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 详细处方信息以本药内容附件PDF文件（201131519085135.pdf）的“原文Priscribing Information”为准
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部分中文萘普生/埃索美拉唑镁处方资料（仅供参考）

Vimovo(PN400)用于关节炎和强直性脊柱炎
    美国FDA受理VIMOVO (enteric-coated naproxen /短效版ESomeprazole magnesium，先前称为PN 400)新药上市申请(NDA)。VIMOVO为固定剂量，合并enteric-coated naproxen与短效版esomeprazole，治疗骨关节炎丶风湿性关节炎与脊椎僵直性脊椎炎病患的症状。
    PN400含有埃索美拉唑与萘普生两种成分，含500mg肠包衣萘普生与20mg的即释型埃索美拉唑；开发用于治疗骨关节炎、风湿性关节炎、强直性脊柱炎，用于那些有发生非甾体抗炎药相关胃溃疡风险的患者。这类患者通常需用非甾体类抗炎药进行长期治疗，而这样治疗容易导致胃溃疡。
    AstraZeneca公司已经向欧盟提交了Vimovo（Ⅰ）作为治疗骨关节病和类风湿关节炎和强直性脊柱炎症状和体征药物的上市许可申请。（Ⅰ）是由肠溶包衣的萘普生和速释的esomeprazole组成的复方制剂，前者是可缓解疼痛的非甾体抗炎药（NSAID），后者是一种质子泵抑制剂（PPI）。

萘普生
　　[性状] 白色或类白色结晶性粉末；无臭或几乎无臭。在甲醇、乙醇或氯仿中溶解，在乙醚中略溶，在水中几乎不溶。
　　[药理及应用] 本品有抗炎、解热、镇痛作用为 PG合成酶抑制剂。口服吸收迅速而完全，1次给药后 2～4小时血浆浓度达峰值，在血中99％以上与血浆蛋白结合，t1/2为13～14小时。约95％自尿中以原形及代谢产物排出。对于类风湿性关节炎、骨关节炎、强直性脊椎炎、痛风、运动系统(如关节、肌肉及腱)的慢性变性疾病及轻、中度疼痛如痛经等，均有肯定疗效。中等度疼痛可于服药后1小时缓解，镇痛作用可持续7小时以上。对于风湿性关节炎及骨关节炎的疗效，类似阿司匹林。对因贫血、胃肠系统疾病或其他原因不能耐受阿司匹林、吲哚美辛等消炎镇痛药的病人，用本药常可获满意效果。
　　可安全地与皮质激素合用，但与皮质激素合用时，疗效并不比单用皮质激素时好。本晶与水杨酸类药物合用也不比单用水杨酸类好。此外，阿司匹林可加速本晶的排出。
　　[用法] 1次0．2～0．3g，1日2～3次。可口服，开始每日剂量0．5～0．75g，维持量每日0．375～ 0．75g，分早晨及傍晚2次服用。轻、中度疼痛或痛经时，开始用0．5g，必需时经6～8小时后再服0．25g，日剂量不得超过1．25g。肌内注射，1次100—200mg，1日1次。栓剂直肠给药，1次0．25g，1日0．5R。
　　[注意]
　　(1)长期服用耐受良好，副作用主要为胃肠道轻度和暂时不适。偶见恶心、呕吐、消化不良、便秘、胃肠道出血、失眠或嗜睡、头痛、头晕、耳鸣、瘙痒、皮疹、血管神经性水肿、视觉障碍及出血时间延长，一般不需中断治疗。
　　(2)与阿司匹林等非甾体抗炎药有交叉过敏反应，禁用于对本品及对阿司匹林过敏的患者。
　　(3)对伴有消化性溃疡或有消化性溃疡病史者慎用；对有活动性胃及十二指肠溃疡患者应在严格监督下使用。
　　(4)本品可加强双香豆素的抗凝血作用。
　　(5)与丙磺舒合用时可增加本品的血浆水平及明显延长本品的血浆t1/2。
　　[贮法] 密闭、避光保存。
 
埃索美拉唑
　　【通用名】
　　埃索美拉唑镁肠溶片
　　【适应症】
　　胃食管反流性疾病(GERD)
　　－糜烂性反流性食管炎的治疗
　　－已经治愈的食管炎患者防止复发的长期维持治疗
　　－胃食管反流性疾病(GERD)的症状控制
　　与适当的抗菌疗法联合用药根除幽门螺杆菌，并且
　　－愈合与幽门螺杆菌感染相关的十二指肠溃疡
　　－防止与幽门螺杆菌相关的消化性溃疡复发
　　【用法用量】
　　药片应和液体一起整片吞服，而不应当咀嚼或压碎。
　　对于存在吞咽困难的患者，可将片剂溶于半杯不含碳酸盐的水中（不应使用其他液体，因肠溶包衣可能被溶解）。搅拌，直至片剂完全崩解，立即或在30分钟内服用，再加入半杯水漂洗后饮用。微丸决不应被嚼碎或压破。
　　对于不能吞咽的患者，可将片剂溶于不含碳酸盐的水中，并通过胃管给药。重要的是应仔细检查选择的注射器和胃管的合适程度。
　　或遵药师和医师医嘱
　　【不良反应】
　　在埃索美拉唑的临床试验中已确定或怀疑有下列不良反应，这些反应均没有剂量相关性。
　　【常见反应】
　　(>1/100, <1/10) 头痛、腹痛、腹泻、腹胀、恶心/呕吐、便秘.
　　【少见反应】
　　(>1/1000, <1/100) 皮炎、瘙痒、荨麻疹、头昏、口干.
　　【罕见反应】
　　(>1/10000, <1/1000) 过敏性反应，如血管性水肿，过敏反应, 肝转氨酶升高.
　　【禁忌】
　　已知对埃索美拉唑 、其它苯并咪唑类化合物或本品的任何其他成份过敏者。

Generic Name:
Naproxen, Esomeprazole Magnesium

Brand Names:
Vimovo

Vimovo Description:
Vimovo is prescribed to patients to treat osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, a disease characterized by inflammation and pain in the joints between the vertebrae of the spine and the joints between the spine and the pelvis.

Vimovo is also prescribed to patients to decrease the risk of developing gastric ulcers in patients at risk of developing ulcers associated with non-steroidal anti-inflammatory (NSAID) medications.

Vimovo is comprised to two medications, naproxen, an NSAID medication, and esomeprazole magnesium, a proton pump inhibitor drug.

Vimovo Side Effects:
The following side effects are associated with the use of Vimovo:
Diarrhea
Gastric ulcer
Abdominal pain
Nausea
Inflammation of the stomach
Wearing away of the stomach lining
Indigestion
For more information, see our Vimovo side effects page.

Vimovo Uses:
Patients take Vimovo to treat the following conditions:
Osteoarthritis
Rheumatoid arthritis
Ankylosing spondylitis (inflammation between the spinal bones and the joints between the pelvis and the spine)

The medication is also used to decrease the risk of developing gastric ulcers in those who are at risk of developing ulcers from the use of non-steroidal anti-inflammatory drugs.

Vimovo Interactions:
Certain medications may interact with Vimovo. Be sure to discuss the use of prescriptions, over-the-counter medications, vitamins and supplements with your doctor before beginning treatment with Vimovo.

Discuss the risks of taking Vimovo with the following medications with your doctor:
ACE inhibitors
Diuretics
Beta-blockers
Methotrexate
Warfarin

Vimovo Dosage Information:
Typical Dosage Recommendations

Take Vimovo according to the dosing recommendations provided by your doctor.

Vimovo is available as a delayed-release tablet in 375 mg/ 20mg or 500 mg/20 mg strengths of naproxen and esomeprazole magnesium.

Patients typically take one Vimovo tablet twice a day and use the lowest effective dose of the medication. The medication should be swallowed whole, with a liquid.

Missing a Dose of Vimovo
If you forget to take a dose of Vimovo, 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 next dose on time. Do not take multiple doses of Vimovo at one time to make up for a missed dose.

Vimovo Overdose
If a Vimovo overdose occurs, seek emergency medical attention.

Symptoms of a Vimovo overdose may include:
Nausea
Heartburn
Vomiting
Bleeding
Weakness
Dizziness
Feeling tired
Change in breathing
Breathing stops
Lack of coordination
Uncontrollable movement
Upper-area stomach pain

Vimovo FDA Approval:
April 30, 2010

Vimovo Recall/Black Box Warning Information:
A Black Box warning cautioning patients about the risk of cardiovascular thrombotic events, stroke and heart attack, which may be fatal, exists for Vimovo due to the medication naproxen, which is found in the drug. The risk may increase as use of the medication is continued. Patients with heart disease or risk factors for heart disease may be at an increased risk.

Vimovo is also contraindicated for the treatment of peri-operative pain during coronary artery bypass graft surgery.

Additionally, a Black Box warning for all NSAID medications, including naproxen which is found in Vimovo, cautions patients about the risk of serious gastrointestinal issues including bleeding, ulceration and perforation of the stomach or intestines. Elderly patients are at an increased risk of these adverse reactions.

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 详细处方信息以本药内容附件PDF文件（201131519085135.pdf）的“原文Priscribing Information”为准
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