新型抗菌素0.5%的Vigamox滴眼液获FDA批准上市.一日三次,疗程一周,主要用于治疗细菌性结膜炎。 药品名称:盐酸莫西沙星滴眼液 英文名称:MOXIFLOXACIN HCL 商标名称:VIGAMOX OPTH SOL 开发剂型:滴眼剂 生产商:NOVARTIS,ALCON 适应症 适用于莫西沙星敏感菌引起的眼睑炎、泪囊炎、麦粒肿、结膜炎、睑板腺炎、角膜炎(包括角膜溃疡)、眼科围手术期的无菌化治疗。 用法用量 眼睑炎、泪囊炎、麦粒肿、结膜炎、睑板腺炎、角膜炎(包括角膜溃疡):通常,一次1滴,一日3次;眼科围手术期的无菌化治疗:通常,术前一次1滴、一日5次,术后一次1滴、一日3次。 包装规格 VIGAMOX OPTH SOL 3ML MOXIFLOXACIN HCL NOVARTIS PHARMACEUTICALS 00065-4013-03
------------------------------------------------------------------------------- 国内外研究及生产情况 2000年Alcon公司从Bayer公司获得授权开发盐酸莫西沙星滴眼液,2003年4月美国FDA批准上市,商品名:Vigamox®,规格3ml:15mg,用于治疗敏感菌引起的细菌性结膜炎,2006年7月日本批准盐酸莫西沙星滴眼液上市,商品名:Vegamox®,规格5ml:25mg,用于治疗敏感菌引起的眼睑炎、泪囊炎、麦粒肿、结膜炎、睑板腺炎、角膜炎(包括角膜溃疡)、眼科围手术期的无菌化治疗目前,现在盐酸莫西沙星滴眼液已在世界50多个国家和地区上市 产品优势 1、结构优势,抗菌活性强,耐药性低,光毒性小 盐酸莫西沙星增加了药物对细菌的结合能力和细胞膜的穿透力,而且抗菌效应强大持久,增强了抗厌氧菌的活性并延缓了耐药性的发生,能同时抑制拓扑异构酶Ⅱ和Ⅳ,可减少微生物主动外排所致的耐药(是氟喹诺酮类交叉耐药的主要机制),保证了其耐药性低的绝对优势。 2、抗菌谱广,起效快 莫西沙星对革兰阳性菌、革兰阴性菌、厌氧菌、衣原体的各种标准株均具有良好的抗菌活性。 3、安全性高,耐受性好,临床应用广,可用于儿童 临床用于包括婴幼儿等的广大年龄层患者,对于儿童(包括婴幼儿)和老年人(≥65岁)的有效性、安全性都已经得到了临床确认。 4、盐酸莫西沙星滴眼液为水性滴眼液,使用方便、刺激性小、不易产生眼膏所致的视物模糊现象等产品优点。 完整说明书附件: 1):https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0e6ab6ba-5eeb-4faf-ba80-4bf21a74228a 2):https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=58839
VIGAMOX 0.5% EYE DROPS Uses Ophthalmic Infections Bacterial Conjunctivitis Moxifloxacin 0.5% ophthalmic solution is used for the topical treatment of bacterial conjunctivitis caused by susceptible gram-positive bacteria, including Staphylococcus (S. aureus,S. arlettae,S. capitis,S. epidermidis,S. haemolyticus,S. hominis,S. saprophyticus,S. warneri), Streptococcus (S. mitis,S. parasanguinis,S. pneumoniae, viridans streptococci), Enterococcus faecalis,Aerococcus viridans,Corynebacterium (C. macginleyi),Micrococcus luteus, or Propionibacterium acnes. Moxifloxacin 0.5% ophthalmic solution also is used for the topical treatment of bacterial conjunctivitis caused by susceptible gram-negative bacteria, including Acinetobacter lwoffii, Escherichia coli,Haemophilus influenzae,H. parainfluenzae,or Klebsiella pneumoniae. Although many cases of mild, acute bacterial conjunctivitis resolve spontaneously without anti-infective therapy, topical ophthalmic anti-infectives may shorten the time to resolution and reduce severity and risk of complications. Treatment of acute bacterial conjunctivitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended; however, indiscriminate use of topical anti-infectives should be avoided. In vitro staining and/or cultures of conjunctival material may be indicated in the diagnosis and management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment. Clinical Experience Efficacy and safety of moxifloxacin 0.5% ophthalmic solution for the topical treatment of bacterial conjunctivitis have been evaluated in several randomized, double-masked, vehicle- or active-controlled, multicenter trials. In a vehicle-controlled trial evaluating a twice-daily regimen of moxifloxacin 0.5% ophthalmic solution (Moxeza) in patients with bacterial conjunctivitis, the clinical cure rate on day 4 was 63% in those treated with moxifloxacin ophthalmic solution and 51% in those treated with vehicle control and the microbiologic success rate (eradication of baseline pathogens) was 75 and 56%, respectively. In 2 trials evaluating a 3-times daily regimen of moxifloxacin ophthalmic solution (Vigamox) applied for 4 days in patients with bacterial conjunctivitis, the clinical cure rate was 66-69% and the microbiologic success rate (eradication of baseline pathogens) was 84-94% on days 5-6 in those treated with moxifloxacin ophthalmic solution. The microbiologic eradication does not always correlate with clinical outcome in anti-infective trials. Chlamydial Conjunctivitis Moxifloxacin 0.5% ophthalmic solution has been used for the topical treatment of conjunctivitis caused by Chlamydia trachomatis. However, systemic anti-infectives are recommended for the treatment of conjunctivitis caused by C. trachomatis. Although topical anti-infectives have been used concomitantly with systemic anti-infectives for the treatment of such infections, concomitant use of topical anti-infectives is not considered necessary. ------------------------------------------------------ 产地国家:美国 原产地英文商品名: VIGAMOX 0.5% EYE DROPS 3ml/bottle 原产地英文药品名: MOXIFLOXACIN HCL 中文参考商品译名: VIGAMOX 0.5%滴眼液 3毫升/瓶 中文参考药品译名: 盐酸莫西沙星 生产厂家中文参考译名: 诺华 爱尔康 厂家英文名: NOVARTIS ------------------------------------------------------ 产地国家:美国 原产地英文商品名: VIGAMOX 0.5% EYE DROPS 3ml/bottle 原产地英文药品名: MOXIFLOXACIN HCL 中文参考商品译名: VIGAMOX 0.5%滴眼液 3毫升/瓶 中文参考药品译名: 盐酸莫西沙星 生产厂家中文参考译名: 爱尔康 生产厂家英文名: ALCON
|