莫西沙星说明书
莫西沙星说明书莫西沙星，主要剂型有片剂、注射剂。
本品对革兰阴性菌、革兰阳性菌、支原体、衣原体及脊髓炎病毒等均具有良好的抗菌活性。
莫西沙星说明书是怎样的呢?本文是店铺整理的莫西沙星说明书资料，仅供参考。
莫西沙星信息介绍中文别名编辑1-环丙基-7-﹛(S,S)-2,8-重氮-二环[4.3.0]壬-8-基﹜-6-氟-8-甲氧-1,4-二氢-4-氧-3-喹啉羧酸[1]英文别名编辑4-dihydroquinoline-3-carboxylic acid(1'S,6'S)-1-Cyclopropyl-7-(2,8-diazabicyclo[4.3.0]non-8-yl)-6-fluoro-8-methoxy-4-oxo-1,分子式编辑C21H24FN3O4分子量编辑401.4314CAS号编辑151096-09-2性状编辑浅黄色至黄色粉末或晶体功能编辑莫西沙星为人工合成的喹诺酮类抗菌药，是一类较新的合成抗菌药。
具有抗菌性强、抗菌谱广、不易产生耐药并对常见耐药菌有效、半衰期长、不良反应少等优点。
药品编辑英文名 Moxifloxacin成品剂型：片剂、水针剂其他名称：莫昔沙星、拜复乐原料产地：印度总代理商：拜耳医药保健有限公司【适应症】治疗患有上呼吸道和下呼吸道感染的成人。
如急性窦炎、慢性支气管炎急性发作、社区获得性肺炎、以及皮肤和软组织感染。
【药理毒性】本品为第四代喹诺酮类广谱抗菌药，是广谱和具有抗菌活性的8-甲氧基氟喹诺酮类抗菌药。
莫西沙星在体外显示出对革兰阳性菌、革兰阴性菌、厌氧菌、抗酸菌和非典型微生物如支原体、衣原体和军团菌有广谱抗菌活性。
抗菌机制为干扰Ⅱ、Ⅳ拓扑异构酶。
拓扑异构酶是控制DNA拓扑和DNA复制、修复和转录中的关键酶。
莫西沙星在体内活性高。
【药代动力学】莫西沙星口服后吸收良好，生物利用度约90%。
[2] 达峰时0.5～4小时。
莫西沙星给药不受进食影响。
半衰期达12小时。
同服二、三价阳离子抗酸药可明显减少吸收。
不经细胞色素P450酶代谢。
减少了药物间相互作用的可能性。
肾脏代谢45%，肝脏代谢52%，肾功能损害和轻度肝功能不全的患者无需调整剂量。
【不良反应】常见不良反应为恶心、腹泻、眩晕、头痛、腹痛、呕吐;肝酶升高;光敏性皮炎低于左氧氟沙星。
【禁忌】禁用儿童、少年、怀孕和哺乳期的妇女。
【注意事项】有喹诺酮过敏史患者禁用，可诱发癫痫的发作。
【药物过量】关于过量的研究资料非常有限，单次最大剂量800mg和每日600mg多次口服，连用10天在健康志愿者身上未发现有任何明确不良反应。
一但服用过量莫西沙星时，应根据患者状况采取适当支持措施。
【贮法】避光、密封、干燥条件下储存评价编辑欧洲药品管理局(EMEA)在完成了莫西沙星安全性评估后得出结论，认为应限制性使用含莫西沙星的药品，在治疗急性细菌性鼻窦炎、慢性支气管炎的急性发作和社区获得性肺炎时，只有当其他抗菌药都无法使用或治疗无效时，才能使用莫西沙星。
EMEA还建议加强莫西沙星口服制剂产品的警告。
莫西沙星是氟喹诺酮类抗菌药，其口服制剂是按照欧盟成员国审批程序批准的，已上市近十年，用于治疗急性细菌性鼻窦炎、慢性支气管炎的急性发作和社区获得性肺炎，一些成员国还将莫西沙星用于轻到中度盆腔炎的治疗。
在德国药品管理当局对口服莫西沙星产品进行了安全性评估(包括7例肝损害导致患者死亡的疑似病例)后，英国药品管理当局对莫西沙星的效益/风险提出质疑，并要求EMEA人用医疗产品委员会(CHMP)给出评价意见。
(见《药物警戒快讯》2008年第5期)根据英国提出的要求，EMEA按照相关程序启动了对莫西沙星的评估工作。
此次评估主要是出于对莫西沙星肝脏安全性的考虑，评估的适应症集中在急性细菌性鼻窦炎、慢性支气管炎急性发作和社区获得性肺炎，评估的资料包括上市公司提供的临床试验、观察性研究数据、公开发表的文献和企业收到的不良反应自发报告。
莫西沙星的注射剂型未在此次评估范围之内。
在2008年7月的会议上，CHMP得出结论，认为口服莫西沙星的效益仍大于风险。
然而，因为安全性原因，主要是考虑到肝损害不良事件的增加，CHMP建议限制性使用该产品。
对于急性细菌性鼻窦炎和慢性支气管炎急性发作，莫西沙星只能用于其他抗菌药无法使用或治疗无效的情况;对于社区获得性肺炎，莫西沙星只能在其他抗菌药无法使用的情况下给与。
莫西沙星说明书【药品名称】通用名：盐酸莫西沙星氯化钠注射液商品名：拜复乐® Avelox®英文名：Moxifloxacin Hydrochloride and Sodium Chloride Injection 汉语拼音：Yansuan Moxishaxing Luhuana Zhusheye 本品主要成份为盐酸莫西沙星，化学名为：1-环丙基-7-{(S，S)-2，8-重氮-二环[4.3.0]壬-8-基}-6-氟-8-甲氧-1，4-二氢-4-氧-3-喹啉羧酸盐酸盐。
分子式：C21H24FN3O4·HCl分子量：437.9【性状】本品为黄色的澄明液体。
【适应症】成人(≥18岁)上呼吸道和下呼吸道感染，如：急性窦炎，慢性支气管炎急性发作，社区获得性肺炎;以及皮肤和软组织感染。
【规格】250ml∶0.4g莫西沙星, 2.0g氯化钠。
【用法用量】给药方法：根据中国健康受试者心脏所能耐受的输液速率以及国内I、II、III期临床研究的结果，推荐本品的输液时间应为90分钟。
(国外推荐0.4g莫西沙星静脉给药的输液时间应大于60分钟。
) 剂量范围(成人)：推荐剂量为一次0.4g,一日一次(一次1瓶，一日一次)。
疗程：根据症状的严重程度或临床反应决定疗程。
治疗上呼吸道和下呼吸道感染时通常可按照下列疗程：慢性支气管炎急性发作：5天社区获得性肺炎：序贯给药(静脉给药后继续口服用药)推荐的总疗程为7～14天。
急性窦炎：7天治疗皮肤和软组织感染的推荐疗程为7天。
莫西沙星可以在开始治疗时静脉给药，之后再根据患者情况口服片剂给药。
0.4g莫西沙星注射液在临床试验中最多用过14天。
给药方法：静脉给药0.4g的时间应为90分钟。
莫西沙星既可以单独给药也可以与一些相容的溶液一同滴注。
下列注射液与莫西沙星注射液的混合液在室温条件下可保持稳定24小时以上，因此被认为可以合并给药：注射用水0.9%氯化钠注射液1摩尔氯化钠注射液5%葡萄糖注射液10%葡萄糖注射液40%葡萄糖注射液20%木糖醇注射液林格氏液乳酸林格氏液Aminofusin10%(生产厂家: Pharmacia&Upjohn)Jonosteril D5 (生产厂家: Fresenius Kabi)若莫西沙星注射液需与其它药物合用，每种药物需单独给药(见不相容性)。
只有澄明的溶液才能使用。
老年人老年人不必调整用药剂量。
儿童莫西沙星对儿童和青少年的疗效和安全性尚未确定。
(见特别提醒和注意事项) 肝损害轻度肝功能损伤(Child-Pugh A，B)的患者不必调整莫西沙星的剂量。
目前尚缺乏严重肝功能损伤患者(Child-Pugh C)的药代动力学数据。
肾损害肾功能受损的病人(包括肌酐清除率≤30ml/min/1.73m2)和慢性透析，如血液透析和持续性不卧床腹膜透析的患者无需调整剂量。
种族差异对高加索人、日本人、黑人及其他种族人群进行了可能的种族间差别试验，未发现临床相关的药代动力学差别。
因此，不同种族间不必调整药物剂量。
【不良反应】在莫西沙星的临床试验中，绝大多数的不良反应为轻中度(约90%)，由于不良反应导致停用莫西沙星治疗的病人为3.6%，序贯治疗(静脉给药后继续口服用药)为5.7%。
根据莫西沙星的临床试验总结出的常见不良反应(其相关程度分为很可能、可能和无法评估)列表如下：发生率≥1%<10%全身症状：腹痛、头痛、注射部位反应(如水肿/过敏/炎症/疼痛)心血管系统：合并低血钾症患者QT间期延长消化系统：恶心、腹泻、呕吐、消化不良、肝功能化验异常特殊感官：味觉倒错神经系统：眩晕发生率≥0.1%<1%全身症状：乏力、念珠菌病、疼痛、不适、胸痛心血管系统：心动过速、高血压、心悸、QT间期延长、静脉炎(注射部位) 消化系统：口干、恶心和呕吐、腹胀、便秘、口腔念珠菌病、食欲下降、口腔炎、胃肠功能失调、舌炎、γGT(γ谷氨酰转肽酶)增高血液和淋巴系统：白细胞减少、凝血酶原减少/国际标准化比值增高、嗜酸细胞增多、血小板增多症代谢和营养：淀粉酶增加骨骼肌肉系统：关节痛、肌肉痛神经系统：失眠、眩晕、神经质、嗜睡、焦虑、震颤、感觉异常呼吸系统：呼吸困难皮肤和附件：皮疹、瘙痒、多汗泌尿生殖系统：阴道念珠菌病、阴道炎发生率≥0.01%<0.1%全身症状：骨盆疼、面部浮肿、背疼、实验室检验异常、过敏反应、腿疼心血管系统：低血压、血管扩张、外周性水肿消化系统：胃炎、舌变色、吞咽困难、黄疸(主要为胆汁淤积性)、腹泻(难辨梭菌)血液和淋巴系统：凝血活酶减少、凝血酶原增加/国际标准化比值降低、血小板减少、贫血代谢和营养：高血糖、高血脂、高尿酸血症、LDH(乳酸脱氢酶)增高(与肝功能检查异常有关)骨骼肌肉：关节炎、肌腱异常神经系统：幻觉、人格解体、紧张、动作失调、激动不安、健忘症、失语症、情绪不稳定、睡眠障碍、语言障碍、思维异常、感觉减退、梦异常、惊厥、精神错乱、忧郁症呼吸系统：哮喘皮肤和附件：皮疹(斑丘疹、紫癜、脓泡)、荨麻疹特殊感官：耳鸣、视觉异常、味觉丧失、嗅觉倒错(包括嗅觉倒错、嗅觉减低及嗅觉丧失)、弱视泌尿生殖系统：肾功能异常(肌酐或尿素升高)上市后报道的不良反应：发生率≥0.01%<0.1%心血管系统：晕厥发生率<0.01%过敏性：过敏反应、过敏性休克(可危及生命)、血管性水肿(包括喉头水肿;潜在生命危险)消化系统：伪膜性结肠炎(在极少数病例伴有危及生命的并发症)，肝炎(主要为胆汁淤积性)肌肉骨胳系统：肌腱断裂皮肤和附件：斯蒂文斯-约翰逊综合征(Stevens-Johnson Syndrome) 神经系统：精神病反应心血管系统：报道在极少数病例尤其是在有严重的潜在性致心律失常条件的病人出现，包括尖端扭转型室速的室性快速性心律失常和心脏停搏。
未在上述不良反应中列出的认为与药物无关的最常见的实验室参数异常为：血细胞压积增加或减少、白细胞增加、红细胞增加或减少、血糖下降、血红蛋白减少、碱性磷酸酶升高、SGOT/AST(血清谷氨酸草酰乙酸转氨酶/天冬氨酸氨基转移酶)升高、SGPT/ALT(血清谷氨酸丙酮酸转氨酶/丙氨酸氨基转移酶)升高、胆红素升高、尿素升高、肌酐升高、血尿素氮升高。
上述异常是否由该药或治疗时患者状况导致尚属未知。
【禁忌】已知对该注射液的任何成分或其他喹诺酮类药物过敏者。
莫西沙星滴眼剂说明书（英文）
VIGAMOX™(moxifloxacin hydrochloride ophthalmic solution) 0.5% as baseDESCRIPTION: VIGAMOX™ (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.C 21H 24FN 3O 4•HCl Mol Wt 437.9Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride.Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL ofVIGAMOX™ contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin base.Contains:Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8.VIGAMOX™ is an isotonic solution with an osmolality of approximately 290 mOsm/kg.CLINICAL PHARMACOLOGY:Pharmacokinetics: Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of VIGAMOX™ 3 times a day. The mean steady-state C max (2.7 ng/mL) and estimated daily exposure AUC (45 ng·hr/mL) values were 1,600 and 1,000 times lower than the mean C max and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.Microbiology:Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at the C7 position. The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of O O FHCH 3N OH HON N H H +Cl -antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10-9 to < 1 x 10-11 for Gram-positive bacteria.Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:Aerobic Gram-positive microorganisms:Corynebacterium species*Micrococcus luteus*Staphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneri*Streptococcus pneumoniaeStreptococcus viridans groupAerobic Gram-negative microorganisms:Acinetobacter lwoffii*Haemophilus influenzaeHaemophilus parainfluenzae*Other microorganisms:Chlamydia trachomatis*Efficacy for this organism was studied in fewer than 10 infections.The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of VIGAMOX™ in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials.The following organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 µg/ml or less (systemic susceptible breakpoint) against most (≥ 90%) of strains of the following ocular pathogens.Aerobic Gram-positive microorganisms:Listeria monocytogenesStaphylococcus saprophyticusStreptococcus agalactiaeStreptococcus mitisStreptococcus pyogenesStreptococcus Group C, G and FAerobic Gram-negative microorganisms:Acinetobacter baumanniiAcinetobacter calcoaceticusCitrobacter freundiiCitrobacter koseriEnterobacter aerogenesEnterobacter cloacaeEscherichia coliKlebsiella oxytocaKlebsiella pneumoniaeMoraxella catarrhalisMorganella morganiiNeisseria gonorrhoeaeProteus mirabilisProteus vulgarisPseudomonas stutzeriAnaerobic microorganisms:Clostridium perfringensFusobacterium speciesPrevotella speciesPropionibacterium acnesOther microorganisms:Chlamydia pneumoniaeLegionella pneumophilaMycobacterium aviumMycobacterium marinumMycoplasma pneumoniaeClinical Studies:In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, VIGAMOX™ solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of the baseline pathogens ranged from 84% to 94%. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.INDICATIONS AND USAGE: VIGAMOX™ solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Aerobic Gram-positive microorganisms:Corynebacterium species*Micrococcus luteus*Staphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneri*Streptococcus pneumoniaeStreptococcus viridans groupAerobic Gram-negative microorganisms:Acinetobacter lwoffii*Haemophilus influenzaeHaemophilus parainfluenzae*Other microorganisms:Chlamydia trachomatis*Efficacy for this organism was studied in fewer than 10 infections. CONTRAINDICATIONS: VIGAMOX™ solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. WARNINGS:NOT FOR INJECTION.VIGAMOX™ solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.PRECAUTIONS:General: As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source.Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.Drug Interactions: Drug-drug interaction studies have not been conducted with VIGAMOX™ solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis).Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.Pregnancy: Teratogenic Effects.Pregnancy Category C: Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day.Since there are no adequate and well-controlled studies in pregnant women, VIGAMOX™ solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing Mothers: Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when VIGAMOX™ solution is administered to a nursing mother.Pediatric Use: The safety and effectiveness of VIGAMOX solution in infants below 1 year of age have not been established.There is no evidence that the ophthalmic administration of VIGAMOX™ has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.ADVERSE REACTIONS:The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients.Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.DOSAGE AND ADMINISTRATION:Instill one drop in the affected eye 3 times a day for 7 days.HOW SUPPLIED: VIGAMOX™ (moxifloxacin hydrochloride ophthalmic solution) 0.5% is supplied as a sterile ophthalmic solution in Alcon’s DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.3 mL in 6 mL bottle - NDC 0065-4013-03Storage: Store at 2˚C- 25˚C (36˚F - 77˚F).R x OnlyManufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 USALicensed to Alcon, Inc. by Bayer AG.U.S. PAT. NO. 4,990,517; 5,607,942; 6,716,830© 2003, 2004 Alcon, Inc.。
盐酸莫西沙星氯化钠的用法用量及注意事项
盐酸莫西沙星氯化钠的用法用量及注意事项
盐酸莫西沙星氯化钠是我们在日常家庭用药中可以看见的药品，有的家庭如果有家人患有鼻窦炎，可能就会吃这个药，因为它主要就是治疗呼吸道感染的，主要的作用就是消除呼吸道里面的炎症，改善我们的呼吸道。
对这个药品不了解的人可以仔细阅读该药品的用法用量，以及在使用中需要注意到的事项。
一、用法用量给药方法：根据中国健康受试者心脏所能耐受的输液速率以及国内I、II、III期临床研究的结果，推荐本品的输液时间应为90分钟。
(国外推荐0.4g莫西沙星静脉给药的输液时间应大于60分钟。
)
剂量范围(成人)：推荐剂量为一次0.4g，一日一次(一次1瓶，一日一次)。
根据症状的严重程度或临床反应决定疗程。
治疗上呼吸道和下呼吸道感染时通常可按照下列疗程：
1.慢性支气管炎急性发作：5天
2.社区获得性肺炎：序贯给药(静脉给药后继续口服用药)推荐的总疗程为7～14天。
3.急性窦炎：7天
4.治疗皮肤和软组织感染的推荐疗程为7天。
二、注意事项：
1.妊娠和哺乳期妇女。
2.由于缺乏患有肝功能严重损伤(Child Pugh C级)的患者和转氨酶升高大于5倍正常值上限的患者使用莫西沙星的临床数据，该药在这类患者中禁止使用。
3.18岁以下患者。
看了上面对盐酸莫西沙星氯化钠的介绍，我们一定知道18岁以下的未成年不能使用该产品。
虽然有时候我们对于一个药的用处很了解，经常会自己去药店买取需要的药品，但是我们也要
注意几点内容，经常去药店买药的朋友要仔细观看药盒上面的注意事项，以及它的用法用量。
盐酸莫西沙星氯化钠注射液
盐酸莫西沙星氯化钠注射液【药品名称】通用名称：盐酸莫西沙星氯化钠注射液英文名称：Moxifloxacin Hydrochloride and Sodium Chloride Injection【成份】本品主要成份为盐酸莫西沙星，化学名为：1-环丙基-7-[(s，s)-2，8-重氮-二环[4.3.0]壬-8-基]-6-氟-8-甲氧-1，4-二氢-4-氧-3-11奎啉羧酸盐酸盐。
【适应症】成人（≥18岁）上呼吸道和下呼吸道感染，如：急性窦炎、慢性支气管炎急性发作、社区获得性肺炎；以及皮肤和软组织感染。
【用法用量】400 mg qd，口服或静滴90分钟。
疗程：慢性支气管炎急性发作- 5天；社区获得性肺炎：序贯给药（静脉给药后继续口服用药）总疗程为7-14天；急性鼻窦炎- 7天；皮肤和软组织感染- 7天。
最多14天。
【不良反应】在莫西沙星的临床试验中，绝大多数的不良反应为轻中度(约90％)，由于不良反应导致停用莫西沙星治疗的病人为36％，序贯治疗(静脉给药后继续口服用药)为5.7％。
根据莫西沙星的临床试验总结出的常见不良反应列表如下：发生率≥1％＜10％全身症状：腹痛、头痛、注射部位反应(如水肿／过敏/炎症／疼痛)心血管系统：合并低血钾症患者QT间期延长消化系统：恶心、腹泻、呕吐、消化不良、肝功能化验异常特殊感官：味觉倒错神经系统：头晕发生率≥0.1％＜1％全身症状：乏力、念珠菌病、疼痛、不适、胸痛心血管系统：心动过速、高血压、心悸、QT间期延长、静脉炎(注射部位)消化系统：口干、恶心和呕吐、腹胀、便秘、口腔念珠菌病、食欲下降、口腔炎、胃肠功能失调、舌炎、γGT(γ谷氨酰转肽酶)增高血液和淋巴系统：白细胞减少、凝血酶原减少/国际标准化比值增高、嗜酸细胞增多、血小板增多症代谢和营养：淀粉酶增加骨骼肌肉系统：关节痛、肌肉痛神经系统失眠、眩晕、神经质、嗜睡、焦虑、震颤、感觉异常呼吸系统：呼吸困难皮肤和附件：皮疹、瘙痒、多汗泌尿生殖系统：阴道念珠菌病、阴道炎发生率≥0.01％＜0.1％全身症状：骨盆疼、面部浮肿、背疼、实验室检验异常、过敏反应、腿疼心血管系统：低血压、血管扩张、外周性水肿消化系统：胃炎、舌变色、吞咽困难、黄疸(主要为胆汁淤积性)、腹泻(难辨梭菌)血液和淋巴系统：凝血活酶减少、凝血酶原增加/国际标准化比值降低、血小板减少、贫血代谢和营养：高血糖、高血脂、高尿酸血症、LDH(乳酸脱氢酶)增高(与肝功能检查异常有关)骨骼肌肉：关节炎、肌腱异常神经系统：幻觉、人格解体、紧张、动作失调、激动不安、健忘症、失语症、情绪不稳定、睡眠障碍、语言障碍、思维异常、感觉减退、梦异常、惊厥、精神错乱、忧郁症呼吸系统：哮喘皮肤和附件：皮疹(斑丘疹、紫癜、脓泡)、荨麻疹特殊感官：耳鸣、视觉异常、味觉丧失、嗅觉倒错(包括嗅觉倒错，嗅觉减低及嗅觉丧失)、弱视泌尿生殖系统：肾功能异常(肌酐或尿素升高)上市后报道的不良反应：发生率≥0.01％＜0.1％心血管系统：晕厥发生率＜0.01％过敏性：过敏反应、过敏性休克(可危及生命)、血管性水肿(包括喉头水肿；潜在生命危险)消化系统：伪膜性结肠炎(在极少数病例伴有危及生命的并发症)，肝炎(主要为胆汁淤积性)肌肉骨胳系统：肌腱断裂皮肤和附件：斯蒂文斯-约翰逊综合征(Stevens-JohnsonSyndrome)神经系统：精神病反应心血管系统：报道在极少数病例尤其是在有严重的潜在性致心律失常条件的病人出现，包括尖端扭转型室速的室性快速性心律失常和心脏停搏。
肺炎拜耳消炎药莫西沙星用量
肺炎拜耳消炎药莫西沙星用量在治疗肺炎等呼吸道感染疾病时，抗生素是一种常用的药物选择。
莫西沙星是一种广谱喹诺酮类抗生素，被广泛用于治疗各种感染疾病，包括肺炎。
本文将介绍莫西沙星的用量和使用注意事项。
莫西沙星的推荐用量莫西沙星的用量应根据医生的建议和患者的具体情况来确定。
一般情况下，莫西沙星的推荐用量如下：•成人用量：每日400毫克至800毫克，分为两次或三次口服。
在严重感染的情况下，每日最大剂量可增加至1200毫克。
•儿童用量：莫西沙星对于12岁以上的儿童可以按照成人剂量使用。
对于12岁以下的儿童，用量应该根据医生的具体指导来确定。
莫西沙星的用量可能会因患者的身体状况、感染的严重程度以及其他因素而有所不同。
因此，在使用莫西沙星之前，务必先咨询医生的建议，并遵循其准确的用量指导。
使用注意事项除了正确使用药物之外，还需要注意以下事项：1. 饭前或饭后服用莫西沙星可以在饭前或饭后服用，但一般情况下建议饭后服用。
进食会减慢莫西沙星的吸收速度，从而减少胃肠道不良反应的发生。
2. 避免与某些药物同时使用莫西沙星可能与某些药物相互作用，影响其疗效或增加副作用的风险。
因此，在使用莫西沙星之前，务必告知医生所有正在使用的药物，包括处方药、非处方药以及补充剂。
3. 注意可能的副作用莫西沙星的使用可能会引起一些常见的副作用，包括恶心、呕吐、腹泻、头痛、失眠等。
如果出现严重的不良反应或不寻常的症状，应立即停止使用，并咨询医生的建议。
4. 不适用于某些人群莫西沙星可能不适合某些人群使用，包括孕妇、哺乳期妇女、儿童和某些患有特定疾病的人。
在使用莫西沙星之前，务必告知医生有关自己的个人情况，以确保药物的安全使用。
5. 完成全程治疗即使症状减轻或消失，也应按照医生的指导完成全程治疗。
中断或提前停止使用莫西沙星可能导致细菌抗药性的发展，使治疗变得更加困难。
结论莫西沙星是一种常用于治疗呼吸道感染疾病的抗生素。
使用莫西沙星时，应注意正确的用量和使用注意事项，遵循医生的指导。
盐酸莫西沙星 Moxifloxacin Hydrochloride说明书
中国食品药品检定研究院
盐酸莫西沙星
Moxifloxacin Hydrochloride
【类别】化学对照品
【批号】510140-202003
【结构式
】
【分子式】C 21H 24FN 3O 4∙HCl
【分子量】437.89
【CAS 号】186826-86-8
【用途】供HPLC 法含量测定用
【特性量值】以C 21H 24FN 3O 4∙HCl 计，含量为95.6%。
【使用方法】使用前不需干燥处理。
【包装】棕色西林瓶
【规格】50mg/支
【贮藏】遮光,密闭,2-8℃保存。
【有效期】国家药品标准物质不设具体有效期，按照规定条件保存的标准物质，在中国食品药品检定研究院发布停用通知前有效。
中国食品药品检定研究院
声明：
1.请按本品说明书规定使用，若作他用，用户须自行证明适用性;
2.因用户使用或储存不当所引起的损害或投诉，用户自行承担相关责任;
3.用户收到本品后应立即核对品种、数量、包装等，若出现质量、数量等不符，相关赔偿只限于标准物质本身，不涉及其他任何损失。
研制发行单位：
中国食品药品检定研究院。
莫西沙星说明书doc
莫西沙星说明书篇一：拜复乐说明书拜复乐说明书【药品名称】通用名：盐酸莫西沙星氯化钠注射液商品名：拜复乐? Avelox?英文名：Moxifloxacin Hydrochloride and Sodium Chloride Injection 汉语拼音：Yansuan Moxishaxing Luhuana Zhusheye本品主要成份为盐酸莫西沙星，化学名为：1-环丙基-7-{（S，S）-2，8-重氮-二环[4.3.0]壬-8-基}-6-氟-8-甲氧-1，4-二氢-4-氧-3-喹啉羧酸盐酸盐。
其结构式为：分子式：C21H24FN3O4·HCl分子量：437.9【性状】本品为黄色的澄明液体。
【适应症】成人(≥18岁)上呼吸道和下呼吸道感染，如：急性窦炎，慢性支气管炎急性发作，社区获得性肺炎；以及皮肤和软组织感染。
【规格】250ml∶0.4g莫西沙星, 2.0g氯化钠。
【用法用量】给药方法：根据中国健康受试者心脏所能耐受的输液速率以及国内I、II、III期临床研究的结果，推荐本品的输液时间应为90分钟。
(国外推荐0.4g莫西沙星静脉给药的输液时间应大于60分钟。
)剂量范围(成人)：推荐剂量为一次0.4g,一日一次(一次1瓶，一日一次)。
疗程：根据症状的严重程度或临床反应决定疗程。
治疗上呼吸道和下呼吸道感染时通常可按照下列疗程：慢性支气管炎急性发作：5天社区获得性肺炎：序贯给药(静脉给药后继续口服用药)推荐的总疗程为7～14天。
急性窦炎：7天治疗皮肤和软组织感染的推荐疗程为7天。
莫西沙星可以在开始治疗时静脉给药，之后再根据患者情况口服片剂给药。
0.4g莫西沙星注射液在临床试验中最多用过14天。
给药方法：静脉给药0.4g的时间应为90分钟。
莫西沙星既可以单独给药也可以与一些相容的溶液一同滴注。
下列注射液与莫西沙星注射液的混合液在室温条件下可保持稳定24小时以上，因此被认为可以合并给药：注射用水0.9%氯化钠注射液1摩尔氯化钠注射液5%葡萄糖注射液10%葡萄糖注射液40%葡萄糖注射液20%木糖醇注射液林格氏液乳酸林格氏液Aminofusin10%(生产厂家: Pharmacia&Upjohn)Jonosteril D5 (生产厂家: Fresenius Kabi)若莫西沙星注射液需与其它药物合用，每种药物需单独给药(见不相容性)。
莫西沙星严重不良反应
05 治疗措施及患者管理建议
立即停药并观察病情变化
一旦发现患者出现莫西沙星严重不良 反应，应立即停止使用该药物，避免 病情进一步恶化。
停药后，密切观察患者的病情变化， 包括症状、体征、实验室检查结果等 ，以便及时调整治疗方案。
针对具体症状进行治疗
针对患者出现的具体症状，采取相应 的治疗措施，如抗过敏、抗炎、保肝 等治疗。
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不遵医嘱用药
未按照医生指导的用药方式、剂量和时间使用莫 西沙星，可能导致不良反应的发生。
过量使用
超过推荐剂量使用莫西沙星，可能增加药物毒性 反应的风险，如肝功能损害、心律失常等。
3
长期使用
长期使用莫西沙星可能导致药物在体内积累，增 加不良反应的风险，如肠道菌群失衡、耐药性增 加等。
04 诊断方法与标准流程
感谢您的观看
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建议患者在用药期间定期随访，及时向医生反馈 病情变化及用药情况，以便及时调整治疗方案。
06 预防措施与监管政策改进
提高医生处方水平培训
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加强莫西沙星用药 指南学习
确保医生全面了解莫西沙星的适 应症、禁忌症、用药剂量等重要 信息。
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规范医生处方行为
通过定期培训和考核，提高医生 对抗生素处方的合理性，减少不 必要的莫西沙星使用。
莫西沙星与其他药物在代谢途径上存在竞争关系，可能导致药物在体内积累，增加毒性反应的风险。
个体差异及遗传因素影响
个体代谢差异
不同个体对莫西沙星的代谢速度和程度 存在差异，可能导致部分人群更容易出 现不良反应。
VS
遗传因素
某些遗传变异可能影响莫西沙星的代谢和 排泄，从而增加不良反应的风险。
用药不当或过量使用引发问题
肺炎首选治疗药物莫西沙星,做到三要一不要,效果好还安全
肺炎首选治疗药物莫西沙星，做到两要两不要，效果好还安全提起来莫西沙星，想必大家并不陌生。
它是第四代氟喹诺酮类抗菌药物，因其能广谱覆盖肺炎链球菌、肺炎支原体、流感嗜血杆菌等呼吸道常见致病菌，因此，与左氧氟沙星、吉米沙星合称为“呼吸喹诺酮类”抗菌药物。
因其抗菌谱广、抗菌作用强、药效持续时间长等优势，被广泛应用于临床。
然而，正确使用莫西沙星需遵循两要两不要。
一、要用够疗程
众所周知，细菌是非常狡猾的，如果未按照足量足疗程使用，细菌会处于半生不死的状态，很难保证机体免疫力低下后，这些细菌不会卷土重来。
因此，莫西沙星使用过程中，一定要用够疗程，指南中推荐莫西沙星用于治疗肺炎时，应当用够7-14天。
二、要避光输液
这主要是由于服用完莫西沙星后，如果暴露于阳光或者紫外线的照射下，部分患者会发生不同程度的光敏反应或者光毒性反应。
表现为皮肤灼热感、红斑、渗出、水肿等。
因此，服药期间，一定要做好防晒措施，避免暴露皮肤在阳光下。
三、不要饮酒
虽然在莫西沙星的说明书中，没有明确提示会与酒精发生双硫仑反应，但已有文献报道，个别患者在服用莫西沙星饮酒后，仍然发生了双硫仑反应。
因此，处于安全考虑，服用莫西沙星后，不要饮酒。
四、不要用于未成年人
莫西沙星说明书中明确规定，该药物对未成年人的骨骼发育有明显的影响，容易造成骨骼和软骨代谢障碍，尤其是膝关节、髋关节等。
因此，非必要，莫西沙星不用于18岁以下的未成年人。
莫西沙星片的功能主治
莫西沙星片的功能主治1. 莫西沙星片的基本信息•药品名称：莫西沙星片•通用名：莫西沙星•英文名：Moxifloxacin Hydrochloride Tablets•药理作用：广谱抗菌药物•药物类别：喹诺酮类抗生素•适应症：感染性疾病•剂型：片剂2. 莫西沙星片的主要功能•抗菌作用：莫西沙星片是一种广谱抗菌药物，对许多革兰氏阳性菌、革兰氏阴性菌、厌氧菌和肺炎支原体等均有效，能够有效抑制细菌的生长和繁殖。
•消炎作用：莫西沙星片能够抑制细菌引起的炎症反应，缓解炎症症状，促进炎症的消退。
•清热解毒：莫西沙星片具有一定的解热作用，在患者发热时可以有效地缓解体温升高的症状。
•改善呼吸道症状：莫西沙星片可以用于治疗呼吸道感染，能够改善咳嗽、咳痰、喉咙痛等症状。
•预防并发症：莫西沙星片在处理感染性疾病时，可以有效地预防并发症的发生，如肺炎、中耳炎等。
3. 莫西沙星片的主治疾病•上呼吸道感染：莫西沙星片可以用于治疗上呼吸道感染，如鼻窦炎、扁桃体炎等。
•下呼吸道感染：莫西沙星片可以用于治疗下呼吸道感染，如肺炎、支气管炎等。
•尿路感染：莫西沙星片可以用于治疗尿路感染，如膀胱炎、肾盂肾炎等。
•皮肤和软组织感染：莫西沙星片可以用于治疗皮肤和软组织感染，如疖痈、蜂窝组织炎等。
•寄生虫感染：莫西沙星片可以用于治疗某些寄生虫感染，如疟疾、阿米巴病等。
4. 使用莫西沙星片的注意事项•禁忌症：对莫西沙星片过敏者禁用。
对氟喹诺酮类抗生素过敏者、青光眼、降钙素缺乏症和抗菌药物相关性肠炎者禁用。
•剂量和用法：成人一般口服，一次200~400mg，一日1次。
剂量可根据患者的具体病情进行调整。
•不良反应：使用莫西沙星片可能会引起头晕、恶心、呕吐、腹泻、食欲减退等不良反应，如有不适，请及时就医。
•注意事项：在使用莫西沙星片期间，应注意避免紫外线照射，避免饮酒和过度劳累。
如果出现肠胃道反应较严重，应停药并就医处理。
5. 与其他药物的相互作用•铝、镁、锌、铁及乳铁制剂妨碍吸收。
盐酸莫西沙星氯化钠注射液说明书
AVELOX®(moxifloxacin hydrochloride) TabletsAVELOX® I.V.(moxifloxacin hydrochloride in sodium chloride injection)XXXXXXX, R.X02/08 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.DESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4 *HCl and its chemical structure is as follows:AVELOX Tablets are available as film-coated tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin). The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide.AVELOX I.V. is available in ready-to-use 250 mL latex-free flexibags as a sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from 4.1 to 4.6. The appearance of the intravenous solution is yellow. The color does not affect, nor is it indicative of, product stability. The inactive ingredients are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment.CLINICAL PHARMACOLOGYAbsorptionMoxifloxacin, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90 percent. Co-administration with a high fat meal (i.e., 500 calories from fat) does not affect the absorption of moxifloxacin. Consumption of 1 cup of yogurt with moxifloxacin does not significantly affect the extent or rate of systemic absorption (AUC).The mean (± SD) C max and AUC values following single and multiple doses of 400 mg moxifloxacin given orally are summarized below.C max (mg/L)AUC(mg•h/L)Half-life(hr)Single Dose OralHealthy (n = 372) 3.1 ± 1.036.1 ± 9.111.5 - 15.6* Multiple Dose OralHealthy young male/female (n = 15) 4.5 ± 0.548.0 ± 2.712.7 ± 1.9 Healthy elderly male (n = 8) 3.8 ± 0.351.8 ± 6.7Healthy elderly female (n = 8) 4.6 ± 0.654.6 ± 6.7Healthy young male (n = 8) 3.6 ± 0.548.2 ± 9.0Healthy young female (n = 9) 4.2 ± 0.549.3 ± 9.5* Range of means from different studiesThe mean (± SD) C max and AUC values following single and multiple doses of 400 mg moxifloxacin given by 1 hour I.V. infusion are summarized below.C max (mg/L)AUC(mg•h/L)Half-life(hr)Single Dose I.V.Healthy young male/female (n = 56) 3.9 ± 0.939.3 ± 8.68.2 - 15.4* Patients (n = 118)Male (n = 64) 4.4 ± 3.7Female (n = 54) 4.5 ± 2.0< 65 years (n = 58) 4.6 ± 4.2≥ 65 years (n = 60) 4.3 ± 1.3Multiple Dose I.V.Healthy young male (n = 8) 4.2 ± 0.838.0 ± 4.714.8 ± 2.2 Healthy elderly (n =12; 8 male, 4 female) 6.1 ± 1.348.2 ± 0.910.1 ± 1.6 Patients** (n = 107)Male (n = 58) 4.2 ± 2.6Female (n = 49) 4.6 ± 1.5< 65 years (n = 52) 4.1 ± 1.4≥ 65 years (n = 55) 4.7 ± 2.7* Range of means from different studies** Expected C max (concentration obtained around the time of the end of the infusion)Plasma concentrations increase proportionately with dose up to the highest dose tested (1200 mg single oral dose). The mean (± SD) elimination half-life from plasma is 12 ± 1.3 hours; steady-state is achieved after at least three days with a 400 mg once daily regimen.Mean Steady-State Plasma Concentrations of Moxifloxacin Obtained With Once Daily Dosing of 400 mg Either Orally (n=10) or by I.V. Infusion (n=12)DistributionMoxifloxacin is approximately 30-50% bound to serum proteins, independent of drug concentration. The volume of distribution of moxifloxacin ranges from 1.7 to 2.7 L/kg. Moxifloxacin is widely distributed throughout the body, with tissue concentrations often exceeding plasma concentrations. Moxifloxacin has been detected in the saliva, nasal and bronchial secretions, mucosa of the sinuses, skin blister fluid, subcutaneous tissue, skeletal muscle, and abdominal tissues and fluids following oral or intravenous administration of 400 mg. Moxifloxacin concentrations measured post-dose in various tissues and fluids following a 400 mg oral or I.V. dose are summarized in the following table. The rates of elimination of moxifloxacin from tissues generally parallel the elimination from plasma.Moxifloxacin Concentrations (mean ± SD) in Tissuesand the Corresponding Plasma Concentrations After a Single 400 mg Oral orIntravenous Dose §Tissue or Fluid NPlasmaConcentration(µg/mL)Tissue or FluidConcentration(µg/mL or µg/g)TissuePlasmaRatio:RespiratoryAlveolar Macrophages5 3.3± 0.761.8± 27.321.2 ± 10.0 Bronchial Mucosa8 3.3± 0.7 5.5± 1.3 1.7 ± 0.3 Epithelial Lining Fluid5 3.3± 0.724.4± 14.78.7 ± 6.1 SinusMaxillary Sinus Mucosa4 3.7± 1.1†7.6± 1.7 2.0 ± 0.3 Anterior Ethmoid Mucosa3 3.7± 1.1†8.8± 4.3 2.2 ± 0.6 Nasal Polyps4 3.7± 1.1†9.8± 4.5 2.6 ± 0.6 Skin, MusculoskeletalBlister Fluid5 3.0± 0.5‡ 2.6± 0.9 0.9 ± 0.2 Subcutaneous Tissue6 2.3± 0.4#0.9± 0.3* 0.4 ± 0.6 Skeletal Muscle6 2.3± 0.4#0.9± 0.2* 0.4 ± 0.1 Intra-AbdominalAbdominal tissue 8 2.9± 0.5 7.6 ± 2.0 2.7 ± 0.8 Abdominal exudate 10 2.3±0.5 3.5 ±1.2 1.6 ± 0.7 Abscess fluid 6 2.7± 0.7 2.3 ±1.5 0.8±0.4§all moxifloxacin concentrations were measured 3 hours after a single 400 mg dose, except the abdominal tissue and exudate concentrations which were measured at 2 hours post-dose and the sinus concentrations which were measured 3 hours post-dose after 5 days of dosing.† N = 5‡N = 7#N = 12* Reflects only non-protein bound concentrations of drug.MetabolismApproximately 52% of an oral or intravenous dose of moxifloxacin is metabolized via glucuronide and sulfate conjugation. The cytochrome P450 system is not involved in moxifloxacin metabolism, and is not affected by moxifloxacin. The sulfate conjugate (M1) accounts for approximately 38% of the dose, and is eliminated primarily in the feces. Approximately 14% of an oral or intravenous dose is converted to a glucuronide conjugate (M2), which is excreted exclusively in the urine. Peak plasma concentrations of M2 are approximately 40% those of the parent drug, while plasma concentrations of M1 are generally less than 10% those of moxifloxacin.In vitro studies with cytochrome (CYP) P450 enzymes indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, suggesting that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these enzymes.ExcretionApproximately 45% of an oral or intravenous dose of moxifloxacin is excreted as unchanged drug (~20% in urine and ~25% in feces). A total of 96% ± 4% of an oral dose is excreted as either unchanged drug or known metabolites. The mean (± SD) apparent total body clearance and renal clearance are 12 ± 2.0 L/hr and 2.6 ± 0.5 L/hr, respectively.Special PopulationsGeriatricFollowing oral administration of 400 mg moxifloxacin for 10 days in 16 elderly (8 male; 8 female) and 17 young (8 male; 9 female) healthy volunteers, there were no age-related changes in moxifloxacin pharmacokinetics. In 16 healthy male volunteers (8 young; 8 elderly) given a single 200 mg dose of oral moxifloxacin, the extent of systemic exposure (AUC and C max)was not statistically different between young and elderly males and elimination half-life was unchanged. No dosage adjustment is necessary based on age. In large phase III studies, the concentrations around the time of the end of the infusion in elderly patients following intravenous infusion of 400 mg were similar to those observed in young patients.PediatricThe pharmacokinetics of moxifloxacin in pediatric subjects have not been studied.GenderFollowing oral administration of 400 mg moxifloxacin daily for 10 days to 23 healthy males (19-75 years) and 24 healthy females (19-70 years), the mean AUC and C max were 8% and 16% higher, respectively, in females compared to males. There are no significant differences in moxifloxacin pharmacokinetics between male and female subjects when differences in body weight are taken into consideration.A 400 mg single dose study was conducted in 18 young males and females. The comparison of moxifloxacin pharmacokinetics in this study (9 young females and 9 young males) showed no differences in AUC or C max due to gender. Dosage adjustments based on gender are not necessary. RaceSteady-state moxifloxacin pharmacokinetics in male Japanese subjects were similar to those determined in Caucasians, with a mean C max of 4.1 µg/mL, an AUC24 of 47 µg•h/mL, and an elimination half-life of 14 hours, following 400 mg p.o. daily.Renal InsufficiencyThe pharmacokinetic parameters of moxifloxacin are not significantly altered in mild, moderate, severe, or end-stage renal disease. No dosage adjustment is necessary in patients with renal impairment, including those patients requiring hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).In a single oral dose study of 24 patients with varying degrees of renal function from normal to severely impaired, the mean peak concentrations (C max) of moxifloxacin were reduced by 21% and 28% in the patients with moderate (CL CR ≥30 and ≤ 60 mL/min) and severe (CL CR < 30 mL/min) renal impairment, respectively. The mean systemic exposure (AUC) in these patients was increased by 13%. In the moderate and severe renally impaired patients, the mean AUC for the sulfate conjugate (M1) increased by 1.7-fold (ranging up to 2.8-fold) and mean AUC andC max for the glucuronide conjugate (M2) increased by 2.8-fold (ranging up to 4.8-fold) and1.4-fold (ranging up to2.5-fold), respectively.The pharmacokinetics of single dose and multiple dose moxifloxacin were studied in patients with CL CR < 20 mL/min on either hemodialysis or continuous ambulatory peritoneal dialysis (8 HD, 8 CAPD). Following a single 400 mg oral dose, the AUC of moxifloxacin in these HD and CAPD patients did not vary significantly from the AUC generally found in healthy volunteers. C max values of moxifloxacin were reduced by about 45% and 33% in HD and CAPD patients, respectively, compared to healthy, historical controls. The exposure (AUC) to the sulfate conjugate (M1) increased by 1.4- to 1.5-fold in these patients. The mean AUC of the glucuronide conjugate (M2) increased by a factor of 7.5, whereas the mean C max values of the glucuronide conjugate (M2) increased by a factor of 2.5 to 3, compared to healthy subjects. The sulfate and the glucuronide conjugates of moxifloxacin are not microbiologically active, and the clinical implication of increased exposure to these metabolites in patients with renal disease including those undergoing HD and CAPD has not been studied.Oral administration of 400 mg QD moxifloxacin for 7 days to patients on HD or CAPD produced mean systemic exposure (AUC ss) to moxifloxacin similar to that generally seen in healthy volunteers. Steady-state C max values were about 22% lower in HD patients but were comparable between CAPD patients and healthy volunteers. Both HD and CAPD removed only small amounts of moxifloxacin from the body (approximately 9% by HD, and 3% by CAPD). HD and CAPD also removed about 4% and 2% of the glucuronide metabolite (M2), respectively. Hepatic InsufficiencyIn 400 mg single oral dose studies in 6 patients with mild (Child Pugh Class A), and 10 patients with moderate (Child Pugh Class B), hepatic insufficiency, moxifloxacin mean systemic exposure (AUC) was 78% and 102%, respectively, of 18 healthy controls and mean peak concentration (C max)was 79% and 84% of controls.The mean AUC of the sulfate conjugate of moxifloxacin (M1) increased by 3.9-fold (ranging up to 5.9-fold) and 5.7-fold (ranging up to 8.0-fold) in the mild and moderate groups, respectively. The mean C max of M1 increased by approximately 3-fold in both groups (ranging up to 4.7- and 3.9-fold). The mean AUC of the glucuronide conjugate of moxifloxacin (M2) increased by 1.5-fold (ranging up to 2.5-fold) in both groups. The mean C max of M2 increased by 1.6- and 1.3-fold (ranging up to 2.7- and 2.1-fold), respectively. The clinical significance of increased exposure to the sulfate and glucuronide conjugates has not been studied. No dosage adjustment is recommended for mild or moderate hepatic insufficiency (Child Pugh Classes A and B). The pharmacokinetics of moxifloxacin in severe hepatic insufficiency (Child Pugh Class C) have not been studied. (See DOSAGE AND ADMINISTRATION.)Photosensitivity PotentialA study of the skin response to ultraviolet (UVA and UVB) and visible radiation conducted in 32 healthy volunteers (8 per group) demonstrated that moxifloxacin does not show phototoxicity in comparison to placebo. The minimum erythematous dose (MED) was measured before and after treatment with moxifloxacin (200 mg or 400 mg once daily), lomefloxacin (400 mg once daily), or placebo. In this study, the MED measured for both doses of moxifloxacin were not significantly different from placebo, while lomefloxacin significantly lowered the MED. (See PRECAUTIONS, Information for Patients.)It is difficult to ascribe relative photosensitivity/phototoxicity among various fluoroquinolones during actual patient use because other factors play a role in determining a subject’s susceptibility to this adverse event such as: a patient’s skin pigmentation, frequency and duration of sun and artificial ultraviolet light (UV) exposure, wearing of sunscreen andprotective clothing, the use of other concomitant drugs and the dosage and duration of fluoroquinolone therapy (See ADVERSE REACTIONS and ADVERSEREACTIONS/Post-Marketing Adverse Event Reports).Drug-drug InteractionsThe potential for pharmacokinetic drug interactions between moxifloxacin and itraconazole, theophylline, warfarin, digoxin, atenolol, probenecid, morphine, oral contraceptives, ranitidine, glyburide, calcium, iron, and antacids has been evaluated. There was no clinically significant effect of moxifloxacin on itraconazole, theophylline, warfarin, digoxin, atenolol, oral contraceptives, or glyburide kinetics. Itraconazole, theophylline, warfarin, digoxin, probenecid, morphine, ranitidine, and calcium did not significantly affect the pharmacokinetics of moxifloxacin. These results and the data from in vitro studies suggest that moxifloxacin is unlikely to significantly alter the metabolic clearance of drugs metabolized by CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 enzymes.As with all other quinolones, iron and antacids significantly reduced bioavailability of moxifloxacin.Itraconazole:In a study involving 11 healthy volunteers, there was no significant effect of itraconazole (200 mg once daily for 9 days), a potent inhibitor of cytochrome P4503A4, on the pharmacokinetics of moxifloxacin (a single 400 mg dose given on the 7th day of itraconazole dosing). In addition, moxifloxacin was shown not to affect the pharmacokinetics of itraconazole. Theophylline:No significant effect of moxifloxacin (200 mg every twelve hours for 3 days) on the pharmacokinetics of theophylline (400 mg every twelve hours for 3 days) was detected in a study involving 12 healthy volunteers. In addition, theophylline was not shown to affect the pharmacokinetics of moxifloxacin. The effect of co-administration of a 400 mg dose of moxifloxacin with theophylline has not been studied, but it is not expected to be clinically significant based on in vitro metabolic data showing that moxifloxacin does not inhibit the CYP1A2 isoenzyme.Warfarin:No significant effect of moxifloxacin (400 mg once daily for eight days) on the pharmacokinetics of R- and S-warfarin (25 mg single dose of warfarin sodium on the fifth day) was detected in a study involving 24 healthy volunteers. No significant change in prothrombin time was observed. (See PRECAUTIONS, Drug Interactions.)Digoxin:No significant effect of moxifloxacin (400 mg once daily for two days) on digoxin (0.6 mg as a single dose) AUC was detected in a study involving 12 healthy volunteers. The mean digoxin C max increased by about 50% during the distribution phase of digoxin. This transient increase in digoxin C max is not viewed to be clinically significant. Moxifloxacin pharmacokinetics were similar in the presence or absence of digoxin. No dosage adjustment for moxifloxacin or digoxin is required when these drugs are administered concomitantly. Atenolol:In a crossover study involving 24 healthy volunteers (12 male; 12 female), the mean atenolol AUC following a single oral dose of 50 mg atenolol with placebo was similar to that observed when atenolol was given concomitantly with a single 400 mg oral dose of moxifloxacin. The mean C max of single dose atenolol decreased by about 10% following co-administration with a single dose of moxifloxacin.Morphine:No significant effect of morphine sulfate (a single 10 mg intramuscular dose) on the mean AUC and C max of moxifloxacin (400 mg single dose) was observed in a study of 20 healthy male and female volunteers.Oral Contraceptives:A placebo-controlled study in 29 healthy female subjects showed that moxifloxacin 400 mg daily for 7 days did not interfere with the hormonal suppression of oral contraception with 0.15 mg levonorgestrel/0.03 mg ethinylestradiol (as measured by serum progesterone, FSH, estradiol, and LH), or with the pharmacokinetics of the administered contraceptive agents.Probenecid:Probenecid (500 mg twice daily for two days) did not alter the renal clearance and total amount of moxifloxacin (400 mg single dose) excreted renally in a study of 12 healthy volunteers.Ranitidine:No significant effect of ranitidine (150 mg twice daily for three days as pretreatment) on the pharmacokinetics of moxifloxacin (400 mg single dose) was detected in a study involving 10 healthy volunteers.Antidiabetic agents:In diabetics, glyburide (2.5 mg once daily for two weeks pretreatment and for five days concurrently) mean AUC and C max were 12% and 21% lower, respectively, when taken with moxifloxacin (400 mg once daily for five days) in comparison to placebo. Nonetheless, blood glucose levels were decreased slightly in patients taking glyburide and moxifloxacin in comparison to those taking glyburide alone, suggesting no interference by moxifloxacin on the activity of glyburide. These interaction results are not viewed as clinically significant. Calcium:Twelve healthy volunteers were administered concomitant moxifloxacin (single 400 mg dose) and calcium (single dose of 500 mg Ca++ dietary supplement) followed by an additional two doses of calcium 12 and 24 hours after moxifloxacin administration. Calcium had no significant effect on the mean AUC of moxifloxacin. The mean C max was slightly reduced and the time to maximum plasma concentration was prolonged when moxifloxacin was given with calcium compared to when moxifloxacin was given alone (2.5 hours versus 0.9 hours). These differences are not considered to be clinically significant.Antacids:When moxifloxacin (single 400 mg tablet dose) was administered two hours before, concomitantly, or 4 hours after an aluminum/magnesium-containing antacid (900 mg aluminum hydroxide and 600 mg magnesium hydroxide as a single oral dose) to 12 healthy volunteers there was a 26%, 60% and 23% reduction in the mean AUC of moxifloxacin, respectively. Moxifloxacin should be taken at least 4 hours before or 8 hours after antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or VIDEX® (didanosine) chewable/ buffered tablets or the pediatric powder for oral solution. (See PRECAUTIONS, Drug Interactions and DOSAGE AND ADMINISTRATION.) Iron:When moxifloxacin tablets were administered concomitantly with iron (ferrous sulfate 100 mg once daily for two days), the mean AUC and C max of moxifloxacin was reduced by 39% and 59%, respectively. Moxifloxacin should only be taken more than 4 hours before or 8 hours after iron products. (See PRECAUTIONS, Drug Interactions and DOSAGE AND ADMINISTRATION.) Electrocardiogram:Prolongation of the QT interval in the ECG has been observed in some patients receiving moxifloxacin. Following oral dosing with 400 mg of moxifloxacin the mean (± SD) change in QTc from the pre-dose value at the time of maximum drug concentration was 6 msec (± 26) (n = 787). Following a course of daily intravenous dosing (400 mg; 1 hour infusion each day) the mean change in QTc from the Day 1 pre-dose value was 9 msec (± 24) on Day 1 (n = 69) and 3 msec (± 29) on Day 3 (n = 290). (See WARNINGS.)There is limited information available on the potential for a pharmacodynamic interaction in humans between moxifloxacin and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous (I.V.) moxifloxacin in dogs. Therefore, moxifloxacin should be avoided with Class IA and Class III antiarrhythmics. (See ANIMAL PHARMACOLOGY, WARNINGS,and PRECAUTIONS.)MICROBIOLOGYMoxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative microorganisms. The bactericidal action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair, and recombination. It appears that the C8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of Gram-positive bacteria compared to the C8-H moiety. The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the NorA or pmrA genes seen in certain Gram-positive bacteria. The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, beta-lactams, aminoglycosides, or tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to moxifloxacin and other quinolones. There is no known cross-resistance between moxifloxacin and other classes of antimicrobials.In vitro resistance to moxifloxacin develops slowly via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10–9 to < 1 x 10–11 for Gram-positive bacteria.Cross-resistance has been observed between moxifloxacin and other fluoroquinolones against Gram-negative bacteria. Gram-positive bacteria resistant to other fluoroquinolones may, however, still be susceptible to moxifloxacin.Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Aerobic Gram-positive microorganismsEnterococcus faecalis (many strains are only moderately susceptible)Staphylococcus aureus (methicillin-susceptible strains only)Streptococcus anginosusStreptococcus constellatusStreptococcus pneumoniae (including multi-drug resistant strains [MDRSP]*) Streptococcus pyogenes* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.Aerobic Gram-negative microorganismsEnterobacter cloacaeEscherichia coliHaemophilus influenzaeHaemophilus parainfluenzaeKlebsiella pneumoniaeMoraxella catarrhalisProteus mirabilisAnaerobic microorganismsBacteroides fragilisBacteroides thetaiotaomicronClostridium perfringensPeptostreptococcus speciesOther microorganismsChlamydia pneumoniaeMycoplasma pneumoniaeThe following in vitro data are available, but their clinical significance is unknown.Moxifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 2 µg/mL or lessagainst most (≥ 90%) strains of the following microorganisms; however, the safety andeffectiveness of moxifloxacin in treating clinical infections due to these microorganisms have notbeen established in adequate and well-controlled clinical trials.Aerobic Gram-positive microorganismsStaphylococcus epidermidis (methicillin-susceptible strains only)Streptococcus agalactiaeStreptococcus viridans groupAerobic Gram-negative microorganismsCitrobacter freundiiKlebsiella oxytocaLegionella pneumophilaAnaerobic microorganismsFusobacterium speciesPrevotella speciesSusceptibility TestsDilution Techniques:Quantitative methods are used to determine antimicrobial minimuminhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteriato antimicrobial compounds. The MICs should be determined using a standardized procedure.Standardized procedures are based on a dilution method1 (broth or agar) or equivalent withstandardized inoculum concentrations and standardized concentrations of moxifloxacin powder.The MIC values should be interpreted according to the following criteria:For testing Enterobacteriaceae and methicillin-susceptible Staphylococcus aureus:MIC (µg/mL)Interpretation≤2.0 Susceptible(S)4.0Intermediate(I)≥8.0Resistant(R)For testing Haemophilus influenzae and Haemophilus parainfluenzae a:MIC (µg/mL) Interpretation(S) ≤1.0 Susceptiblea This interpretive standard is applicable only to broth microdilution susceptibility tests withHaemophilus influenzae and Haemophilus parainfluenzae using Haemophilus Test Medium1.The current absence of data on resistant strains precludes defining any results other than“Susceptible”. Strains yielding MIC results suggestive of a “nonsusceptible” category should besubmitted to a reference laboratory for further testing.For testing Streptococcus species including Streptococcus pneumoniae b and Enterococcus faecalis:MIC (µg/mL)Interpretation≤1.0 Susceptible(S)2.0Intermediate(I)≥ 4.0Resistant(R)b These interpretive standards are applicable only to broth microdilution susceptibility tests using cation-adjusted Mueller-Hinton broth with 2 - 5% lysed horse blood.A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard moxifloxacin powder should provide the following MIC values:Microorganism MIC (µg/mL)Enterococcus faecalis ATCC 292120.06- 0.5Escherichia coli ATCC 259220.008- 0.06Haemophilus influenzae ATCC 49247c0.008- 0.03Staphylococcus aureus ATCC 292130.015- 0.06Streptococcus pneumoniae ATCC 49619d0.06- 0.25c This quality control range is applicable to only H. influenzae ATCC 49247 tested by a broth microdilution procedure using Haemophilus Test Medium (HTM)1.d This quality control range is applicable to only S. pneumoniae ATCC 49619 tested by a broth microdilution procedure using cation-adjusted Mueller-Hinton broth with 2 - 5% lysed horse blood.Diffusion Techniques:Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 5-µg moxifloxacin to test the susceptibility of microorganisms to moxifloxacin.Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5-µg moxifloxacin disk should be interpreted according to the following criteria:。