部份奥美拉唑碳酸氢钠中文处方资料（仅供参考）
药品名称： 复方奥美拉唑碳酸氢钠
适应症：用于十二指肠溃疡、胃溃疡、胃食管返流病(GERD)、腐蚀性食管炎的维持治 疗以及减少危重患者上消化道出血的风险。
用法用量：
本品应空腹（餐前至少1小时）服用，一天服用一次。
复方优势：
本品是质子泵抑制剂(PPI)口服迅速释放制剂，能迅速中和胃酸，且有效而持久的抑制胃酸分泌。
国内外研究情况及上市情况
1、消化性溃疡的治疗现状
消化性溃疡是一种常见病和多发病，全世界大约有5% ~ 6%的人患过此病。虽然近年来治疗消化性溃疡的药物进展很快，但是最古老的抗酸药在溃疡病的治疗上仍有相应的地位，抗酸剂主要是一些无机弱碱，常用药物有碳酸氢钠、氢氧化镁、三硅酸镁等，口服后能直接中和胃酸，可减轻或解除胃酸对溃疡面的刺激和腐蚀作用；70年代西咪替丁等H2受体拮抗剂的出现，使消化性溃疡并发症的发生率明显下降；80年代H+-K+-ATP酶(质子泵)抑制剂的问世，使消化性溃疡的治疗取得突破性进展，成为目前最强的新型抑酸药物。奥美拉唑等质子泵抑制剂开辟了治疗消化性溃疡的新作用途径，使消化性溃疡的治疗不再是难题。由于国产奥美拉唑具有疗效显著、复发率低、不良反应少、溃疡愈合比H2受体拮抗剂更快，且溃疡愈合率更高及服用方便等特点，临床应用日趋广泛。
2、复方奥美拉唑碳酸氢钠的药理作用机制及其治疗优势
碳酸氢钠为临床常用抗酸剂，口服后能直接中和胃酸，可减轻或解除胃酸对溃疡面的刺激和腐蚀作用，具有价格低廉、制酸迅速的特点。
奥美拉唑为脂溶性弱碱性药物，口服后可特异地分布于胃黏膜壁细胞的分泌小管中，并在此高酸环境下转化为亚磺酞胺的活性形式，然后通过二硫键与壁细胞分泌膜中的H+-K+-ATP酶的巯基呈不可逆性的结合，生成亚磺酞胺与质子泵的复合物，从而抑制该酶活性阻断胃酸分泌。此外，还能提高胃黏膜电位，维持胃细胞的稳定，保护胃黏膜屏障，利于胃、十二指肠病变黏膜的修复及止血。
由于奥美拉唑在酸性环境下不稳定，因此此前上市的奥美拉唑剂型多为肠溶制剂，采用包肠溶衣来保护药物免受酸降解，但其延缓了药物的吸收和对胃酸的初始抑制作用。将奥美拉唑与碳酸氢钠作为复方制剂，药理作用独特，设计巧妙，碳酸氢钠能快速中和胃酸，即刻缓解溃疡症状，还能提高胃内的pH值，避免奥美拉唑胃内遇酸降解，快速被吸收入血，从而延长奥美拉唑的作用时间，长久抑制胃酸分泌，得到理想的治疗结果。
本品是首个和唯一的质子泵抑制剂(PPI)口服迅速释放制剂，是唯一获准用于临床危重患者使用的口服PPI，为医生和患者提供了速释和强效的大剂量制剂，它能持续控制胃酸分泌，使胃液pH保持在4.0以上达18.6 h。血药浓度达峰时间约在口服后30 min内，可整日有效控制胃酸。每天口服1次奥美拉唑碳酸氢钠40 mg，除可控制白天胃酸分泌外，还可有效地控制夜间胃酸(夜间平均pH 4.1，24小时内为pH 4.7)，其治疗优势之强悍，显而易见！
Indication for ZEGERID
ZEGERID® (omeprazole/sodium bicarbonate) is a prescription medicine called a proton pump inhibitor (PPI). ZEGERID reduces the amount of acid in your stomach.
ZEGERID is used in adults for:
•short term to heal ulcers in the first part of the small bowel (duodenal ulcers).
•short term healing of stomach ulcers.
•treatment of heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
•healing of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE).
•maintenance of healing of the esophagus. It is not known if ZEGERID is safe and effective if used longer than 12 months (1 year).
•reduction of the risk of stomach bleeding in critically ill people.
Important Safety Information about ZEGERID
Do not take ZEGERID® (omeprazole/sodium bicarbonate) if you are allergic to omeprazole or any of the other ingredients in ZEGERID, or are allergic to any other proton pump inhibitor (PPI) medicine.
Before you take ZEGERID, tell your doctor if you have been told that you have low magnesium, calcium, or potassium levels in your blood, liver problems, heart failure, or have Bartter’s syndrome (a rare kidney disorder).
Tell your doctor about all the medicines you take, including prescription and non-prescription drugs, anti-cancer drugs, vitamins and herbal supplements. ZEGERID may affect how other medicines work, and other medicines may affect how ZEGERID works. This can cause serious side effects. Be sure to tell your doctor if you are taking:
•Mycophenolate mofetil (Cellcept)
•diazepam (Valium®)
•warfarin (Coumadin® Jantoven)
•phenytoin (Dilantin®)
•cyclosporine (Gengraf, Neoral, Sandimmune)
•disulfiram (Antabuse®)
•a benzodiazepine medicine
•ketoconazole (Nizoral®)
•an antibiotic that contains ampicillin
•products that contain irondigoxin (Lanoxin®)
•voriconazole (Vfend®)
•atazanavir (Reyataz®)
•nelfinavir (Viracept®)
•tacrolimus (Prograf®)
•saquinavir (Fortovase®)
•clarithromycin (Biaxin®, Biaxin XL)
•clopidogrel (Plavix®)
•St. John's Wort (Hypericum perforatum)
•rifampin (Rifater, Rifamate, Rimactane, Rifadin)
•methotrexate
Do not substitute two 20 mg capsules for one 40 mg capsule of ZEGERID because you will receive twice the amount of sodium bicarbonate. Do not substitute two 20 mg packets for one 40 mg packet of ZEGERID Powder for Oral Suspension because you will receive twice the amount of sodium bicarbonate.
Taking ZEGERID for a long period of time may increase the risk of inflammation to your stomach lining (atrophic gastritis). You may or may not have symptoms. Tell your doctor if you have stomach pain, nausea, vomiting, or weight loss.
ZEGERID may cause vitamin B-12 deficiency. ZEGERID reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on ZEGERID for a long time (more than 3 years).
Your doctor may stop ZEGERID if you have low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.
People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.
If you are on a low-sodium diet or at risk of developing congestive heart failure (CHF), you and your doctor should decide if you will take ZEGERID.
It is not known if ZEGERID is safe and effective in children and adolescents less than 18 years of age.
If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking ZEGERID. It is unknown if ZEGERID can harm your unborn baby.
The most common side effects with ZEGERID include headache, abdominal pain, nausea, diarrhea, vomiting, and gas. However, tell your doctor right away if you develop the following symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, spasm of the voice box.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
ZEGERID ® (omeprazole / sodium bicarbonate) is the first and only immediate-release oral PPIs. Santarus has received FDA approval of ZEGERID for Capsules® and Powder for Oral Suspension dosage forms. Santarus obtain FDA approval of ZEGERID ® capsules and bulk oral suspension dosage forms. These products are intended to treat or prevent a variety of upper GI diseases and disorders. The purpose of these products is the treatment or prevention of various diseases and upper gastrointestinal diseases. PPIs are used widely due to their potent acid suppression, demonstrated safety and once-a-day dosing. The producer price index is widely used due to its strong acid suppression, indicating that safety and once-daily dose.
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. Santarus received FDA approval ZEGERID capsules in February 2006, ZEGERID Powder for Oral Suspension 40 mg, in December 2004, and ZEGERID Powder for Oral Suspension 20 mg in June 2004.
ZEGERID Capsules and Powder for Oral Suspension dosage forms are immediate-release formulations, providing rapid absorption of omeprazole and continued acid control. ZEGERID capsules and powder for oral suspension dosage form is an immediate release formulation of omeprazole and continue to be able to quickly absorb acid control . The immediate-release formulation of ZEGERID is unique. ZEGERID immediate release formulation is unique. Except for ZEGERID, all other oral PPIs are delayed release, and require enteric coatings to protect against acid degradation. In addition ZEGERID, all other oral PPIs are delayed release, and asked intestinal coating to prevent acid degradation. These enteric coatings delay absorption and initial acid suppression. These coatings delay intestinal 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. Santarus exclusive license in the world, enjoy specific formulation patents and patent applications related to the the immediate release of the University of gastrointestinal diseases and disorders of Missouri on price index and producer antacid treatment. The initially issued US patents on which our ZEGERID products are based, expire in U.S. Patent ZEGERID July 2016. Originally released on the basis of our products, expires in July 2016.
ZEGERID (omeprazole / sodium bicarbonate) is indicated for: ZEGERID (omeprazole / sodium bicarbonate) is applicable to:
Short-term treatment of active duodenal ulcer short-term treatment of active duodenal ulcer
Short-term treatment (4-8 weeks) of active benign gastric ulcer short-term treatment (4-8 weeks) of active benign gastric ulcer
Heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) 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 short-term treatment (4-8 weeks) of erosive esophagitis had endoscopic diagnosis
Maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months) to maintain healing of erosive esophagitis (controlled studies no more than 12 months)
Reduction of critically ill patients on the risk of upper GI bleeding in critically ill patients (powder for oral suspension only) to reduce the risk of gastrointestinal bleeding (powder for oral suspension only)
On 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. ZEGERID Powder for Oral Suspension 40 mg / 1680 mg is the only FDA approved to reduce the risk of prices upper gastrointestinal bleeding in critically ill patients.
Product Description 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. ZEGERID ® (omeprazole / sodium bicarbonate ) contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate antacids, which raises the gastric pH, thereby protecting the omeprazole acid degradation.
Indications and Dosing for ZEGERID flag and ingredients 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 eva luated). ZEGERID for heartburn and other symptoms and gastroesophageal reflux disease (GERD) (20 mg) for short-term treatment (4-8 weeks) of erosive esophagitis endoscopic diagnosis (20 mg); for maintenance of healing of erosive esophagitis (20 mg) (Control Study no more than 12 months); the 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) ; on critically ill patients and reduce the risk of gastrointestinal bleeding (only powder for oral suspension 40 mg / 1680 mg; using more than 14 days have not been eva luated).
Important Safety Information about ZEGERID important safety information ZEGERID
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. ZEGERID adverse events most frequently reported were headache, diarrhea, 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. 178 个 critically ill patients ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical conditions of patients, but some of the frequency of adverse events in patients with more ZEGERID Powder treatment than those who compare oral suspension (acid control) of the drug. For more information about these and other events, please see Table 13 of the full Prescribing Information. For more information on these and other activities, see Table 13 of the full prescribing information. Symptomatic response to therapy does not preclude the presence of gastric malignancy. 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. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from the patients with long-term omeprazole.
ZEGERID Capsules contain 304 mg of sodium per dose. ZEGERID capsules containing 304 milligrams of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 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. It should take into account the patient's sodium-restricted diet.
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. Sodium bicarbonate in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in any part of the patients with known hypersensitivity to any component of the formulation. Patients ZEGERID known allergy 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. Because both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg capsules, 1680 mg packet powder for oral suspension), two 20 mg capsules is not equal to, and should not be substituted, a 40 mg capsule, and the two packages is not equal to 20 mg, and should not be substituted, a pack 40 mg.