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 详细处方信息以本药内容附件PDF文件（20119618254911.pdf）的“原文Priscribing Information”为准
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部分中文布洛芬处方资料（仅供参考）

布洛芬Ibuprofen 
中文别名：布洛芬、拔怒风、异丁苯丙酸、异丁洛芬

英文别名：Algofen、Amersol、Andran、Apsifen、Brufen、Ebufac、Emodin、Inflam、Motrin、Rurana

药品类别：非甾体抗炎镇痛药
 
药理药动
【药效学】
本品的镇痛、消炎作用机制尚未完全阐明，可能作用于炎症组织局部，通过抑制前列腺素或其他递质的合成而起作用，由于白细胞活动及溶酶体酶释放被抑制，使组织局部的痛觉冲动减少，痛觉受体的敏感性降低。治疗痛风是通过消炎、镇痛、并不能纠正高尿酸血症。治疗痛经的作用机理可能是前列腺素合成受到抑制使子宫内压力下降、宫缩减少。
【药动学】
口服易吸收，与食物同服时吸收减慢，但吸收量不减少。与含铝和镁的抗酸药同服不影响吸收。血浆蛋白结合率为99%。服药后1.2～2.1小时血药浓度达峰值, 用量200mg,血药浓度为22～27μg/ml, 用量400mg时为23～45μg/ml, 用量600mg时为43～57μg/ml。一次给药后半衰期一般为1.8～2小时。本品在肝内代谢, 60～90%经肾由尿排出，100%于24小时内排出，其中约1％为原形物，一部分随粪便排出。

适应症
本品为非甾体类消炎药，具有镇痛、退热和消炎作用，适用于：
①关节炎，可缓解急慢性类风湿性关节炎及骨关节炎的发作，仅使症状减轻，不能控制病程的进展，还需应用皮质激素或其他药物；
②疼痛，用于轻度至中等度疼痛，如牙科、产科或矫形手术后的疼痛，以及软组织运动性损伤后的肌肉骨骼病等，也能缓解滑囊炎、肌腱炎等非风湿性炎症的疼痛；
③痛风，能缓解急性痛风性关节炎的炎症及疼痛，但不能纠正高尿酸血症，不适用于慢性痛风的长期治疗；
④痛经，可缓解原发性痛经及放置宫内节育器引起的继发性痛经，除可缓解疼痛外，还可减少过多的月经失血量。

用法用量
1．成人常用量口服。
①抗风湿，一次 0.4—0.8g，一日 3—4次，类风湿性关节炎比骨关节炎用量要大些；
②轻或中等疼痛及痛经的止痛，一次 0.2—0.4，每 4—6小时一次。成人用药最大限量一般为每天 2.4g(国外有人用至每天 3.6g)。
2．小儿常用量口服。每次按体重 5—10mg/kg，一日 3次。

不良反应
①过敏性皮疹、胃烧灼感或消化不良、胃痛或不适感(胃肠道刺激或溃疡形成)、恶心、呕吐、头晕等，发生率可达 3—9％；
②皮肤瘙痒、耳鸣、下肢水肿或体重骤增、腹胀、便秘、腹泻、食欲减退或消失、头痛、精神紧张等，发生率可达 1—3％；
③血便或柏油样便(胃肠道出血)、过敏性肾炎、膀胱炎、肾病综合征、肾乳头坏死或肾功能衰竭、荨麻疹、支气管痉挛、视力模溯、耳聋、肝功能减退、精神恍惚、嗜睡、失眠等很少见，发生率＜1％。
个别病例有皮疹,消化不良,胃肠道溃疡及出血,转氨酶升高。
最常见的不良反应是胃肠系统，其发生率高达30％，从腹部不适到严重的出血或使消化溃疡复发。中枢神经系统的不良反应极为常见，但较轻，如头痛或头晕。长期大剂量使用时可发生血液病或肾损伤。肝毒性作用十分轻微。过敏反应不常见，可能出现伴有皮疹的发热、腹痛、头痛、恶心和呕吐，肝脏损害甚至出现脑膜炎症状。
应用此药时常见盐及体液潴留，从而引起充血性心衰，但很罕见。
此药对易感者能引起哮喘发作。它能引起哮喘患者的支气管收缩。
中枢神经系统症状较常见，其中头痛、眩晕、耳鸣和失眠的发生率最高，但很少出现抑郁或其他精神症状。有些中枢神经系统症状如假性脑膜炎、脑膜炎、嗜睡及易激惹，可能是由于过敏反应。
此药具有强的胃毒性作用，各种胃肠道的刺激症状(如恶心、呕吐、厌食、消化不良、烧心、腹痛、隐血、呕血和溃疡发作而致大出血)的发生率极高，一般在30～40％左右。使用布洛芬栓剂后可发生疼痛和刺激直肠粘膜。
布洛芬在体内、体外均抑制血小板聚集，剂量低于1g时，血凝试验无明显变化；但大剂量下可使出血时间延长，但不如阿司匹林。它还可诱致不同程度的各种血液病，如粒细胞缺乏症、粒细胞减少症、血小板缺乏症及致命的全细胞减少症。有报告发生不易恢复的白细胞再生不良伴骨髓浆细胞增多及血清中有依赖IgG抗体的补体。个别病例可因胃肠道隐血而导致贫血。
它使血浆中尿酸浓度升高，甚至有时达到有病理学意义。
过敏性皮肤反应不常见，多为短暂性荨麻疹、紫癜性或红斑性改变，常伴有瘙痒。也有报告发生脱发者。

禁忌症
(1)交叉过敏：对阿司匹林或其他非甾体类消炎药过敏者对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)用于晚期妊娠妇女可使孕期延长，引起难产及产程延长。孕妇及哺乳期妇女不宜用。
(3)对阿司匹林或其他非甾体类消炎药有严重过敏反应者禁用。
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血友病或其他出血性疾病(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有消化道溃疡病史者，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脏不良反应增多，甚至导致肾功能衰竭。
有潜在的消化性溃疡患者应慎用此药。周身性红斑狼疮患者发生过敏反应的危险大大高于类风湿病患者。

药物相互作用
(1)饮酒或与其他非甾体类消炎药同用时增加胃肠道副作用，并有致溃疡的危险。长期与对乙酰氨基酚同用时可增加对肾脏的毒副作用。
(2)与阿司匹林或其他水杨酸类药物同用时，药效不增强，而胃肠道不良反应及出血倾向发生率增高。
(3)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。
(4)与呋塞米同用时，后者的排钠和降压作用减弱。
(5)与维拉帕米、硝苯啶同用时，本品的血药浓度增高。
(6)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。
(7)本品可增强抗糖尿病药(包括口服降糖药)的作用。
(8)本品与抗高血压药同用时可影响后者的降压效果。
(9)丙磺舒可降低本品的排泄，增加血药浓度，从而增加毒性，故同用时宜减少本品剂量。
(10)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疗法同用。
它使各种降压药的降压作用减低，它抑制苯妥英的降解。

What is Pedea?
Pedea is a solution for injection that contains the active substance ibuprofen.

What is Pedea used for?
Pedea is used to treat ‘patent ductus arteriosus’ in newborn premature babies who were born six or more weeks too early (less than 34 weeks gestational age). Patent ductus arteriosus is a condition where the ductus arteriosus (the blood vessel that allows blood to bypass the baby’s lungs before birth) fails to close after birth. This causes heart and lung problems in the baby.

Because the number of babies born with patent ductus arteriosus is low, the disease is considered ‘rare’, and Pedea was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 February 2001.

The medicine can only be obtained with a prescription.

How is Pedea used?
Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist (a doctor specialising in newborn babies).

Pedea is given as three injections into a vein at 24-hour intervals. Each injection lasts 15 minutes. The first injection is given when the baby is at least six hours old. If the ductus arteriosus has not closed by 48 hours after the final injection, or if it re-opens, a second course of three doses of Pedea may be given. If the condition is unchanged after the second course of therapy, surgery may be necessary.

Pedea should not be used before there is proof that the baby has patent ductus arteriosus.

How does Pedea work?
The active substance in Pedea, ibuprofen, has been used since the 1960s as a painkiller and an anti-inflammatory medicine. It works by reducing the level of chemical messengers called prostaglandins within cells. As prostaglandins are also involved in keeping the ductus arteriosus open after birth, Pedea is thought to work by reducing the levels of prostaglandins, allowing this blood vessel to close.

How has Pedea been studied?
Because ibuprofen has been in use for a long time, the company presented information from the published literature. It also presented the results of studies, including one study looking at different doses of Pedea in 40 newborn premature babies. The main measure of effectiveness was the number of babies whose ductus arteriosus closed without the need for surgery.

A further study compared the effects of Pedea and placebo (a dummy treatment) in 131 newborns who were treated before there was proof that they had patent ductus arteriosus.

What benefit has Pedea shown during the studies?
In the study looking at the treatment of patent ductus arteriosus, the approved dose of Pedea led to a closure rate of 75% in babies born 11 to 13 weeks premature (six out of eight) and 33% in babies born 14 to 16 weeks premature (two out of six).

In study looking at the use of Pedea before there was proof that the babies had patent ductus arteriosus, Pedea seemed to be more effective than placebo at preventing surgery. However, the study had to be stopped early because of side effects (kidney and lung problems).

What is the risk associated with Pedea?
The cause of any side effects seen in babies receiving Pedea is difficult to assess because they may be related to the patent ductus arteriosus or to Pedea itself. The most common side effects seen in babies receiving the medicine (seen in more than 1 baby in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely), increased blood creatinine levels (a marker of kidney problems) and decreased blood sodium levels. For the full list of all side effects reported with Pedea, see the Package Leaflet.

Pedea should not be used in babies who may be hypersensitive (allergic) to ibuprofen or any of the other ingredients. It must not be used in babies who have a life-threatening infection, bleeding, blood clotting problems or kidney problems. It must also not be used in babies with congenital heart disease where an open ductus arteriosus is needed for the blood to flow, or in babies with necrotising enterocolitis (a severe bacterial infection causing patches of dead tissue in the gut).

Why has Pedea been approved?
The Committee for Medicinal Products for Human Use (CHMP) accepted that the information presented by the company showed that Pedea is effective in treating patent ductus arteriosus. The Committee decided that Pedea’s benefits are greater than its risks for the treatment of patent ductus arteriosus in preterm (less that 34 weeks gestational age) newborn infants. The Committee recommended that Pedea be given marketing authorisation.

Other information about Pedea
The European Commission granted a marketing authorisation valid throughout the European Union to Orphan Europe SARL on 29 July 2004. The marketing authorisation was renewed on 29 July 2009.

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 详细处方信息以本药内容附件PDF文件（20119618254911.pdf）的“原文Priscribing Information”为准
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