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当前本网站药物产品种数共 8524 处方药 8148 非处方药 269 保健品/医疗用具 107

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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗微生物药物->抗炎
处方药:处方药
包装规格: 50毫克/胶囊 100胶囊/瓶
计价单位:
   
该药品相关信息网址1:
http://www.medicinenet.com/ketoprofen/article.htm
该药品相关信息网址2:
http://www.rxlist.com/orudis-drug.htm
原产地英文商品名:
KETOPROFEN CAPSULE (ORUDIS GENERIC) 50MG/CAP 100CAPS/BOTTLE
原产地英文药品名:
KETOPROFEN
中文参考商品译名:
酮洛芬胶囊(ORUDIS仿制药) 50毫克/胶囊 100胶囊/瓶
中文参考药品译名:
酮洛芬
中文参考化合物名称:
-甲基-3-苯甲酰基-苯乙酸
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Anti-inflammatory
英文适应病症2:
Analgesic
英文适应病症3:
Arthritis
临床试验期:
完成
中文适应病症参考翻译1:
抗炎
中文适应病症参考翻译2:
镇痛
中文适应病症参考翻译3:
关节炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(201172722301316.pdf)的“原文Priscribing Information”为准
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部分中文酮洛芬处方资料(仅供参考)

化学名
    -甲基-3-苯甲酰基-苯乙酸

英文名
    Ketoprofen Capsules

成份
    本品主要成分为酮洛芬

药理毒理
  本品为非甾体抗炎药。除抑制环氧化酶外,尚有一定抑制脂氧酶及减少缓激肽的作用,从而减轻炎症和损伤部位疼痛感觉。急性毒性试验结果:大鼠经口LD50为101mg/kg。

药代动力学
  与食物、奶类同服时吸收减慢,但吸收仍较完全。一次给药后约4~6小时血药浓度达峰值。血浆蛋白结合率为99%(老年人可较低)。T1/2为1.6~4小时(平均3小时),主要以葡萄糖醛酸结合物形式从尿排出,以原形物排出约10%。老年人、肝肾功能不全者其清除率下降22%~50%。

用法和用量
  成人口服:每次75mg-100mg,每日二次或一次0.2g(1粒),一日1次。每日最大剂量不超过0.2g(1粒)。为避免对胃肠道刺激,应饭后服用,整个胶囊吞服。

不良反应
(1)以胃肠道反应为主,如胃部疼痛或不适、胀气、恶心、呕吐、腹泻、便秘等,严重者出现胃溃疡、出血甚至穿孔。
(2)其次有水潴留(体重增加快、尿量减少、面部水肿等);过敏性皮炎、口腔炎、耳鸣、精神抑郁、头晕、嗜睡、视力模糊等亦可出现。
(3)其他如心律不齐、血压升高、心悸、幻觉、偏头痛、听力下降、四肢麻木、皮肤瘙痒、剥脱性皮炎、鼻衄、肝酶上升、间质性肾炎、肾功能下降、粒细胞减少、血小板减少、溶血性贫血等。

禁忌
①对本品或其它非甾体抗炎药有过敏者禁用;
②有活动性消化性溃疡者禁用。

临床研究
【功效主治】用于各种关节炎:类风湿关节炎、骨性关节炎、强直性脊柱炎、痛风性关节炎等的关节痛、肿以及各种疼痛,如痛经、牙痛、手术后痛、癌性疼痛等。
【化学成分】本品主要成分及其化学名称为:本品主要成分为酮洛芬,其化学名为?-甲基-3-苯甲酰基-苯乙酸。
【药理作用】本品为芳香基丙酸衍生物,属非甾体抗炎镇痛药。本品除抑制环氧合酶外尚有一定抑制脂氧酶及减少缓激肽的作用,从而减轻炎症损伤部位疼痛感觉。因缓激肽与前列腺素一起可引起疼痛。缓激肽还可引起子宫收缩,故本品用于痛经,主要是通过抑制缓激肽,从而抑制子宫收缩和镇痛而起到疗效。本品尚有一定的中枢性镇痛作用。急性毒性试验结果:大鼠经口LD50为101mg/kg。
【药物相互作用】1 对乙酰氨基酚同用时可增加对肾脏的毒副作用; 2 与肝素、双香豆素等抗凝药及血小板聚集抑制药同用时有增加出血的危险; 3 与呋塞米同用时,后者的排钠和降压作用减弱; 4 与维拉帕米、硝苯地平同用时,本品的血药浓度增高; 5 本品可增高地高辛的血浓度,同用时须注意调整地高辛的剂量; 6 本品可增强口服抗糖尿病药的作用; 7 本品与抗高血压药同用时可影响后者的降压效果; 8 本品不应与丙磺舒同用,因后者可明显降低本品肾脏清除率(降低66%)和蛋白结合率(降低28%),导致血药浓度增高,而有引起中毒的危险; 9 本品可降低甲氨蝶呤的排泄,增高其血浓度,甚至可达中毒水平,故本品不应与中或大剂量甲氨蝶呤同用。
【不良反应】 1 胃肠道反应较常见,如胃部疼痛或不适、胀气、恶心、呕吐、食欲减退、腹泻、便秘等,严重者可出现上消化道溃疡、出血及穿孔 2 过敏反应:过敏性皮炎、皮肤瘙痒、剥脱性皮炎、喉头水肿、支气管痉挛(过敏性)等 3 眼:视力模糊、视网膜出血 4 心血管系统:心律不齐、血压升高、心悸 5 中枢神经系统:头晕、头痛、耳鸣、听力下降、精神紧张、精神抑郁、幻觉、嗜睡、四肢麻木等 6 肝肾:肝损害、肾功能下降、间质性肾炎、肾病 7 血液系统:鼻衄、粒细胞减少、血小板减少、溶血性贫血等 8 其它:水潴留(体重增加快、尿量减少、面部水肿等)、口腔炎、多汗等。
【禁忌症】 1 对阿司匹林或其他非甾体抗炎药有过敏者; 2 有活动性消化性溃疡者。

注意事项
(1)交叉过敏:对阿司匹林或其它非甾体抗炎药过敏者,本品可有交叉过敏反应。对阿司匹林过敏的哮喘患者,本品也可引起支气管痉挛。
(2)有下列情况者应慎用:①哮喘,用药后可加重;②心功能不全、高血压,用药后可致水潴留、水肿;③血友病或其它出血性疾病(包括凝血障碍及血小板功能异常),用药后出血时间延长,出血倾向加重;④有消化性溃疡病史者,应用本品时易出现胃肠道副作用,包括产生新的溃疡;⑤肾功能不全者用药后肾功能不良反应增多,甚至导致肾功能衰竭;⑥本品用于肝硬变患者尤应慎重,因血中游离的药物浓度可升高,必要时可用最小有效量,并应密切监测。
(3)本品治疗关节炎,用药几天至1周见效,达最大疗效需连续用药2~3周。
(4)肾功能低下者用量应减少33%~50%。
(5)为了减少对胃肠道刺激,可与食物同服或饭后服用。对急需止痛患者,可于进食前30分钟或进食后2小时服药。
(6)长期用药时应定期随诊,检查血象及肝、肾功能。一旦出现胃肠道出血、肝肾功能损害、视力障碍、精神异常、血象异常及过敏反应等异常情况,应立即停药、就诊。
(7)诊断的干扰:①由于本品对血小板聚集有抑制作用,可使出血时间延长3~4秒;②本品可使血钠浓度降低,血红蛋白及红细胞压积降低;③本品可致血清碱性磷酸酶、乳酸脱氢酶及转氨酶升高;④由于本品在尿中代谢产物的干扰,可影响尿17一羟皮质类固醇(17一OHCS)的测定结果。

孕妇及哺乳期妇女用药
  孕妇及哺乳期妇女禁用。

儿童用药
  尚不明确。

老年患者用药
  老年人应用本品时血浆蛋白结合率及药物排出速度可减低,导致血药浓度升高及半衰期延长,因而需注意剂量调整。

药物相互作用
(1)饮酒或与其它非甾体抗炎药同用时可增加胃肠道不良反应及出血倾向。长期与对乙酰氨基酚同用时可增加对肾脏的毒副作用。
(2)与肝素、双香豆素等抗凝药及血小板聚集抑制药同用时有增加出血的危险。
(3)与呋塞米同用时,后者的排钠和降压作用减弱。
(4)与维拉帕米、硝苯地平同用时,本品的血药浓度增高。
(5)本品可增高地高辛的血药浓度,同用时须注意调整地高辛的剂量。
(6)本品可增强口服抗糖尿病药的作用。
(7)本品与抗高血压药同用时可影响后者的降压效果。
(8)本品不应与丙磺舒同用,因后者可明显降低本品肾脏清除率(降低66%)和蛋白结合率(降低28%),导致血药浓度增高,而有引起中毒的危险。
(9)本品可降低甲氨蝶呤的排泄,增高其血药浓度,甚至可达中毒水平,故本品不应与中或大剂量甲氨蝶呤疗法同用。

药物过量
  服用常规剂量的5~10倍可导致嗜睡、恶心、呕吐和上腹部疼痛。大剂量的酮洛芬可引起呼吸抑制和昏迷。胃肠道出血、低血压、高血压或急性肾功能衰竭也可发生,但较少见。服药超量时应作紧急处理,包括催吐或洗胃。口服活性炭、抗酸药或(和)利尿剂,并给予检测及其它支持治疗。

贮藏
  遮光,密封保存。

GENERIC NAME: ketoprofen

BRAND NAMES: None (Note: previous brand names no longer available in the US include Orudis, Oruvail)

DRUG CLASS AND MECHANISM: Ketoprofen is an oral drug that belongs to a class of drugs called nonsteroidal antiinflammatory drugs (NSAIDs). Other members of this class include ibuprofen (Motrin), indomethacin (Indocin), naproxen (Aleve) and many others. These drugs are used for the management of mild to moderate pain, fever, and inflammation. They work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever, and inflammation. Ketoprofen reduces prostaglandins by blocking the enzyme that makes them (cyclooxygenase). As a consequence, inflammation, pain and fever are reduced.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Capsules (immediate release): 50, 75 mg; Capsules (extended-release): 100, 150, 200 mg

STORAGE: Ketoprofen should be stored in a sealed container at room temperature, 15-30 C (59-86 F) avoiding moisture and protected from excessive heat.

PRESCRIBED FOR: Ketoprofen is used for the treatment of inflammation and pain caused by rheumatoid arthritis and osteoarthritis. It also is used for menstrual cramps and mild to moderate pain of many causes. Extended release capsules are not used for acute pain because they do not begin working as quickly as the immediate release capsules.

DOSING: The usual starting dose of ketoprofen is 50 or 75 mg with immediate release capsules every 6 to 8 hours or 200 mg with extended release capsules once daily. The maximum dose is 300 mg daily of immediate release capsules or 200 mg daily of extended release capsules. Ketoprofen should be taken with food in order to avoid stomach upset.

DRUG INTERACTIONS: Ketoprofen may increase the blood levels of lithium (Eskalith) by reducing the excretion of lithium by the kidneys which may lead to lithium toxicity.

Ketoprofen may reduce the blood pressure lowering effects of blood pressure medications. This occurs because prostaglandins play a role in reducing blood pressure.

When NSAIDs are combined with methotrexate (Rheumatrex, Trexall) or aminoglycosides (for example, gentamicin) the blood levels of methotrexate or aminoglycoside may increase because the elimination of methotrexate and aminoglycosides is reduced. This may lead to more methotrexate or aminoglycoside side effects.

Individuals taking blood thinners or anticoagulants, for example, warfarin (Coumadin), should avoid ketoprofen because ketoprofen also thins the blood, and excessive blood thinning may lead to bleeding.

Persons who have more than three alcoholic beverages per day are at increased risk of developing stomach ulcers when taking ketoprofen or other NSAIDs.

PREGNANCY: There are no adequate studies of ketoprofen in pregnant women. Therefore, ketoprofen is not recommended during pregnancy.

NURSING MOTHERS: It is not known whether ketoprofen is excreted in breast milk.

SIDE EFFECTS: The most common side effects from ketoprofen are rash, ringing in the ears, headaches, dizziness, drowsiness, abdominal pain, nausea, diarrhea, constipation, heartburn, retention of fluid and shortness of breath.

NSAIDs reduce the ability of blood to clot and therefore increase bleeding after an injury. Ketoprofen also may cause stomach and intestinal bleeding from ulcers. Sometimes, stomach ulceration and intestinal bleeding occur without any abdominal pain. Black tarry stools (due to blood in the stool), weakness, and dizziness upon standing (orthostatic hypotension) may be the only signs of the bleeding.

People who are allergic to other NSAIDs should not use ketoprofen. NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously. Individuals with asthma are more likely to experience allergic reactions to ketoprofen and other NSAIDs. Fluid retention, blood clots, heart attacks, hypertension, and heart failure also have been associated with the use of NSAIDs.

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 详细处方信息以本药内容附件PDF文件(201172722301316.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2011-7-28
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