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 详细处方信息以本药内容附件PDF文件（20109723291924.pdf）的“原文Priscribing Information”为准
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部分中文Diovan处方资料（仅供参考）

Diovan可持久控制血压
    美国，纽约1999年6月讯3项独立研究提供的数据证明，Novartis制药公司研制的血管紧张素Ⅱ受体阻滞剂（ARB）Diovan（Valsartan）在有和无氢氯噻嗪（HCTZ）治疗时均能长期和持久地控制血压，且有很好的耐受性。
　　3项研究包括823例接受Diovan3年的高血压病人，研究目的是确定Diovan单独应用或者与低剂量HCTZ合用的长期效果和安全性。这3项研究分别是：1项为期1年的开放标记扩大范围的安慰剂对照研究；1项为期2年的苯丁酸赖脯酸（lisinopril）在老年人中的随机对照研究；和1项为期3年的开放标记扩大范围的安慰剂对照试验。
　　3项研究均显示，Diovan单独治疗以及Diovan加HCTZ联合治疗均可使病人的舒张压（DBP）与收缩压（SBP）降低，并具有临床意义。不管病人的种族、年龄和性别如何，在3项研究的整个过程中DBP和SBP都得到很好的控制。
　　在规模最大的一项研究中，399例病人接受Diovan或Diovan联合低剂量HCTZ治疗达3年之久。治疗企图达到使DBP比原高度降低10毫米汞柱，然后维持到研究结束。收集了连续3个为期1年的随访期的数据，表明DBP平均降低12.7（第一年），12.1（第二年）和12.6（第三年）毫米汞柱。老年人的2年研究和1年试验表明，在研究结束时DBP分别降低15.3和14.1毫米汞柱。
　　在3项研究中，Diovan均能很好地耐受不良副作用的严重程度为轻至中度，而且大多数副作用被认为与研究药物无关。没有证据表明研究期间不良反应的次数或类型增加。
　　在一项最大规模的ARB临床试验规划中研究调查了Diovan对许多种危及生命疾病治疗的益处，这些疾病包括高危高血压、充血性心衰和心肌梗死。Diovan也是研究控制血压使其成为对成年（2型）糖尿病患者合并症发病率影响的临床试验的主要制剂。涉及35 000例病人的试验已启动，因为Novartis被指定用于调查Diovan除降低血压以减少心脏病发作和延长生命之外，可能存在的其他作用。
　　由于氢氯噻嗪成分，Diovan HCTZ禁用于无尿症病人或对其他磺胺衍生药物过敏的病人。Diovan和Diovan HCTZ所见副作用是轻度至中度的，其中包括头痛、头晕或疲劳。与所有作用于肾素-血管紧张素系统的药物相同，Diovan和Diovan HCTZ在妊娠6个月和9个月应用时能引起发育中胎儿的损伤甚至死亡。在发现妊娠时应当尽快停止使用Diovan和Diovan HCTZ。

药品名称和成分
通用名：缬沙坦
商品名：代文
英文名：Valsartan
本品主要成分及其化学名称为：缬沙坦，其化学名称为(S)-N-戊酰基-N｛［2-（1H-四唑-5）-二苯-4］甲基｝-缬氨酸。
分子式：C24H29N5O3
分子量：435.5

适应症
治疗轻、中度原发性高血压。

用法用量
推荐剂量：代文80毫克，每天一次，剂量与种族、年龄、性别无关，可能在进餐时或空腹服用（见吸收）。建议每天同一时间用药（如早晨）。
用药2周内达确切降压效果，4周后达最大疗效。降压效果不满意时，每日剂量可增加至160毫克，或加用利尿剂。
肾功能不全（严重肾衰见禁忌）及非胆管源性、无淤胆的肝功能不全患者无需调整剂量。
代文可以与其他抗高血压药物联合应用。
如果您有任何疑问，请遵医嘱。

不良反应
包括2316名患者的安慰剂对照试验，全面比较了代文和安慰剂的副作用。
下表显示了10个安慰剂对照试验报告的不良反应发生情况，患者服用缬沙坦10-320毫克/日最多为12周。2316名患者中1281人、660人分别服用80毫克、160毫克，所见的不良反应的发生与剂量及用药时间无关，因此，将各种剂量下发生的不良反应合并统计。不良反应的发生率与性别、年龄、种族无关。所有发生率大于（或等于）1的不良反应均列于下表中（无论是否与研究的药物有关）。其他发生率低于1%的不良反应有：水肿、无力、失眠、皮疹、性欲降低。这些不良反应是否与缬沙坦治疗有因果关系尚不知晓。
产品投入市场后，曾出现一些罕见的报道，包括：血管神经性水肿、皮疹、瘙痒及其他超敏反应如血清病、血管炎等过敏性反应。
实验室研究结果
罕见情况下，缬沙坦引起血红蛋白和血球压积降低。临床对照试验发现，缬沙坦治疗组血红蛋白和血球压积明显降低（大于20%）的分别占0.8%和0.4%。安慰剂组占0.1%。
临床对照试验发现中性粒细胞减少见于1.9%缬沙坦治疗患者、1.6%ACEI治疗患者。缬沙坦组血清肌酐、血钾、总胆红素显著升高者分别为0.8%、4.4%、6%，ACEI组分别为1.6%、6.4%、12.9%。
偶见肝功能指标升高。
对原发性高血压患者接受缬沙坦治疗来说，不需要监测特殊实验室指标。

禁忌
对任何成分过敏者
妊娠
对严重肾功能衰竭（肌苷清除率小于10ml/mim）患者尚无应用代文的经验。

注意事项
低钠和/或血容量不足
极少数情况下，严重缺钠和/或血容量不足患者（如：大剂量应用利尿剂），代文治疗开始时，可能出现症状性低血压。应该在用药之前，纠正低钠和/或血容量不足，或将利尿剂减量。如果发生低血压，应该让患者平卧，必要时静脉输注生理盐水。血压稳定后恢复代文治疗。
12例因单侧肾动脉狭窄导致的继发性血管性高血压患者服用代文4天，没有引起肾血流动力学、肌酐、尿素氮（BUN）明显变化。由于其他作用于RAAS的药物可能使单侧或双侧肾动脉狭窄患者的BUN和肌酐升高，建议进行监测确保安全。
肾功能不全
肾功能不全患者不需要调整剂量。
肝功能不全
肝功能不全患者无需调整剂量。
轻至中度肝功能不全患者缬沙坦剂量不应超过80毫克/日。
缬沙坦主要以原形从胆汁排泄，胆道梗阻患者排泄减少，对这类患者使用缬沙坦应特别小心。
与其它抗高血压药物一样，服药患者在驾驶、操作机器时应小心。

孕妇及哺乳期妇女用药
早期（妊娠头3个月）：妊娠种类B
动物实验表明对胎儿没有危害。
中期和晚期（妊娠第2、第3个月）：妊娠种类D。
有证据表明对人类胎儿有危险，但相对母亲获得的治疗益处而言，利大于弊。鉴于血管紧张素Ⅱ拮抗剂的作用机制，不能排除对胎儿的危害。
妊娠中、晚期应用直接作用于RAAS的药物，可以导致胎儿伤害或死亡。胎儿从妊娠中期开始出现肾灌注，后者依赖于RAAS系统的发育，因此妊娠中晚期应用代文，风险增高。
与其他直接作用于RAAS的药物相似，代文不宜用于妊娠期。如果在用药期间发现妊娠，应尽早终止。
所有在宫内与药物接触过的新生儿应密切观察，保证足够的尿量、防止高血钾、监测血压。必要时采用适当治疗措施（如再水化），清除药物。
缬沙坦可以从兔的乳汁排出，目前尚无对哺乳期女性的研究，因此代文不宜用于哺乳期。

儿童用药
代文用于儿童的有效性和安全性尚无相关研究，尚无儿童用药的经验。

老年患者用药
尽管服用缬沙坦后，对老年人的全身性影响多于年轻人，但并无任何临床意义。

药物相互作用
临床没有发现明显的药物相互作用，已对以下药物进行了研究：西米替丁、华法令、呋塞米、地高辛、阿替洛尔、吲哚美辛、双氢克尿噻、氨氯地平和格列本脲。由于缬沙坦几乎不经过代谢，临床没有发现相关药物在诱导或抑制细胞色素P450系统方面与之发生相互影响。
虽然缬沙坦大部分与血浆蛋白结合，但是体外实验没有发现它在这一水平与其他血浆蛋白结合药物(如双氯芬酸、呋塞米、华法令)发生相互影响。
与保钾利尿剂(如螺内脂、氨苯蝶啶、阿米洛利)联合应用时，补钾或使用含钾制剂可导致血钾浓度升高。因此，联合用药需要格外注意。

药物过量
虽然对代文过量尚无经验，但其主要症状可能是明显低血压，若服药时间不长，应该催吐治疗，否则常规治疗给予生理盐水静脉输注。

贮藏
应保存于30摄氏度以下的干燥处。

Diovan
Generic Name: valsartan (val SAR tan)
Brand Names: Diovan

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

Diovan is used to treat high blood pressure (hypertension) or heart failure. It is also used to reduce the risk of death after a heart attack.

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

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Important information about Diovan
Do not use Diovan without telling your doctor if you are pregnant. Diovan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using Diovan and tell your doctor right away if you become pregnant during treatment. You should not use this medication if you are allergic to valsartan. Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of Diovan. Do not use potassium supplements or salt substitutes while you are taking Diovan, unless your doctor has told you to.

To be sure Diovan is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

In rare cases, Diovan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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Before taking Diovan
You should not use Diovan if you are allergic to valsartan.

Before using Diovan, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease;
liver disease;
congestive heart failure; or
if you are dehydrated.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category D. Diovan can cause harm to an unborn baby. Diovan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Do not use Diovan without your doctor's consent if you are pregnant. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. It is not known whether Diovan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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How should I take Diovan?
Take Diovan exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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

You may take Diovan with or without food.

To be sure Diovan is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

It may take 2 to 4 weeks of using this medicine before your blood pressure is under control. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store Diovan 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 fast or slow heartbeat, dizziness, or feeling like you might pass out.

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What should I avoid while taking Diovan?
Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of Diovan. Do not use potassium supplements or salt substitutes while you are taking Diovan, 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.

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Diovan 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. In rare cases, Diovan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects such as:
feeling like you might pass out;
chest pain, fast or pounding heartbeats;
numbness or tingly feeling; or
swelling, weight gain.

Less serious Diovan side effects may include:
runny or stuffy nose, sore throat, cough;
back pain;
diarrhea, constipation;
dry mouth, stomach pain, loss of appetite;
mild itching, skin rash;
sleep problems (insomnia);
headache, dizziness, anxiety;
tired feeling;
weakness; or
impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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What other drugs will affect Diovan?
Before taking Diovan, tell your doctor if you are also taking a diuretic (water pill).

There may be other drugs that can interact with Diovan. 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.

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

Remember, keep this and all other medicines out of the reach of children. Never share your medicines with others and only use Diovan for the condition prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件（20109723291924.pdf）的“原文Priscribing Information”为准
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