制造商:
泉生古治疗
类药物:
质子泵抑制剂+抗生素(大环内酯类+青霉素)。
活性成分(S):
奥美拉唑20mg(2 DEL-REL含有肠溶颗粒的上限),克拉霉素500毫克(2标签),阿莫西林500毫克(4帽);每日常管理卡。
指示(S):
治疗的患者与幽门螺旋杆菌感染和十二指肠球部溃疡病(主动或一年的历史),以根除幽门螺旋杆菌。
药理作用:
奥美拉唑,取代苯并咪唑的抑酸药物,抑制胃酸分泌特异性抑制胃壁细胞分泌表面的H + / K + ATP酶的酶系统。奥美拉唑,因为这种酶系统胃黏膜内的酸(质子)泵,已具有作为胃酸泵抑制剂,因为它阻止了硫酸生产的最后一步。
克拉发挥其抗菌活性,通过抑制蛋白质的合成,导致敏感微生物的核糖体亚基的50S结合。
阿莫西林通过的合成细胞壁mucopeptide的抑制行为。
临床试验:
美国三大,随机,双盲幽门螺旋杆菌感染和十二指肠溃疡病的患者的临床研究(n = 558)相比,奥美拉唑,加上克拉霉素加阿莫西林与克拉霉素加阿莫西林。两项研究(1和2)进行了积极十二指肠溃疡患者,与其他研究(3)在历史与十二指肠溃疡的患者在过去5年,但无溃疡目前在入学时进行。在研究的剂量方案是奥美拉唑20mg,每天两次,加上克拉霉素500毫克,每天两次加阿莫西林1克,每天两次为10天;或克拉霉素500毫克,每天两次加阿莫西林1克10天每天两次。在研究1和2,患者参加奥美拉唑方案也获得额外的18天奥美拉唑20毫克,每天一次。端点研究根除幽门螺旋杆菌和十二指肠球部溃疡愈合(研究1和2只)。幽门螺旋杆菌的地位是确定由CLOtest,组织学和文化在所有三个研究。对于一个给定的病人,根除幽门螺旋杆菌被认为,如果这些测试中至少有两个结果均为阴性,并没有呈阳性。
奥美拉唑+阿莫西林,克拉霉素加相结合,有效地根除幽门螺旋杆菌。
法律分类:
RX
成人:
吞下。就饿着肚子。奥美拉唑20mg +克拉霉素500毫克+阿莫西林1G,每天两次为10天(上午+下午)。
儿童:
不成立的。
禁忌症(S):
伴随ergots,匹莫齐特。
警告/注意事项:
肝功能损害,亚洲患者:避免。重症肌无力(显示器)。单核细胞增多。肾功能不全。怀孕(Cat.C)。哺乳母亲:不推荐。
互动(补):
见禁忌。克拉霉素:心律失常伴匹莫齐特。与ergots血管痉挛和缺血。秋水仙碱毒性(尤其是老年人)。尖端扭转与奎尼丁,丙吡胺。 Potentiates地高辛,茶碱,卡马西平,西地那非,他汀类药物(洛伐他汀,辛伐他汀)。显示器QT间期延长,同时抗心律失常药物。会增强口服抗凝血剂。中枢神经系统的影响与triazolobenziodidiazepines(如三唑仑,阿普唑仑)和苯二氮(例如,咪唑安定)。奥美拉唑:增加INR和随之而来的华法林的PT。拮抗阿扎那韦,奈非那韦:不建议。考虑伴随沙奎那韦,西洛他唑的剂量减少。 Potentiates他克莫司;显示器。可能会干扰药物吸收,其中胃的pH值是很重要的(如,酮康唑,氨苄西林酯,铁盐)。阿莫西林:由丙磺舒Potentiated的。可能会干扰尿液中使用Clinitest,本笃或斐林的解决方案的血糖测试。
不良反应(S):
腹泻,味觉异常,头痛;二重感染(停止,如果发生),艰难梭菌相关性腹泻。
如何提供:
日常管理卡-1,10
最后更新:
2012年6月11日
Manufacturer:
Pernix Therapeutics
Pharmacological Class:
Proton pump inhibitor + antibiotics (macrolide + penicillin).
Active Ingredient(s):
Omeprazole 20mg (2 del-rel caps containing enteric-coated granules), clarithromycin 500mg (2 tabs), amoxicillin 500mg (4 caps); per daily administration card.
Indication(s):
Treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori.
Pharmacology:
Omeprazole, an antisecretory drug with the substituted benzimidazoles, suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.
Clarithromycin exerts its antibacterial activity by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis.
Amoxicillin acts through the inhibition of biosynthesis of cell wall mucopeptide.
Clinical Trials:
Three U.S., randomized, double-blind clinical studies in patients with H. pylori infection and duodenal ulcer disease (n = 558) compared omeprazole plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study (3) was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The dose regimen in the studies was omeprazole 20mg twice daily plus clarithromycin 500mg twice daily plus amoxicillin 1g twice daily for 10 days; or clarithromycin 500mg twice daily plus amoxicillin 1g twice daily for 10 days. In Studies 1 and 2, patients who took the omeprazole regimen also received an additional 18 days of omeprazole 20mg once daily. Endpoints studied were eradication of H. pylori and duodenal ulcer healing (Studies 1 and 2 only). H. pylori status was determined by CLOtest, histology and culture in all three studies. For a given patient, H. pylori was considered eradicated if at least two of these tests were negative and none was positive.
The combination of omeprazole plus clarithromycin plus amoxicillin, was effective in eradicating H. pylori.
Legal Classification:
Rx
Adults:
Swallow whole. Take on an empty stomach. Omeprazole 20mg + clarithromycin 500mg + amoxicillin 1g, all twice daily (AM + PM) for 10 days.
Children:
Not established.
Contraindication(s):
Concomitant ergots, pimozide.
Warnings/Precautions:
Hepatic impairment, Asian patients: avoid. Myasthenia gravis (monitor). Mononucleosis. Renal impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interaction(s):
See Contraindications. Clarithromycin: cardiac arrhythmias possible with concomitant pimozide. Vasospasm and ischemia with ergots. Colchicine toxicity (esp. in elderly). Torsades de pointes with quinidine, disopyramide. Potentiates digoxin, theophylline, carbamazepine, sildenafil, statins (lovastatin, simvastatin). Monitor QT prolongation with concomitant antiarrhythmics. May potentiate oral anticoagulants. CNS effects with triazolobenziodidiazepines (eg, triazolam, alprazolam) and benzodiazepines (eg, midazolam). Omeprazole: Increased INR and PT with concomitant warfarin. Antagonizes atazanavir, nelfinavir: not recommended. Consider dose reduction of concomitant saquinavir, cilostazol. Potentiates tacrolimus; monitor. May interfere with absorption of drugs for which gastric pH is important (eg, ketoconazole, ampicillin esters, iron salts). Amoxicillin: Potentiated by probenecid. May interfere with testing for glucose in urine using Clinitest, Benedict's or Fehling's Solution.
Adverse Reaction(s):
Diarrhea, taste perversion, headache; superinfection (discontinue if occurs), C. difficile-associated diarrhea.
How Supplied:
Daily administration card—1, 10