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Aciphex tabs(雷贝拉唑钠缓释片)

2013-11-16 11:15:13  作者:新特药房  来源:互联网  浏览次数:133  文字大小:【】【】【
简介:Generic Name and Formulations:Rabeprazole sodium 20mg; delayed-release, e-c tabs.Company:Eisai and JanssenIndications for ACIPHEX:Triple therapy (w. amoxicillin + clarithromycin) for H. pylori er ...

部份中文雷贝拉唑钠资料(仅供参考)
【中文品名】雷贝拉唑钠
【药效类别】抗消化性溃疡病药>苯并咪唑衍生物类
【通用药名】RABEPRAZOLE SODIUM
【别  名】Aciphex
【化学名称】 1H–Benzimidazole, 2-[[[4-(3-methoxypropoxy)-3-methyl-2- pyridinyl]-methyl]sulfinyl]-, sodium salt
【CA登记号】[117976-90-6]
【结 构 式】


【分 子 式】C18H20N3NaO3S
【分 子 量】381.43
【收录药典】
【开发单位】Eisai


ACIPHEX(rabeprazole sodium) Delayed-Release Tablets
Generic Name and Formulations:
Rabeprazole sodium 20mg; delayed-release, e-c tabs.
Company:
Eisai and Janssen
Indications for ACIPHEX:
Triple therapy (w. amoxicillin + clarithromycin) for H. pylori eradication in duodenal ulcer disease. Short-term treatment of erosive or ulcerative gastroesophageal reflux disease (GERD) or duodenal ulcers. Short-term treatment of symptomatic GERD in patients ≥12 years of age. Maintenance of healing and reduction in relapse rates of heartburn symptoms in erosive or ulcerative GERD. Long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome). Treatment of GERD in pediatric patients 1–11 years of age.

Adult Dose for ACIPHEX:
Swallow tabs whole. ≥18yrs: Triple therapy: rabeprazole 20mg + amoxicillin 1g + clarithromycin 500mg, all twice daily (w. AM and PM meals) for 7 days. GERD healing: 20mg once daily for 4–8 weeks; may repeat for 8 more weeks. GERD symptoms: 20mg once daily for 4 weeks; may repeat for 4 more weeks. GERD maintenance: 20mg once daily. Duodenal ulcer healing: 20mg once daily after breakfast for up to 4 weeks. Hypersecretory conditions: initially 60mg once daily; titrate; doses up to 100mg once daily or 60mg twice daily have been used.

Children's Dose for ACIPHEX:
Sprinkle caps: take 30 minutes before meal. Open capsule and sprinkle contents on a small amount of soft food (eg, applesauce, fruit or vegetable based baby food, yogurt) or into a small amount of liquid (eg, infant formula, apple juice, pediatric electrolyte solution). <1yr: not recommended. Treatment of GERD: 1–11yrs (<15kg): 5mg once daily for up to 12 weeks; may increase to 10mg if inadequate response; (>15kg):10mg once daily for up to 12 weeks. Tabs: swallow whole. Treatment of symptomatic GERD: ≥12yrs: 20mg tab once daily for up to 8 weeks.

See Also:
ACIPHEX SPRINKLE

Pharmacological Class:
Proton pump inhibitor.

Warnings/Precautions:
Gastric malignancy. Increased risk of osteoporosis-related fractures of the hip, wrist or spine with long-term and multiple daily dose PPI therapy. Severe hepatic impairment. Monitor magnesium levels with long-term therapy. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
May alter absorption of gastric pH-dependent drugs (eg, ketoconazole, digoxin). Concomitant digoxin or drugs that cause may hypomagnesemia (eg, diuretics): consider monitoring magnesium levels. May give antacids concomitantly. May antagonize atazanavir (not recommended). Monitor warfarin, cyclosporine. May potentiate methotrexate (see literature).

Adverse Reactions:
Headache, pain, pharyngitis, flatulence, infection, constipation; rare: hypomagnesemia (w. prolonged PPI therapy), possible C. difficile associated diarrhea.

Note:
Note: See Amoxil entry for more information on amoxicillin. See Biaxin entry for more information on clarithromycin.

How Supplied:
Tabs—30, 90; Caps—30
Proper storage of Aciphex :
Store Aciphex at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aciphex out of the reach of children and away from pets.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d103551-978f-472a-9c62-51e6e4dea068
FDA批准Aciphex缓释片治疗胃食管反流病
美国食品和药物管理局今天批准Aciphex(雷贝拉唑钠)的第一个仿制缓释片,用于治疗成人和青少年(12岁以上)胃食管反流病(GERD)。
胃食管反流病,也称为反酸或酸返流,是一种常见的疾病,其中从胃酸的逆流引起烧心和可能发生的伤害食管(连接的咽喉和胃的管)。
雷迪博士实验室有限公司,Kremers城市制药公司,卢平制药公司,Mylan的制药公司,梯瓦制药美国和洪流制药有限公司已经获得FDA批准上市的通用雷贝拉唑。
“医疗保健专业人士和消费者可以放心,FDA批准的仿制药已达到质量为品牌药同样的硬性标准,”凯瑟琳·乌尔博士,在FDA的仿制药办公室代理主任说,药品评价和研究。 “这种药物被广泛谁拥有胃食管反流病的人使用,所以能够获得负担得起的治疗方案是非常重要的。”
雷贝拉唑是一类药物称为质子泵抑制剂。药物的工作原理通过降低在胃中制成酸的量,治疗GERD的症状如胃灼热,酸性的返流,恶心。药物有助于使食道愈合,并防止对食道进一步损害。雷贝拉也用于治疗其中胃产生太酸,如佐林格 - 埃利森综合征的条件。此外,雷贝拉唑是用于治疗溃疡(溃疡在胃或肠的衬里)并在与其他药物结合使用,以消除幽门螺杆菌,一种细菌,导致溃疡。
在成人临床试验Aciphex,通过服用Aciphex报告的最常见的不良反应为咽喉肿痛,腹胀,感染,便秘等。在青少年研究中,最常服用Aciphex报告的不良反应为腹痛,腹泻和头痛。

责任编辑:admin


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