部分中文盐酸马尼地尼处方资料（仅供参考）
英文名：Manidipine Hydrochloride
商品名：Calslot Tablets
中文名：盐酸马尼地尼片
生产商：武田制药
药品简介
Manidipine是一种钙离子拮抗剂，由日本武田药品工业株式会社开发，于1990年以商品名为Calslot在日本上市，用于治疗轻到中度原发性高血压。 
カルスロット錠5/カルスロット錠10/カルスロット錠20
药用类别名称
持续的钙拮抗剂抗高血压药物
批准日期：1990年8月
商標名
CALSLOT TABLETS
化学構造式
一般名
マニジピン塩酸塩（Manidipine Hydrochloride）〔JAN〕
化学名
3-{2-［4-（Diphenylmethyl）piperazin-1-yl］ethyl}5-methyl（4RS）-2,6-dimethyl-4-（3-nitrophenyl）-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride
分子式
C35H38N4O6・2HCl
分子量
683.62
融点
約207℃（分解）
性状
盐酸曼地平是一种白色至细黄色的结晶或结晶粉末。溶于二甲基亚硫酸, 几乎不溶于甲醇, 几乎不溶于乙醇(99.5), 几乎不溶于水。二甲基亚硫醚溶液(1→100) 不显示光学旋转。光线变成略带淡黄色的白色。
药用药理学
1. 降压作用机制
该制剂的降压作用, 主要是通过作用在血管平滑肌膜电位依赖性钙通道抑制CA2+流入, 以放松血管平滑肌, 相信是通过延长血管带来的。
(1) 与受体结合
大鼠心肌膜标本中 [3H]-硝苯地平与受体的结合明显抑制, 即使在标本洗涤(体外)后也能保持抑制作用。
这被认为具有很高的结合受体的膜电位依赖的钙通道。
(2) 钙拮抗作用
对兔肺动脉标本中的钙离子电流具有选择性和持续性的抑制作用, 也抑制了兔主动脉标本(体外)细胞中 45Ca2+的流入。建议有阻止钙通道的作用。
(3) 对心脏和血管的影响
对于高血压患者 (成人)的心血管行为, 只有外周血管总阻力显著降低, 这被认为是一种主要的抗高血压机制, 而心功能作用不大。
2. 降压作用
(1) 在高血压患者(成人)的血压日变异试验中, 经口服每日一次测量, 可获得全天稳定的降压效果。
(2) 在高血压患者(成人)的24小时血压监测试验中, 观察到每天口服24小时的降压效果, 夜间降压量较小。
3. 对肾脏循环动力学的影响
对于高血压患者(成人)的肾循环, 为了降低肾血管阻力, 肾血流率和肾小球滤过值, 尽管肾灌注压力降低, 但在轻度时显著增加。
适应症
高血压
用法与用量
通常情况下, 成人在早餐后口服一次, 每天10至20毫克作为盐酸曼地地平。然而, 要开始给药从1天5毫克, 如有必要, 逐渐增加。
通常成人每日规律和另一种配方的剂量如下。
◇ Callot 平板电脑5
每天2-4 片, 早餐后口服
◇ Callot 片10
每日1-2 片, 早餐后口服
◇ Callot 平板电脑20
每天半至1片, 早餐后口服
临床结果
1. 临床疗效
基本震颤高血压, 高血压与肾功能衰竭, 为每一个严重高血压患者, 剂量高达20毫克, 每天, 主要是4至10周的一般临床试验, 在双盲比较对照试验12周口服临床试验, 对642例降压效果的高血压类型有效率进行了评价。
此外, 长期给药试验中的原发性震颤高血压 (轻度和中度) 口服一年, 患者的 "下降" 率超过有效率84.5(131例155例)。
此外, 基本震颤高血压(轻和中度)结果双盲比较对照试验的病人, 剂的效用被观察到。
2. 对老年人的管理
在使用这种制剂的老年人(70岁或70岁以上)中, "下降" 或更高的有效比率为72.3(47例为34例), 其副作用包括临床试验值的异常, 在76例中, 有76例(2.3%) 观察到 (在重新审议结束时)。
包装
片
5毫克:100片(10片x10), 500片(10片 x50)
10毫克:100片(10片x10), 500片 (瓶装, 10片x50), 700片(14片x50)
20毫克:100片(10片x10), 500片(10 片x50), 700片(14片x50)
制造商和分销商
武田特瓦制药有限公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明书附件：
http://www.info.pmda.go.jp/go/pack/2149027F1020_2_01/
CALSLOT TABLETS 20（Manidipine hydrochloride）
Brand name :
CALSLOT TABLETS 20
　Active ingredient:
Manidipine hydrochloride
　Dosage form:
light orange-yellow tablets, φ8.1 mm, thickness 3.2 mm
　Print on wrapping:
(Face) 230 20, (Back) カルスロット20
Effects of this medicine
This medicine reduces blood pressure by relaxing and dilating blood vessels through its action on the calcium channel of 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 hepatic disorder.
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))
General dosage regimen: For adults, take 1/2 to 1 tablet (10 to 20 mg of the active ingredient) at a time, once a day, after breakfast. Start taking 5 mg of the active ingredient a day and the dosage will then be increased as needed. Each tablet contains 20 mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist.
If you missed a dose, take the missed dose as soon as possible if you noticed it within that day. If you noticed it at night, skip the missed dose and then go back to your regular dosing schedule, beginning after breakfast. 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.
Avoid taking grapefruit juice with this medicine, since some components contained in grapefruit juice may intensify the therapeutic effects of this medicine.
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, hot flush, heat sensation, palpitation, tachycardia, dizziness, dizziness on standing up, headache, dull headache, nausea, vomiting, loss of appetite, abdominal discomfort, heart burn, abdominal pain, enlarged feeling of abdomen, constipation, dry mouth, general malaise, lassitude, edema, frequent urination, photosensitivity, gingival hyperplasia, chylous ascites in renal failure patients, gynecomastia, 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.
dizziness on standing up, dullness, twilight state [transient loss of consciousness due to excessive falloff blood pressure]
one-sided paralysis of hands/feet and face, impaired speech/visual disturbance, headache, disturbance of consciousness [cerebral infarction]
fever, throat pain, dullness, nose bleeding/subcutaneous hemorrhage [agranulocytosis, thrombocytopenia]
chest discomfort, palpitation, chest pain [ventricular extrasystoles, supraventricular extrasystoles]
generalized red rash, skin exfoliation, fever  [erythroderma]
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 light, heat and humidity.
Discard the remainder. Do not store them. If you dispose of unused medicines, ask the pharmacy or the medical institution about proper disposal of drugs.
Internal
Revised: 1/2017
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.