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  药店国别: 美国药房
产地国家: 美国
所属类别: 眼科药物->抗炎滴眼液
处方药:处方药
包装规格: 2.5毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
该药品相关信息网址1:
http://www.drugs.com/voltaren.html
该药品相关信息网址2:
http://www.rxlist.com/voltaren-drug.htm
该药品相关信息网址3:
http://en.wikipedia.org/wiki/Diclofenac
原产地英文商品名:
VOLTAREN 0.1% EYE DROPS 2.5mls/bottle
原产地英文药品名:
DICLOFENAC SODIUM
中文参考商品译名:
服他宁0.1%滴眼液 2.5毫升/瓶
中文参考药品译名:
双氯芬酸钠
中文参考化合物名称:
[邻-(2,6-二氯苯胺)苯乙酸钠
原产地国家批准上市年份:
1991/03/28
英文适应病症1:
Diminish inflammation
英文适应病症2:
Analgesic
临床试验期:
完成
中文适应病症参考翻译1:
消炎
中文适应病症参考翻译2:
镇痛
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(2010102001511632.pdf)的“原文Priscribing Information”为准
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部分中文双氯芬酸钠处方资料(仅供参考)

名称
通用名:双氯芬酸钠滴眼液
英文名: DICLOFENAC SODIUM EYE DROPS
其化学名称为:邻-(2,6二氯苯胺)-苯乙酸钠。
分子式:C14H10Cl2NO2Na   
分子量:318.13   
类别:非甾体类抗炎药。主要用于眼科非感染性炎症的抗炎治疗。

适应症
用于治疗葡萄膜炎、角膜炎、巩膜炎,抑制角膜新生血管的形成,治疗眼内手术后、激光滤帘成形术后或各种眼部损伤的炎症反应,抑制白内障手术中缩瞳反应;用于准分子激光角膜切削术后止痛及消炎;春季结膜炎、季节过敏性结膜炎等过敏性眼病,预防和治疗白内障及人工晶体术后炎症及黄斑囊样水肿,以及青光眼滤过术后促进滤过泡形成等。   

性状:本品为无色或微黄色澄明水溶液。

药理毒理
药理作用:双氯芬酸钠是一种衍生于苯乙酸类的非甾体消炎镇痛药,其作用机理为抑制环氧化酶活性,从而阻断花生四烯酸向前列腺素的转化。同时,它也能促进花生四烯酸与甘油三脂结合,降低细胞内游离的花生四烯酸浓度,而间接抑制白三烯的合成。动物实验证实,前列腺素是引起眼内炎症的介质之一,能导致血-房水屏障崩溃、血管扩张、血管通透性增加、白细胞趋化、非胆碱能机制性瞳孔缩小等。双氯芬酸钠是非甾体消炎药中作用较强的一种,它对前列腺素合成的抑制作用强于阿司匹林和消炎痛等。双氯芬酸钠滴眼液对机械、化学、生物等刺激引起的血-房水屏障崩溃有较强的抑制作用。临床研究显示,0.1%双氯芬酸钠治疗白内障术后炎症,可降低前房的闪辉和细胞数;应用于角膜放射状切开术或激光屈光角膜切削术的病人,能缓解术后疼痛和畏光,优于安慰剂。非临床毒理研究:给大鼠口服双氯芬酸钠达每日2mg/kg,长期观察,没有发现肿瘤发生率增加。一项对小鼠二年的研究中,每日用药2mg/kg,也未见到任何肿瘤易发倾向。各种突变研究没有发现双氯芬酸钠诱发基因突变。给大鼠用药每日4mg/kg,雌雄均未发生不育。
药代动力学: 给人0.1% 双氯芬酸钠50?l滴眼后,10分钟在房水中即可检测到药物,2.4 小时达到高峰值,为82 ng/ml;浓度保持在20 ng/ml以上的持续时间超过4个小时,而维持在3~16ng/ml水平可超过24小时;房水平均药物滞留时间为7.4 小时。如果一次滴眼多滴,房水药物水平将增加,达峰时间可提前至1小时左右。给人两眼同时滴0.1%双氯芬酸钠各二滴后,4个小时内未检测到血浆内药物(最低检测限为10ng/ml),表明药物滴眼后的全身吸收是非常有限的。

用法用量
一日4~6次,一次1滴;眼科手术用药:术前3、2、1和0.5小时各滴眼一次,一 次1滴。白内障术后24小时开始用药,一日4次,持续用药二周;角膜屈光术后15分钟即可用药,一日4次,持续用药三天。   不良反应: 滴眼有短暂烧灼、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、恶心等全身反应。   

禁忌症:对本品过敏者禁用。

注意事项
1.本品仅限于滴眼用。
2.本品可妨碍血小板凝聚,有增加眼组织术中或术后出血的倾向。
3.戴接触镜者禁用本品,但角膜屈光术后暂时配戴治疗性亲水软镜者除外。   

孕妇及哺乳期妇女用药:在动物致畸研究中,给小鼠用药量至人局部用量的5000倍(20mg/kg/day) ,大鼠和兔用至2500倍(10mg/kg/day),均未发现致畸作用,尽管这些量已经达到对母体和胎儿产生毒性。大鼠母体对双氯芬酸钠的毒性表现为难产,妊娠延长,胎儿体重、生长和成活率下降。已经显示,双氯芬酸钠可透过大鼠和小鼠的胎盘屏障。但目前尚无在人体的研究报告,因此孕妇应慎用。   

儿童用药:本品在儿童的安全性和作用尚未考察。   

药物相互作用:尚不明确。   

药物过量:过量使用一般不会引起急症,如不慎口服,可饮水稀释之。   

贮藏:置凉暗处密闭保存。

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

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What is the most important information I should know about Voltaren?
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 Voltaren. 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 Voltaren. 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 Voltaren (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 Voltaren. Alcohol can increase the risk of stomach bleeding caused by Voltaren.

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

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

Voltaren may also be used for purposes other than those listed in this medication guide.

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What should I discuss with my healthcare provider before taking Voltaren?
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 Voltaren, 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 Voltaren:
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. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Voltaren during the last 3 months of pregnancy may harm the unborn baby. Do not take Voltaren 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 Voltaren?
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 Voltaren, your dose needs may change. Follow your doctors 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.

If you take Voltaren 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 Voltaren 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. Symptoms of a Voltaren overdose may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

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What should I avoid while taking Voltaren?
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 Voltaren (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 Voltaren. Alcohol can increase the risk of stomach bleeding caused by Voltaren. Avoid prolonged exposure to sunlight. Voltaren 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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What are the possible side effects of Voltaren?
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 Voltaren 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 Voltaren 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 Voltaren?
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 Voltaren may cause you to bruise or bleed easily.

Before taking Voltaren, 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; or
an 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 Voltaren.

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What does my medication look like?
Diclofenac is available with a prescription under the brand names Cataflam and Voltaren. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Cataflam 50 mg round, biconvex, light-brown tablets
Voltaren 25 mg triangular, biconvex, yellow tablets
Voltaren 50 mg triangular, biconvex, light-brown tablets
Voltaren 75 mg triangular, biconvex, light-pink tablets
Voltaren XR 100 mg round, biconvex, light-pink, coated tablets

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(2010102001511632.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2012-2-23
附件:
2010102001511632.pdf    





 
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