【药品名称】
通用名：双氯芬酸钠片剂
英文名：Diclofanac Sodium Tablets
其化学名称为：[邻-(2,6-二氯苯胺)苯乙酸钠。
分子式：C14H10Cl2NNaO2 　　
分子量：318.13

【孕妇及哺乳期妇女用药】在妊娠期间，一般不宜使用，尤其是妊娠后3个月。哺乳期妇女不宜服用。 　　

【儿童用药】16岁以下的儿童不宜服用。

【老年患者用药】慎用。

【药物相互作用】双氯芬酸可增加地高辛与含锂制剂的血浆浓度，减少肾对氨甲喋呤的排泄。因此，与这些药合用时应特别谨慎。

【贮藏】遮光，密闭，在干燥处保存。

【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。 　　
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。 　　
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。 　　
急性毒性试验结果：大鼠经口LD50 为150mg/kg；小鼠经口390mg/kg。 　　

【药代动力学】本品口服吸收快，血浆蛋白结合率为99.5%，大约50%在肝脏代谢，40%～65%从肾脏排出，35%从胆汁、粪便排出。

【适应症】
1．急慢性风湿性、急慢性关节炎、急慢性强直性脊椎炎、骨关节炎。 　　
2．肩周炎、滑囊炎、肌腱炎及腱鞘炎。 　　
3．腰背痛、扭伤、劳损及其他软组织损伤。 　　
4．急性痛风。 　　
5．痛经或附件炎、牙痛和术后疼痛。 　　
6．创伤后的疼痛与炎症，如扭伤、肌肉拉伤等； 　　
7．耳鼻喉严重的感染性疼痛和炎症（如扁桃体炎、耳炎、鼻窦炎等），应同时使用抗感染药物。 　　

【用法用量】
成人：作为常规，最初每日剂量为100-150mg(4片至6片)。对轻度病人或需长期治疗的病人，每日剂量为75-1OOmg(3片至4片)。通常将每日剂量分2—3次服用。
对原发性痛经，通常每日剂量为50-150mg(2片至6片)，分次服用。最初剂量应是50-1OOmg(2片至4片)，必要时，可在若干个月经周期之内提高剂量达到最大剂量200mg(8片)每日。症状一旦出现应立即开始治疗，并持续数日，治疗方案依症状而定。 　　
药片应完整吞服，以液体送下。宜于饭前服用。 　　
儿童：对1岁或1岁以上的儿童，根据病情，每曰服剂量为0.5-2mg／kg体重，分2-3次服。 　　
对青少年型类风湿关节炎，每日剂量最高可达3mg／kg体重，分次服。 　　
本品不得用于12月以下的婴儿。 　　

【不良反应】
1．可引起头痛及腹痛、便秘、腹泻、胃烧灼感、恶心、消化不良等胃肠道反应。 　　
2．偶见头痛、头晕、眩晕。血清谷氨酸草酰乙酸转氨酶（GOT），血清谷氨酸丙酮酸转氨酶（SGPT）升高。 　　
3．少见的有肾功能下降，可导致水钠潴留，表现尿量少、面部水肿、体重骤增等。极少数可引起心律不齐、耳鸣等。
4．罕见：皮疹、胃肠道出血、消化性溃疡、呕血、黑便、胃肠道溃疡、穿孔、出血性腹泻、困睡、过敏反应如哮喘、肝炎、水肿。 　　
5．有导致骨髓抑制或使之加重的可能。 　　
6. 长期服用会导致胃部不适，转氨酶升高

【禁忌】
1．对本品及阿司匹林或其他非甾体抗炎药过敏反应、哮喘、荨麻疹或其他变态反应的患者禁用。 　　
2．消化道溃疡禁用。 　　

【注意事项】
1．血液系统异常、高血压、心脏病患者慎用。 　　
2．因含钠，对限制钠盐摄入量的病人应慎用。 　　
3．对那些有胃肠道症状或曾有胃肠溃疡病史，严重肝功能损害患者，如需应用双氯芬酸，应置于严密的医疗监护之下。 4．心、肾功能损害者正在应用利尿剂治疗、进行大手术后恢复期患者以及由于任何原因细胞外液丢失的患者慎用，应慎用双氯芬酸。 　　
5．用药过程中，如出现明显不良反应，应停药。 　　
6．服用需整片吞服，不能弄碎。 　　
7．个别需要长期治疗的患者，应定期检查肝功能和血象，发生肝功损害时应停用。 　　
8．有眩晕史或其他中枢神经疾病史的患者在服用期间，应禁止驾车或操纵机器。 　　
9．应注意与锂制剂、地高辛制剂、保钾利尿剂、抗凝血剂、降糖药和氨甲喋呤等配合使用的剂量及不良反应。 　　
10．体重较低的患者应降低用量。

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

原产地英文药品名:
DICLOFENAC SODIUM
中文参考商品译名:
服他宁缓释肠溶片 75毫克/片 100片/瓶
中文参考药品译名:
双氯芬酸钠
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS