.
Important Safety Information Warnings and Precautions: Pigmentation Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.
Intraocular Inflammation LUMIGAN® 0.01% and 0.03% should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01% and 0.03% 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.
Adverse Reactions: In clinical studies with bimatoprost ophthalmic solutions (0.01% or 0.03%) the most common adverse event was conjunctival hyperemia (range 25% – 45%). Approximately 0.5% to 3% of patients discontinued therapy due to conjunctival hyperemia with 0.01% or 0.03% bimatoprost ophthalmic solutions. Other common events (>10%) included growth of eyelashes and ocular pruritus.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201141719180738.pdf)的“原文Priscribing Information”为准 ---------------------------------------------------------------
2011-4-18更新 |