部分中文AVELOX处方资料（仅供参考）

先灵葆雅公司宣布美国FDA已批准该公司的每日仅需用药一次的抗生素AVELOX（盐酸莫西沙星）用于治疗由对甲氧西林敏感的金黄色葡萄球菌埃希氏大肠杆菌克雷白肺炎杆菌或阴沟肠杆菌等引起的成人复杂性皮肤及皮肤组织感染（cSSSI）AVELOX由拜耳公司开发其在美国的销售由先灵葆雅公司负责。
据悉美国每年发生250万例cSSSI其中约40万人需住院治疗[1]以往cSSSI治疗通常有赖于大剂量抗生素且每日需多次给药。
位于加州圣莫尼卡的R.M. Alden科研实验室主任兼UCLA David Geffen药学院教授Ellie J.C. Goldstein博士认为：“复杂性皮肤及皮肤组织感染可发展到十分严重的程度并需外科手术治疗而每日仅需给药一次的AVELOX为患者提供了方便有效的治疗选择”。
先灵葆雅学院医学总监兼分管医疗事务的副总裁Robert J. Spiegel博士认为：“FDA对AVELOX新适应症的批准意味着患者将能获得有益的治疗选择而这对于充实先灵葆雅公司已有的感染类药物系列而言也具有重大意义”。
先灵葆雅公司于2004年10月获得了拜耳公司开发的氟喹诺酮类抗生素AVELOX和CIPRO（环丙沙星）在美国的独家销售代理权作为新药应用申请批文（ND）及AVELOX专利权的持有者拜耳公司完成了与新药相关的研发工作并向FDA提出申报。
促成FDA批准的临床试验的结果表明每日一次（QD）静脉滴注（IV）或口服（PO）AVELOX用于治疗cSSSI的效果与对照方案（每日静脉应用哌拉西林/他唑巴坦后改用每日2次口服阿莫西林/克拉维酸）的效果相当。
此次FDA批准AVELOX治疗cSSSI是该药第5个适应症其余4个适应症分别为急性细菌性鼻窦炎慢性支气管炎急性细菌感染性恶化社区获得性肺炎和单纯性皮肤及皮肤组织感染。

AVELOX用于cSSSI治疗的相关研究

迄今已有2项针对cSSSI的随机对照研究其中1项在北美开展的双盲前瞻性多中心试验对AVELO（400mgIV/POQD7-14d）与β-内酰胺类/β-内酰胺酶抑制剂用于治疗cSSSI的效果进行了对比研究共纳入617位患者其中335位的资料符合有效性分析标准试验对象所患感染包括脓肿蜂窝织炎褥疮外科伤口感染创伤等另一跨国研究比较了AVELOX（400mgQD7-21d）与β-内酰胺类/β-内酰胺酶抑制剂（IV/PO）用于治疗cSSSI的效果研究纳入了804位患者其中632位的资料符合有效性分析标准。
在北美试验中AVELOX与对照药物的有效性分别位77.2%和81.5%；两者对甲氧西林敏感的金黄色葡萄球菌的清除率相当分别为82.2%和87.6%而甲氧西林敏感的金黄色葡萄球菌正是导致cSSSI的主要病原体对2项试验数据进行汇总分析后发现AVELOX及对照药物的临床治疗成功率分别为81.6%和84.8%（大肠杆菌）91.7%和70%（肺炎克雷白菌）及81.8%和57.1％（阴沟肠杆菌）

有关cSSSI
众多皮肤及皮肤组织感染（如浅部皮肤感染蜂窝织炎及单纯性脓肿）的病原体谱较为相似一旦皮肤感染累及深部软组织（肌肉脂肪等）即被称为cSSSI并可能需要外科干预（如感染性溃疡烧伤大型脓肿等）；如伴有其他基础性疾病则对常规治疗的反应较差可引发cSSSI的细菌种类众多并与患者临床状况损伤或感染部位及既往病史有关。

关于AVELOX
AVELOX获准治疗以下疾病：由肺炎链球菌流感嗜血杆菌副流感嗜血杆菌肺炎克雷白菌金黄色葡萄球菌或卡他莫拉菌导致的慢性支气管炎急性细菌感染性恶化（ABECB）；肺炎链球菌流感嗜血杆菌或卡他莫拉菌导致的急性细菌性鼻窦炎（ABS）；肺炎链球菌（包括多药耐受菌株*）流感嗜血杆菌卡他莫拉菌金黄色葡萄球菌肺炎克雷白菌肺炎支原体或肺炎衣原体导致的社区获得性肺炎（CAP）；金黄色葡萄球菌及化脓性链球菌导致的uSSSI；由对甲氧西林敏感的金黄色葡萄球菌埃希氏大肠杆菌克雷白肺炎杆菌或阴沟肠杆菌等引起的cSSSI。
*多药耐受性肺炎链球菌包括耐青霉素肺炎链球菌株（PRSP）以及至少对以下抗生素中的2中耐药的菌株：青霉素（MIC≥2ug/ml）第二代头孢菌素（如头孢呋辛）大环内酯类四环素类及甲氧苄氨嘧啶-磺胺甲基异恶唑等。

AVELOX的安全性信息
机体对AVELOX通常具有良好的耐受性其不良反应发生率与其他标准治疗相差无几AVELOX最常见的副作用就是头晕恶心和腹泻但通常都较为轻微在明确AVELOX是否会导致个体产生头晕之前建议在用药后谨慎驾驶或操作机械设备一旦出现药物不良反应患者应及时告知医生。
曾对AVELOX过敏或对其他喹诺酮类药物（如环丙沙星和左氧氟沙星）过敏者不应使用AVELOX。
患有心律失常及正在使用抗心律失常药物（奎尼定普鲁卡因可达龙和心得宜等）的患者应避免使用AVELOX。
由于AVELOX对胎儿或接受母乳喂养的幼儿的影响目前尚未明确故该药不应用于妊娠期或哺乳期女性AVELOX不适用于18岁以下儿童。
曾有接受喹诺酮类药物治疗的患者出现抽搐的报道如果之前就由癫痫史应事先告知医生
抗酸剂和复合维生素制剂可能干扰AVELOX的吸收从而影响其有效性患者应在服用上述药物之前4小时或之后8小时服用AVELOX。
 
适应症
患有上呼吸道和下呼吸道感染的成人（≥18岁），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

剂量范围：一次400 mg（1片），1日1次。成年人 服用方法：片剂用一杯水送下，服用时间不受饮食影响。治疗时间：治疗时间应根据症状的严重程度或临床反应决定。

治疗上呼吸道和下呼吸道的感染时可按照下列方法：

慢性气管炎急性发作：5天，社区获得性肺炎：10天，急性鼻窦炎：7天，治疗皮肤和软组织感染的推荐治疗时间为7天，莫西沙星400 mg片剂在临床试验中最多用过14天疗程。
老年人：老年人不必调整用药剂量。
儿童：儿童和发育阶段的青少年不建议使用莫西沙星。肝损伤：轻度肝功能异常（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受损者（Child-Pugh C）的药代动力学数据。
肾功能异常：任何程度的肾功能受损的病人均不必调整莫西沙星的剂量（包括肌酐清除率≤30 mL/分/1.73 m2。

目前缺乏透析病人的药代动力学数据。

种族差别：不同种族间不必调整药物剂量。用药过量　关于过量的研究资料非常有限，单次最大剂量800 mg和每日600 mg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。
 
Avelox
Generic Name: moxifloxacin (moxi FLOX a sin)
Brand Names: Avelox
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What is Avelox?
Avelox is an antibiotic in the class of drugs called fluoroquinolones. It fights bacteria in the body. It kills sensitive bacteria by stopping the production of essential proteins needed by the bacteria to survive.
Avelox is used to treat bacterial infections caused by certain bacteria.
Avelox may also be used for other purposes not listed in this medication guide.
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Important information about Avelox
You should not use Avelox if you are allergic to moxifloxacin or similar antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.
Before taking Avelox, tell your doctor if you have kidney or liver disease, myasthenia gravis, joint problems, diabetes, a history of seizures, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 8 hours before or 4 hours after you take Avelox. These other medicines can make Avelox much less effective when taken at the same time.
Taking Avelox can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.
Avelox may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Avelox and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share Avelox with another person (especially a child), even if they have the same symptoms you do.
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Before taking Avelox
Do not use Avelox if you are allergic to moxifloxacin or similar medications such as ciprofloxacin (Cipro), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.
Before taking Avelox, tell your doctor if you have a heart rhythm disorder, especially if you are being treated with one of these medications: quinidine (Cardioquin, Quinidex, Quinaglute), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace).
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Avelox, tell your doctor if you have:
a history of allergic reaction to an antibiotic;
myasthenia gravis;
joint problems;
kidney or liver disease, cirrhosis;
epilepsy or a history of seizures;
diabetes;
low levels of potassium in your blood (hypokalemia); or
a personal or family history of "Long QT syndrome."
FDA pregnancy category C: It is not known whether Avelox is harmful to an unborn baby. Do not use Avelox without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Moxifloxacin passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Avelox may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Avelox and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share Avelox with another person (especially a child), even if they have the same symptoms you do.
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How should I take Avelox?
Take Avelox exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.
Take Avelox with a full glass of water (8 ounces). Drink several extra glasses of fluid each day while you are taking this medicine.
Avelox may be taken with or without food, but take it at the same time each day.
Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may get better before the infection is completely treated. Avelox will not treat a viral infection such as the common cold or flu. Store this medicine at room temperature away from moisture and heat.
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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include tremors, nausea, vomiting, diarrhea, and seizures (convulsions).
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What should I avoid while taking Avelox?
You may be taking certain other medicines that should not be taken at the same time as Avelox. Avoid taking the following medicines within 8 hours before or 4 hours after you take Avelox. These other medicines can make Avelox much less effective when taken at the same time:
antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids);
the ulcer medicine sucralfate (Carafate);
didanosine (Videx) powder or chewable tablets; or
vitamin or mineral supplements that contain iron or zinc.
Avoid exposure to sunlight, sunlamps, or tanning beds. Avelox can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use a sunscreen (SPF-15 or higher) if you must be out in the sun. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
Avelox can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
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Avelox side effects
Stop using Avelox and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Avelox and call your doctor at once if you have any of these serious side effects:
dizziness, fainting, fast or pounding heartbeat;
sudden pain or swelling near your joints (especially in your arm or ankle);
diarrhea that is watery or bloody;
confusion, hallucinations, depression, unusual thoughts or behavior;
seizure (convulsions);
pale or yellowed skin, dark colored urine, fever, weakness;
urinating less than usual or not at all;
easy bruising or bleeding;
numbness, tingling, or unusual pain anywhere in your body;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
the first sign of any skin rash, no matter how mild.
Less serious Avelox side effects may include:
nausea, vomiting;
drowsiness;
blurred vision;
feeling nervous, anxious, or agitated;
sleep problems (insomnia or nightmares); or
mild skin itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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What other drugs will affect Avelox?
Before taking Avelox, tell your doctor if you are taking any of the following drugs:
insulin or diabetes medication you take by mouth, such as glyburide (Micronase, Diabeta, Glynase);
a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), etodolac (Lodine), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), nabumetone (Relafen), meloxicam (Mobic), naproxen (Aleve, Naprosyn, Anaprox), piroxicam (Feldene), and others; or
an oral steroid medication such as betamethasone (Celestone), dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), prednisolone (Orapred), prednisone (Meticorten, Sterapred), and others.
This list is not complete and there may be other drugs that can interact with Avelox. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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Where can I get more information?
Your pharmacist can provide more information about Avelox.
Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
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201062823470618.PDF    

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原产地英文商品名:
AVELOX 400mg/tab 5tabs/box
原产地英文药品名:
MOXIFLOXACIN HCL
中文参考商品译名:
拜复乐 400毫克/片 5片/盒
中文参考药品译名:
盐酸莫西沙星
生产厂家中文参考译名:
拜耳
生产厂家英文名:
BAYER

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原产地英文商品名:
AVELOX 400mg/tab 30tabs/box
原产地英文药品名:
MOXIFLOXACIN HCL
中文参考商品译名:
拜复乐 400毫克/片 30片/盒
中文参考药品译名:
盐酸莫西沙星
生产厂家中文参考译名:
拜耳
生产厂家英文名:
BAYER