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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗过敏药物->消炎药物
处方药:处方药
包装规格: 100毫克/片 10片/盒
计价单位:
   
该药品相关信息网址1:
http://en.wikipedia.org/wiki/Nimesulide
原产地英文商品名:
NIMESULIDE 100mg/tab 10tabs/box
原产地英文药品名:
NIMESULIDE
中文参考商品译名:
尼美舒利 100毫克/片 10片/瓶
中文参考药品译名:
尼美舒利
中文参考化合物名称:
4-硝基-2-苯氧基甲磺酰苯胺
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Osteoarthritis
英文适应病症2:
Extra-articular rheumatism
英文适应病症3:
Surgery and acute post-traumatic pain and inflammation
英文适应病症4:
Acute upper respiratory inflammation caused by pain and fever
英文适应病症5:
Dysmenorrhea
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:
关节外风湿病
中文适应病症参考翻译3:
手术和急性创伤后的疼痛和炎症
中文适应病症参考翻译4:
急性上呼吸道炎症引起的疼痛和发烧
中文适应病症参考翻译5:
痛经
药品信息:

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 详细处方信息以本药内容附件PDF文件(201092419074027.pdf)的“原文Priscribing Information”为准
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部分中文nimesulide处方资料(仅供参考)

    尼美舒利(nimesulide),商品名为美舒宁(mesulid),是一新型的非甾体抗炎药(NSAIDs)。适用于多种需要抗炎治疗的疾病,如骨关节炎,关节外风湿病,手术和急性创伤后的疼痛和炎症,急性上呼吸道炎症引起的疼痛和发烧,痛经。

    尼美舒利(nimesulide),商品名为美舒宁(mesulid),是一新型的非甾体抗炎药(NSAIDs)。化学名称为4-硝基-2-苯氧基甲磺酰苯胺,结构式如下。

1 药理作用
  本品是磺酰苯胺的衍生物,故对环氧化酶(COX)有选择性的抑制作用,是前列腺素(PG)生物合成的关键酶。COX有两个亚型,即COX1和COX2。COX1是结构酶,主要在胃内合成前列腺素类物质,通过各种机制,帮助维持胃粘膜的完整性和正常的肾功能。COX2是诱导酶,存在于白细胞中,在炎症和疼痛时合成PG。本品高度选择性抑制COX2的活性,对COX1抑制作用不明显,故在发挥有效的抗炎作用的同时,减少了其它NSAIDs常见的消化性溃疡和出血的副作用。本品对COX2的IC50值与COX1的IC50值之比是139[1]。吲哚美辛对COX2与COX1的IC50值之比是0.02。当以吲哚美辛对COX2的IC50值为1时,本品对COX2的选择作用是吲哚美辛的6950倍。本品减少激活的中性粒细胞产生超氧阴离子,清除已形成的次氯酸,抑制蛋白水解酶(弹性蛋白酶和金属蛋白酶)的活性起到强大的抗炎、消肿作用,对呼吸道结缔组织及软骨组织作用更明显。通过抑制磷酸二酯酶Ⅳ型而抑制嗜碱性细胞释放组胺,不会促使白三烯的合成,因而不会像阿司匹林等引起变态反应,导致支气管痉挛,故可安全用于哮喘病人。
  大鼠实验表明,po本品和直肠给药对酵母诱发的发热有明显的退热作用,且比对乙酰氨基酚更强更持久。本品的退热作用以半数有效量(ED50)计,po比对乙酰氨基酚强200倍,直肠给药则强60倍。po解热持续时间比对乙酰氨基酚长3倍,其镇痛作用强而持久,为阿司匹林的25倍,丙氧芬的5倍。

2 药动学
  po本品吸收迅速安全,健康志愿者po 100 mg后[2],平均血浆浓度为2.86mg*L-1~4.58 mg*L-1,达峰时间为1.22 h~3.83h。其吸收速率和吸收程度不受食物影响。栓剂的生物利用度为po的54%~96%。药物吸收后主要分布在细胞外液,表观分布容积为0.19L*kg-1~0.39 L*kg-1。广泛与血浆蛋白结合,游离型药物仅占0.7%~4.0%。终末消除半衰期为1.96h~4.73 h。本品主要在肝内代谢,其代谢产物为4-羟基衍生物,分别在尿和粪便中排出约80%和20%,几乎均为代谢物。80岁以下老人po后药动参数与成人相似。因此,不必调整剂量。7岁~9岁儿童,po本品颗粒剂50mg[3],平均血浆峰浓度为(3.46±1.4)mg*L-1,达峰时间为(1.93±0.83)h,平均消除半衰期为2.4h。药时曲线下面积为18.4 mg*h*L-1,但个体差异大,中等肾功能不全患者(肌酐清除率>5.4L*h-1)时药动学参数无明显改变。但其羟基代谢物的半衰期有所延长。

3 适应证
  适用于多种需要抗炎治疗的疾病,如骨关节炎,关节外风湿病,手术和急性创伤后的疼痛和炎症,急性上呼吸道炎症引起的疼痛和发烧,痛经。

4 用法用量
  成人:口服每次100 mg,每日2次,餐后服用。儿童:颗粒剂和混悬剂,每日5mg*kg-1,分2次~3次服。

5 禁忌证、不良反应和相互作用
  活动性消化性溃疡病、严重肝功能不全、严重肾功能障碍、对本品过敏者禁用。
  充血性心功能不全,孕妇和哺乳期妇女应慎用。
  本品耐受性良好,胃肠道反应少,偶有上腹痛,灼热恶心,头痛眩晕及转氨酶、碱性磷酸酶升高。
  本品降低po利尿药的生物利用度及血浆浓度;可置换水杨酸,呋塞米及甲磺丁脲与血浆蛋白的结合,干扰抗凝血药的肝代谢。

6 临床评价
  软组织损伤及骨关节炎[4]600例运动引起的软组织损伤病人,用随机双盲对照法,po本品300mg*d-1,对照组服萘普生750 mg*d-1,疗程均5d。结果显示,两组在减轻水肿程度和疼痛强度的疗效相似,但本品胃肠道的耐受性优于萘普生。Mele[5]等调查了用本品治疗6
  489例骨关节炎患者,结果用药1周后疼痛由83%减至50%,至3周时降为18%,医生和患者对有效性的评价分别为82%和73%。本组中本品治疗膝关节骨关节炎的总改善率,用药1周后为70.7%,至用药3周时为96.6%,而双氯芬酸组用药1周和3周时的总改善率则分别为31.1%和62.3%,两组间有显著差异,结果显示,本品的疗效明显优于双氯芬酸。
  对940例耳鼻喉炎症病人临床研究[6],po本品100mg,每日2次,疗程平均10 d,能使体征和症状明显减轻,功能恢复,有效率76.3%,另一组53例耳鼻喉科非感染性炎症的疗效优于萘普生。
  对250例双盲对照试验表明,本品对外科手术、牙科及面部手术,耳鼻喉科及痔切除术等引起的中、重度疼痛有良好的止痛效果,且能消除术后充血,水肿及使术后升高的体温下降。牙科止痛比布洛芬快而强。耳鼻喉科手术止痛与酮洛芬同样有效。痔切除术后止痛有效率92%,而萘普生为78%[7]。

7 规格及包装
  片剂:每片100 mg

MESULID (NIMESULIDE)
Mesulid Information
Mesulid is a popular medicine that is also commonly known under the generic name of Nimesulide. This drug belongs to a wide class of medicines called  anti-inflammatory nonsteroidal drugs (NSAID). NSAIDs are well known  for their anti-pyretic, anti-inflammatory, and analgesic properties. What makes Mesulid different from the other NSAIDs is that this drug’s functional acidic group is a sulfonanilide. This enables Nimesulide to effectively and rapidly provide the relief of inflammation and pain symptoms that are usually associated with a large variety of medical conditions. This medicine has proven itself to be highly effective especially in the treatment of patients who have not adequately responded to other non-steroidal anti-inflammatory medicines or to extremely sensitive patients who have gastric-intolerance or NSAID-intolerance.

Mesulid Indications
Mesulid is usually prescribed for an average short-term treatment in the case of patients who are suffering from any of the following medical conditions: painful extra-articular medical disorders; symptomatic Osteoarthritis; post-operative dental inflammation and pain; primary dysmenorrheal, etc. However, if you have any doubts regarding why you have been prescribed to start taking this medicine, you should ask your personal physician, because Mesulid can be given to treat or to prevent some other disorders that have not been listed here.

Mesulid Warnings
You should not start a treatment with this medicine without your physician’s approval. You must not take Mesulid if you are suffering from allergic reactions to this drug or to nay of its ingredients, to other medicines, foods, dyes or preservatives, or to any other type of substances. You might not be allowed to take this drug if:

You are suffering from known hypersensitivity to the inactive or to the active ingredients of this medicine;
If you are under 14 years old;
If you are suffering from liver disorders or from hepatic impairment;
If you are suffering from serious renal impairment;
If you are suffering from gastrointestinal bleeding, active duodenal or gastric ulcers;
If you have a history of  recurrent duodenal or gastric ulcers.
If you are suffering from coagulation disorders (for example hemophilia).

If you have any of the medical disorders that have been listed here, you might not be allowed to start taking Mesulid, or you might have to take a lower dose of this medicine. You should not combine this medicine with any hepatotoxic drugs (this includes any other NSAIDs and alcoholic beverages).

You should not start a treatment with Nimesulide 8 weeks after you have taken a clavulanic acid/amoxicillin (such as Augmentin). It is not known whether a treatment with this medicine could harm a growing fetus. It is highly recommended that you should ask for your personal physician’s approval before you start taking Mesulid if you are currently pregnant (or if you are planning to be so soon). It has not been clearly determined whether this medicine’s main ingredients are able to pass into breastmilk. Ask your personal physician if you may (if it is safe to) start taking this medicine if you are currently breastfeeding an infant.

This medicine should not be given to a child under 14 years old. Although elderly patients usually react to a treatment with Mesulid just as a younger adult would, in some cases, older adults should be prescribed a lower dose of this medicine. Elderly patients should be closely monitored during their treatment with this drug in order to prevent irreparable damage to the liver or to the kidneys.

Mesulid Intake Guidelines
Ask your doctor how and for how long you have to take Mesulid. You should avoid disobeying from any of the instructions (advices) that your personal doctor has given you. You can also rely on the instructions that are supposed to be written on the drug’s label. If you fail to understand some of these instructions, you should ask a nurse, a doctor or a pharmacist for further advice and recommendations. You must not stop your treatment with Mesulid without your physician’s approval even if you start to feel better after a few days.

Mesulid Dosage
Ask your personal physician to tell you the correct dose of Mesulid that you should take in during your treatment with it. You must not alter the dose that he or she prescribes you in any way without your doctor’s approval.

Mesulid Overdose
If you think you may be suffering from an overdose with Mesulid, you are probably in need for immediate medical attention. You should contact your local poison control centre as soon as possible.

Mesulid Missed Dose
In order to get the proper beneficial results from your treatment with Mesulid, you should do your best and try to take this drug on a regular basis. If you happen to miss one of your prescribed doses of this drug, you should contact your personal physician and ask him or her what to do next.

Mesulid Side Effects
Although a treatment with Mesulid is usually well tolerated, some patients have experienced nausea, epigastric discomfort, abdominal cramps, heartburn, diarrhea, vomiting, etc. Other more severe side effects are pruritus, skin rash, Edema, dizziness, headache, drowsiness and some hypersensitivity reactions.

Mesulid Drug Reactions
During your treatment with Mesulid, you should avoid taking Hepatotoxic/Nimesulide Drugs (this also includes Augmentin, Other NSAIDs),  hepatotoxins (for example
anti-convulsants, anti-fungals, anti-tuberculous medicines like isoniazid, tacrine, amiodarone, pemoline, methyldopa, methotrexate, etc). If you have to start taking any of the medicines that have been listed here, you might not be allowed to continue your treatment with Mesulid, or you may have to take in a lower dose of this medicine.

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 详细处方信息以本药内容附件PDF文件(201092419074027.pdf)的“原文Priscribing Information”为准
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2010-9-25更新

更新日期: 2010-9-25
附件:
 
调控比例: 100%
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