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 详细处方信息以本药内容附件PDF文件（2010121418004412.pdf）的“原文Priscribing Information”为准
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部分中文Tribenzor处方资料（仅供参考）

    日本第一三共公司研发的新型复方抗高血压药物Tribenzor获FDA批准用于治疗联合2种常用抗高血压药疗效不佳的难治性患者，Tribenzor由氨氯地平、奥美沙坦酯、氢氯噻嗪组成，能有效降低患者血压，但不作为一线用药。

    日前，美国FDA批准，在应用血管紧张素受体阻滞剂、钙通道阻滞剂和利尿剂中任意2种药物仍无法充分控制患者血压的情况下，可考虑使用三联药物Tribenzor。

    Tribenzor是日本第一三共公司研发的新型复方抗高血压药物，含氨氯地平、奥美沙坦酯、氢氯噻嗪。Tribenzor被FDA批准用于那些应用抗高血压药物的其他组合不能使高血压得到很好控制的患者。但不宜用作一线抗高血压药。

    一项研究试验结果证明了Tribenzor的有效性，该试验共纳入2,492例高血压患者(平均基线血压为168.5/100.9 mmHg)。在患者接受了氨氯地平/氢氯噻嗪(10/25 mg)，奥美沙坦/氢氯噻嗪(40/25 mg)和奥美沙坦/氨氯地平(40/10 mg)这3种双药组合疗法中的其中一种后，医生开始改用Tribenzor(40/10/25 mg)对患者进行抗高血压治疗。在接受了为期8周的Tribenzor治疗后，患者的平均血压进一步降低(分别为8.1/5.4 mmHg、7.6/5.4 mmHg和8.4/4.5 mmHg，对每一种双药组合治疗而言，P值均<0.0001)。

    Tribenzor最常见不良反应包括头晕、外周水肿、头痛、乏力、鼻咽炎、肌肉痉挛、恶心、上呼吸道感染、腹泻、尿道感染和关节肿胀。

    高血压是一种常见的多发性疾病，有效平稳控制血压是目前治疗高血压的主要目标。但在目前接受抗高血压治疗的患者中，大约有56%的患者在血压控制方面并未达到现行推荐目标。此外，有超过66%的高血压患者需要联用2种或2种以上的抗高血压药物方能达到期望的血压控制目标。

    Tribenzor是一种新型的3三联混合型药物，每日只需服药1次，有望简化血压难以控制患者的给药方案，减少药丸负荷，并可以减少整张处方的费用。为难治性高血压患者提供一种更方便有效的治疗方法，一天一次用药能避免患者忘服漏服药物，避免出现血压波动现象.

    Tribenzor禁用于无尿或对其他磺胺类药物过敏的患者。对肾素-血管紧张素业已激活的患者[如那些血容量耗竭和(或)盐耗竭的患者]而言，其一旦开始接受Tribenzor治疗后便有可能发生症状性低血压。当患者(尤其是那些存在严重阻塞性冠状动脉疾病的患者)开始接受钙通道阻滞剂治疗或增加给药剂量时，其可能会出现心绞痛发作频率增高、持续时间延长，或病情严重程度加重，其发生急性心肌梗死的几率也会增高。应该避免对那些存在严重肾功能损害的患者使用Tribenzor。

Tribenzor
Generic Name: amlodipine, hydrochlorothiazide, and olmesartan (am LOE di peen, HYE droe KLOR oh THYE a zide, and OL me SAR tan)
Brand Names: Tribenzor

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What is Tribenzor?
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Tribenzor contains a combination of amlodipine, hydrochlorothiazide, and olmesartan. Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Olmesartan is in a group of drugs called angiotensin II receptor antagonists. Olmesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Tribenzor is used to treat high blood pressure (hypertension). This medication is usually given after others have been tried without successful treatment of hypertension.

Tribenzor may also be used for purposes not listed in this medication guide.

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Important information about Tribenzor?
Do not take Tribenzor if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Do not use Tribenzor if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic), or olmesartan (Benicar), or if you have severe kidney disease, if you are unable to urinate, or if you are allergic to sulfa drugs.

Before you take Tribenzor, tell your doctor if you have kidney or liver disease, congestive heart failure, angina (chest pain), severe coronary artery disease, lupus, diabetes, if you are dehydrated, or if you are vomiting or having diarrhea.

You should not breast-feed while you are taking Tribenzor.

Call your doctor at once if you have any signs of an electrolyte imbalance, such as: headache, trouble concentrating, memory problems, weakness, feeling unsteady, nausea, loss of appetite, extreme thirst, increased urination, leg discomfort, jerking muscle movements, muscle weakness or limp feeling, shallow breathing, uneven heart rate, confusion, feeling tired or restless, hallucinations, fainting, or seizure.

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Before taking Tribenzor
Do not use Tribenzor if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic), or olmesartan (Benicar), or if you have:
severe kidney disease;
if you are unable to urinate; or
if you are allergic to sulfa drugs.

To make sure you can safely take Tribenzor, tell your doctor if you have any of these other conditions:
kidney disease;
liver disease;
congestive heart failure;
angina (chest pain), severe coronary artery disease;
lupus;
diabetes;
if you are dehydrated; or
if you are vomiting or having diarrhea.

FDA pregnancy category D. Do not take Tribenzor if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking Tribenzor. It is not known whether amlodipine, hydrochlorothiazide, and olmesartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Tribenzor.

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How should I take Tribenzor?
Take Tribenzor exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Tribenzor is usually taken once per day. Follow your doctor's instructions.

Tribenzor may be taken with or without food.

You may have new or worsening chest pain when you first start taking Tribenzor or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Keep using Tribenzor as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

Store Tribenzor 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness, fast or slow heartbeat, or fainting.

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What should I avoid while taking Tribenzor?
Do not use potassium supplements or salt substitutes while you are taking Tribenzor, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Tribenzor.

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Tribenzor side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Tribenzor: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effects, such as:
feeling like you might pass out;
swelling in your hands, ankles, or feet;
urinating less than usual or not at all;
pain or burning when you urinate;
joint pain or swelling with fever, swollen glands, muscle aches, unusual thoughts or behavior, patchy skin color, red spots, or skin rash on your face;
headache, trouble concentrating, memory problems, weakness, feeling unsteady, hallucinations, fainting, seizure, shallow breathing;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
electrolyte imbalance-nausea, loss of appetite, uneven heart rate, extreme thirst, increased urination, leg discomfort, jerking muscle movements, muscle weakness or limp feeling, confusion, and feeling tired or restless.

Less serious Tribenzor side effects may include:
dizziness;
diarrhea;
muscle spasms;
cold symptoms such as stuffy nose, sneezing, sore throat; or
flushing (warmth, redness, or tingly feeling).

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 Tribenzor?
Tell your doctor about all other medicines you use, especially:
other medications that lower blood pressure;
heart medication or another diuretic (water pill);
potassium supplements or salt substitutes;
cholestyramine (Prevalite, Questran) or colestipol (Colestid);
insulin or oral diabetes medication;
lithium (Eskalith, LithoBid);
steroid medication such as prednisone and others;
a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or
narcotic pain medication such as codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid, Palladone), oxycodone (OxyContin, Percocet), propoxyphene (Darvon, Darvocet), fentanyl (Actiq, Duragesic), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph), and many others.

This list is not complete and other drugs may interact with Tribenzor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Compare Tribenzor with other medications
High Blood Pressure

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

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

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 详细处方信息以本药内容附件PDF文件（2010121418004412.pdf）的“原文Priscribing Information”为准
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