英文药名: Froben SR(Flurbiprofen Sustained Release Capsules)

中文药名: 氟比洛芬缓释胶囊

生产厂家: Abbott

药品名称

中文通用名称：氟比洛芬
英文通用名称：Flurbiprofen
中文其它名称：平风, 氟联苯丙酸, 风平, 氟苯布洛芬, 氟布洛芬, 苯氟布洛芬, 氟比洛芬片, 氟比洛芬缓释片, 泽普思
英文其它名称：Forben, Froben, Flugalin, Flurbiprom, Cebutid, Lipfen, Ansaid, Fladolef-B, Flurofen, Lople, Ocuflur, Reupax, Flurbiprofen Sustained Release Tablets, Flurbiprofen Buccal Tablets, Flurbiprofen Poultice, Flurbiprofen Tablets, Zpolas
产品所属分类：免疫系统用药\抗炎/抗风湿药\环氧酶抑制药类, 镇痛药\解热镇痛抗炎药\丙酸类
适应症

1.适用于类风湿关节炎、骨性关节炎及强直性脊柱炎等。
2.也可用于软组织病(如扭伤、劳损)以及轻、中度疼痛(如手术后疼痛、痛经和牙痛等)。
3.本药滴眼液用于激光小梁成形术后的炎症反应，以及其它眼前段炎症；防治白内障人工晶体植入术后的黄斑囊样水肿；治疗巨乳头性结膜炎，以及抑制内眼手术中的瞳孔缩小及其术后抗炎。
用法用量

成人
*常规剂量
*口服给药
一次50mg，一日3-4次，必要时可增量。一日剂量不超过300mg；缓释片的推荐剂量为一次0.1g，早、晚各1次。
*静脉注射
一次50mg，每4-6小时1次。
*经眼给药
1.抑制内眼手术时的瞳孔缩小及其术后抗炎：术前2小时开始使用，一次1滴，每30分钟1次，共4次。术后次日起一次1滴，一日4次，连用2-3周。
2.激光小梁成形术等术后抗炎：一次1滴，每4小时1次，一日4次，连用7日。
[国外用法用量参考]
成人
*常规剂量
*口服给药
1.急性痛风：使用400mg的负荷用量后(24小时内给药)，再一日用200mg，最多用5日。
2.强直性脊柱炎：一日150-300mg。
3.滑囊炎：一日200-300mg，分3-4次服。根据治疗效果，用药疗程可达14日。
4.口腔科手术：术前或术后可予50-100mg。
5.痛经：痛经开始发作时服50mg，一日4次，连续使用直到疼痛缓解。
6.骨性关节炎：建议一日200-300mg，一日2-4次。最大单次用量为100mg。建议一日不超过300mg。治疗开始或患者疼痛严重时，使用大剂量较合适。症状改善后即应逐渐降至最小有效维持量。
7.妇产科的术后疼痛：50-100mg。
8.类风湿关节炎：建议一日200-300mg，分2-4次服。最大单次用量为100mg。建议一日不超过300mg。有发现本药100mg在睡时用更有益于减少晨僵的持续时间。
9.软组织创伤：用于全部或部分半月板切除术，一日150-400mg。
*经眼给药
抑制术中瞳孔缩小，可使用0.3%本药滴眼液，于术前2小时开始使用，一次1滴，每30分钟1次，共4次。
*直肠给药
建议使用栓剂，最大剂量为100mg，一日2次。
*肾功能不全时剂量
应减少用量。
儿童
*常规剂量
儿童用药的安全性和有效性尚不明确，报道有以下用法。
*口服给药
用于减少睾丸固定术后的炎性反应，3-10岁患儿：一日50-125mg。
*静脉用药
用于斜视手术后镇痛，2-11岁患儿：0.5-1mg/kg(1mg/kg更有效)。
任何疑问，请遵医嘱！
给药说明

1.使用本药缓释片应整片吞服，不得掰开或弄碎服用。
2.本药与阿仑膦酸钠合用时应慎重，因两者都可引起胃肠道刺激症状。
3.使用本药滴眼液与其它滴眼液，两者之间至少应间隔15分钟。
4.本药无抗菌作用，眼部感染患者使用本药滴眼液时，其眼部急性感染症状可能被掩盖，应在抗感染的同时谨慎使用本药。
5.为防止凝血功能异常，建议在手术前停用本药2周。
6.如服药过量，可洗胃、纠正血电解质紊乱等，无特效解毒药。
不良反应

1.常见消化不良、恶心、呕吐、腹胀、腹痛、腹泻、便秘、胃肠道出血等胃肠道不良反应。15%的病例出现血氨基转移酶增高。
2.偶见中枢神经系统不良反应，如头痛、头晕、嗜睡等。
3.本药在动物实验中可引起肾乳头坏死，对人类亦可能有此作用。
4.应用本药直肠栓剂时耐受较好，但有局部刺激、不适、里急后重及腹泻等反应。
5.本药滴眼液可能延缓伤口愈合，滴眼时可有轻度刺痛、烧灼感。
6.其它不良反应包括尿路感染样症状、皮炎、皮疹、视力变化等。
[国外不良反应参考]
1.血液
不良反应的发生率低于1%，包括溶血性贫血、缺铁性贫血、再生障碍性贫血、淋巴结病、血红蛋白和血细胞比容降低、白细胞减少、嗜酸粒细胞增多及血小板减少。另外，本药可延长出血时间。
2.心血管系统
有3%-9%的患者出现体液潴留和周围性水肿。高血压和充血性心力衰竭的发生率低于1%。
3.精神神经系统
不良反应较吲哚美辛少，最常出现头痛(发生率为3%-9%)。其它不良反应还有：中枢神经刺激症状(如焦虑、失眠、震颤)、中枢神经抑制症状(如记忆缺失、抑郁、不适、衰弱无力、嗜睡)及神经质。有使用本药出现严重帕金森综合征的个案报道。
4.胃肠道
胃肠道反应是本药最常见的不良反应。发生率为3%-9%的有消化不良、腹泻、腹痛、恶心。发生率为1%-3%的有呕吐、胃肠胀气、胃肠道出血及便秘。在临床试验中，有5.8%的患者因胃肠道反应而停药。此外，使用NSAID尚有引起结肠炎、溃疡性结肠炎、小肠疾病、食管炎甚至溃疡、出血或穿孔的报道。
5.泌尿生殖系统
本药可能与其它NSAID一样，能使依赖前列腺素维持肾血流的患者发生急性肾衰竭，并与间质性肾炎和肾病综合征有关。据报道，使用本药3%-9%的患者可出现泌尿道感染。有研究表明，血尿素氮或血清肌酸酐明显增高的发生率是0.3%。有膜性肾病、肾乳头坏死和间质性肾炎的个案报道。
6.肝
有本药导致肝功能指标异常的报道。
7.眼
眼部用药时，常出现烧灼感、刺痛感及其它眼部刺激症状。据报道，使用氟比洛芬(全身作用)治疗的患者，视力改变的发生率为1%-3%。本药在手术前运用还可能导致结膜下出血。
8.呼吸系统
据报道，接受氟比洛芬(全身作用)治疗的患者，有1%-3%出现鼻炎。还有部分患者长期用药出现肺部不良反应。
9.皮肤
在临床试验期间，有1%-3%的患者出现皮疹。还有引起脉管炎的报道。
10.其它
本药可引起过敏反应。1%-3%的患者用药后可出现耳鸣。
注意事项

1.交叉过敏 本药与乙酰水杨酸类药及其它NSAID可能存在交叉过敏。
2.禁忌症
(1)对本药及其它NSAID过敏者。
(2)活动性消化性溃疡患者。
(3)活动性单纯疱疹性角膜炎患者禁用本药滴眼液。
(4)过敏性体质者。
(5)儿童。
3.慎用
(1)支气管痉挛患者、服用其它NSAID曾发生支气管痉挛者及有支气管哮喘病史者。
(2)肾功能不全者。
(3)高血压、血友病、心功能不全及心脏疾病恶化(因体液潴留和水肿导致)患者(国外资料)。
(4)肝功能不全者。
(5)有凝血功能障碍史者(国外资料)、出血时间延长患者。
(6)用药前存在感染者(国外资料)。
(7)胃肠道溃疡患者。
(8)眼病患者(可引起视力变化)。
(9)有单纯疱疹病毒性角膜炎病史者慎用本药滴眼液。
4.药物对老人的影响 虽然老年人对氟比洛芬能很好耐受，但在部分患者(尤其是肾功能不全者)当中，氟比洛芬排泄较慢。在这种情况下用药应谨慎，剂量应个体化。
5.药物对妊娠的影响 尚未发现氟比洛芬有致畸作用。在妊娠晚期频繁使用NSAID可导致妊娠期延长、产期延长、子宫内脐带动脉关闭不全和新生儿肺高压。不推荐孕妇使用本药。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为B级。
6.药物对哺乳的影响 不推荐哺乳期妇女使用本药。
7.用药前后及用药时应当检查或监测
(1)治疗初期，应经常监测血压。
(2)有发生肾衰竭危险的患者，建议治疗最初几周监测血清肌酸酐。
(3)眼病患者应进行眼科检查。
(4)类风湿性关节炎患者(常可观察到贫血)长期用药时应定期检查血象及肝、肾功能。
规格

氟比洛芬片 (1)50mg。(2)100mg。

包装规格: 50毫克、100毫克、200毫克

生产厂家:雅培公司（Abbott Laboratories）

Froben (flurbiprofen)
Main use：Pain and inflammation
Active ingredient：Flurbiprofen
Manufacturer：Abbott Laboratories
 
How does it work?
Froben tablets contain the active ingredient flurbiprofen, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). Flurbiprofen is also available without a brand name, ie as the generic medicine.

NSAIDs are used to relieve pain and inflammation.

Flurbiprofen works by blocking the action of a substance in the body called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins.

Prostaglandins are produced by the body in response to injury and certain diseases and conditions, and cause pain, swelling and inflammation. Flurbiprofen blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.

Flurbiprofen is used to relieve pain and inflammation in a wide range of musculoskeletal conditions, including various forms of arthritis, sprains and strains, back pain, tendinitis and frozen shoulder. It is also used to relieve mild to moderate pain such as period pain or migraine.

The tablets should preferably be taken with food to help avoid irritating the stomach.

What is it used for?
Froben tablets are used to relieve pain and inflammation in a wide range of conditions in adults, including those listed below.
Rheumatoid arthritis.
Osteoarthritis.
A form of arthritis affecting the joints of the spine (ankylosing spondylitis).
Acute disorders of the muscles and skeleton, such as frozen shoulder (periarthritis), tendon inflammation (tendinitis), tenosynovitis, bursitis.
Painful conditions due to accidents, such as sprains and strains.
Lower back pain.
Toothache.
Period pain.
Migraine.
Pain following surgery.

Warning!
Froben tablets should be taken with or after food.
This medicine may mask the signs and symptoms of infection, such as fever and inflammation. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.
Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimise the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.
NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see below). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people taking this medicine should stop treatment and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine during treatment, for example vomiting blood and/or passing black/tarry/bloodstained stools.
Non-steroidal anti-inflammatory drugs such as this one may be associated with a small increase in the risk of experiencing a heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. If you have heart problems, have ever had a stroke, or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
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. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.
If you have cirrhosis of the liver, heart failure or kidney disease, you are on a low sodium diet, or you are taking diuretic medicines, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.
During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.

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.
Kidney disease.
Liver disease.
Heart failure.
High blood pressure (hypertension).
Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack.
Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA).
Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
Diabetes.
Smokers.
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
People in whom aspirin or other NSAIDs, eg diclofenac, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
Active peptic ulcer or bleeding in the gut, or a history of this.
Severe heart failure.
Liver failure.
Kidney failure.
Third trimester of pregnancy.
This medicine is not recommended for children under 12 years old.
Froben tablets contain lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to 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.

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 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.
This medicine may pass into breast milk, but in such small quantities that it is unlikely to harm the nursing infant. However, it should be used with caution during breastfeeding. As with all medicines, seek medical advice from your doctor before taking this medicine if you are breastfeeding.

Label warnings
Take this medication with or after food.

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, it does not mean that all people using this medicine will experience that or any side effect.
Disturbances of the gut such as indigestion, diarrhoea, constipation, nausea, vomiting or abdominal pain.
Ulceration or bleeding in the stomach or intestines.
Sensation of spinning (vertigo).
Sensation of ringing, or other noise in the ears (tinnitus).
Retention of water in the body tissues, resulting in swelling (oedema).
Increase in blood pressure.
Visual disturbances.
Dizziness.
Headache.
Fatigue.
Depression.
Hallucinations.
Skin reactions such as rash or itching.
Inflammation of the pancreas (pancreatitis).
Hypersensitivity reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), severe skin reactions or anaphylactic shock.
Kidney, liver or blood disorders.

The side effects listed above may not include all of the side effects reported by the medicine'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 make sure that the combination is safe.

Flurbiprofen should not be used in combination with painkilling doses of aspirin or any other NSAID taken by mouth, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of cyclo-oxgenase 2 such as celecoxib or etoricoxib should also be avoided for the same reason.

There may be an increased risk of ulceration or bleeding from the gut if flurbiprofen is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding from the gut if flurbiprofen is taken with the following medicines:
anti-blood-clotting (anticoagulant) medicines, such as warfarin or heparin
anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
dabigatran
erlotinib
selective serotonin re-uptake inhibitors (SSRIs) antidepressants, eg fluoxetine, paroxetine, citalopram
venlafaxine.

Flurbiprofen may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking flurbiprofen with an anticoagulant medicine should be closely monitored by their doctor.

There may be an increased risk of side effects on the kidneys if flurbiprofen is used with any of the following medicines:
ACE inhibitors, eg enalapril
angiotensin II receptor antagonists, eg losartan
ciclosporin
diuretics, eg furosemide
tacrolimus.

Flurbiprofen may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, including the following:
ACE inhibitors such as captopril
angiotensin II receptor antagonists, eg losartan
beta-blockers such as propranolol
diuretics such as furosemide.

Flurbiprofen 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. People using flurbiprofen with any of these should be closely monitored by their doctor:
digoxin
lithium
methotrexate.

If this medicine is used in combination with quinolone antibiotics, such as ciprofloxacin or norfloxacin there may be an increased risk of seizures (fits). This may occur in people with or without a previous history of epilepsy or convulsions.

Other medicines containing the same active ingredient
Froben SR
Ocufen eye drops
Strefen lozenges

Flurbiprofen tablets are also available without a brand name, ie as the generic medicine.