英文药名：BESTRON FOR OPHTHALMIC 0.5%（Cefmenoxime Hydrochloride） 中文药名：盐酸头孢甲肟0.5% 滴眼用 生产厂家：千寿製薬 ベストロン点眼用0.5% 药物分类名称 Cephem抗生素制剂 批准日期：2007年12月 商標名 BESTRON FOR OPHTHALMIC 0.5% 一般名 セフメノキシム塩酸塩(Cefmenoxime Hydrochloride)〔JAN〕　略号：CMX 化学名 (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)- 2-(methoxyimino)acetylamino]-3-(1-methyl-1H-tetrazol-5-ylsulfanylmethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride 構造式 分子式 (C16H17N9O5S 3)2・HCl 分子量 1059.58 融点(分解点) 130℃付近から黄変し始め、徐々に褐変し約190℃で炭化するが、明確な融点及び分解点を示さない。 性状 头孢匹肟盐酸盐是一种白色至浅橙色结晶或结晶性粉末。 易溶于甲酰胺或二甲基亚砜，难溶于甲醇，极易溶于水，难溶于乙醇（95）。 滴度 定量时，头孢匹肟盐酸盐含有890至975μg（效能）/ mg转化脱水。 然而，该产物的效力表示为头孢氨肟（C 16 H 17 N 9 O 5 S3：511.56）的质量（滴度）。 处理注意事项 存储方式 1.室温下储存 存储方式 2.溶解后，存放在寒冷的地方，7天内使用。 药效药理 1. 抗菌作用 (1) 对革兰氏阴性/革兰氏阳性好氧细菌和厌氧菌的抗菌作用 革兰阴性细菌如铜绿假单胞菌，变形杆菌和葡萄球菌，链球菌和肺炎链球菌的革兰氏阳性菌，其作用是杀菌的（体外）。 (2) 针对临床分离的眼科细菌的抗菌作用 革兰阴性菌如绿脓假单胞菌，流感嗜血杆菌，莫拉氏菌属（Moller and Acnfeldt），变形杆菌属等分离自患有眼睛感染性疾病和革兰氏阳性的金黄色葡萄球菌，表皮葡萄球菌，肺炎链球菌 它显示出对真菌的强抗菌活性（体外）。 (3) 实验铜绿假单胞菌角膜感染的治疗效果 刮去小鼠的角膜基质，用铜绿假单胞菌（ET-1081,1028,1111）的临床分离物接种，并确认角膜炎的发作（真菌接种后9至10小时） 在其中将0.5％或作为对照的生理盐水溶液滴注2天（每天25次）30天的试验中，在Bestrin滴眼剂的0.5％滴注组中发现角膜损伤进展的显着抑制作用。 (4) 对实验金黄色葡萄球菌角膜感染的治疗作用 对于将妥布霉素耐药金黄色葡萄球菌接种到兔角膜基质上制备的角膜感染，接种真菌后立即给予Bestrin眼药水或生理盐水溶液0.5％，每1小时1次，每次1滴，1天 在第9和第7次滴注试验中，在Bestrin滴眼液的0.5％滴注组中观察到抑制感染症状的效果。 2. 作用机序 作用机制是细菌细胞壁的合成抑制。 适应病症 <适应性真菌种类> 头孢匹肟对葡萄球菌，链球菌，链球菌，莫拉沙氏菌（Moller and Acnfeld），粘质沙雷氏菌属（Serratia marcescens），变形杆菌属（Morganella·Morganii），普罗维登斯（Providencia），流感嗜血杆菌（Haemophilus influenzae），嗜血杆菌（Haemophilus），埃及（Koch·Weeks） 细菌），铜绿假单胞菌，痤疮细菌 <适应症> 眼睑炎，泪囊炎，口腔炎，结膜炎，肾炎，角膜炎（包括角膜溃疡），眼周围绝育治疗 用法与用量 用附着的溶解溶液将该药物稀释至浓度为5mg（效力），每1mL头孢他肟盐酸盐，每天一次，每天降1至2滴，每日4次。 此外，根据症状适当地增加或减少次数。 但是，如果在症状中没有观察到改善，则不要连续进行长期连续给药。 包装 〔25mg(力価)・溶解液5mL〕×5 制造厂商 千寿製薬株式会社 完整说明书资料附件：http://www.info.pmda.go.jp/go/pack/1317713Q1038_1_04/ 盐酸头孢甲肟滴眼用0.5% 2.5mg+(稀释后的溶液 5ml) BESTRON FOR OPHTHALMIC 0.5% 5ml Manufacturer's name : Senju Pharmaceutical Co.,Ltd. 620006517 Revised: 01/2011 Brand name : BESTRON FOR OPHTHALMIC 0.5% 　Active ingredient: Cefmenoxime hydrochloride 　Dosage form: white to orangish pale yellow powder, clear and colorless solvent, after dissolution; clear and colorless to pale yellow ophthalmic solution, (solvent bottle) with large white cap and small pink cap 　Printings on wrapping:  Effects of this medicine This medicine inhibits synthesis of bacterial cell wall, and shows antibacterial action. It is usually used in the treatment of eye infections such as conjunctivitis and hordeolum (sty), and for the sterilization before and after eye surgery. Before using this medicine, tell your doctor/pharmacist If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you or your family member have/ has a tendency to develop allergic symptoms such as bronchial asthma, rash and urticaria. If you wear contact lenses. If you are pregnant or breastfeeding. If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosage regimen (proper use of this medicine) Your dosage regimen is:(order of your doctor) General dosage regimen: Dissolve 1 vial into 5 mL of the attached solvent. Apply 1 to 2 drops at a time, 4 times daily. The dosage may be adjusted according to the symptoms. Strictly follow the instructions of your doctor/pharmacist. Push up the upward arrow (↑) on the powder vial and remove the top. Unscrew the large white cap of the solvent bottle. Insert firmly the bottle into the vial, not to spill the solvent, and then shake them well to dissolve the powder completely. After pouring the dissolved medicine into the bottle, remove the vial and recap the bottle tightly. When using the medicine, remove the small pink cap only. Then apply the medicine making sure that the tip of eyedropper does not touch the eye. Missed dose: If you remember that you missed a dose, apply a dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT apply double doses to make up for the missed dose. Overdose: If you used too much of the medicine (more than ordered), check with your doctor/pharmacist. Others: Do not stop using the medicine without the instructions of your doctor. Precautions while using this medicine Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: rash, urticaria, irritation in the eye, itching sensation in the eye, conjunctival congestion, blepharitis (eyelid inflammation), swelling and redness in the eyelid, etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop using your medicine and check with your doctor immediately. facial pallor, cold sweat, orthostatic dizziness [shock] Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.  Storage and other information Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight. After dissolution, store in a cold place (1-15℃), and use within 7 days. Discard the remainder. Do not store them.