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Nurofen Plus(布洛芬组合片剂)

2012-04-19 23:23:44  作者:新特药房  来源:中国新特药网天津分站  浏览次数:6018  文字大小:【】【】【
简介:部分中文Nurofen Plus处方资料(仅供参考)【概论】通用名称:布洛芬   英文名称:Ibuprofen   中文别名:拔怒风、异丁苯丙酸、异丁洛芬   英文别名:Algofen、Amersol、Andran、Apsifen、Brufen、Ebufac ...

部分中文Nurofen Plus处方资料(仅供参考)
【概论】
通用名称:布洛芬   
英文名称:Ibuprofen   
中文别名: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
【药理】
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】
1. 关节炎:该药可缓解急慢性类风湿性关节炎、骨关节炎、强直性脊柱炎、软组织风湿的发作,并可长期服用。用布洛芬缓释胶囊治疗风湿性关节炎与芬必得治疗该疾病进行了对照,结果显示:布洛芬缓释胶囊与芬必得治疗类风湿性关节炎的疗效相似。
2. 疼痛:用于缓解轻度或中度疼痛。如,牙科、产科、矫形手术后的疼痛以及软组织运动损伤后的肌肉、骨骼引起的疼痛。也可缓解头痛、滑囊炎、肌腱炎等非类风湿性关节炎性疼痛。   
3. 痛风:该药对痛风具有镇痛和抗炎作用。   
4. 痛经,对原发性痛经及宫内异物(如宫内节育器)引起的继发性痛经,除缓解疼痛外,还能减少月经失血量。 5. 退热:主要用于一般感冒或流行性感冒引起的高热。秦玉生等在布洛芬栓对发热患儿的解热实验中,60例发热儿童在常规退热的基础上应用小儿布洛芬栓,而58例对照组的儿童仅给以常规退热。结果治疗组显效率为35%,总有效率为91.7%,均高于对照组的5.2%和75.9%,显示小儿布洛芬栓在治疗小儿发热方面具有满意疗效。
【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。  
[制剂与规格]布洛芬片(1)0.1g(2)0.2g   
口服,一日0.6g,分3次饭时服.
【禁用慎用】
(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。
【给药说明】
①有些应用阿司匹林引起胃肠道不良反应的患者,可改用本品,但应密切注意不良反应、形成溃疡或发生出血等;②治疗类风湿性关节炎,本品还可与金制剂或皮质激素同用,症状缓解可更明显;
③用药期间如出现胃肠出血,肝、肾功能损害,视力障碍、血象异常以及过敏反应等情况,应立即停药。   
长期用药时应定期检查血象及肝、肾功能。
【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。
【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。
【同类药物】
萘普生(naproxen)、非诺洛芬(fenoprofen)、酮洛芬(ketoprofen)、氟比洛芬(flurbiprofen)、奥沙普嗪(丙恶嗪,oxaprozin)以上药物均为丙酸类药物,药效相似。

Nurofen plus
Main use:Mild to moderate pain
Active ingredient:Ibuprofen 200mg, codeine phosphate 12.8mg
Manufacturer:Reckitt Benckiser
---------------------------------------------------------
How does it work?
Nurofen plus tablets contain two active ingredients, ibuprofen and codeine phosphate. Both are pain-relieving medicines.
Ibuprofen is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). It relieves pain and inflammation. Ibuprofen works by blocking the action of a substance in the body called cyclo-oxygenase. Cyclo-oxygenase is an enzyme involved in the production of various chemicals in the body. Some of these natural chemicals are known as prostaglandins, and are produced by cyclo-oxygenase in response to injury or certain diseases and conditions. Prostaglandins cause pain, swelling and inflammation. By blocking the action of cyclo-oxygenase, ibuprofen stops the production of these inflammatory prostaglandins, and therefore reduces inflammation and pain.
Codeine phosphate is a type of painkiller called an opioid. It is related to morphine but is not as strong. Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.
Codeine phosphate mimicks the action of natural endorphins by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.
Nurofen plus tablets contain 12.8mg of codeine, which in combination with the ibuprofen, is effective at relieving mild to moderate pain.
---------------------------------------------------------
What is it used for?
Mild to moderate pain including non-serious arthritic and rheumatic pain, soft tissue injuries such as sprains and strains, tendonitis, backache, nerve pain (neuralgia), migraine, headache, toothache, period pain.
---------------------------------------------------------
Warning!
Codeine can cause drowsiness, although at the dose contained in this medicine this is very unlikely. However, if you do find this medicine makes you feel sleepy or dizzy you should not drive or operate machinery and avoid alcoholic drink.
Do not exceed the recommended dose of this medicine, which will be stated in the product packaging or information leaflet supplied with the medicine. The minimum effective dose should be used for the shortest time necessary to relieve your symptoms. If symptoms persist despite treatment, seek medical advice from your doctor or pharmacist.
Do not take this medicine for longer than three days without consulting your doctor. If codeine is taken regularly for long periods of time, the body can become tolerant to it and it may become less effective at relieving pain. With prolonged use, the body may also become dependent on the codeine. As a result, when you then stop taking the medicine you may get withdrawal symptoms such as restlessness and irritability.
If you find you need to use this medicine all the time you should consult your doctor for advice.
Taking a painkiller for headaches too often or for too long can actually make the headaches worse.
Ibuprofen is generally well-tolerated and most people do not experience any side effects. The most common side effects are related to stomach irritation and include abdominal pain, indigestion and nausea. These can mainly be avoided by taking the ibuprofen with food. Rarely, serious side effects such as ulceration or bleeding in the stomach or intestines may occur. These are more likely with high doses and in elderly people. If you experience any sign of bleeding from the stomach or bowels after taking this medicine, such as vomiting blood and/or passing black/tarry/bloodstained stools, you should stop taking this medicine and consult your doctor immediately.

Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine.
---------------------------------------------------------
Use with caution in
Elderly people.
History of disorders affecting the stomach or intestines.
Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
Decreased kidney function.
Decreased liver function.
Heart failure.
High blood pressure (hypertension).
People with blood clotting problems or taking anticoagulant medicines.
History of asthma.
History of allergies.
Diseases affecting connective tissue, eg systemic lupus erythematosus.
---------------------------------------------------------
Not to be used in
Children under 12 years of age.
People in whom aspirin or other NSAIDs, eg ibuprofen, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
Current or previous peptic ulcer.
People who have experienced bleeding or perforation of the gut as a result of previous treatment with an NSAID.
Severe heart failure.
Severe liver failure.
Severe kidney failure.
Third trimester of pregnancy.
People taking other NSAIDs, including COX-2 inhibitors (see end of factsheet for more details).
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
---------------------------------------------------------
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
If you are pregnant or trying for a baby you should not use this medicine without consulting your doctor first. This medicine is not recommended for use in pregnancy unless considered essential by your doctor. This is particularly important in the first and third trimesters. If codeine is used in the third trimester it may cause withdrawal symptoms in the baby after birth. If ibuprofen is taken in the third trimester it may delay labour, increase the length of labour and cause complications in the newborn baby. Some evidence suggests that NSAIDs should also be avoided by women attempting to conceive, as they may temporarily reduce female fertility during treatment and may also increase the risk of miscarriage or malformations. Seek medical advice from your doctor.
Ibuprofen and codeine may pass into breast milk in amounts that are probably too small to be harmful in most people. However, on very rare occasions, codeine taken by a nursing mother may cause side effects in the breast-fed baby. These side effects may include drowsiness or sedation, difficulty breastfeeding, vomiting, breathing difficulties and floppiness in the nursing baby. The baby may be more likely to experience side effects if the mother experiences side effects such as drowsiness, nausea, vomiting, loss of appetite or breathing difficulties after taking codeine. You should seek medical advice from your doctor before taking this medicine if you are breastfeeding.You should stop taking this medicine and consult your doctor immediately or seek emergency medical care if your baby shows any of the symptoms just mentioned.
---------------------------------------------------------
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Abdominal pain.
Nausea.
Indigestion (dyspepsia).
Constipation.
Headache.
Dizziness.
Codeine can cause drowsiness, although at the dose contained in this medicine this is very unlikely. However, if you do find this medicine makes you feel sleepy or dizzy you should not drive or operate machinery and avoid alcoholic drink.
Hearing disturbances.
Ulceration or bleeding in the stomach or intestine.
Hypersensitivity reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), itchy blistering rash or anaphylactic shock.
Kidney, liver or blood disorders.
Slow, shallow breathing.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
---------------------------------------------------------
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Ibuprofen should not be taken in combination with painkilling doses of aspirin or any other NSAID (eg naproxen, diclofenac) that is taken by mouth, as this increases the risk of side effects on the stomach and intestines. This medicine should not be taken by people taking selective inhibitors of COX-2, such as celecoxib or etoricoxib, for the same reason.
There may be an increased risk of ulceration or bleeding from the gut if ibuprofen is taken with corticosteroids such as prednisolone.
There may also be an increased risk of bleeding from the gut if ibuprofen is taken with the following medicines:
anti-blood-clotting (anticoagulant) medicines such as warfarin
antiplatelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, dipydridamole, clopidogrel
SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
venlafaxine.
There may be an increased risk of side effects on the kidneys if ibuprofen is taken in combination with any of the following medicines:
ACE inhibitors, eg enalapril
ciclosporin
diuretics, eg furosemide
tacrolimus.
Ibuprofen may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines:
digoxin
lithium
methotrexate.
Ibuprofen may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, such as the following:
amlodipine
ACE inhibitors such as captopril
beta-blockers such as atenolol.
In the unlikely event that the codeine in this medicine makes you feel drowsy, this may be enhanced by other medicines that can cause drowsiness, such as the following:
antipsychotics, eg haloperidol
barbiturates, eg phenobarbital, amobarbital
benzodiazepines, eg diazepam, temazepam
other opioids, eg morphine, dihydrocodeine
sedating antihistamines, eg chlorphenamine, hydroxyzine
sleeping tablets, eg zopiclone
tricyclic antidepressants, eg amitriptyline.
---------------------------------------------------------
Other medicines containing the same active ingredients
Cuprofen plus 
Solpadeine migraine 
Solpaflex 
---------------------------------------------------------------
原产地英文商品名:
Nurofen Plus 200mg/tab 48tabs/box
原产地英文药品名:
Ibuprofen Combination
中文参考商品译名:
Nurofen Plus 200毫克/片 48片/盒
中文参考药品译名:
布洛芬组合
生产厂家中文参考译名:
利洁时
生产厂家英文名:
Reckitt Benckiser

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