英文药名: Vimovo(Naproxen and Esomeprazole Magnesium Delayed Release Tablets)

中文药名: 萘普生&埃索美拉唑缓释片

生产厂家: AstraZeneca
药品介绍
美国食品药品监督管理局（FDA）已批准一种同时含有延释肠溶型萘普生（naproxen）和速释型埃索美拉唑镁（esomeprazole magnesium）的混合剂量片剂（商品名为Vimovo，生产商为阿斯利康和Pozen公司）用于缓解骨关节炎（osteoarthritis）、类风湿性关节炎（rheumatoid arthritis）和强直性脊椎炎（ankylosing spondylitis）的体征和症状，同时在易感患者中可降低因NSAID引起的胃溃疡风险。
FDA此次的批准是基于来自PN400-301和PN400-302两项为期6个月的关键性研究的数据，这些数据显示，与每天给予2次500mg肠溶型萘普生相比，每天2次使用萘普生/埃索美拉唑延释片可降低内镜检查下的胃溃疡的发生率（分别为4.1%比23.1%，和7.1%比24.3%；两项研究的P值均小于0.001）。已报告的与使用萘普生/埃索美拉唑相关的最常见不良事件（>5%）包括糜烂性胃炎、消化不良、胃炎、腹泻、胃溃疡、上腹痛和恶心。
萘普生/埃索美拉唑不应用于治疗冠状动脉旁路移植血管（CABG）手术时的围手术期疼痛。同时禁用于已知对其中一种组分或被其它基团替代的苯并咪唑类药物过敏的患者；对阿司匹林或其它NSAID有哮喘、荨麻疹或其它类似过敏反应史的患者；严重肝功能不全患者；妊娠末期的妇女。建议谨慎用于治疗伴有体液潴留、心衰、高血压、肾或肝功能不全、心血管疾病的患者及老年患者。萘普生/埃索美拉唑延释片目前正在接受欧洲药品管理局（European Medicines Association）的审核。

Vimovo(Naproxen and Esomeprazole Magnesium Delayed Release Tablets)
VIMOVO Rx
Arthritis/rheumatic disorders  Only 4 drugs may be compared at once
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Generic Name and Formulations:
Naproxen, esomeprazole (as magnesium trihydrate); 375mg/20mg, 500mg/20mg; del-rel tabs.
Company:
Horizon Pharma
Select therapeutic use: Arthritis/rheumatic disorders
Indications for VIMOVO:
Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis (JIA): to relieve signs/symptoms and reduce risk of developing naproxen-associated gastric ulcers.
Limitations Of use:
Not interchangeable with its individual components. Not for initial treatment of acute pain.
Adult:
Use lowest effective dose for shortest duration. Swallow whole. Take at least 30 mins before meals. ≥18yrs: one 375mg/20mg or 500mg/20mg tab twice daily. Consider dose reduction in mild-to-moderate hepatic impairment.
Children:
Use lowest effective dose for shortest duration. Swallow whole. Take at least 30 mins before meals. JIA: <12yrs or <38kg: not established. ≥12yrs (≥38kg–<50kg): one 375mg/20mg tab twice daily; (>50kg): one 375mg/20mg or 500mg/20mg tab twice daily.
Contraindications:
Aspirin allergy. Coronary artery bypass graft surgery. Concomitant rilpivirine-containing products.
Warnings/Precautions:
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease, GI bleeding, or inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Hypertension; monitor BP closely. Moderate-to-severe renal impairment (CrCl <30mL/min) or severe hepatic impairment: not recommended. Discontinue if signs/symptoms of liver disease develop, if abnormal LFTs persist or worsen, or if acute interstitial nephritis, cutaneous/systemic lupus erythematosus, bleeding occurs. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Symptomatic response does not preclude gastric malignancy. Long-term therapy may lead to malabsorption/deficiency of Vit. B12 or hypomagnesemia (monitor Mg+ levels). Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Elderly. Debilitated. Labor & delivery. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.
Interactions:
See Contraindications. Concomitant St. John's wort, rifampin, atazanavir, nelfinavir, voriconazole: not recommended. Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin, saquinavir, tacrolimus, diazepam; monitor. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Consider dose reduction of concomitant cilostazol (50mg twice daily). Antagonizes clopidogrel; consider alternative anti-platelets. May affect absorption of pH-dependent drugs (eg, ketoconazole, erlotinib, mycophenolate mofetil, iron salts). May interfere with neuroendocrine diagnostic tests; discontinue esomeprazole ≥14 days prior to CgA level assessment.
Pharmacological Class:
NSAID + proton pump inhibitor.
Adverse Reactions:
Gastritis, diarrhea; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia, bone fracture, possible C. difficile-associated diarrhea.
Metabolism:
Hepatic (CYP2C9, 1A2, 2C19, 3A4); 99% protein bound.
Elimination:
Renal (primarily), fecal.
Generic Availability:
NO
How Supplied:
Tabs—60
英国上市的说明书附件：http://www.medicines.org.uk/emc/medicine/23883
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产地国家：美国 
原产地英文商品名:
VIMOVO TABLET DR 12HR (375/20)mg/tab 60tabs/bottle
原产地英文药品名:
NAPROXEN/ESOMEPRAZOLE MAG
中文参考商品译名:
VIMOVO12小时缓释片 (375/20)毫克/片 60片/瓶
中文参考药品译名:
萘普生/埃索美拉唑
生产厂家中文参考译名:
HORIZON PHARMA USA INC
生产厂家英文名:
HORIZON PHARMA USA INC
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产地国家：美国
原产地英文商品名:
VIMOVO TABLET DR 12HR (500/20)mg/tab 60tabs/bottle
原产地英文药品名:
NAPROXEN/ESOMEPRAZOLE MAG 
中文参考商品译名:
VIMOVO12小时缓释片 (500/20)毫克/片 60片/瓶
中文参考药品译名:
萘普生/埃索美拉唑
生产厂家中文参考译名:
HORIZON PHARMA USA INC
生产厂家英文名:
HORIZON PHARMA USA INC
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产地国家：英国 
原产地英文商品名:
VIMOVO modified-release tablets (500/20)mg/tab 60tabs/box
原产地英文药品名:
naproxen and esomeprazole
中文参考商品译名:
VIMOVO缓释片 (500/20)毫克/片 60片/盒
中文参考药品译名:
萘普生/埃索美拉唑
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca
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产地国家：英国
原产地英文商品名:
VIMOVO modified-release tablets(500/20)mg/tab 100tabs/box
原产地英文药品名:
naproxen and esomeprazole
中文参考商品译名:
VIMOVO缓释片 (500/20)毫克/片 100片/盒
中文参考药品译名:
萘普生/埃索美拉唑
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca
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产地国家：加拿大
原产地英文商品名:
VIMOVO TABLET DR 12HR(375/20)mg/tab 60tabs/box
原产地英文药品名:
naproxen and esomeprazole
中文参考商品译名:
VIMOVO缓释片 (375/20)毫克/片 60片/盒
中文参考药品译名:
萘普生/埃索美拉唑
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca
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产地国家：加拿大
原产地英文商品名:
VIMOVO TABLET DR 12HR(500/20)mg/tab 100tabs/box
原产地英文药品名:
naproxen and esomeprazole
中文参考商品译名:
VIMOVO缓释片 (500/20)毫克/片 100片/盒
中文参考药品译名:
萘普生/埃索美拉唑
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca
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产地国家：瑞士
原产地英文商品名:
VIMOVO Filmtabl(500/20)mg/tab 60tabs/bottle 
原产地英文药品名:
naproxen/esomeprazole magnesium
中文参考商品译名:
VIMOVO混合片(500/20)毫克/片 60片/瓶
中文参考药品译名:
萘普生/埃索美拉唑镁 
生产厂家中文参考译名:
阿斯利康公司
生产厂家英文名:
AstraZeneca AG
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产地国家：瑞士
原产地英文商品名:
VIMOVO Filmtabl(500/20)mg/tab 30tabs/bottle 
原产地英文药品名:
naproxen/esomeprazole magnesium
中文参考商品译名:
VIMOVO混合片(500/20)毫克/片 30片/瓶
中文参考药品译名:
萘普生/埃索美拉唑镁 
生产厂家中文参考译名:
阿斯利康公司
生产厂家英文名:
AstraZeneca AG