英文药名: Naprosyn(Naproxen Suspension)

中文药名: 萘普生口服液

生产厂家: Roche Pharmaceuticals

药品名称

中文通用名称: 萘普生
英文通用名称: Naproxen
其 它 名 称: 消痛灵, 消炎宁, 甲氧萘丙酸, Naprosyn, Naxen, Equiproxen, Bayley, 帕诺丁, 劳斯叮, Neproxen, 适洛特, 金康普力, 步生, Methoxypropiocin, 萘普生缓释片, 萘普生胶囊, 萘普生片, 萘普生栓, 萘普生注射液, 萘普生颗粒, Ipdas, Naprelan, Napren-E, Naprooxen, Nycopren, 芬斯呵, 希普生, 澳普利, Naproxen Suppositoris, Naproxen Dispersible Tablets, Naproxen Injection, Naproxen Suppositories, Naproxen Sustained Release Tablets, Napton,Napton SR, 那普洛, 萘普生肠溶微丸胶囊, 萘普生分散片, 萘普生缓释胶囊, Naproxen Capsules, Naproxen Granules, Naproxen Powder, Naproxen SR Tablets, Naproxen Sustained Release Capsules, Naproxen Tablets, 芬斯叮, 惠可, 萘普生散, Naproxen Enteric-coated Pellets Capsules
产 品 分 类: 西药\镇痛药\解热镇痛抗炎药\丙酸类
规格

萘普生片 125mg, 250mg, 375mg, 500mg。萘普生肠溶片 250mg, 375mg, 500mg。萘普生缓释片 750mg。
适应症

1.用于治疗风湿性关节炎和类风湿关节炎、骨性关节炎、强直性脊柱炎、幼年型关节炎(Juvenilearthritis)、肌腱炎、腱滑膜炎、滑囊炎及急性痛风性关节炎。对关节炎的疼痛、肿胀及活动受限均有缓解作用。
2.用于缓解各种轻、中度疼痛，如手术后疼痛、牙痛、神经痛、原发性痛经及头痛等。
3.也用于关节及肌肉扭伤、挫伤和纤维组织炎的消炎及镇痛。
4.栓剂还可用于宫腔手术和检查时的镇痛，如早期妊娠的人工流产手术、诊断性刮宫术、清宫术、节育环安取术及子宫内镜检查手术。
用法用量

成人
•常规剂量
•口服给药
1.普通口服制剂：
(1)抗风湿：一次0.25-0.5g，早晚各1次；或早晨服0.25g，晚上服0.5g。
(2)镇痛：首剂0.5g，以后必要时一次0.25g，每6-8小时1次。
(3)痛风性关节炎急性发作：首剂0.75g，以后一次0.25g，每8小时1次，直到急性发作停止。
(4)痛经：首剂0.5g，以后必要时一次0.25g，每6-8小时1次。
2.缓释口服制剂：一次0.5g，一日1次。
•直肠给药
1.用于关节炎及镇痛等：一次0.125-0.25g，一日0.5g。
2.用于宫腔手术和检查：0.4g(1枚)置入肛门内，15分钟后即可手术。
•肌内注射一次0.1-0.2g，一日1次。
•肾功能不全时剂量
应减少剂量。
•肝功能不全时剂量
肝硬化患者服用本药时剂量应减半。
•老年人剂量
用量应酌减。
儿童
•常规剂量
•口服给药抗风湿：一日0.01g/kg，分2次服。
任何疑问，请遵医嘱！
给药说明

1.肾功能不全患者用药期间应监测血清肌酸酐和(或)肌酐清除率；某些患者特别是肾血流受损者(如细胞外脱水、钠盐限制、充血性心力衰竭、肝功能不全及先天性肾病)，治疗前及治疗期间应监测肾功能。在进行肾功能测试前，应暂停使用本药40小时
2.嗜酒引起的慢性肝病及其它肝硬化患者使用本药高剂量时应谨慎。因血浆中的药物总浓度会下降，但血浆中未结合(游离)药物的浓度会升高。
3.胃肠道疾病患者应在严密医疗监护下服用本药。
4.本药缓释制剂应整片(粒)吞服，不得咀嚼。
5.本药与皮质激素合用较安全，但两者合用的疗效并不比单用皮质激素好。
6.由于本药血浆蛋白结合率较高，对同时服用乙内酰脲类(Hydantoins)药物的患者须密切监测，必要时调整用药剂量。
7.抗风湿治疗长期给药时，须根据患者对药物的反应来调整剂量，通常应用最低有效量。
8.使用本药栓剂以镇痛不得超过5日。
9.用药期间，如患者出现胃肠出血、肝肾功能异常、过敏反应、水潴留、血液异常、视物模糊、听力下降以及精神异常等情况时，应立即停药，并作相应处理；其它不良反应持续存在时也应注意。
10.用药过量中毒时应予以紧急处理，包括催吐或洗胃、口服活性炭及抗酸药、给予对症及支持治疗及合理使用利尿药。
不良反应

1.发生率为3%-9%的不良反应有：皮肤瘙痒、呼吸短促、呼吸困难、哮喘、耳鸣、下肢水肿、消化不良、恶心及呕吐、胃烧灼感、胃痛或其它胃部不适、便秘、头晕、头痛及嗜睡等。
2.发生率为1%-3%的不良反应有：视物模糊或视觉障碍、听力减退、腹泻、口腔刺激或痛感、心悸及多汗、胃肠道出血、肾脏损害(过敏性肾炎、肾乳头坏死及肾衰竭等)、荨麻疹、血管性水肿、过敏性皮疹、抑郁、肌无力、出血、粒细胞减少及肝功能损害等。
3.长期服用本药口服制剂，患者耐受良好。
注意事项

1.交叉过敏对阿司匹林或其它非甾体类抗炎药过敏者，对本药也过敏。
2.禁忌症
(1)对本药或同类药过敏者。
(2)曾因使用阿司匹林或其它非甾体类抗炎药引起哮喘、鼻炎及鼻息肉综合征者的患者。
(3)消化性溃疡活动期或有溃疡合并出血和穿孔史者。
(4)哺乳妇女。
(5)2岁以下儿童。
3.慎用
(1)有凝血机制或血小板功能障碍者。
(2)哮喘患者。
(3)心功能不全或高血压患者。
(4)肝功能不全者。
(5)肾功能不全者(肌酐清除率低于20ml/min的患者不应长期服用本药)。
(6)有消化性溃疡史者。
(7)胃肠道疾病患者。
4.药物对儿童的影响2岁以下儿童使用本药的安全性及疗效尚未确立，2岁以下儿童禁用。
5.药物对老人的影响本药在老人体内血浆半衰期长，老年人应慎用。
6.药物对妊娠的影响本药能延缓动物的分娩时间，同时也能影响胎仔的心血管系统(动脉导管的闭合)。对胎儿的影响尚无充分研究。妊娠期(尤其是妊娠早期和晚期)，使用本药应权衡利弊。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(妊娠早、中期)和D级(妊娠晚期)。
7.药物对哺乳的影响本药在乳汁中的浓度相当于血药浓度的1%。哺乳妇女禁用。
8.药物对检验值或诊断的影响本药可影响尿5-羟吲哚醋酸(5-HIAA)及尿17-酮的测定值。
9.用药前后及用药时应当检查或监测长期用药应定期进行肝功能、肾功能、血常规及眼科检查。

规格： 125mg/5ml  1 x 500ml

Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Monograph title
NAPROXEN SUSPENSION - ORAL

Phonetic pronunciation
(nah-PROX-en)

Common brand name(s)
Naprosyn

Warning
Nonsteroidal anti-inflammatory drugs (including naproxen) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG).This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning at any time while taking this drug. Older adults may be at higher risk for this effect.Stop taking naproxen and get medical help right away if you notice any of these rare but serious side effects: black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, slurred speech, sudden vision changes.Talk to your doctor or pharmacist about the benefits and risks of taking this drug.

Uses
Naproxen is used to relieve pain from various conditions such as headaches, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation.If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

How to use
Read the Medication Guide provided by your pharmacist before you start using naproxen and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Take this medication by mouth as directed by your doctor, usually 2 times a day. To prevent stomach upset, take this medication with food, milk, or an antacid.The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor.For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit.If you are taking this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.Tell your doctor if your condition does not improve or if it worsens.

Missed dose
If you are taking this drug on a regular schedule (not just "as needed") and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Precautions
Before taking naproxen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, severe loss of body water (dehydration), stroke, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers).This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This medication contains salt (sodium). Tell your doctor if you are on a salt-restricted diet.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding.Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor before using this medication.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Side effects
See also Warning section.Upset stomach, nausea, heartburn, headache, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, hearing changes (such as ringing in the ears), mental/mood changes, swelling of the ankles/feet/hands, sudden/unexplained weight gain, change in the amount of urine, unexplained stiff neck, vision changes.This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Products that may interact with this drug include: cidofovir.This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Some affected drugs include anti-platelet drugs such as clopidogrel, "blood thinners" such as enoxaparin/warfarin, bisphosphonates such as alendronate, corticosteroids such as prednisone, SSRI antidepressants such as fluoxetine/sertraline, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to naproxen and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This medication can affect the results of certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, extreme drowsiness, seizures.

Notes
Do not share this medication with others.Laboratory and/or medical tests (such as blood pressure, complete blood count, liver/kidney function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.If you have arthritis, lifestyle changes (such as weight loss if needed, strengthening/conditioning exercises) may help improve your flexibility and joint function. Consult your doctor for specific instructions.

Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.