部分中文坎地沙坦酯/苯磺酸氨氯地平处方资料（仅供参考）
英文名：Candesartan Cilexetil/Amlodipine Besilate
商标名：UNISIA Combination Tablets LD/HD
中文名：复方坎地沙坦酯/苯磺酸氨氯地平片剂
日文名：
生产商：
药物分类名称
持续血管紧张素II受体拮抗剂/持续性Ca拮抗剂组合
批准日期：2010年6月
商標名
UNISIA Combination Tablets LD
UNISIA Combination Tablets HD
坎地沙坦西酯
化学構造式
一般名カンデサルタン シレキセチル（Candesartan Cilexetil）〔JAN〕
化学名（1RS）-1-（Cyclohexyloxycarbonyloxy）ethyl 2-ethoxy-1-｛［2´-（1H-tetrazol-5-yl）biphenyl-4-yl］methyl｝-1H-benzimidazole-7-carboxylate
分子式C33H34N6O6
分子量610.66
性状
Candesartan cilexetil是一种白色晶体或结晶粉末。 微溶于乙酸（100），微溶于甲醇，溶于乙醇（99.5），难溶于水。 甲醇溶液（1→100）显示没有旋光。 观察到晶体多态性。
氨氯地平苯磺酸盐
化学構造式
一般名アムロジピンベシル酸塩（Amlodipine Besilate）〔JAN〕
化学名3-Ethyl 5-methyl （4RS）-2-［（2-aminoethoxy）methyl］-4-（2-chlorophenyl）-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate monobenzenesulfonate
分子式C20H25ClN2O5・C6H6O3S
分子量567.05
性状
氨氯地平苯磺酸盐是白色至黄白色结晶粉末。 易溶于甲醇，微溶于乙醇（99.5），难溶于水。 甲醇溶液（1→100）显示没有旋光
药用药理学
1.低血压行动机制
坎地沙坦酯的抗高血压作用在体内的吸收过程迅速水解成为活性代谢物坎地沙坦，拮抗血管紧张素II的血管平滑肌受体，其强大的血管的主要血管紧张素II类型1（AT1）由于抑制收缩作用引起的外周血管阻力减少。此外，在通过AT1受体肾上腺醛固酮释放的抑制作用被认为是负责在降压的一部分。
苯磺酸氨氯地平表现出动作作为二氢吡啶类钙拮抗剂，但是具有作用开始的一个特征是在缓慢持久的。
二氢吡啶类钙拮抗剂特异性地结合到膜电位依赖性L-型钙通道，通过降低钙流入细胞，放松冠状或周围血管的平滑肌。
2.对肾素 - 血管紧张素系统的影响
74例高血压患者（56例原发性高血压患者和18例伴有肾功能损害的高血压患者）每日1至12毫克坎地沙坦西酯的重复剂量试验，血浆肾素活性，血浆血管紧张素I 观察到血浆血管紧张素II浓度的浓度和增加。
适应症
高血圧症
用法与用量
成人，每天服用1片（口服8mg/2.5mg或8mg/5mg坎地沙坦西酯或氨氯地平）。 该药不用作治疗高血压的一线药物。
临床结果
对于原发性高血压患者，使用坎地沙坦西酯和氨氯地平8 mg / 5 mg，8 mg / 2.5 mg，8 mg /0mg，0mg/5mg或0mg/ d治疗的双盲患者 对比试验的结果如表4所示。
低谷时坐位舒张压变化和低谷时收缩压变化均为8 mg / 0 mg给药组和8 mg / 0 mg给药组8mg/0mg给药组与8mg/0mg给药组和0mg/0组相比 与给药组相比，观察到显着差异。
此外，在联合* 5给予坎地沙坦西酯和苯磺酸氨氯地平的长期给药试验（52周）中，抗高血压作用持续，没有观察到作用的降低，并且获得稳定的血压控制。
注5）每日一次饭前不要开餐（【药代动力学】3.生物等效性）
包装
配合錠LD ： 100錠（10錠×10）、140錠（14錠×10）、500錠（バラ、10錠×50）、700錠（14錠×50）、1,000錠（10錠×100）
配合錠HD ： 100錠（10錠×10）、140錠（14錠×10）、500錠（バラ、10錠×50）、700錠（14錠×50）、1,000錠（10錠×100）
制造供应商
武田特瓦制药有限公司
完整资料附件：http://www.info.pmda.go.jp/go/pack/2149116F1020_2_02/
Brand name : UNISIA Combination Tablets HD
Active ingredient: Candesartan cilexetil
Amlodipine besilate
Dosage form: light red oval tablets, major axis 8.6 mm, minor axis 5.1 mm, thickness 3.0 mm
Print on wrapping: （Face） ユニシアHD 273, （Back） ユニシアHD
Effects of this medicine
This medicine lowers blood pressure by reducing peripheral vascular resistance via antagonism against receptor for the pressor substance angiotensin II as well as via its action upon the calcium channel in the vascular smooth muscle.
Usually, used for treatment of hypertension.
Before using this medicine, be sure to tell your doctor and pharmacist
If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you have renal disorder, liver disorder, heart failure, hyperkalemia, or hyponatremia; are on hemodialysis, or on low-salt diet therapy; or in a preoperative state.
If you are 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, take 1 tablet at a time, once a day. Strictly follow the instructions of your doctor/pharmacist.
If you missed a dose, take the missed dose as soon as possible. If it is less than 8 hours to the next dose, skip the missed dose and then continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
Do not stop taking the medicine without the instructions of your doctor.
Precautions while taking this medicine
As dizziness and light-headedness may appear due to excessive lowering of blood pressure, take extra care when working at heights or operating dangerous machinery such as driving a car.
Do not take the medicine together with grapefruits juice.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: rash, itching, photosensitivity, angiitis, dizziness, light-headedness, dizziness on standing up, glow, fall in blood pressure, abdominal discomfort, enlarged feeling of the abdomen, diarrhea, cough, ear ringing, etc.
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 of face, tongue and throat, breathlessness [angioedema]
feeling cold, vomiting, loss of consciousness [shock, syncope, loss of consciousness]
decreased urinary output, swelling of face and hands/feet, fever [acute renal failure]
numbness of hands/feet and lips, muscle weakness [hyperkalemia]
yellowing of the skin or whites of the eyes, dullness, loss of appetite [liver dysfunction, jaundice]
fever, sore throat, dullness [agranulocytosis, decreased white blood cell count]
lassitude, muscle pain, brown urine [rhabdomyolysis]
fever, dry cough, breathlessness [interstitial pneumonia]
cold sweat, feeling hungry, tremor in hands [hypoglycemia]
nose bleeding, gingival bleeding, subcutaneous bleeding [decreased platelet count]
bradycardia, dizziness [atrioventricular block]
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 humidity.
Discard the remainder. Do not store them.
Takeda Chemical Industries, Ltd. Internal
Revised: 12/2010
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.
