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部分中文Zegerid OTC处方资料（仅供参考）
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【项目名称】：复方奥美拉唑胶囊（奥美拉唑碳酸氢钠胶囊）、复方奥美拉唑咀嚼片
【注册类别】：化药3.2类
2006年2月27日，FDA批准了复方速释质子泵抑制剂奥美拉唑胶囊（商品名：Zegerid）的新药申请，目前上市的Zegerid有口服混悬剂和胶囊、咀嚼片三个剂型。
【药理】：奥美拉唑为质子泵抑制剂。本品为脂溶性弱碱性药物，易浓集于酸性环境中，因此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酰胺的活性形式，然后通过二硫键与壁细胞分泌膜中的H+，K+-ATP酶（又称质子泵）的巯基呈不可逆性的结合，生成亚磺酰胺与质子泵的复合物，从而抑制该酶活性，阻断胃酸分泌的最后步骤，因此本品对各种原因引起的胃酸分泌具有强而持久的抑制作用。口服碳酸氢钠能迅速中和或缓冲胃酸，而不直接影响胃酸分泌，因而胃内pH 迅速升高缓解高胃酸引起的症状。奥美拉唑对各种原因引起的胃酸分泌具有强而持久的抑制作用；而碳酸氢钠为临床上常用的制酸剂，快速中和胃酸。
【本品特点】：该产品不但药理作用独特，而且服用方便，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。本品可用于治疗反流性食管炎、功能性消化不良、胃溃疡、十二指肠溃疡等。有效率达96％ ，其疗程短，疗效高，不良反应少，是易为病人接受的治疗药物。
【适应症】：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、腐蚀性食管炎的维持治疗。
【规格】奥美拉唑/碳酸氢钠，20mg/1100mg ， 40mg/1100mg
【临床疗效】在一项对293例内镜检查确诊的十二指肠溃疡患者进行的多中心双盲研究中，服用复方奥美拉唑胶囊（20mg）一日1次第4周时患者治愈率较服用雷尼替丁150mg一日2次显著高，服用复方奥美拉唑患者的治愈较服用雷尼替丁150mg一日2次显著快（P＜0.01）。

FDA Approves Zegerid OTC
The U.S. Food and Drug Administration (FDA) has approved Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), for over-the-counter treatment of frequent heartburn.

Zegerid OTC is a proton pump inhibitor (PPI), the strongest and most effective class of acid-reducing medications available for frequent heartburn. Zegerid OTC treats frequent heartburn by controlling and suppressing acid for a full 24 hours, all day and all night. Zegerid OTC contains a patented dual-ingredient formulation that combines the prescription acid reducing medicine (omeprazole) with sodium bicarbonate, which protects the omeprazole from acid in the stomach.

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What is Zegerid OTC?
Zegerid OTC contains a combination of omeprazole and sodium bicarbonate. Omeprazole decreases the amount of acid your stomach produces. Sodium bicarbonate is an antacid that raises the pH in your stomach to keep the omeprazole from breaking down in stomach acid.

Zegerid OTC is used to treat frequent heartburn (heartburn that occurs 2 or more days a week).

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Important information about Zegerid OTC
Zegerid OTC can change the way your body absorbs or eliminates certain other drugs. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Zegerid OTC contains sodium bicarbonate, a form of salt. Each capsule contains the equivalent of 303 mg of sodium. If you are on a low-salt or low-sodium diet, you may not be able to use Zegerid OTC. Talk with your doctor.

Take Zegerid OTC with water on an empty stomach, at least 1 hour before eating a meal.

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Before taking Zegerid OTC
Allergy alert: Do not use if you are allergic to omeprazole.

Do not use Zegerid OTC if you have:
trouble or pain swallowing food
vomiting with blood
bloody or black stools
These may be signs of a more serious condition. See your doctor.

Ask your doctor before using Zegerid OTC if you have:
heartburn more than 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck, or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
a sodium-restricted diet

Zegerid OTC contains sodium bicarbonate, a form of salt. Each capsule contains the equivalent of 303 mg of sodium. If you are on a low-salt or low-sodium diet, you may not be able to use Zegerid OTC. Talk with your doctor.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Omeprazole can pass into breast milk and may harm a nursing baby. Do not use Zegerid OTC without telling your doctor if you are breast-feeding a baby.

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How should I take Zegerid OTC?
Directions for Use
for use in adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for 14 days
Zegerid OTC is not intended for the immediate relief of heartburn. It may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment
swallow one capsule with a full glass of water at least one hour before eating in the morning
take every day for 14 days
do not take more than one capsule a day
swallow whole, do not crush or chew the capsule
do not open capsule and sprinkle on food
do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)
you may repeat a 14-day course every four months
do not take for more than 14 days or more often than every four months unless directed by a doctor
children under 18 years of age; ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Stop use and ask a doctor if:
your heartburn continues or worsens
you need to take this product for more than 14 days
you need to take more than one course of treatment every 4 months

Take Zegerid OTC only as directed. Do not take it in larger doses or for longer than recommended.

Always follow the directions on package label.

Store this medicine at room temperature away from moisture and heat.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, drowsiness, blurred vision, fast heartbeat, sweating, dry mouth, nausea or vomiting.

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Zegerid OTC side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:
easy bruising or bleeding, unusual weakness; or
fast, slow, or uneven heartbeat.

Less serious Zegerid OTC side effects may include:
headache;
nausea, stomach pain; or
diarrhea or constipation;white patches or sores inside your mouth or on your lips;
mild fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Zegerid OTC?
Ask a doctor or pharmacist before use if you are taking:
warfarin (blood-thinning medicine)
clopidogrel (used to prevent blood clots)
prescription antifungal or anti-yeast medicines
diazepam (anxiety medicine)
digoxin (heart medicine)
phenytoin (seizure medicine)
tacrolimus (immune system medicine)
prescription antiretrovirals (medicines for HIV infection)
any other prescription drugs. Sodium bicarbonate may interact with certain prescription drugs

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Where can I get more information?
Your pharmacist can provide more information about Zegerid OTC.

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Other Information
read the directions, warnings and accompanying label information before use
store at 20-25°C (68-77°F)
tamper evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with "Sealed for your protection" is missing, open or broken.
keep product out of high heat and humidity
protect product from moisture
Keep out of the reach of children.

Inactive Ingredients
croscarmellose sodium, FD&C blue No. 1, gelatin, magnesium stearate, pharmaceutical ink, polysorbate 80, titanium dioxide

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