兰索拉唑片(可意林)的说明书

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注射用右兰索拉唑-详细说明书与重点

注射用右兰索拉唑-详细说明书与重点

注射用右兰索拉理[成份]:本品活性成份为右兰索拉哗。

化学名称:(R)2[I[3-甲基4(222-三氟氧基)2此基]:甲基]:亚硫酷基]:-IH-苯并咪化学结构式。

分子式:C16H14F3N3O2S ,分子量:369.36。

辅料:葡甲胺、甘露醇、氢氧化钠。

[规格]:20mg o[用法用量]:静脉滴注:通常成年人一次20mg ,一日2次,疗程不超过5天。

一旦患者可以口服药物,应改为口服用药。

临用前将瓶中内容物用5mL0.9%氯化钠注射液溶解,再用IOOLO.9%氧化钠注射液释,一日2次,静脉滴注,推荐给药时间不少于30分钟。

使用时注意:1.经本品治疗的前3日内达到止血效果的,应改用口服用药,不可无限制静脉给药。

临床试验中,本品目前尚无超过6天的用药经验。

2.本品临床试验中未入选Forrestla级喷射样出血者。

对于内镜下见喷射样出血、活动性渗血、血管裸露等高危人群,建议参考临床诊治指南首先考虑进行内镜止血。

3.本品仅用于静脉滴注。

溶解后应尽快使用,勿保存。

避免与0.9%氯化钠注射液以外的液体和其他药物混合静滴。

4.使用本品时应使用专用的输液器,不得与其他药物共用。

万不得已需要通过其他药物的输液器侧管给予本品时应停止输注其他药物,并在本品给药之前和之后用0.9%氯化钠注射液冲管。

5.本品静消使用时应配有孔径为1.2um的过滤器,以便去除输液过程中可能产生的沉淀物。

这些沉淀物有可能引起小血管栓塞而产生严重后果。

[适应症]:用于口服疗法不适用的伴有出血的胃、十二指肠溃疡。

6禁忌症]:1.对本品中任何成份过敏的患者禁止使用本品。

2.正在使用硫酸阿扎那韦、盐酸利匹韦林的患者禁止使用本品。

[注意事项]:L以下患者慎重用药。

(1)有药物过敏症既往史的患者。

(2)肝功能障碍的患者(因本药的代谢、排泄延迟)。

2 .本品治疗可能会掩盖消化道肿瘤的症状,应排除恶性肿瘤后方可用药。

3 .本品治疗时密切观察病情,治疗无效时应改用其它疗法。

兰索拉唑片

兰索拉唑片

1.1 兰索拉唑处方资料
通 用 名:兰索拉唑 英 文 名:Lansoprazole 化学结构:C16H14F3N3O2S
规 格:15mg 包 装:7粒/盒、 14粒/盒 适 应 症:胃溃疡、十二指肠溃疡、反流性食管炎
卓-艾综合症(Zollinger-Ellison综合症)。 用法用量:每日一次,一次30mg
[1]黄云峻,新一代质子泵抑制剂兰索拉唑的药理与临床应用新进展[J] 中国新药杂志,1997,6(2):107
3.2 PPI产生的抑酸ቤተ መጻሕፍቲ ባይዱ泌作用的效应速度
平均 24-h 胃 pH
5
4 3 2 1 0 治疗前
兰索拉唑 30 mg 每天一次 奥美拉唑 20 mg 每天一次 对14位健康受试者的双盲交叉实验
5.市场概况 6.市场定位 7.同类厂家
2.1 质子泵抑制剂(PPI)作用机制
▪ PPI即H+/K+-ATP酶抑制剂,其抑 酸作用强,特异性高,持续时间长久。
▪ 抑制H+/K+-ATP酶的药物必须具有 3个结构部分:吡啶环、SO基和苯并 咪唑环。
▪ 目前几种上市的PPIs多为苯并咪唑 类衍生物,都是通过对吡啶环或苯并 咪唑环进行不同的修饰而增强其抑制 胃酸的功能。
兰索拉唑 30 mg
平均时间 达 pH 4 (分钟)
89
埃索美拉唑 40 mg 兰索拉唑 15 mg
埃索美拉唑 20 mg
82 110
126
差异 (分钟)
-7
16
Eriksson et al., Scand J Gastroenterol 2001; 36(Suppl 233): 49.
*p<0.001
3.6 抑酸起效时间的比较

2017执业药师辅导资料:兰索拉唑使用注意事项

2017执业药师辅导资料:兰索拉唑使用注意事项

/zyys/ 2017执业药师辅导资料:兰索拉唑使用注意事项
小编为大家搜集了2017年执业西药师药学专业知识一中的辅导资料,希望对大家
有所帮助。

兰索拉唑使用注意事项
1.兰索拉唑长期使用经验不足,故不推荐用于维持疗法,应针对每个病例和症状使
用必需的最低剂量;
2.兰索拉唑副作用发生率占2%一4%,2.9%的患者临床化验值可能发生异常变化。

主要副作用或不良反应有:荨麻疹、皮疹、瘙痒、头痛、口苦、困倦、失眠或抑郁、口
干、腹泻、胃胀满、便血、便秘、尿频、发烧、总胆固醇及泥沙酸值升高、贫血、白细
胞减少、ALT、AST、ALP、LDH及γ-GTP升高等。

轻度不满、便血、便秘、尿频、发
烧、总胆固醉及尿酸值升高、贫血、白细胞减少,ALT、AST、ALP、I‘四音及Y—GTP
升高等。

轻度不良反应不影响继续用药,但如发生过敏性反应、肝功能异常或较为严重
副作用时应及时停药或采取适当措施;
3.有药物过敏史、肝功能障碍患者及老龄患者应慎重用药。

4.对孕妇,除非判定治疗的益处超过可能带来的危险时,一般不宜用。

哺乳妇女不
宜用此药,如必需用应停止哺乳。

护佑可意林兰索拉唑片(兰索拉唑肠溶片)使用说明

护佑可意林兰索拉唑片(兰索拉唑肠溶片)使用说明

护佑可意林兰索拉唑片(兰索拉唑肠溶片)【用法用量】治疗胃溃疡和十二指肠溃疡,每日清晨口服1次,一次15~30mg。

或遵医嘱。

【注意事项】1.治疗过程中应注意观察,因长期使用的经验不足,暂不推荐用于维持治疗。

2.本品服用时请不要嚼碎,应整片用水吞服。

3.肝功能障碍者及高龄者须慎用。

4.使用本品有时会掩盖胃癌的症状,所以要在排除胃癌可能性的基础上方可给药。

【不良反应】1.过敏症:偶有皮疹、瘙痒等症状,如出现上述症状时请停止用药。

2.血液系统:偶有贫血、白细胞减少,嗜酸球增多等症状,血小板减少之症状极少发生。

3.消化系统:偶有便秘,腹泻,口渴,腹胀等症状。

偶有ALT、AST、ALP、LDH、γ-GTP上升等现象,所以须细心观察,如有异常现象应采取停药等适当的处置。

4.精神神经系统:偶有头痛、嗜睡等症状。

失眠,头晕等症状极少发生。

5.其它:偶有发热,总胆固醇上升,尿酸上升等症状。

【禁忌】1.对本品过敏者禁用。

2.8岁以下儿童禁用。

3.孕妇及哺乳期妇女禁用。

【适应症】本品适用于胃溃疡﹑十二指肠溃疡﹑反流性食管炎﹑卓-艾综合征(Zollinger-Ellison综合征)。

【药物相互作用】兰索拉唑会延迟地西泮(diazepam)及苯妥英钠(phenytoin)的代谢与排泄;使对乙酰氨基酚的血药浓度峰值升高,达峰时间缩短。

【药理毒理】1.本品为苯并咪唑类化合物,口服吸收后转移至胃粘膜,在酸性条件下转化为活性代谢体,该活化体特异性地抑制胃黏膜壁细胞H+/K+-ATP酶系统而阻断胃酸分泌的最后步骤。

2.本品以剂量依赖性方式抑制基础胃酸分泌以及刺激状态下的胃酸分泌。

3.本品对胆碱和组胺H2受体无拮抗作用。

【儿童用药】对的安全性尚未确立(小儿的临床经验极少)。

【老人用药】一般而言,老年患者的胃酸分泌能力和其他生理机能均会降低,故用药期间请注意观察。

【包装】15mg*14片/盒。

【药物过量】目前无的临床经验供参考,但兰索拉唑不能通过血液透析从循环系统中清除。

奥维加

奥维加

奥维加(注射用兰索拉唑)使用说明书【药品名称】通用名称:注射用兰索拉唑商品名称:奥维加英文名:lansoprazoleforInjection【参考价格】98元【成分】兰索拉唑。

【性状】本品为白色或类白色疏松块状物或粉末。

【适应症】用于各种类型的腐蚀性食道炎治疗。

反流性食管炎、胃溃疡、十二指肠溃疡。

【包装规格】30mg【药理毒理】本品为质子泵抑制剂(PPIs),抑制胃酸的分泌,它作用于胃壁细胞的H+-K+-ATP酶,使壁细胞的H+不能转运到胃中去,以致胃液中胃酸量大为减少。

【药代动力学】本品口服后1小时左右可在血中检出,达峰时间为3.6小时,吸收相半衰期为1.3小时,消除相半衰期为2.1小时。

该药从小肠吸收经门脉而广泛分布于以胃壁和小肠壁为中心的各组织中。

该药主要在肝脏被代谢,大多经胆汁于粪中排泄。

原型药及其代谢物在体内无蓄积。

【用法用量】腐蚀性食道炎患者不易经口服给药时,使用本品。

成人剂量,每天30mg静脉滴注,滴注时间不少于30分钟,疗程7天。

一旦发现有沉淀物,使用线性过滤器过滤后使用。

一旦病情许可,应迅速将静脉用药改为口服给药。

【不良反应】本品副作用轻微,主要表现为口干、头晕、恶心。

不良反应:国内临床研究中,本品一日2次,每次30mg静脉滴注,5天疗程。

127例受试者中发生4例(3.64%)不良反应,主要是白细胞减少(1.82%),转氨酶轻度升高(0.91%)和皮疹(0.91%)。

白细胞减少者一周后复查正常,转氨酶轻度升高者十天后复查正常。

国外上市后超过1000名患者使用注射用兰索拉唑后有较好的耐受性。

在美国4个临床试验中有161名患者使用注射用兰索拉唑,超过1%的不良反应有恶心(1.3%)、头痛(1%)、注射部位痛感(1%);低于1%的不良反应有腹痛、腹泻、消化不良、呕吐、头晕、感觉异常、味觉异常、皮疹和血管扩张。

未见和口服给药不同的不良反应。

日本221例受试者使用注射用兰索拉唑的临床研究资料报道,发生31例(14.0%)临床实验室检查值异常,主要为ALT升高(6.2%)、AST升高(5. 7%)、LDH升高(2.0%)、γ-GTP升高(1.5%)等检查值异常变化。

健利思(兰索拉唑)

健利思(兰索拉唑)

化学、神经、激素刺激
壁细胞内小管泡与分泌小管融合 质子泵转移到小管膜上
质子泵抑制剂自由通透生物膜, 进入壁细胞的分泌小管,酸性 环境下与H+结合,不再透过生 物膜,活化,抑制质子泵
H+从pH7.04的壁细胞浆中跨梯度 转运到pH10.0的分泌小管管腔内
胃腔,形成胃酸
独创氟元素导入机制,药理活性增强
等效酸抑制:兰索拉唑vs埃索美拉唑
7 6 5 平均pH值 4
每一治疗组随时间变化的平均pH值
兰索拉唑 15 mg
埃索美拉唑 20 mg
3
2 1
0 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 时间 (分) Baxter . Scand J Gastroenterol. 2001;36(Suppl 233):50.
胃溃疡(GU) n=247 十二指溃疡(DU) n=54117.8 Nhomakorabea2W
4W
6W
8W
Ref:H,Licht,et al:Med.Chir.Dig,19,251
缓解烧心症状:兰索拉唑VS 埃索美拉唑
随机、双盲、多中心研究,n= 3034 GERD 1天 3天 1周 2周
白天/夜间烧心缓解率%
兰索拉唑 30mg qd 46/48 45/47 53/53 51/52 60/58 57/57 64/62 62/61
健利思®
安全控酸,保胃健康
兰索拉唑肠溶片
乐普药业学术部
乐普医疗
专注高端介入诊疗器械、设备及药品的中美合资央企控股上市企业 实际控制人:中国船舶重工集团公司 国家心脏病植介入诊疗器械及设备工程技术研究中心

注射用右兰索拉唑

注射用右兰索拉唑
系统疾病的药物。
药物作用
注射用右兰索拉唑通过抑制胃酸 分泌,减轻胃酸对胃黏膜的刺激,
从而缓解胃痛、胃胀等症状。
药物剂量
注射用右兰索拉唑的剂量应根据 患者的病情和身体状况来确定, 一般建议在医生的指导下使用。
药物作用机制ຫໍສະໝຸດ 抑制胃酸分泌右兰索拉唑通过抑制胃壁细胞上的质子泵,减少胃 酸分泌,从而缓解胃酸过多引起的不适症状。
保护胃黏膜
右兰索拉唑能够保护胃黏膜,减少胃酸对胃黏膜 的刺激,缓解胃部不适症状。
03
注射用右兰索拉 唑的适应症
胃溃疡
01
胃溃疡的成因
胃溃疡主要是由于胃酸分 泌过多,导致胃黏膜受损, 形成溃疡。
02
右兰索拉唑的作用
右兰索拉唑是一种质子泵 抑制剂,可以抑制胃酸分 泌,减轻胃溃疡的症状。
03
治疗效果
在手术、创伤、严重感染等应激状态下, 注射用右兰索拉唑能有效预防应激性溃疡 的发生。
03
辅助其他治疗
在某些特殊情况下,如重症监护、机械通 气等,注射用右兰索拉唑可与其他药物联 合使用,辅助治疗相关疾病。
02
注射用右兰索拉 唑的药理作用
对胃酸分泌的抑制作用
01 抑制质子泵活性
右兰索拉唑通过抑制质子泵的活性,减少胃酸分泌,从 而缓解胃酸过多引起的不适症状。
反流性食管炎
疾病定义
反流性食管炎是由胃、十二指肠内容物反流入食管引起的食管炎 症性病变
症状表现
典型症状表现为胸骨后烧灼感、反流和胸痛
治疗方法
注射用右兰索拉唑可用于治疗反流性食管炎,有效缓解患者症状
04
注射用右兰索拉 唑的用法用量
成人用量
常规剂量
成人每日一次,每次30mg,溶于100ml 生理盐水或5%葡萄糖注射液中,静脉滴 注,时间不得少于30分钟。

兰索拉唑

兰索拉唑

兰索拉唑一基本情况化学名称:(+)-2【3—甲基—4—(2,2,2—三氟乙氧基)—2吡啶基】—1H—苯并咪唑。

分子结构:主要剂型:片剂、胶囊、注射剂适应症:胃溃疡、十二指肠溃疡、反流性食管炎、佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)。

不良反应:1.过敏反应:偶有皮疹、瘙痒等症状,如出现上述症状时请停止用药。

2.血液系统:偶有贫血、白细胞减少,嗜酸球增多等症状,血小板减少之症状极少发生3.消化系统:偶有便秘,腹泻,口渴,腹胀等症状。

偶有GOT、GPT、ALP、LDH、γ-GTP上升等现象,所以须细心观察,如有异常现象就应采取停药等适当的处置。

4.精神神经系统:偶有头痛、嗜睡等症状。

失眠,头晕等症状极少发生。

5.其他:偶有发热,总胆固醇上升,尿酸上升等症状。

用法与用量:十二指肠溃疡,通常成人每日一次,口服兰索拉唑15mg~30mg,连续服用4~6周;胃溃疡、反流性食道炎、Zollinger-Ellison症候群、吻合口部溃疡,通常成人每日一次,口服兰索拉唑30mg,连续服用6~8周。

但用做维持治疗、高龄者、有肝功能障碍、肾功能低下的患者,每日一次,口服兰索拉唑15mg。

.对小儿的用药:对小儿的安全性尚未被确立(由于在小儿的临床经验极少)二、市场情况1.全国共有92家生产厂家,天津武田制药公司生产,商品名为“ 达克普隆”兰索拉唑肠溶胶囊,国内兰索拉唑原料和肠溶片由汕头经济特区鮀滨制药厂研究开发,于1994年1月获得二类新药证书和生产批文。

价格从5元多到30多不等,天津武田进口的兰悉多和汕头鮀滨制药的达克普隆占据很大的市场,超过98%(2005年)。

生产厂家主要有:兰索拉唑胶囊湖北潜龙药业有限公司国药准字H20066197兰索拉唑胶囊天津武田药品有限公司国药准字H10980036兰索拉唑胶囊天津武田药品有限公司国药准字H10980035兰索拉唑肠溶片汕头经济特区鮀滨制药厂国药准字H10980136兰索拉唑肠溶片郑州瑞康制药有限公司国药准字H20083439兰索拉唑肠溶片河南帅克制药有限公司国药准字H20065318兰索拉唑片扬子江药业集团有限公司国药准字H20054142兰索拉唑片上海信谊有限公司国药准字H20067605兰索拉唑片昆明源瑞制药有限公司国药准字H20103669兰索拉唑片湖北科益药业股份有限公司国药准字H200738622.同类产品还有:奥美拉唑肠溶胶囊(片剂、注射剂)(评价较高,兰索拉唑是其第二代产品),埃索美拉唑、雷尼替丁、阿莫西林、胃灵颗粒、康复新液(溶液剂)、诺森(进口药,比较贵)、甲磺酸左氧氟沙星、枸橼酸铋钾胶囊(丽珠得乐)、铝碳酸镁片、等。

兰索拉唑缓释胶囊说明书(英文)

兰索拉唑缓释胶囊说明书(英文)

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for:PREVACID (lansoprazole) Delayed-Release Capsules PREVACID SoluTab (lansoprazole) Dela y ed-Release Orally Disintegrating TabletsFor oral administrationInitial U.S. Approval: 1995 ---------------------------RECENT MAJOR CHANGES--------------------------- WARNINGS AND PRECAUTIONS• Bone Fracture (5.2)8/2010• Hypoma g nesemia (5.3)5/2011----------------------------INDICAT I ONS AN D USAGE----------------------------PREVACID is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (belo w ) for indications and usage.-----------------------DOSAGE AND ADMINISTRATION------------------------Indication Dose FrequencyDuodenal Ulcers (1.1, 1.3) Short-Term Tre a tment Maintenance of Healed 15 mg 15 mg y for 4 wksOnce dail Once daily H. pylori Erad duce Rec o l Ulcer (1.2)ication to Re urrence f Duodena Triple Therapy: PREVACID Amoxicil Clarithro lin mycin Dual Therapy: PREVACID Amoxicillin 0 mg3 1 gram500 mg 30 mg 1 gram rTwice daily for 10 o 14 days Three times daily for 14 days Benign Gastric Ulcer (1.4) Short-Term Treatment 30 mg Once daily up to 8wksNSAID-associated Gastric Ulcer (1.6)Healing Risk Reduction 30 mg 15 mg Once daily for 8 wks Once daily up to 12 wks GERD (1.7)Short-Term Treatment of Symptomatic GERDShort-Term Treatment of EE 15 mg30 mg Once daily up to 8 wksOnce daily up to 8wksPediatric (8.4) (1 to 11 years of age) Short-Term Tre f S matic GERD atment o ympto and Short-Term Treatment of EE ≤ 30 kg 15 mg Once daily up to 12wks> 30 kg 30 mg Once daily up to 12wks(12 to 17 years of age) Short-Term Treatment of Symptomatic GERDNonerosive GERD EE15 mg 30 mg Once daily up to 8wksOnce daily up to 8 wks Maintenance of Healing of EE (1.8)15 mg Once daily Pathological Hypersecretory Conditions (i.e., ZES) (1.9) 60 mgOnce daily -------------------DOSAGE FORMS AND STRENGTHS------------------Capsules and Tablets: 15 mg and 30 mg. (3)-----------------------------CONTRAINDICATIONS--------------------------- Contraindicated in patients with known severe hypersensitivity to any component of the PREVACID formulation. (4)---------------------WARNINGS AND PRECAUTIONS--------------------• Symptomatic response with PREVACID does not preclude th epresence of gastric maligna n cy. (5.1) • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.2) • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. (5.3) ---------------------------ADVERSE REACTIONS----------------------------Most commonly reported adverse reactions (≥1%): diarrhea, d ab ominal pain, nausea and constipation. (6) To report SUSPECTED ADVERSE REACTIONS, contact Taked aPharmaceuticals America Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or /medwatch. -----------------------------DRUG INTE R ACTIONS---------------------------• Do not co-administer with atazanavir. (7)• May interfere with th e absorption of drugs where gastric pH isimportant for bioavailability. (7)• Concomitant warfarin use may require mo n itoring for increases inINR and prothrombin time. (7) • Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. (7) • Titration of theophylline dosage may be required when concomitan tPREVACID use is started or stopped. (7) ----------------------USE IN SPECIFIC POPULATIONS-------------------• Consider dose adjustment in patients with severe liver impairm e nt.(8.7)• PREVACID is not effective in patients with symptom a tic GERD 1month to less than 1 year of age. (8.4) See 17 for PATIENT COUNSELIN G INFORMATION and FDA -Approved Patient LabelingRevised: May 2011 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Short-Term Treatment of Active Duodenal Ulcer 1.2 H. pylori Eradication to Reduce the Risk of Duodenal UlcerRecurrence 1.3 Maintenance of Healed Duodenal Ulcers 1.4 Short-Term Treatment of Active Benign Gastric Ulcer 1.5 Healing of NSAID-Associa t ed Gastric Ulcer1.6 Risk Reduction of NSAID-Associated Gastric Ulcer 1.7 Gastroesophageal Ref l ux Disease (GERD) 1.8 Maintenance of Heali n g of Erosive Esophagitis (EE) 1.9 Pathological Hypersecretory Condition s Including Zollinger-Ellison Syndrome (ZES) 2 DOSAGE AND ADMINISTRA T ION2.1 R ecommended Dose 2.2 Special Populations 2.3 Important Administration Information 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS5WARNINGS AND PRE C AUTIONS 5.1 Gastric Malignancy 5.2 Bone Fracture 5.3 Hypomagn e semia 6 A DVERSE RE A CTIONS6.1 C linical6.2 Postmarketing Experience 6.3 Combination Therapy with Amoxicillin and Clarithromycin 6.4 L aboratory Values 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULA T IONS8.1 P regnancy 8.3 N ursing Mothers 8.4 P ediatric Use 8.5 G eriatric Use 8.6 R enal Impairment 8.7 H epatic Impairment 8.8 G ender 8.9 R ace10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics12.4 Specific Populations12.5 Drug-Drug Interactions13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityPage 2 of 2413.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES15 REFERENCES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.FULL PRESCRIBING INFORMATION1 INDICATIONSANDUSAGE1.1 Short-Term Treatment of Active Duodenal UlcerPREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)].1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple Therapy: PREVACID/amoxicillin/clarithromycinPREVACID in combination with amoxicillin plus clarithro m ycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duoden a l ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].Please refer to the full prescribing information for amoxicillin and cla r ithromycin.Dual Therapy: PREVACID/amoxicillinPREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allerg i c or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].Please refer to the full prescribing information for amoxicilli n.1.3 Maintenance of Healed Duodenal UlcersPREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies (14)].1.4 Short-Term Treatment of Active Benign Gastric UlcerPREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of a c tive benign gastric ulcer [see Clinical Studies (14)].1.5 Healing of NSAID-Associated Gastric UlcerPREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [see Clinical Studies (14)].1.6 Risk Reduction of NSAID-Associated Gastric UlcerPREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies (14)].1.7 Gastroesophageal Reflux Disease (GERD)Short-Term Treatment of Symptomatic GERDPREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14)].Short-Term Treatment of Erosive EsophagitisPREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients whodo not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered [see Clinical Studies (14)].1.8 Maintenance of Healing of Erosive Esophagitis (EE)PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [see Clinical Studies (14 )].1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14)].2 DOSAGEANDADMINISTRATIONPREVACID is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. PREVACID should be taken before eating. PREVACID products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with PREVACID.2.1 Recommended DoseDoseFrequency Indication RecommendedDuodenal UlcersShort-Term Treatment 15 mg Once daily for 4 weeksMaintenance of Healed 15 mg Once dailyH. pylori Eradication to Reduce the Risk ofDuodenal Ulcer Recurrence*Triple Therapy:PREVACID 30 mg Twice daily (q12h) for 10 or 14 daysAmoxicillin 1 gram Twice daily (q12h) for 10 or 14 daysClarithromycin 500 mg Twice daily (q12h) for 10 or 14 daysDual Therapy:PREVACID 30 mg Three times daily (q8h) for 14 daysAmoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric UlcerShort-Term Treatment 30 mg Once daily for up to 8 weeksNSAID-associated Gastric UlcerHealing 30 mg Once daily for 8 weeks†Risk Reduction 15 mg Once daily for up to 12 weeks†Gastroesophageal Reflux Disease (GERD)Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeksShort-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡Pediatric(1 to 11 years of age)Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg 15 mg Once daily for up to 12 weeks§> 30 kg 30 mg Once daily for up to 12 weeks§(12 to 17 years of age)Short-Term Treatment of Symptomatic GERDNonerosive GERD 15 mg Once daily for up to 8 weeksErosive Esophagitis 30 mg Once daily for up to 8 weeksMaintenance of Healing of Erosive Esophagitis 15 mg Once dailyPathological Hypersecretory Conditions Including60 mg Once daily¶Zollinger-Ellison Syndrome*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and forinformation regarding dosing in elderly and renally-impaired patients.†Controlled studies did not extend beyond indicated duration.‡For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. Ifthere is a recurrence of erosive esophagitis, an additional 8 week course of PREVACID may be considered.§The PREVACID dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if theyremained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patientneeds and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose ofgreater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treatedcontinuously with PREVACID for more than 4 years.Populations2.2 SpecialRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].InformationAdministration2.3 ImportantAdministration OptionsPREVACID Delayed-Release Capsules – Oral Administration• PREVACID Delayed-Release Capsules should be swallowed whole.• Alternatively, for patients who have difficulty swallowing capsules, PREVACID Delayed-Release Capsules can be opened and administered as follows:capsule.o Openo Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.immediately.o Swallow• PREVACID Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:capsule.o Openo Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).o Mix briefly.o Swallow immediately.o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.PREVACID Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration• For patients who have a nasogastric tube in place, PREVACID Delayed-Release Capsules can be administered as follows:capsule.o Openo Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.o Inject through the nasogastric tube into the stomach.o Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets• PREVACID SoluTab should not be broken or cut.• PREVACID SoluTab should not be chewed.o Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.o The tablet typically disintegrates in less than 1 minute.o Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be delivered in two different ways.PREVACID SoluTab – Oral SyringeFor administration via oral syringe, PREVACID SoluTab can be administered as follows:Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.Shake gently to allow for a quick dispersal.After the tablet has dispersed, administer the contents within 15 minutes.Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.PREVACID SoluTab – Nasogastric Tube (≥ 8 French) AdministrationFor administration via a nasogastric tube, PREVACID SoluTab can be administered as follows:Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.Shake gently to allow for a quick dispersal.After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.3 DOSAGE FORMS AND STRENGTHS• 15 mg capsules are opaque, hard gelatin, colored pink and green with the TAP logo and “PREVACID 15” imprinted on the capsule.• 30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and “PREVACID 30” imprinted on the capsule.• 15 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with “15” debossed on one side of the tablet.• 30 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with “30” debossed on one side of the tablet.4 CONTRAINDICATIONSPREVACID is contraindicated in patients with known severe hypersensitivity to any component of the formulation of PREVACID. For information on contraindications for amoxicillin or clarithromycin, refer to their full prescribing information, CONTRAINDICATIONS sections.PRECAUTIONS5 WARNINGSAND5.1 Gastric MalignancySymptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.5.2 Bone FractureSeveral published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2)].For information on warnings and precautions for amoxicillin or clarithromycin, refer to their full prescribing information, WARNINGS and PRECAUTIONS sections.5.3 HypomagnesemiaHypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2)].6 ADVERSE REACTIONS6.1 ClinicalWorldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials.Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of PREVACID-treated patients and occurred at a greater rate in PREVACID-treated patients than placebo-treated patients in Table 1.Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactionsin Short-Term, Placebo-Controlled PREVACID StudiesBody System/Adverse Event PREVACID(N= 2768)%Placebo(N= 1023)%Body as a WholeAbdominal Pain 2.1 1.2 Digestive SystemConstipation Diarrhea Nausea 1.03.81.30.42.31.2Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9%, 1.4%, 4.2%, and 7.4%, respectively).The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.In the risk reduction study of PREVACID for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with PREVACID, misoprostol, and placebo was 5%, 22%, and 3%, respectively.Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with PREVACID included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic painCardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilationDigestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitisEndocrine System – diabetes mellitus, goiter, hypothyroidismHemic and Lymphatic System – anemia, hemolysis, lymphadenopathyMetabolism and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libidodecreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigoRespiratory System – asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridorSkin and Appendages – acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticariaSpecial Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defectUrogenital System – abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.6.2 Postmarketing ExperienceAdditional adverse experiences have been reported since PREVACID has been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.Body as a Whole - anaphylactic/anaphylactoid reactions; Digestive System -hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Metabolism and Nutritional Disorders – hypomagnesemia; Musculoskeletal System – bone fracture, myositis; Skin and Appendages - severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses -speech disorder; Urogenital System - interstitial nephritis, urinary retention.6.3 Combination Therapy with Amoxicillin and ClarithromycinIn clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with PREVACID, amoxicillin, or clarithromycin.Triple Therapy: PREVACID/amoxicillin/clarithromycinThe most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.Dual Therapy: PREVACID/amoxicillinThe most frequently reported adverse reactions for patients who received PREVACID three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with PREVACID three times daily plus amoxicillin three times daily dual therapy than with PREVACID alone.For information on adverse reactions with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.6.4 Laboratory ValuesThe following changes in laboratory parameters in patients who received PREVACID were reported as adverse reactions:Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and PREVACID, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received PREVACID reported jaundice at any time during the study.In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.For information on laboratory value changes with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.INTERACTIONS7 DRUGDrugs with pH-Dependent Absorption KineticsPREVACID causes long-lasting inhibition of gastric acid secretion. PREVACID and other PPIs are likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, PREVACID and other PPIs should not be co-administered with atazanavir [see Clinical Pharmacology (12.5)].It is theoretically possible that PREVACID and other PPIs may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole) [see Clinical Pharmacology (12.5)].WarfarinIn a study of healthy subjects, co-administration of single or multiple 60 mg doses of PREVACID and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time [see Clinical Pharmacology (12.5)]. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [see Clinical Pharmacology (12.5)]. TacrolimusConcomitant administration of lansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.TheophyllineA minor increase (10%) in the clearance of theophylline was observed following the administration of PREVACID concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when PREVACID is started or stopped to ensure clinically effective blood levels [see Clinical Pharmacology (12.5)].For information on drug interactions for amoxicillin or clarithromycin, refer to their full prescribing information, DRUG INTERACTIONS sections.8 USE IN SPECIFIC POPULATIONS8.1 PregnancyTeratogenic effectsPregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology (13.2)].See full prescribing information for clarithromycin before using in pregnant women.。

兰索拉唑肠溶片的说明书

兰索拉唑肠溶片的说明书

兰索拉唑肠溶片的说明书肠胃不好,生活就不会好,人们的生活总是跟吃分不开关系。

目前患上胃肠疾病的人群很多,正确选择药物就成了您治愈疾病的重要选择了。

兰索拉唑肠溶片是如今治疗胃肠疾病非常好的药物,在众多的胃肠药物当中当属疗效最好的。

那么关于兰索拉唑肠溶片的各种药性和服药原则您了解吗。

【药品名称】通用名称:兰索拉唑片商品名称:兰索拉唑肠溶片拼音全码:LanSuoLaZuoPian【主要成份】本品主要成份为兰索拉唑。

化学名:2-[[[3-甲基-4-(2,2,2-三氟乙氧基)-2-吡啶基]甲基]亚磺酰基]-1H -苯并咪唑。

分子式:C16H14F3N3O2S分子量:369.37【性状】白色肠溶片,除去肠溶衣后显白色或类白色。

【适应症/功能主治】胃溃疡、十二指肠溃疡、反流性食管炎、佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)。

【规格型号】15mg*12s【用法用量】每日清晨口服1次,一次15~30mg,或遵医嘱。

【不良反应】副作用轻微,主要表现为口干、头晕、恶心。

【禁忌】孕妇、哺乳期妇女忌用。

【注意事项】曾发生药物过敏症的患者及肝机能障碍的患者应慎重用药。

【儿童用药】对小儿的安全性尚未被确立(由于在小儿的临床经验极少)。

【老年患者用药】老年患者的胃酸分泌能力和其他生理机能均会降低,故用药期间请注意观察。

【孕妇及哺乳期妇女用药】孕妇、哺乳期妇女忌用。

【药物相互作用】会延迟安定(diazepam)及苯妥英钠(phenytoin Sodium)的代谢与排泄,资料已被发表于类似药物奥美拉唑的报告中。

【药物过量】未进行该项实验且无可靠文献。

【药理毒理】该品为新型的抑制胃酸分泌的药物,它作用于胃壁细胞的H+-K+-ATP酶,使壁细胞的H+不能转运到胃中去,以致胃液中胃酸量大为减少,临床上用于十二指肠溃疡、胃溃疡、反流性食管炎,佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)的治疗,疗效显著,对幽门螺杆菌有抑制作用。

兰索拉唑肠溶胶囊 说明书 30mg7粒盒

兰索拉唑肠溶胶囊 说明书 30mg7粒盒
妊娠期妇女及哺乳期妇女用药 :
1、已确认兰索拉唑在大白鼠胎仔的血浆浓度比在母鼠中高。又在兔子(经口给药30mg/kg)的实验发现胎仔死亡率增加,故对孕妇或有可能怀孕的妇女,需事先判断治疗上的益处超过危险性时,方可用药。2、曾有报告指出,在动物实验中药品会转移到乳汁中。所以本药品不适合用于正在哺乳中的妇女。如不得已需服药时,应避免哺乳。
4.慢性溃疡的治愈促进作用。于大白鼠的实验,兰索拉唑能明显地促进由醋酸引起的慢性胃及十二指肠溃疡的愈合(经口给药)。
5.溃疡形成的抑制作用。于大白鼠的实验,对因水浸应激试验、阿司匹林或乙醇引起的胃溃疡,及因mepirisol或半光胺引起的十二指肠溃疡,和反流性食管炎皆有明显的抑制作用(经口或十二指肠内给药)。
1.(H++K+)-ATPase活性抑制作用。兰索拉唑可抑制狗胃粘膜内微粒体的(H++K+)-ATPase活性(体外实验)。
2.壁细胞酸生成抑制作用。兰索拉唑对狗胃粘膜离体壁细胞由组胺、乙酰胆碱及胃泌素的刺激所产生的酸分泌,皆具有抑制作用(体外实验)。
3.胃酸分泌抑制作用。1)对胃泌素刺激引起的酸分泌:于健康成人,1天1次兰索拉唑30mg口服给药,连续7天,可明显地抑制由胃泌素引起的酸分泌,且此作用能持续24小时。2)对胰岛素刺激引起的酸分泌:于健康成人,1天1次兰索拉唑30mg口服给药,连续7天,可明显地抑制由胰岛素引起的酸分泌。3)对夜间的酸分泌:于健康成人,1天1次兰索拉唑30mg口服给药,连续7天,具有明显地抑制夜间胃酸分泌的作用。4)对24小时的酸分泌:于健康成人24小时胃液采样试验,以1天1次兰索拉唑30mg口服给药连续7天,24小时的胃酸分泌明显地受到抑制。5)24小时胃内pH值的监测:对健康成人以及十二指肠溃疡患者,以1天1次兰索拉唑30mg口服给药连续7天,24小时的胃酸分泌皆明显地受到抑制。6)24小时下部食道pH值的监测:于反流性食管炎患者,以1天1次兰索拉唑30mg口服给药连续7天~9天,对胃食管反流现象,有明显地抑制作用。7)对大白鼠及胃pouch狗的胃酸分泌:本药对于大白鼠的基础酸分泌和因组胺、胃泌素、氨基甲酰基胆碱、2-脱氧-D-葡萄糖或水浸应激试验(waterimmersionstress)所引起的酸分泌均能明显且持续地抑制(在十二指肠内)。对胃pouch狗因各种刺激所引起的酸分泌,本药亦有明显且持续地抑制作用,在反复给药期间,均能显示稳定的酸分泌抑制作用(经口给药)。

兰索拉唑肠溶胶囊说明书

兰索拉唑肠溶胶囊说明书

兰索拉唑肠溶胶囊说明书药品名称:兰索拉唑肠溶胶囊生产厂家:北京红林制药有限公司批准文号:国药准字H20123070 药品剂型:胶囊剂药品规格:30mg 医保类型:国家基本药物:否OTC类别:【药品名称】: 兰索拉唑肠溶胶囊【是否处方】:处方【是否医保】:是【用法用量】:十二指肠溃疡,通常成人每日一次,口服兰索拉唑15mg~30mg,连续服用4~6周;胃溃疡、反流性食管炎、卓-艾综合征(Zollinger-Ellison症候群)、吻合口部溃疡,通常成人每日一次,口服兰索拉唑30mg,连续服用6~8周。

但用做维持治疗、高龄者、有肝功能障碍、肾功能低下的患者,每日一次,口服兰索拉唑15mg。

【不良反应】:1.过敏症:偶有皮疹、瘙痒等症状,如出现上述症状时请停止用药。

2.肝脏:偶有GOT、GPT、ALP、LDH、γ-GTP上升等现象,所以须细心观察,如有异常现象应采取停药等适当的处置。

3.血液系统:偶有贫血、白细胞减少,嗜酸性粒细胞增多等症状,血小板减少之症状极少发生。

4.消化系统:偶有便秘,腹泻,口渴,腹胀等症状。

5.精神神经系统:偶尔有头痛、嗜睡等症状。

失眠,头晕等症状极少发生。

6.其他:偶有发热,总胆固醇上升,尿酸上升等症状。

【禁忌】:对本品过敏者禁用。

【注意事项】:1、在治疗过程中,应充分观察,按其症状使用治疗上所需最小剂量。

2、下列患者慎重用药1)曾发生药物过敏症的患者;2)肝功能障碍的患者。

3、其它对大白鼠经口给药52周的实验,50mg/kg/日组(约为临床用量100倍),发现1例有良性精巢间细胞瘤。

于大白鼠经口给药24个月的实验,15mg及50mg/kg/日组中,精巢间细胞瘤发生率会增加,在50mg/kg/日组中发现1例雌大白鼠有胃部类癌(carcinoid)出现。

因本药会掩盖胃癌的症状,所以须先排除胃癌,方可给药。

【是否处方】:处方【是否医保】:是【用法用量】:十二指肠溃疡,通常成人每日一次,口服兰索拉唑15mg~30mg,连续服用4~6周;胃溃疡、反流性食管炎、卓-艾综合征(Zollinger-Ellison症候群)、吻合口部溃疡,通常成人每日一次,口服兰索拉唑30mg,连续服用6~8周。

兰索拉唑片(泰左欣)的说明书

兰索拉唑片(泰左欣)的说明书

兰索拉唑片(泰左欣)的说明书
肠胃的重要性是不言而喻的,中国古代人对于肠胃的养生保健是非常重视的,只有大便通畅,脾胃安宁,才能更好的预防其他疾病,肠胃是为我们人类提供能量的重要场所。

如今推出了一种叫做兰索拉唑片(泰左欣)的肠胃药,它能有效治愈您的肠胃疾病,还能起到一定的预防保健作用。

【药品名称】
通用名称:兰索拉唑片
商品名称:兰索拉唑片(泰左欣)
【适应症/功能主治】胃溃疡、十二指肠溃疡、反流性食管炎、佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)。

【规格型号】30mg*7s
【用法用量】治疗胃溃疡和十二指肠溃疡,每日清晨口服1次,一次15~30mg。

或遵医嘱。

【有效期】0 月
【批准文号】国药准字H20113166
【生产企业】南京海辰药业股份有限公司
综上所述,您对于兰索拉唑片(泰左欣)这种肠胃药有了一个全面的了解了吗?治疗肠胃疾病我们一定不能盲目用药,只有选择科学正规的药物,并且遵循医生的用药原则才能很好的治愈您的疾病,切勿讳疾忌医。

兰索拉唑肠溶片(兰悉多)的说明书

兰索拉唑肠溶片(兰悉多)的说明书

兰索拉唑肠溶片(兰悉多)的说明书民以食为天,身体是革命的本钱,肠胃不好的话容易造成身体各方面出现病变。

饮食不合理容易导致肠胃疾病的发生,肠胃不好的话对于食物的吸收也是个问题。

所以我们一定要保证肠胃的健康,今天,我们为您介绍一种叫做兰索拉唑肠溶片(兰悉多)的药物,该药物就是肠胃特效药当中比较好的一种,下面来看看介绍。

【药品名称】通用名称:兰索拉唑肠溶片商品名称:兰索拉唑肠溶片(兰悉多)拼音全码:LanSuoLaZuoPian(LanXiDuo)【主要成份】本品主要成份为兰索拉唑。

化学名:2-[[[3-甲基-4-(2,2,2-三氟乙氧基)-2-吡啶基]甲基]亚磺酰基]-1H -苯并咪唑。

分子式:C16H14F3N3O2S分子量:369.37【性状】本品为肠溶片,除去肠溶衣后显白色至淡黄褐色。

【适应症/功能主治】胃溃疡、十二指肠溃疡、反流性食管炎、佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)。

【规格型号】15mg*7s【用法用量】口服,不可咀嚼。

1.通常成人口服兰索拉唑片,每日一次,一次1至2片(12-30mg)。

2.十二指肠溃疡,需连续服用4-6周。

3.胃溃疡、反流性食管炎、卓-艾综合征,需连续服用6-8周;或遵医嘱。

【不良反应】副作用轻微,主要表现为口干、头晕、恶心。

【禁忌】对本品过敏者禁用。

【注意事项】曾发生药物过敏症的患者及肝机能障碍的患者应慎重用药。

【儿童用药】对小儿的安全性尚未被确立(由于在小儿的临床经验极少)。

【老年患者用药】老年患者的胃酸分泌能力和其他生理机能均会降低,故用药期间请注意观察。

【孕妇及哺乳期妇女用药】孕妇、哺乳期妇女忌用。

【药物相互作用】会延迟安定(diazepam)及苯妥英钠(phenytoin Sodium)的代谢与排泄,资料已被发表于类似药物奥美拉唑的报告中。

【药物过量】未进行该项实验且无可靠文献。

【药理毒理】该品为新型的抑制胃酸分泌的药物,它作用于胃壁细胞的H+-K+-ATP酶,使壁细胞的H+不能转运到胃中去,以致胃液中胃酸量大为减少,临床上用于十二指肠溃疡、胃溃疡、反流性食管炎,佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)的治疗,疗效显著,对幽门螺杆菌有抑制作用。

兰索拉唑胶囊说明书

兰索拉唑胶囊说明书

兰索拉唑胶囊说明书兰索拉唑胶囊(南国春)用于胃溃疡、十二指肠溃疡、返流性食道炎、卓-艾综合征(Zollinger-Ellison症候群)、吻合口溃疡。

下面是学习啦小编整理的兰索拉唑胶囊说明书,欢迎阅读。

兰索拉唑胶囊商品介绍通用名:兰索拉唑胶囊生产厂家: 湖北潜龙药业有限公司批准文号:国药准字H20084570药品规格:15mg*7粒药品价格:¥32元兰索拉唑胶囊说明书【通用名称】兰索拉唑胶囊【商品名称】兰索拉唑胶囊(南国春)【英文名称】LansoprazoleCapsules【拼音全码】LanSuoLaZuoJiaoNang(NanGuoChun)【主要成份】兰索拉唑胶囊(南国春)主要成份为兰索拉唑。

化学名:2-[[[3-甲基-4-(2,2,2-三氟乙氧基)-2-吡啶基]甲基]亚磺酰基]-1H-苯并咪唑。

分子式:C16H14F3N3O2S分子量:369.37【性状】兰索拉唑胶囊(南国春)为白色胶囊,内容物为白色或类白色肠溶球状颗粒。

【适应症/功能主治】胃溃疡、十二指肠溃疡、返流性食道炎、卓-艾综合征(Zollinger-Ellison症候群)、吻合口溃疡。

【规格型号】15mg*7s【用法用量】十二指肠溃疡,通常成人每日一次,口服兰索拉唑15mg~30mg,连续服用4~6周;胃溃疡、反流性食管。

【不良反应】1.过敏症:偶有皮疹、瘙痒等症状,如出现上述症状时请停止用药。

2.肝脏:偶有GOT、GPT、AL-P、LDH、γ-GTP上升等现象,所以须细心观察,如有异常现象应采取停药等适应的处置。

3.血液:偶有贫血、白细胞减少,嗜酸球增多等症状,血小板减少之症状极少发生。

4.消化器:偶有便秘,腹泻,口渴,腹胀等症状。

5.精神神经系:偶尔头痛、嗜睡等症状。

失眠,头晕等症状极少发生。

6.其他:偶有发热,总胆固醇上升,尿酸上升等症状。

【禁忌】对兰索拉唑胶囊(南国春)过敏者禁用。

【注意事项】1.治疗过程中应注意观察,因长期使用的经验不足,暂不推荐用于维持治疗。

注射用兰索拉有什么作用

注射用兰索拉有什么作用

注射用兰索拉有什么作用我们日常生活中食用太多酸的食物会引起胃酸,这时不仅要注意保暖更要用药物治疗。

注射用兰索拉是一种白色或着类白色疏松块状物或粉末状药物。

它是一种处方药,抑制胃酸分泌。

最好用于口服治疗法,需要限制注射次数,会引起不良反应,不适用的伴有出血的十二指肠溃疡。

在使用的时候,应该格外注意。

下面介绍一下注射用兰索拉的具体情况。

★1.成份本品主要成份为兰索拉唑。

化学名称:2-[[[3-甲基-4-(2,2,2-三氟乙氧基)-2-吡啶基]甲基]亚磺酰基-1H-苯并咪唑。

★2.适应症用于口服疗法不适用的伴有出血的十二指肠溃疡。

★3.用法用量静脉滴注:通常成年人一次30mg,用0.9%氯化钠注射液100ml溶解后,一日2次,推荐静滴时间30分钟,疗程不超过7天。

★使用时注意:★(1)本品静滴使用时应配有孔径为1.2μm的过滤器,以便去除输液过程中可能产生的沉淀物。

这些沉淀物有可能引起小血管栓塞而产生严重后果。

★(2)在喷出性或涌出性大量出血、血管暴露等危险性大的情况下,应先采用内窥镜下止血措施。

(3)本品仅用于静脉滴注。

溶解后应尽快使用,勿保存。

避免与0.9%氯化钠注射液以外的液体和其他药物混合静滴。

★(4)经本品治疗的前3日内达到止血效果的,应改用口服用药,不可无限制静脉给药。

★4.不良反应国内临床研究中,本品一日2次,每次30mg静脉滴注,5天疗程。

127例受试者中发生4例(3.64%)不良反应,主要是白细胞减少(1.82%)、转氨酶轻度升高(0.91%)和皮疹(0.91%)。

白细胞减少者一周后复查正常,转氨酶轻度升高者十天后复查正常。

国外上市后超过1000名患者使用注射用兰索拉唑后有较好的耐受性。

在美国4个临床试验中有161名患者使用注射用兰索拉唑,超过1%的不良反应有恶心(1.3%)、头痛(1%)、注射部位痛感(1%);低于1%的不良反应有腹痛、腹泻、消化不良、呕吐、头晕、感觉异常、味觉异常、皮疹和血管扩张。

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兰索拉唑片(可意林)的说明书
生活交际当中难免遇到吃喝聚会,因此一部分人的胃肠疾病也就接踵而至了。

目前治疗胃肠疾病最好的药物当属兰索拉唑片(可意林)了,它对于人体没有任何副作用,您可以放心使用。

针对胃肠疾病比较严重的患者,我们极力推荐您使用兰索拉唑片(可意林)进行治疗,其效果立竿见影。

【药品名称】
通用名称:兰索拉唑片
商品名称:兰索拉唑片(可意林)
英文名称:Lansoprazole Tablets
拼音全码:LanSuoLaZuoPian(KeYiLin)
【主要成份】本品主要成份为兰索拉唑。

化学名:(+)-2[3—甲基—4—(2,2,2—三氟乙氧基)—2吡啶基]—1H—苯并咪唑。

【成份】
分子式:C16H14F3N3O2S
分子量:369.37
【性状】该品为肠溶片,除去包衣后显白色或类白色。

【适应症/功能主治】胃溃疡、十二指肠溃疡、反流性食管炎、佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)。

【规格型号】15mg*14s
【用法用量】治疗胃溃疡和十二指肠溃疡,每日清晨口服1次,一次15~30mg。

或遵医嘱。

【不良反应】本品副作用轻微,主要表现为口干、头晕、恶心。

【禁忌】孕妇、哺乳期妇女忌用。

【注意事项】1、治疗过程中应注意观察,因长期使用的经验不足,暂不推荐用于维持治疗。

2、本品服用时请不要嚼碎,应整
片用水吞服。

3、下列患者慎重用药。

(1)曾发生药物过敏症的患者。

(2)肝肾功能障碍的患者。

4、因本药会掩盖胃癌的症状,所以须先排除胃癌,方可给药。

【儿童用药】遵医嘱。

【老年患者用药】遵医嘱。

【孕妇及哺乳期妇女用药】孕妇、哺乳期妇女忌用。

【药物相互作用】如与其他药物同时使用可能会发生药物相互作用,详情请咨询医师或药师。

【药物过量】尚不明确。

【药理毒理】该品为新型的抑制胃酸分泌的药物,它作用于胃壁细胞的H+-K+-ATP酶,使壁细胞的H+不能转运到胃中去,以致胃液中胃酸量大为减少,临床上用于十二指肠溃疡、胃溃疡、反流性食管炎,佐-艾(Zollinger-Ellison)综合征(胃泌素瘤)的治疗,疗效显著,对幽门螺杆菌有抑制作用。

【药代动力学】该品口服后1小时左右可在血中检出,达峰时间
为3.6小时,吸收相半衰期为1.3小时,消除相半衰期为2.1小时。

该药从小肠吸收经门脉而广泛分布于以胃壁和小肠壁为中心的各组织中。

该药主要在肝脏被代谢,大多经胆汁于粪中排泄。

原型药及其代谢物在体内无蓄积。

【贮藏】密封。

【包装】每盒14片。

【有效期】24 月
【批准文号】国药准字H20065186
【生产企业】扬子江药业集团四川海蓉药业有限公司
好了,看完上面的内容介绍,您是否对于兰索拉唑片(可意林)
有了一个比较全面的认识呢?治疗胃肠疾病属于常见的现象,许多人都患有胃肠疾病,治疗是刻不容缓的,选择最好的药物往往能达到最理想的治疗结果。

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