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 详细处方信息以本药内容附件PDF文件（20105918473811.pdf）的“原文Priscribing Information”为准
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部分中文Cataflam处方资料（仅供参考）

药品名称
中文通用名称: 双氯芬酸钾
英文通用名称: Cataflam(Diclofenac Potassium)
其它名称: 双氯灭酸钾,凯扶兰,Potassium Diclofenac,久宁,Kaflan,Cataflam,Diclofenac K,依柯,迪普,毕斯福,芬佳泰,双氯芬酸钾片,双氯芬酸钾栓,双氯芬酸钾胶囊,双氯芬酸钾凝胶,Diclofenac Potassium Capsules,Diclofenac Potassium Dispersible Tablets,Diclofenac Potassium Gel,Diclofenac potassium Granules,Diclofenac Potassium Suppositories,Diclofenac Potassium Tablets,春康欣,格得,洛普佳,普他宁,双氯芬酸钾分散片,双氯芬酸钾颗粒,双氯芬酸钾喷雾剂,昔舒,至清,Diclofenac Potassium Spray,Diclofenac Pottassium,得富卡,菲亚宁,扶他捷,吉松,天君利,欣普芬,依林,宜克林 产 品 分 类: 西药\镇痛药\解热镇痛抗炎药\灭酸类

适应症
1.用于缓解风湿性关节炎、类风湿关节炎、骨性关节炎、强直性脊柱炎、痛风性关节炎等多种慢性关节炎的急性发作期或持续性的关节肿痛症状。
2.用于非关节性的各种疼痛。

给药说明
1.本药口服制剂须整片(粒)吞服。
2.肠溶片口服起效迅速但排出亦快，待急性疼痛控制后宜用缓释剂型，减少服药次数，维持稳定血药浓度。
3.体重较低的患者使用本药含片剂量应相应减少。
4.外用制剂仅可用于完整皮肤，不可用于皮肤破损部位，勿与眼睛及粘膜接触，切勿入口。
5.由于本药局部应用也可吸收，故应严格按照规定剂量使用，避免长期大面积使用。
6.本药滴眼液仅限于滴眼用，戴角膜接触镜者禁用，但角膜屈光术后暂时配戴治疗性亲水软镜者除外。滴眼液可影响血小板凝聚，有增加眼组织术中或术后出血的倾向。
7.直肠给药时先将栓剂用少量温水润湿，然后轻轻塞入直肠内2cm处。
8.使用本药期间出现眩晕或其它中枢神经系统不良反应时，应避免驾驶车辆或操作机械。
9.用药期间如出现严重的不良反应，应停药并给予对症治疗。
10.药物过量时应采用下列治疗措施：
(1)紧急处理：包括催吐或洗胃、口服活性炭、使用抗酸药和(或)利尿药。输液以保持全身良好血液循环并促进药物代谢和排出。
(2)监测肝肾及其它生命脏器功能。
(3)对并发症，如血压过低、肾衰竭、惊厥、胃肠刺激、呼吸抑制，应进行支持和对症治疗。

用法用量
成人
*常规剂量
*口服给药
1.用于关节炎、疼痛等：
(1)缓释片、缓释胶囊：一次100mg，一日1次。
(2)肠溶微粒胶囊：一次50mg，一日2次。
(3)肠溶片：用于关节炎，一日75-150mg，分3次服用，疗效满意后可逐渐减量。用于急性疼痛，首次50mg，以后一次25-50mg，每6-8小时1次。用于原发性痛经，一日50-150mg，分次服用，必要时可在若干月经周期之内增量至一日200mg(最大剂量)，在出现症状时开始治疗，并持续数日，剂量及疗程视症状而定。
2.用于口、咽部小手术及口腔溃疡引起的疼痛：使用含片，一次2mg，两次至少间隔2小时，一日不超过10mg。
*肌内注射深部注射，一次50mg，一日1次，必要时数小时后再注射1次。
*外用
1.搽剂：根据疼痛部位大小，一次1-3ml均匀涂于患处，一日2-4次，一日总量不超过15ml。
2.乳膏：根据疼痛部位大小，一次2-4g涂于患处，并轻轻按摩，一日3-4次，一日总量不超过30g。
3.凝胶：根据疼痛部位大小，一次2-4g涂于患处，并轻轻按摩，一日3-4次，一日总量不超过15g。
*直肠给药一次50mg，一日50-100mg。
*经眼给药
1.一般情况：一次1滴，一日4-6次。
2.眼科手术用药：一次1滴，术前3小时、2小时、1小时和0.5小时各1次。
3.白内障术后：术后24小时开始用药，一次1滴，一日4次，持续使用2周。
4.角膜屈光术后：术后15分钟即可用药，一次1滴，一日4次，持续使用3日。
*局部给药使用喷雾剂，一次3-4揿(每揿0.5mg)，每2-3小时1次。
儿童
*常规剂量
*口服给药肠溶片：一日0.5-2mg/kg，分3次服用，一日最大量为3mg/kg。
任何疑问,请遵医嘱!

注意事项
1.交叉过敏对阿司匹林或其它非甾体类抗炎药(NSAID)过敏者对本药可有交叉过敏反应。对阿司匹林过敏的哮喘患者，使用本药也可引起支气管痉挛。
2.禁忌症
(1)对本药、阿司匹林或其它NSAID过敏，或应用NSAID后出现急性鼻炎、哮喘、荨麻疹或其它变态反应的患者。
(2)消化性溃疡活动期患者或以往应用本药引起过严重消化道病变(如溃疡、出血、穿孔)者。
(3)高过敏体质者。
(4)对丙二醇过敏者禁用本药搽剂、凝胶剂。
(5)对异丙醇过敏者禁用本药凝胶剂。
(6)肛门炎患者禁用本药栓剂。
(7)孕妇。
(8)哺乳期妇女。
3.慎用
(1)消化性溃疡患者、有消化性溃疡病史者、溃疡性结肠炎或克隆病患者。
(2)血液系统异常患者。
(3)高血压、心脏病患者。
(4)须限制钠盐摄入量的患者(因本药含钠)。
(5)大手术后恢复期患者。
(6)任何原因造成细胞外液丢失的患者。
(7)荨麻疹患者。
(8)有哮喘史的患者。
(9)肝、肾功能不全者(严重肝功能不全者应在严密的医疗监护下应用)。
4.药物对儿童的影响
(1)1岁以下的儿童不宜使用本药口服制剂。
(2)儿童使用本药滴眼液的安全性和疗效尚未确立。
(3)本药含片尚无儿童用药经验。
5.药物对老人的影响本药可能诱导或加重老年人胃肠道出血、溃疡和穿孔。老年患者使用本药含片不良反应发生率较高。老年人应慎用。
6.药物对妊娠的影响本药可通过胎盘。动物试验表明本药对胎鼠有毒性，但不致畸。国内资料认为孕妇应禁用。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为C级。
7.药物对哺乳的影响有研究认为，每隔8小时口服50mg，本药活性物质进入乳汁的量极少，不会对婴儿产生

不良影响。
8.用药前后及用药时应当检查或监测用药期间应定期检查肝、肾功能，尤其是对肝肾功能有损害或潜在性损害者、老年人、慢性饮酒者、正在服用利尿药的患者、任何原因造成细胞外液丢失的患者及长期使用本药的患者。长期使用者，还应定期检查血常规。

不良反应
1.消化系统
(1)胃肠道反应为本药的主要不良反应。表现为胃肠道刺激症状，如恶心、呕吐、腹泻、上腹痛、便秘、胃不适、胃烧灼感、消化不良、纳差、反酸等，上述症状在停药后均可消失。少数患者可出现胃溃疡、十二指肠溃疡、胃粘膜出血、穿孔等。
(2)少见肝功能损害，可由此引起畏食、右上腹痛，亦可能仅出现肝酶一过性轻度或中度升高，个别患者出现可逆性黄疸。也有发生急性肝炎的报道。罕见肝功能紊乱。
(3)使用喷雾剂，少数患者口腔溃疡局部有一过性刺激痛。
2.中枢神经系统偶见头痛、眩晕、嗜睡、失眠、兴奋等。偶可出现视力、听力障碍。
3.泌尿生殖系统偶有肾功能下降，可导致水钠潴留，表现为尿量减少、面部水肿、体重骤增等。个别病例可出现急性肾功能不全、血尿、肾病综合征。另可见血清尿酸含量下降、尿中尿酸含量升高(因肾清除功能增强)。
4.血液十分罕见粒细胞减少、血小板减少、溶血性贫血。个别病例可出现白细胞减少。也有导致骨髓抑制或使之加重的可能。
5.皮肤可见一过性过敏性皮疹(约0.4%)。严重的皮肤反应有多形渗出性红斑、中毒性表皮松解(Lyell综合征)，均十分罕见。个别病例可出现脱发。
6.其它
(1)极少数患者可出现心律不齐、耳鸣等。
(2)有发生全身性中毒反应伴脑炎的报道。
(3)滴眼后可出现短暂烧灼、刺痛、流泪等，极少数可有结膜充血、视物模糊。不足3%患者可出现乏力、困倦等全身反应。

Cataflam
Generic Name: diclofenac (dye KLOE fen ak)
Brand Names: Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor

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What is diclofenac?
Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body.

Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis.

Diclofenac powder (Cambia) is used to treat a migraine headache attack. Do not use this medication to treat a cluster headache.

Cambia will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Diclofenac may also be used for other purposes not listed in this medication guide.

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What is the most important information I should know about diclofenac?
This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking diclofenac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac.

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What should I discuss with my healthcare provider before taking diclofenac?
Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to diclofenac, or if you have a history of allergic reaction to aspirin or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to

safely take diclofenac:
a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
a history of stomach ulcers or bleeding;
liver or kidney disease,
asthma;
polyps in your nose;
a bleeding or blood clotting disorder; or
if you smoke.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking diclofenac during the last 3 months of pregnancy may harm the unborn baby. Do not take diclofenac during pregnancy unless your doctor has told you to. Diclofenac can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

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How should I take diclofenac?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you switch brands of diclofenac, your dose needs may change. Follow your doctor's instructions about how much medicine to take.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. Dissolve the diclofenac powder (Cambia) with 1 to 2 ounces of water. Do not use any other type of liquid. Stir this mixture and drink all of it right away. Diclofenac powder works best if you take it on an empty stomach. Call your doctor if your headache does not completely go away after taking Cambia. Do not take a second dose of diclofenac powder without your doctor's advice.

Do not crush, chew, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. If you take diclofenac for a long period of time, your liver function may need to be checked with blood tests on a regular basis. Do not miss any scheduled visits to your doctor.

Store diclofenac at room temperature away from moisture and heat.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, and fainting.

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What should I avoid while taking diclofenac?
Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac. Avoid prolonged exposure to sunlight. Diclofenac may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

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Diclofenac side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking diclofenac and seek medical attention or call your doctor at once if you have any of these serious side effects:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
swelling or rapid weight gain, urinating less than usual or not at all;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
bruising, severe tingling, numbness, pain, muscle weakness; or neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:
upset stomach, mild heartburn or stomach pain, diarrhea, constipation bloating, gas;
dizziness, headache, nervousness;
skin itching or rash;
blurred vision; or
ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect diclofenac?
Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with diclofenac may cause you to bruise or bleed easily.

Tell your doctor about all other medications you use, especially:
a blood thinner such as warfarin (Coumadin);
cyclosporine (Neoral, Sandimmune);
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexall);
diuretics (water pills) such as furosemide (Lasix).
steroids (prednisone and others);
aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; oran ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

This list is not complete and there may be other drugs that can interact with diclofenac. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about diclofenac.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件（20105918473811.pdf）的“原文Priscribing Information”为准
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于2010年5月10日更新