英文药名: Anaprox(Naproxen Sodium Tablets)

中文药名: 萘普生钠片

品牌药生产厂家: Roche Pharmaceuticals

药物名称和成分

英文药名: Anaprox DS (Naproxen Sodium Double Strength Tablets)
中文药名: 萘普生钠双强度片
成份: 萘普生钠
性状: 本品白色或类白色片。
适应症

本品为非甾体抗炎药。适用于缓解各种轻度至中等度的疼痛，如拔牙及其他手术后的疼痛、原发性痛经及头痛等。也适用于类风湿关节炎、骨关节炎、强直性脊柱炎、幼年型关节炎(Juvenile arthritis)、肌腱炎、滑囊炎及急性痛风性关节炎，对于关节炎的疼痛、肿胀及活动受限均有缓解症状的作用。与阿司匹林和吲哚美辛比较，症状缓解的效应相仿，但胃肠道和神经系统的不良反应的发生率和严重程度均较低。
规格

0.550g(相当于萘普生550mg)
用法用量

口服
成人常用量
1．抗风湿，一次0.25g～0.5g，每天早晚各1次，或早晨服0.25g，晚上服0.5g。
2．止痛，首次0.5g以后一次0.25g，必要时每6～8小时1次。
3．痛风性关节炎急性发作，首次0.7g，以后一次0.25g，每8小时1次，直到急性发作停止。
4．痛经，首次0.5g，以后必要时0.25g，每6～8小时1次，直到急性发作停止。
任何疑问，请遵医嘱！
不良反应

1．皮肤瘙痒、呼吸短促、呼吸困难、哮喘、耳鸣、下肢水肿、胃烧灼感、消化不良、胃痛或不适、便秘、头晕、嗜睡、头痛、恶心及呕吐等，发生率一般为3%～9%。
2．视力模糊或视觉障碍、听力减退、腹泻、口腔刺激或痛感、心慌及多汗等，发生率1%～3%。
3．胃肠出血、肾脏损害(过敏性肾炎、痛病、肾乳头坏死及肾功能衰竭等)、荨麻疹、过敏性皮疹、精神抑郁、肌肉无力、出血或粒细胞减少及肝功损害等较少见，发生率1%～3%。
禁忌

对阿司林过敏者禁止使用，对伴有消化道溃疡或消化道溃疡史者慎用。
注意事项

1．交叉过敏。对阿司匹林或其他非甾体抗炎药过敏者，对本品也过敏。
2．本品对胎儿的影响研究尚不充分，由于其他非甾体抗炎药可使胎儿动脉导管早闭，又因可抑制前列腺素合成导致难产或产程延长，故除非另有原因，否则孕妇不宜应用。
3．本品分泌入乳汁中的浓度相当于血药浓度的1%，哺乳期妇女不宜应用。
4．对诊断的干扰：可影响尿5-羟吲哚醋酸(5-HIAA)及17-酮的测定值。
5．下列情况应慎用：有凝血机制或血小板功能障碍时，哮喘、心功能不全或高血压、肝和肾功能不全，活动性胃肠出血或活动性消化道溃疡及老年人。
6．长期用药应定期进行肝、肾功能、血象及眼科检查。
7．丙磺舒与本品合用时可增强本品的血浆水平并延长本品血浆半衰期。
孕妇及哺乳期妇女用药

禁用。
儿童用药

小儿常用量 抗风湿，每日按体重10mg/kg，分2次服。
药物相互作用

1．饮酒或与其他抗炎药同用时，胃肠道的不良反应增多，并有溃疡发生的危险。
2．与肝素及双香豆素等抗凝药同用，出血时间延长，可出现出血倾向，并有导致消化性溃疡的可能。
3．与阿司匹林或其他水杨酸制剂同用时，对症状缓解并无增效，反而增加胃肠道不良反应。
4．本品可降代呋塞米的排钠和降压作用。
5．本品可抑制锂随尿排泄，使锂的血药浓度升高。
6．与丙磺舒同用时，本品的血药浓度升高，t1/2延长，可增加疗效，但毒性反应也相应加大，故无实用价值也不宜推荐于临床。
药理毒理

萘普生具有剂量依赖性的抗炎镇痛和解热作用。抗炎作用强度约为等剂量保泰松的11倍，镇痛、解热作用是阿司匹林的7倍和22倍。抗炎、镇痛、解热作用相当于吲哚美辛。
作用机制为萘普生通过抑制COX活性，从而抑制PG合成而产生作用，但对COX2的选择性抑制作用更强，故其抗炎作用强，而胃肠道不良反应较小。
药代动力学

萘普生游离酸和钠盐的应用等效剂量为1：1.1。口服后均易自胃肠道吸收，且完全，但其钠盐吸收速度更快，服药1小时后达血药峰浓度，游离酸则需2小时。胃内容物可延长其吸收时间，但不影响其吸收率。血浆蛋白的结合率高(>99.5%)。可分布于全身组织，滑膜液中达有效浓度，并可透过胎盘，进入胎儿体内。经肝脏代谢，肾脏排泄，排泄物中大部分为代谢产物，少量原形。约有3%自粪便排出，1%乳汁分泌。血浆t1/2为13小时。本品亦可直肠给药，但吸收速度比口服慢。
贮藏

遮光，密封，在凉处保存。

包装规格：275mg *100 片

Anaprox
Generic Name: naproxen (na PROX en)
Brand Names: Aleve, Aleve Caplet, Aleve Easy Open Arthritis, Aleve Gelcap, Anaprox, Anaprox-DS, Comfort Pac with Naproxen, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan 375, Naprelan 500, Naprelan 750, Naprosyn

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

Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

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

What is the most important information I should know about Anaprox (naproxen)?
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 naproxen. 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 naproxen. 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 naproxen (such as ibuprofen or ketoprofen). 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, or ketoprofen. Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result.
What should I discuss with my healthcare provider before taking Anaprox (naproxen)?
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 naproxen, 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 use naproxen:

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. Before using naproxen, tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take naproxen during pregnancy unless your doctor has told you to. Naproxen 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 younger than 2 years old without the advice of a doctor.
How should I take Anaprox (naproxen)?
Take this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended.

EC-Naprosyn is a slower-acting form of naproxen and this brand should be used only for treating arthritis or ankylosing spondylitis. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release or enteric-coated tablet. Swallow the pill whole. The extended-release pill 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. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you take naproxen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store naproxen at room temperature away from moisture and heat.
What happens if I miss a dose?
Since naproxen is sometimes taken only when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. Overdose symptoms may include nausea, vomiting, stomach pain, confusion, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.
What should I avoid while taking Anaprox (naproxen)?
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 naproxen (such as ibuprofen or ketoprofen). 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, or ketoprofen. Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.
Anaprox (naproxen) 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 naproxen 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

fever, headache, 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.