英文药名: DIOVAN（Valsartan Tablets） 中文药名: 缬沙坦片 生产厂家: 诺华制药 ディオバン錠20mg／ディオバン錠40mg／ディオバン錠80mg／ディオバン錠160mg 治疗类别名称 选择性AT1受体阻滞剂 商標名 DIOVAN Tablets 構造式 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 性状 白色粉末。甲醇，乙醇（99.5），以非常可溶，几乎不溶于水。 适应症 治疗轻、中度原发性高血压。 用法用量 成年人：每天一次的40-80毫克。此外，年龄，将适当地增加或减少取决于条件，就可以增加1天160mg。 儿童：6岁以上的孩子按体重低于35公斤时，每次服20毫克，比体重更35公斤的情况下，口服每天一次40毫克。所述剂量可根据年龄，体重和症状来调节。然而，一天最高剂量，在重量小于35公斤，和40毫克的的情况。 如果您有任何疑问，请遵医嘱。 药效药理 缬沙坦结合至血管紧张素II受体的AT 1受体亚型，表示通过拮抗抗血管紧张素II，其充当升压系统中的降血压作用。 （1）降压作用 1) 通过口服，肾性高血压大鼠，自发性高血压大鼠（SHR），但耗尽钠狨猴的剂量依赖性下降的血压，不影响DOCA/盐高血压大鼠的血压。 2) 将随后连续（4周）后撤出药物口服，肾性高血压大鼠，自发性高血压大鼠（SHR），表明无反弹现象。 3) 长期连续（44周）口服，但持续降低脑卒中发病容易发生自发性高血压大鼠（SHR-SP）的血压，不显示的显著变化率心脏。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的影响 1) 通过口服缬沙坦，而不降低器官血流自发性高血压大鼠（SHR），显著增加肾血流量 2) 缬沙坦连续（4周）缺血性心脏衰竭模型大鼠的心肌肥厚口服，长期连续（48周），以抑制由口服（SHR-SP）易卒中发作自发性高血压大鼠心肌肥厚。 (3) 对肾功能的影响 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 缬沙坦选择性结合的血管紧张素II受体的AT 1受体亚型，相对于该受体水平血管紧张素II，其充当升压系统已显示出竞争性拮抗。 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。此外，它显示了比AT1受体其它受体的亲和性。 2) 缬沙坦在离体兔主动脉环标本，去甲肾上腺素，显示对收缩无抑制作用，由于血清素和氯化钾，专门抑制收缩，由于血管紧张素II。 3) 通过口服缬沙坦，没有显示出通过在脊髓破坏大鼠交感神经刺激和去甲肾上腺素的升压反应的抑制作用，特别是抑制由血管紧张素II的升压反应。 4) 缬沙坦显著抑制醛固酮生产的血管紧张素II在牛肾上腺球层细胞。 5) 缬沙坦不影响ACE活性和人支气管上皮细胞的缓激肽的降解。 包装规格 片剂 20毫克：140片（PTP） 40毫克：140片（PTP），700片（PTP），500粒（瓶） 80毫克：140片（PTP），500片（PTP），700片（PTP），500粒（瓶） 160mg：100片（PTP），140片（PTP），300片（PTP），700片（PTP） 制造商 诺华制药有限公司 DIOVAN Tablets（Valsartan）缬沙坦片 DIOVAN Tablets 20mg（ディオバン錠20mg） Brand name : DIOVAN Tablets 20mg 　Active ingredient: Valsartan 　Dosage form: pale yellow tablet, φ: 7.1 mm, thickness: 2.6 mm 　Print on wrapping: ディオバン20mg, DIOVAN20mg, NV132 DIOVAN Tablets 40mg（ディオバン錠40mg） Brand name : DIOVAN Tablets 40mg 　Active ingredient: Valsartan 　Dosage form: white tablet, φ: 7.1 mm, thickness: 2.8 mm 　Print on wrapping: ディオバン40mg, DIOVAN40mg, NV133 DIOVAN Tablets 80mg（ディオバン錠80mg） Brand name : DIOVAN Tablets 80mg 　Active ingredient: Valsartan 　Dosage form: white tablet, φ: 8.6 mm, thickness: 3.7 mm 　Print on wrapping: ディオバン80mg, DIOVAN80mg, NV134 DIOVAN Tablets 160mg（ディオバン錠160mg） Brand name : DIOVAN Tablets 160mg 　Active ingredient: Valsartan 　Dosage form: white tablet, major axis: 14.6 mm, minor axis: 5.8 mm, thickness: 5.7 mm 　Print on wrapping: ディオバン160mg, DIOVAN160mg, NV135 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. •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 took 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/throat/tongue, breathlessness [angioedema] •loss of appetite, general malaise, yellowness in skin or conjunctiva [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 the reach of children. Store away from direct sunlight, heat and moisture. •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/2149041F1020_2_19/