英文药名：DIOVAN OD Tablets（Valsartan）

中文药名：缬沙坦口腔崩解片

生产厂家：诺华制药
治疗类别名称
选择性AT1受体阻滞剂
商標名
DIOVAN OD Tablets
一般名
バルサルタン（Valsartan）
化学名
（2S）-3-Methyl-2-（N-｛［2'-（1H-tetrazol-5-yl）biphenyl-4-yl］methyl｝pentanamido）butanoic acid
分子式
C24H29N5O3
分子量
435.52
構造式

性状
它是一种白色粉末。甲醇，这是非常易溶于乙醇（99.5），并且几乎不溶于水。
操作注意事项
因为这种药物具有吸湿性，存储保持的PTP片（不适合于自动包装机）。
薬効薬理
缬沙坦表示通过拮抗抗血管紧张素II抗高血压作用结合于血管紧张素II受体AT1受体亚型，其充当升压系统。
(1) 降圧作用
1) 缬沙坦通过口服给药，肾性高血压大鼠，自发性高血压大鼠（SHR），但钠耗竭狨猴的血压是剂量依赖性下降，它不会影响DOCA/盐高血压大鼠的血压。
2) 在肾性高血压大鼠口服给药后缬沙坦可以是静止的连续（4周），在自发性高血压大鼠（SHR），不显示反弹现象。
3)缬沙坦长期连续（44周）口服给药，但持续的降低中风发病容易发生自发性高血压大鼠（SHR-SP），血压，显示心脏率无显著的变化。此外，长期的连续（48周）通过口服给药，以抑制主动脉血管的增厚。
(2) 对血流动力学和心脏
1) 通过口服缬沙坦，而不降低器官血液的自发性高血压大鼠的流量（SHR），在肾血流量一个显著增加。
2) 缬沙坦缺血性心脏衰竭的模型大鼠的由连续（4周）心肌肥大的口服给药，可长期连续（48周）通过口服给药来抑制中风倾向的发病自发性高血压大鼠（SHR-SP）的心脏肥大。
(3)影响及对肾功能
通过连续口服给药，肾部分切除大鼠（6周）和中风倾向的发病自发性高血压大鼠（SHR-SP）（32周，40周，44周）缬沙坦抑制肾衰竭的恶化。
(4) 作用机序
缬沙坦选择性地耦合到的血管紧张素II受体的AT1受体亚型，受体水平拮抗竞争性已被证实对血管紧张素II，其充当升压系统。
1) 缬沙坦的大鼠主动脉平滑肌，竞争性地抑制血管紧张素II的对AT1受体的结合。也显示了受体比AT1受体其他的小亲和力。
2) 缬沙坦在离体兔动脉环标本，去甲肾上腺素，并表现出对所造成的血清素和氯化钾收缩无抑制作用，特别是通过血管紧张素Ⅱ抑制收缩。
3) 通过口服缬沙坦，表明由交感神经刺激和去甲肾上腺素在脊髓破坏大鼠升压反应的无抑制作用，特异性抑制血管紧张素Ⅱ的升压反应。
4) 缬沙坦在牛肾上腺球层细胞显著抑制醛固酮生产的血管紧张素II。
5) 缬沙坦是关于ACE活性和人支气管上皮细胞的缓激肽降解没有影响
适应症
治疗轻、中度原发性高血压。
用法用量
推荐剂量：
每日一次口服40〜80毫克的缬沙坦成人。此外，年龄，则增加或减少适当根据症状，它可以提高到1天160mg。
超过6岁的儿童，缬沙坦，如果体重低于35千克，在20毫克，如果超过体重35千克，口服给药，每天一次40毫克。此外，将根据年龄，体重和症状调整。然而，每日最大剂量，在体重低于35千克，和40毫克的情况。
如果您有任何疑问，请遵医嘱。
包装规格
OD片：20毫克
140片（PTP）

OD片：40毫克
140片（PTP）700片（PTP）

OD片：80毫克
140片（PTP）500片（PTP）700片（PTP）

OD片剂：160mg
100片（PTP）140片（PTP）300片（PTP）700片（PTP）

生产商
诺华制药有限公司
DIOVAN OD Tablets（ディオバンOD錠 Valsartan）
DIOVAN OD Tablets 20mg（ディオバンOD錠20mg）
Brand name : DIOVAN OD Tablets 20mg
　Active ingredient: Valsartan
　Dosage form: white tablet, diameter: 6.0 mm, thickness: 3.1 mm
　Print on wrapping: ディオバンOD20mg, DIOVAN OD20mg, 141
DIOVAN OD Tablets 40mg（ディオバンOD錠40mg）
Brand name : DIOVAN OD Tablets 40mg
　Active ingredient: Valsartan
　Dosage form: white tablet, diameter: 8.0 mm, thickness: 3.6 mm
　Print on wrapping: ディオバンOD40mg,DIOVAN OD40mg,NV142
DIOVAN OD Tablets 80mg（ディオバンOD錠80mg）
Brand name : DIOVAN OD Tablets 80mg
　Active ingredient: Valsartan
　Dosage form: white tablet, diameter: 9.5 mm, thickness: 5.4 mm
　Print on wrapping: ディオバンOD80mg, DIOVAN OD80mg, NV143
DIOVAN OD Tablets 160mg（ディオバンOD錠160mg）
Brand name : DIOVAN OD Tablets 160mg
　Active ingredient: Valsartan
　Dosage form: white tablet, major axis: 15.0 mm, minor axis: 8.0 mm, thickness: 6.1 mm
　Print on wrapping: ディオバンOD160mg, DIOVAN OD160mg, NV144
Effects of this medicine
This medicine binds to angiotensin II receptor produced in the body, and inhibits the hypertensive activity of angiotensin II by blocking its vasoconstrictive effects. It consequently lowers blood pressure in patients with hypertension.
It is usually used to treat hypertension.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you are a patient with diabetes mellitus, renal disorder, hyperkalemia or schedule of surgery.
If you are a patient on hemodialysis or low-salt diet.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•For adults: In general, take 40 to 80 mg of the active ingredient at a time, once a day. The dosage should be adjusted according to the age or symptoms. However, daily dose may be increased to 160 mg.
For children aged 6 years and older: In general, for children weighing less than 35 kg, take 20 mg of the active ingredient at a time, once a day. For children weighing 35 kg and more, take 40 mg of the active ingredient at a time, once a day. The dosage should be adjusted according to the age, body weight or symptoms. However, for children weighing less than 35 kg, the maximum daily dose is restricted to 40 mg.
This product contains 160 mg of the active ingredient in a tablet. Strictly follow the instructions.
•You can take the medicine without water. Soak the tablet with saliva on your tongue and crush it lightly with your tongue, then swallow it with saliva. You can also take it with water or warm water as you do an ordinary tablet. However, you should never take the tablet without water when you are in a lying position.
•Tablets may be cracked or chipped. However, the quality of the tablet is unaffected. Take the entire prescribed amount of the medicine including the fragments.
•If you missed a dose, take a dose as soon as possible. However, if it is 8 hours or less before the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•The medicine may cause dizziness or light-headedness since the blood pressure is decreased. Pay attention when you work at heights, drive a car or operate dangerous machinery.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include dizziness, headache, palpitation, abdominal pain, dry cough, nausea, malaise, rash, hypotension, itch and photosensitivity. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•swelling in face/lip/throat/tongue, breathlessness [angioedema]
•loss of appetite, general malaise, yellowness in the skin and/or the white of the eye [hepatitis]
•decrease of urine output, swelling in limbs, loss of appetite [renal failure]
•loss of consciousness, vomiting, cold feeling [shock, faint, loss of consciousness]
•muscle weakness, numbness of limbs or lips, paralysis in limbs [hyperkalemia]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture. Keep in press-through package (PTP) sheet just before taking.
•Discard the remainder. Do not store them.
Novartis Pharma K.K.Internal
Revised: 3/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.info.pmda.go.jp/go/pack/2149041F5026_1_08/2149041F5026_1_08?view=body