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  药店国别: 美国药房
产地国家: 美国
所属类别: 骨科药物->类风湿关节炎
处方药:处方药
包装规格: 50毫克/胶囊 60胶囊/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
GD SEARLE
生产厂家英文名:
GD SEARLE
该药品相关信息网址1:
http://www.CELEBREX.com
该药品相关信息网址2:
http://www.drugs.com/celebrex.html
该药品相关信息网址3:
http://www.rxlist.com/celebrex-drug.htm
原产地英文商品名:
CELEBREX 50mg/cap 60Caps/bottle
原产地英文药品名:
CELECOXIB
中文参考商品译名:
西乐葆 50毫克/胶囊 60胶囊/瓶
中文参考药品译名:
塞来昔布
原产地国家批准上市年份:
1998/12/31
英文适应病症1:
Osteoarthritis
英文适应病症2:
Rheumatoid arthritis
临床试验期:
完成
中文适应病症参考翻译1:
骨关节炎
中文适应病症参考翻译2:
类风湿关节炎
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(200821620430516.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文西乐葆处方资料(仅供参考)

商品名:西乐葆 胶囊  Celebrex       

通用名:塞来昔布 celecoxib

药物分类:抗风湿和消炎止痛药 

性状:   
    本药为口服硬胶囊,除活性成分外,尚含有一水乳糖、十二烷基硫酸钠、聚乙烯吡咯烷酮、羟甲基纤维素钠和硬脂酸镁。 
 
药理作用:
    塞来昔布是具有独特作用机制的新一代化合物,即特异性抑制环氧化酶- 2。炎症刺激可诱导环氧化酶- 2(COX- 2)生成,因而导致炎性前列腺素类物质的合成和聚积,尤其是前列腺素E2,可引起炎症、水肿和疼痛。而塞来昔布可通过抑制环氧化酶- 2阻止炎性前列腺素类物质的产生,达到抗炎、镇痛及退热作用。
    体外及体内试验表明,塞来昔布与基础表达的环氧化酶- 1(COX- 1)的亲和力极弱,治疗剂量的塞来昔布不影响由COX- 1激活的前列腺素类物质的合成。因此不干扰组织中与COX- 1相 关的正常生理过程,尤其在胃、肠、血小板和肾等组织中。
    临床资料 有关COX- 2特异性的生物学术语的定义目前已有统一标准,它包括需要证实无COX- 1型不良反应的发生,尤其是无药物导致的胃、十二肠溃疡和严重的上消化道不良反应(出血、穿孔、幽门梗阻),并且没有COX- 1抑制血小板聚集活性的降低。基于上述标准,临床上本品的特异性在对照临床试验中得到了证实,这些临床试验包括治疗时间长达6个月的对照临床试验,及总数超过3000病人年的进一步的开放临床试验。
    本品严重上消化道并发症(出血、穿孔、幽门梗阻)的发生率与安慰剂组相比无显著性差异,与其他非特异性COX抑制剂相比,其发生率减少约为8倍。
    在5个随机双盲对照试验中,对4000多例患有骨关节炎及类风湿关节炎的患者用内窥镜检查,比较本品与安慰剂组,以及非特异性COX- 1/ COX- 2抑制剂组的溃疡发生率,结果表明,本品的溃疡发生率与安慰剂组相比无显著差异,在50- 400 mg, 一天2次用药的剂量范围内,溃疡发生率与本品应用剂量无关,且比非特异性COX- 2/ COX- 2抑制剂小3- 4倍。
    多剂给药600 mg,每日2次后(此为最高推荐剂量的3倍),与安慰剂组相比,本品对血小板聚集和出血时间无影响,而阳性对照(非特异性COX抑制剂)组中,血小板聚集功能显著降低且出血时间延长。
    肝功能损害 :伴轻度肝功能损害患者的塞来昔布血药浓度与相同年龄和性别的对照组相比无显著性差异 ;伴中度肝功能损害患者的塞来昔布血药浓度是其他条件相似的对照组的血药浓度的2倍。因为塞来昔布治疗窗大,所以不需要针对这种改变调整剂量。未在重度肝功能损害的患者中进行有关研究,因塞来昔布的主要代谢途径在肝脏,故可以推测在这类患者中会出现原形药物蓄积现象。
    肾功能损害 :在与年龄有关的肾小球滤过率降低(均值> 65 mL/分/1.73 m2)的老年志愿者和慢性稳定的患肾功能不全(肾小球滤过率在35- 60 mL/分/1.73 m2)的患者中,塞来昔布的药代动力学与肾功能正常的患者相似。没有发现血肌酐(或肌酐清除率)和塞来昔布清除之间存在明显的相关。因为塞来昔布的消除主要是在肝脏代谢,形成无活性的代谢产物,推测严重的肾功能不全估计不会改变药物的清除。
    肾脏效应 :目前COX-1和COX-2 在肾脏生理中的相对作用尚未完全清楚。本品减少了PGE2和6-酮基- PGE1α(前列腺素代谢产物)在尿中的排泄,但不影响血浆血栓素B2(TXB2)和11- 羟- TXB2,即血栓素的代谢产物(均为COX- 1的产物)在尿中的排泄。一些特别的研究表明,本品不会降低老年人或伴慢性肾功能不全患者的肾小球滤过率,这与非特异性COX抑制剂不同,后者可降低上述人群的肾小球滤过率。这些研究同时表明,本品导致暂时性的钠排泄分数的降低。在对关节炎患者的研究中,本药和非特异性COX抑制剂(具有同样的COX- 2抑制活性)引起外周水肿的发生率相似,这在同时服用利尿剂治疗的患者中最为明显。然而,没有观察到高血压和心力衰竭发生率的增加,发生的外周水肿轻微且具有自限性。
 
药代动力学   
    大约在1500个个体中进行了塞来昔布的药代动力学研究。空腹给药的塞来昔布吸收良好,约2-3小时达到血浆峰浓度,胶囊口服后的生物利用度为口服混悬液后生物利用度的99%(混悬液为口服利用的最佳剂型)。在整个治疗剂量范围内,塞来昔布具有线性、且与剂量成正比的药代动力学特征。本药的血浆蛋白结合率与浓度无关,在治疗血浆浓度时,血浆蛋白结合率约为97%。药物在血中并不是优先与红细胞结合。与进食(高脂食物)同时给药,则本药的吸收延迟,Tmax延至4个小时,生物利用度增加约20%。健康受试者每日1次或分2次口服400 mg本品后,其生物利用度相同。而在骨关节炎患者,每日1次或分2次口服200 mg本品后,其临床疗效及安全性相当。
    在大于65岁的人群中,塞来昔布的Cmax和AUC均值增加1.5- 2倍。这种增加主要与体重相关(而非与年龄相关)。在低体重患者中,塞来昔布的水平较高,因此在平均体重较年轻人群低的老年人群中,塞来昔布的水平较高。在老年女性中,塞来昔布的血药浓度与老年男性相比有轻度增高的趋势。因为塞来昔布的治疗窗范围大,所以不必针对老年患者调整剂量。
塞来昔布在肝脏内经羟化、氧化和葡萄糖醛酸化进行代谢。体外及体内试验表明,代谢主要通过细胞色素P450-CYP2C9。原形药具有药理活性,循环中其主要代谢产物未测得COX- 1和COX- 2抑制活性。塞来昔布的清除主要通过肝脏进行,少于1%剂量的药物以原形从尿中排出。多剂服药后清除半衰期为8- 12小时,清除率约为500 mL/分。连续给药5天内达到其稳态分布容积均值,约为500 L/70 kg,表明塞来昔布在组织中的广泛分布。临床前研究表明本药可通过血脑屏障。 
 
毒理研究   
    基于多剂量毒性、生殖、致畸性、致突变或致癌性等方面的常规研究,临床前数据表明本药对人体无特殊危害。 
 
适应症:治疗急性期或慢性期骨关节炎和类风湿关节炎的症状和体征。 
 
用法用量   
成人骨关节炎 :推荐剂量为200 mg,每日1次或分2次口服。临床研究中也曾用至每日400 mg的剂量。
类风湿关节炎 :推荐剂量为100 mg或200 mg,每日2 次。临床研究中的剂量曾用至每日800 mg。
老年人:不必调整剂量。
肝功能损伤患者 :轻至中度肝功能损害患者无需调整剂量,对于重度肝功能损害患者无临床使用经验。
肾功能损伤患者 :轻至中度肾功能损害患者无需调整剂量,对于重度肾功能损害患者无临床使用经验。
儿童:塞来昔布没有在18岁以下人群中进行过临床研究。
 
不良反应  
    在对照临床试验中报告的不良反应按发生率分类为 :> 1%,但等于或少于安慰剂组 :中枢神经系统 :头痛。胃肠道 :便秘、恶心。其他 :关节痛、腰背痛、失眠、肌痛、外周痛、瘙痒。
    > 1%,发生率高于安慰剂组(括号内%为高于安慰剂组的百分数) :中枢神经系统 :眩晕(0.4%)。胃肠道 :腹痛(1.8%)、腹泻(2.3%)、消化不良(2.2%)、胀气(1.2%)、牙齿疾病(0.1%)、呕吐(0.6%)。呼吸道 :支气管炎(0.2%)、咳嗽(0.7%)、咽炎(1.2%)、鼻炎(0.6%)、鼻窦炎(0.1%)、上呼吸道感染(0.2%)。其他 :意外受伤(0.4%)、过敏加重(0.2%)、流感样症状(0.4%)、外周水肿(0.4%)、皮疹(0.1%)、尿道感染(0.2%)。
在超过3000病人年的临床研究中,未证实本品与致命的、严重的或罕见的不良反应有因果关系。

禁忌症:对本产品中任何成份过敏者。已知对磺胺过敏者。
 
注意事项
    塞来昔布含有磺胺基团。临床研究中,哮喘患者服用本品后未发生支气管痉挛,但由于未在阿司匹林或其他非甾类抗炎药诱发哮喘、荨麻疹或急性鼻炎的患者中评估本品,因此,尚未有研究资料以前,此类患者应避免服用本品。
    对驾驶和操作机器能力的影响 :没有研究过本品对驾驶汽车和操作能力的影响,但基于其药效学及总体安全性特征来看,应不会影响这类能力。 

孕妇及哺乳期妇女用药   
    没有关于妊娠期应用本品的资料,只有潜在益处大于对胎儿的危害时,妊娠妇女才可以考虑用本品治疗。动物试验中观察到的对早期胚胎的影响主要与COX- 2的抑制有关,如胚胎着床前后流产,但对长期的生殖功能无影响。致畸研究发现,塞来昔布对家兔无致畸作用。在大鼠中进行的2项试验中,有一项试验发现给药量为最高剂量(即每日400 mg)的7倍时,可发现与塞来昔布剂量相关的膈疝的发生,塞来昔布对分娩无不良影响,不导致难产。临床前研究证实,塞来昔布能通过胎盘。在大鼠中进行的研究显示,塞来昔布能经乳汁分泌,浓度与血浆浓度相似,因没有在人体中进行类似研究,故本品不应用于哺乳期妇女。 
 
药物相互作用   
    体外与体内试验证实,塞来昔布主要经细胞色素P450-CYP2C9代谢。在健康男性志愿者试验中,氟康唑(一种CYP2C9抑制剂)能抑制塞来昔布的代谢,从而使其血浆浓度大约增加一倍,而Tmax和半衰期无显著变化。因为塞来昔布有很宽的治疗窗口,所以当此两种药合用时,不需要调整塞来昔布的剂量。酮康唑(一种CYP3A4抑制剂)与塞来昔布之间无明显的相互作用。在健康志愿者中进行的本品与其它经CPY2C9代谢的物质的相互作用研究中,证实本品与苯妥英或甲苯磺丁脲合用时,其药代动力学不产生有临床意义的改变,此外,本品也不影响华法林的药效学或药代动力学。
    在接受了至少3个月氨甲喋呤稳定剂量治疗的类风湿关节炎患者中,与本品合用7天后,对氨甲喋呤的生物利用度及肾消除率没有明显影响。
    在健康志愿者中,本品对通过肾脏清除的锂剂不产生具临床意义的药代动力学作用。
    本品表现为非浓度依赖性蛋白结合,与高蛋白结合药物如华法林和格列苯脲合用时无相互作用。
    抗酸剂(铝剂和镁剂)能使塞来昔布的吸收降低10%,但并不影响其临床作用。 
 
药物过量   
    没有药物过量的临床经验。在健康受试者单剂口服至1200 mg和多剂量口服600 mg,每日2次的研究中,没有发现有临床意义的不良影响。假如怀疑有药物过量,应采取适当的支持疗法,血液透析不是去除过量药物的有效办法。

有效期:2年

Celebrex Oral Warnings
Rarely, this medication can cause serious (very rarely fatal) stomach/intestinal bleeding. Also, this medication and related drugs have rarely caused blood clots to form, resulting in possibly fatal heart attacks and strokes. Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other medication choices.

If you notice any of these rare but very serious side effects, stop taking celecoxib and seek immediate medical attention: coffee-ground vomit, black stools, persistent stomach/abdominal pain, chest pain, weakness on one side of the body, slurred speech, sudden vision changes.

This medication should not be used right before or after heart bypass surgery.

Celebrex Oral Uses
This medication is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, which relieves pain and swelling (inflammation). It is used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by this medication helps you perform more of your normal daily activities.

This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

How to use Celebrex Oral
Read the Medication Guide provided by your pharmacist before you start using celecoxib and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take by mouth, usually once or twice daily, or as directed by your doctor. To decrease the chance of stomach upset, this drug is best taken with food. Dosage is based on your medical condition and response to therapy. The lowest effective dosage should always be used, and only for the prescribed length of time (see also Warning section).

Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication.

In certain conditions (e.g., arthritis), it may take up to two weeks, taken regularly, before significant benefits of this drug take effect.

If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medicine may not work as well.

Celebrex Oral Side Effects
See also Warning section.

Stomach upset or gas may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe headache, unexplained weight gain, swelling of the hands or feet, pain/swelling/warmth in the groin/calf, change in amount of urine, difficult/painful swallowing.

This drug may rarely cause serious liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking celecoxib and consult your doctor or pharmacist immediately: yellowing eyes or skin, dark urine, persistent stomach/abdominal pain, unusual fatigue.

In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Celebrex Oral Precautions
Before taking celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (e.g., ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood flow problem in the brain (e.g., stroke, cerebrovascular disease), kidney problems, liver problems, heart disease (e.g., angina, heart attack, high blood pressure, congestive heart failure), alcohol use, swelling (e.g., edema), blood disorders (e.g., anemia), serious infections, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), bleeding/clotting problems, asthma, growths in the nose (nasal polyps), dehydration, poorly controlled diabetes.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of this medication, especially stomach bleeding and kidney effects.

Caution is advised when using this drug in children with a certain type of arthritis (systemic onset juvenile rheumatoid arthritis) because they may be at increased risk for a very serious bleeding/clotting problem (disseminated intravascular coagulation). Seek immediate medical attention if your child develops sudden bleeding/bruising or bluish skin in the fingers/toes.

This medication should be used only when clearly needed during the first 6 months of pregnancy. It should not be used during the last 3 months of pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Celebrex Oral Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: cidofovir.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting celecoxib.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: anti-platelet drugs (e.g., cilostazol, clopidogrel), high blood pressure drugs (including ACE inhibitors such as captopril, lisinopril and angiotensin II receptor blockers such as losartan, valsartan), oral bisphosphonates (e.g., alendronate), "blood thinners" (e.g., enoxaparin, heparin, warfarin), corticosteroids (e.g., prednisone), desmopressin, fluconazole, lithium, pemetrexed, "water pills" (diuretics such as furosemide, hydrochlorothiazide, triamterene).

Check all prescription and nonprescription medicine labels carefully for other pain/fever drugs (NSAIDs such as aspirin, naproxen, ibuprofen). These drugs are similar to this medication, so taking one of these drugs while also taking this medication may increase your risk of side effects. However, if your doctor has prescribed low doses of aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue to take the aspirin. Daily use of NSAIDs (e.g., ibuprofen) may decrease aspirin's ability to prevent heart attack/stroke. Consult your doctor or pharmacist for more details and to discuss other possible treatments (e.g., acetaminophen) for your pain/fever.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Celebrex Oral Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, change in amount of urine, slow or shallow breathing, severe headache or loss of consciousness.

NOTES:
Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

MISSED DOSE:
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2011 Copyright(c) 2011 First DataBank, Inc.

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