部分中文左氧氟沙星处方资料（仅供参考）
英文药名: Levaquin (Levofloxacin tablets)
中文药名: 左氧氟沙星
药品名称
【别名】 左旋氧氟沙星, 可乐必妥片剂, 利复星, 左氧氟沙星片, 可乐必妥, 来立星, 来立信, 乳酸左旋氧氟沙星
【外文名】Levofloxacin, Cravit Tablets, LVFX
【性状】 本品为白色薄膜衣片，除去薄膜衣后显白色至淡黄色。
药理毒理
本品具有广谱抗菌作用，抗菌作用强，对多数肠杆菌科细菌，如大肠埃希菌、克雷伯菌属、变形杆菌属、沙门菌属、志贺菌属和流感嗜血杆菌、嗜肺军团菌、淋病奈瑟菌等革兰阴性菌有较强的抗菌活性。对金黄色葡萄球菌、肺炎链球菌、化脓性链球菌等革兰阳性菌和肺炎支原体、肺炎衣原体也有抗菌作用，但对厌氧菌和肠球菌的作用较差。本品为氧氟沙星的左旋体，其体外抗菌活性约为氧氟沙星的两倍。其作用机制是通过抑制细菌DNA旋转酶的活性，阻止细菌DNA的合成和复制而导致细菌死亡。
药代动力学
口服后吸收完全，相对生物利用度接近100%。单剂量空腹口服0.1g和0.2g后，血药峰浓度（Cmax）分别达1.36mg/L和3.06mg/L，达峰时间（Tmax）约为1小时。血消除半衰期（t1/2β）约为5.1～7.1小时。蛋白结合率约为30%～40%。本品吸收后广泛分布至各组织、体液，在扁桃体、前列腺组织、痰液、泪液、妇女生殖道组织、皮肤和唾液等组织和体液中的浓度与血药浓度之比约在1.1～2.1之间。本品主要以原形自肾排泄，在体内代谢甚少。口服48小时内尿中排出量约为给药量的80%～90%。本品以原形自粪便中排出少量，给药后72小时内累积排出量少于给药量的4%。
适应症
适用于敏感菌引起的：
1．泌尿生殖系统感染，包括单纯性、复杂性尿路感染、细菌性前列腺炎、淋病奈瑟菌尿道炎或宫颈炎（包括产酶株所致者）。
2．呼吸道感染，包括敏感革兰阴性杆菌所致支气管感染急性发作及肺部感染。
3．胃肠道感染，由志贺菌属、沙门菌属、产肠毒素大肠杆菌、亲水气单胞菌、副溶血弧菌等所致。
4．伤寒。
5．骨和关节感染。
6．皮肤软组织感染。
7．败血症等全身感染。
美国FDA已经批准美国Ortho-Mc-Neil制药公司的Levaquin（Levofloxacin，左氧氟沙星）五天为一疗程，750mg每日一次治疗方案。该抗生素片剂用于治疗急性细菌性鼻窦炎。
用法用量
口服。 成人常用量：
1．支气管感染、肺部感染：一次0.2g，一日2次，或一次0.1g，一日3次，疗程7～14日。
2．急性单纯性下尿路感染：一次0.1g，一日2次，疗程5～7日；复杂性尿路感染：一次0.2g，一日2次，或一次0.1g，一日3次，疗程10～14日。
3．细菌性前列腺炎：一次0.2g，一日2次，疗程6周。
成人常用量为一日0.3～0.4g，分2～3次服用，如感染较重或感染病原体敏感性较差者，如铜绿假单胞菌等假单胞菌属细菌感染的治疗剂量也可增至一日0.6g，分3次服。
任何疑问，请遵医嘱！
不良反应
1．胃肠道反应：腹部不适或疼痛、腹泻、恶心或呕吐。
2．中枢神经系统反应可有头昏、头痛、嗜睡或失眠。
3．过敏反应： 皮疹、皮肤瘙痒，偶可发生渗出性多形性红斑及血管神经性水肿。光敏反应较少见。
4．偶可发生：
(1)癫痫发作、精神异常、烦躁不安、意识混乱、幻觉、震颤。
(2)血尿、发热、皮疹等间质性肾炎表现。
(3)静脉炎。
(4)结晶尿，多见于高剂量应用时。
(5)关节疼痛。
5．少数患者可发生血清氨基转移酶升高、血尿素氮增高及周围血象白细胞降低，多属轻度，并呈一过性。
禁忌症
对本品及氟喹诺酮类药过敏的患者禁用。
注意事项
1．由于目前大肠埃希菌对氟喹诺酮类药物耐药者多见，应在给药前留取尿培养标本，参考细菌药敏结果调整用药。
2．本品大剂量应用或尿pH值在7以上时可发生结晶尿。为避免结晶尿的发生，宜多饮水，保持24小时排尿量在1200ml以上。
3．肾功能减退者，需根据肾功能调整给药剂量。
4．应用本品时应避免过度暴露于阳光，如发生光敏反应或其他过敏症状需停药。
5．肝功能减退时，如属重度（肝硬化腹水）可减少药物清除，血药浓度增高，肝、肾功能均减退者尤为明显，均需权衡利弊后应用，并调整剂量。
6．原有中枢神经系统疾患者，例如癫痫及癫痫病史者均应避免应用，有指征时需仔细权衡利弊后应用。
7．偶有用药后发生跟踺炎或跟踺断裂的报告，如有上述症状发生，须立即停药，直至症状消失。
孕妇及哺乳期妇女用药
动物实验未证实喹诺酮类药物有致畸作用，但对孕妇用药进行的研究尚无明确结论。鉴于本药可引起未成年动物关节病变，故孕妇禁用，哺乳期妇女应用本品时应暂停哺乳。
儿童用药
本品在婴幼儿及18岁以下青少年的安全性尚未确定。但本品用于数种幼龄动物时，可致关节病变。因此不宜用于18岁以下的小儿及青少年。
老年患者用药
老年患者常有肾功能减退，因本品部分经肾排出，需减量应用。
药物相互作用
1．尿碱化剂可减低本品在尿中的溶解度，导致结晶尿和肾毒性。
2．喹诺酮类抗菌药与茶碱类合用时可能由于与细胞色素P450结合部位的竞争性抑制，导致茶碱类的肝消除明显减少，血消除半衰期延长，血药浓度升高，出现茶碱中毒症状，如恶心、呕吐、震颤、不安、激动、抽搐、心悸等。本品对茶碱的代谢虽影响较小，但合用时仍应测定茶碱类血药浓度和调整剂量。
3．本品与环孢素合用，可使环孢素的血药浓度升高，必须监测环孢素血浓度，并调整剂量。
4．本品与抗凝药华法林合用时虽对后者的抗凝作用增强较小，但合用时也应严密监测患者的凝血酶原时间。
5．丙磺舒可减少本品自肾小管分泌约50%，合用时可因本品血浓度增高而产生毒性。
6．本品可干扰咖啡因的代谢，从而导致咖啡因消除减少，血消除半衰期（t1/2β）延长，并可能产生中枢神经系统毒性。
7．含铝、镁的制酸药、铁剂均可减少本品的口服吸收，不宜合用。
8．本品与非甾体类抗炎药芬布芬合用时，偶有抽搐发生，因此不宜与芬布芬合用。
9．本品与口服降血糖药合用可能会引起血糖失调，因此用药过程中应注意监测血糖浓度，一旦发生低血糖时应立即停用本品，并给予适当处理。

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
LEVAQUIN?
LEVAQUIN belongs to a class of antibiotics called fluoroquinolones. LEVAQUIN can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away.
Talk with your healthcare professional about whether you should continue to take LEVAQUIN.
Fluoroquinolones, including LEVAQUIN, are associated with an increased risk of tendon rupture or swelling of the tendon (tendinitis) in all ages. This risk is higher if you are over 60 years of age, are taking steroids (corticosteroid drugs), or if you have a kidney, heart, or lung transplant.
Tendon rupture can happen while you are taking LEVAQUIN or up to several months after you have finished taking it. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation
Get medical help right away if you hear or feel a snap or pop, have severe pain, rapid, or immediate bruising after an accident, or are unable to use the affected area
Stop taking LEVAQUIN until tendinitis or tendon rupture have been ruled out by your healthcare professional and avoid exercise and using the affected area
LEVAQUIN may cause a worsening of the symptoms of myasthenia gravis (a disease which causes muscle weakness), including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
Who should not take LEVAQUIN?
Do not take LEVAQUIN if you have ever had a severe allergic reaction to LEVAQUIN or other fluoroquinolone antibiotics (Avelox, Cipro®, Cipro XR, Proquin XR, Noroxin, Factive), or if you are allergic to any of the ingredients in LEVAQUIN;
What should I tell my healthcare professional before taking LEVAQUIN?
Tell your healthcare professional if:
You are pregnant or planning to become pregnant. It is not known if LEVAQUIN® will harm an unborn child
You are breast-feeding or planning to breast-feed.
LEVAQUIN is thought to pass into breast milk. You and your healthcare professional should decide if you will take LEVAQUIN or breast-feed
Tell your healthcare professional if you have the following conditions:
Tendon problems
A disease that causes muscle weakness (myasthenia gravis)
Central nervous system problems (seizures, hallucinations, confusion, depression, anxiety, trouble sleeping, nightmares, feeling more suspicious, or other changes in mood or behavior)
Nerve problems (tingling, burning or numbness of an arm, leg, or foot)
If you or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
Low blood potassium
A history of seizures
Kidney problems (you may need a lower dose of LEVAQUIN®)
Liver problems
Rheumatoid arthritis or other bone and joint problems What are other possible side effects of LEVAQUIN?
Liver damage can happen in people who take LEVAQUIN. Call your healthcare professional right away if you have symptoms such as: nausea or vomiting, stomach pain, fever, weakness, abdominal pain or tenderness, itching, unusual or unexplained tiredness, loss of appetite, light colored bowel movements, dark colored urine, or yellowing of your skin or the whites of your eyes
Central nervous system side effects may occur as soon as fter taking the first dose. Talk to your physician right away if you experience seizures, hallucinations, confusion,
depression, anxiety, trouble sleeping, nightmares, feeling more suspicious, or other changes in mood or behavior
Serious allergic reactions can occur even after only one dose. Stop taking LEVAQUIN® and get emergency help right away if you get any of the following symptoms of allergic reaction: hives, skin rash, trouble breathing or swallowing, swelling of the lips, tongue or face, throat tightness, rapid heartbeat, feel faint
Damage to nerves in the arms, legs and hands can happen. Tell your healthcare professional right away if you feel pain, burning, tingling, numbness, or weakness in your arms, hands, legs, or feet
An intestinal infection (pseudomembranous colitis) can happen with most antibiotics, and can happen during or up to 2 months after the use of antibiotics. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools (with or without stomach cramps and fever)
Serious heart rhythms changes can occur in people taking LEVAQUIN®. Tell your healthcare professional right away if you have a change in heartbeat (fast or irregular), or if you faint
Changes in blood sugar (low blood sugar levels or high blood sugar levels) can happen while taking LEVAQUIN if you are a diabetic patient taking an oral anti-diabetes medicine such as metformin (Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet®), glyburide (Micronase, Diabeta, Glynase), glipizide (Glucotrol®) or insulin. Follow your healthcare professional’s instructions for monitoring your blood sugar.
If you have diabetes and get low blood sugar, stop taking LEVAQUIN and call your healthcare professional right away
The most common side effects of LEVAQUIN include: nausea, headache, diarrhea, constipation, and dizziness
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit.
Please read the LEVAQUIN Medication Guide and discuss any questions you have with your healthcare professional.
Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, herbal and dietary supplements, or if you take:
A nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin AdvilMedipren, Nuprin), celecoxib (Celebrex®)
Oral anti-diabetes medicine or insulin
A blood thinner such as warfarin (Coumadin, Jantoven)
A medicine to control your heart rate or rhythm, such as sotalol (Betapace)
An antipsychotic medicine such as risperidone (Risperdal), aripiprazole (Abilify), olanzapine (Zyprexa), quetapine (Seroquel), and ziprasidone (Geodon)
A tricyclic antidepressant such as Elavil amitriptyline, nortriptyline (Pamelor)
A water pill (diuretic) such as furosemide (Lasix), or hydrocholrothiazide
A steroid
Theophylline (such as Theo-24 Elixophyllin, Theochron, Uniphyl Theolair)
Antacids or multivitamins that have magnesium or aluminum, iron, or zincSucralfate (Carfate)Didanosine (Videx)Ask your healthcare professional if you are not sure any of
your medicines are listed above.
What should I avoid while taking LEVAQUIN?
Avoid sunlamps, tanning beds and limit your time in the sun.
LEVAQUIN can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters, or swelling of
your skin
LEVAQUIN can make you feel dizzy and lightheaded. Do not drive, operate machinery or do other activities that require mental alertness until you know how LEVAQUINaffects you
Can LEVAQUIN be taken with other medications?
Certain medications may keep LEVAQUIN from working correctly.
Take LEVAQUIN tablets or oral solution either 2 hours before or 2 hours after taking these products:An antacid, multivitamin or other product containing magnesium or aluminum, iron, zinc
Didanosine (Videx) chewable/buffered tablets or the pediatric powder for oral solution
Sucralfate (Carafate)
附件:
201262720034115.PDF
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产地国家: 美国
原产地英文商品名:
LEVAQUIN SOLUTION 25MG/ML 480MLS/BOTTLE
原产地英文药品名:
LEVOFLOXACIN
中文参考商品译名:
LEVAQUIN溶液剂 25毫克/毫升 480毫升/瓶
中文参考药品译名:
左氧氟沙星
生产厂家中文参考译名:
杨森制药
生产厂家英文名:
JANSSEN PHARMS