ntarus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 ...
      
  ntarus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。 

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  2006年2月27日，专注于胃肠道药物开发的Santarus公司宣布，即释型质子泵抑制剂ZEGERID胶囊（奥美拉唑/碳酸氢钠）的新药申请获得FDA的批准，Zegerid胶囊用于治疗胃酸过多、胃食管反流病、糜烂性食道炎（4-8周短期治疗，经内窥镜检查）、良性活动性胃溃疡和活动性十二指肠溃疡等疾病。
  ZEGERID在空腹（至少餐前1小时）服用，一天只需服用一次，能迅速达到最大血药浓度（约30分钟以内），强效控制胃酸，其中抗酸剂碳酸氢钠能提高胃内pH值从而保护质子泵抑制剂奥美拉唑被酸降解。
  目前上市的ZEGERID有口服混悬剂和胶囊两个剂型。ZEGERID胶囊分奥美拉唑/碳酸氢钠：40mg/1100mg和20mg/1100mg两个规格。
美国FDA批准桑塔茹斯（Santarus）公司的奥美拉唑（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Zegerid40mg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。Zegerid40mg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Zegerid40mg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。

Products

ZEGERID® (omeprazole/sodium bicarbonate) is the First and Only Immediate- Release oral PPI. Santarus has received FDA approval of ZEGERID for Capsules® and Powder for Oral Suspension dosage forms. These products are intended to treat or prevent a variety of upper GI diseases and disorders. PPIs are used widely due to their potent acid suppression, demonstrated safety and once-a-day dosing.

Santarus received FDA approval for ZEGERID Capsules in February of 2006, ZEGERID Powder for Oral Suspension 40 mg in December of 2004, and ZEGERID Powder for Oral Suspension 20 mg in June of 2004.

ZEGERID Capsules and Powder for Oral Suspension dosage forms are immediate-release formulations, providing rapid absorption of omeprazole and continued acid control. The immediate-release formulation of ZEGERID is unique. Except for ZEGERID, all other oral PPIs are delayed release, and require enteric coatings to protect against acid degradation. These enteric coatings delay absorption and initial acid suppression.

Santarus has licensed exclusive, worldwide rights to patents and patent applications covering specific formulations of immediate-release PPIs and antacids for treating upper GI diseases and disorders from the University of Missouri. The initially issued U.S. patents on which our ZEGERID products are based, expire in July 2016.

ZEGERID (omeprazole/sodium bicarbonate) is indicated for:

• Short-term treatment of active duodenal ulcer
• Short-term treatment (4-8 weeks) of active benign gastric ulcer
• Heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
• Short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed in endoscopy
• Maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months)
• Reduction of risk of upper GI bleeding in critically ill patients (powder for oral suspension only)

ZEGERID Powder for Oral Suspension 40 mg/1680 mg is the only FDA approved PPI for reduction of risk of upper GI bleeding in critically ill patients.


Product Description
ZEGERID® (omeprazole/sodium bicarbonate) 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); for the short-term treatment (4-8 weeks) of erosive esophagitis diagnosed by endoscopy (20 mg); for maintenance of healing of erosive esophagitis (20 mg) (controlled studies do not extend beyond 12 months); for short-term treatment (4-8 weeks) of active duodenal ulcer (20 mg); for short-term treatment (4-8 weeks) of active benign gastric ulcer (40 mg); and for reduction of risk of upper gastrointestinal bleeding in critically ill patients (only powder for oral suspension 40 mg/1680 mg; 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 178 critically ill patients treated with ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, but some adverse events occurred with more frequency in patients treated with ZEGERID Powder for Oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 13 of the full Prescribing Information. 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 304 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.

For the full Prescribing Information please visit www.zegerid.com

Please consult with your healthcare professional to see if ZEGERID is right for you. The content of this website is not a substitute for professional medical advice and should not be interpreted as treatment recommendations or relied on for medical diagnosis or treatment. Please see complete Legal Disclaimer.