What is ZEGERID? ZEGERID Capsules and Powder for Oral Suspension contain omeprazole, a proton pump inhibitor and sodium bicarbonate, an antacid. This unique formulation provides a built-in buffer that protects omeprazole from acid degradation while facilitating immediate release of omeprazole and rapid onset of initial acid suppression.1,2 All other oral PPIs, including oral suspensions, disintegrating tablets, and capsules are delayed release.3-7 The only oral PPI that provides immediate release with the power of continued acid control. Product Description ZEGERID contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects omeprazole from acid degradation. Indications and Dosing for ZEGERID ZEGERID is indicated for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) (20 mg QD); for the short-term treatment (4-8 weeks) of erosive esophagitis diagnosed by endoscopy (20 mg QD); for maintenance of healing of erosive esophagitis (20 mg QD) (controlled studies do not extend beyond 12 months); for short-term treatment (4-8 weeks) of active duodenal ulcer (20 mg QD); for short-term treatment (4-8 weeks) of active benign gastric ulcer (40 mg QD); and for reduction of risk of upper gastrointestinal bleeding in critically ill patients (only powder for oral suspension 40 mg/1680 mg QD; use beyond 14 days has not been evaluated). Important Safety Information about ZEGERID The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with ZEGERID and with the comparator (acid-controlling) drug. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole. ZEGERID Capsules contain 303 mg of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation. Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet. 【原产地英文商品名】ZEGERID Powder Oral Suspension (40mg+1680mg)x30 packs 【原产地英文药品名】Omeprazole/Sodium Bicarbonate Powder for Oral Suspension 【原产地英文化合物名称】Omeprazole/Sodium Bicarbonate 【中文参考商品译名】 注：以下药品不同的规格及不同价格，购买时请以电话咨询为准 ·复方奥美拉唑口服混悬剂粉(40毫克+1680毫克碳酸氢钠)/袋,30袋/盒 ·复方奥美拉唑口服混悬剂粉(20毫克+1680毫克碳酸氢钠)/袋,30袋/盒 【中文参考药品译名】复方奥美拉唑/碳酸氢钠口服混悬剂粉末 【中文参考化合物名称】奥美拉唑/碳酸氢钠 【生产厂家中文参考译名】美国桑塔茹斯公司 【生产厂家英文名】SANTARUS,INC. 美国FDA批准桑塔茹斯（Santarus）公司的奥美拉（omeprazole）40mg供配制口服混悬剂的散剂（Zegerid）上市，用于减少危急患者上消化道出血和短期（4～6周）治疗良性活动期胃溃疡。 本品是首个和唯一的质子泵抑制药（PPI）口服速释制剂，是唯一获准用于临床危急患者用药的PPI。该公司计划在2005年第一季度销售Zegerid口服干混悬剂40mg。该产品是其获准上市的第二个产品，Zegerid口服干混悬剂20mg已在2004年10月上市。 桑塔茹斯公司总裁Proehl称，随着Zegerid 40mg的批准，可向医生和病人提供速释和强效的大剂量制剂，持续控制胃酸，使胃液pH值保持在4.0以上达18.6小时。Zegerid 40mg上市将在120亿美元的PPI市场上赢得一席之地。 Zegerid口服干混悬剂已批准20和40mg2种剂量上市，此奥美拉唑速释制剂血药达峰时间约在口服后30分钟内，可整日有效控制胃酸。一日1次Zegerid 40mg除白日可控制胃酸外，还可有效地控制夜间胃酸（夜间平均pH4.1，24小时内为pH4.7）。 Zegerid专利制剂采用抗酸技术避免奥美拉唑在胃内遇酸降解，使药物快速被吸收进入血液循环。所有其他上市的口服PPI均是利用肠溶包衣制成的缓释制剂防止药物降解，故延缓吸收和初始抑酸。 --------------------------------------------------------------------- Santarus公司宣布，FDA已批准其Zegerid胶囊（奥美拉唑／碳酸氢钠）的新药申请，该药为质子泵速效抑制剂（PPI）。至此，Santarus公司所申请的该药的所有适应症均已通过批准。   Zegerid胶囊用于治疗胃酸过多、胃食管反流病、糜烂性食道炎（作为短期治疗药）、活动性胃溃疡和活动性十二指肠溃疡（作为短期治疗药）等疾病。   Zegerid的产品线包括口服混悬剂粉末和胶囊。目前市场上销售的其他PPI类产品均为缓释药物，通过一种肠溶衣防止药物发生酸降解，而Zegerid则利用碳酸氢钠防止Omeprazole被胃酸降解，在抑制胃酸的同时使奥美拉唑快速地被吸收。该产品不但药理独特，而且服用方便，服药后人体的血药浓度很快就能达到峰值水平，并能够有效地控制胃酸。