部份中文阿托伐他汀钙处方资料（仅供参考）
英文名：Atorvastatin Calcium Hydrate
商品名：Lipitor Tablets
中文名：阿托伐他汀钙片
生产商：安斯泰来制药
药品简介
Lipitor（Atorvastatin Calcium Hydrate，阿托伐他汀钙）是一种降胆固醇药物，通过抑制在肝脏中有助生产胆固醇的酶从而 降低胆固醇水平。用于高胆固醇血症或高脂血症。
リピトール錠5mg／リピトール錠10mg
药效分类名称
HMG-CoA还原酶抑制剂
批准日期：2000年5月
商標名
Lipitor Tablets
一般的名称
アトルバスタチンカルシウム水和物（Atorvastatin Calcium Hydrate）
化学名
Monocalcium bis｛（3R,5R）-7-［2-（4-fluorophenyl）-5-（1-methylethyl）-3-phenyl-4-（phenylcarbamoyl）-1H-pyrrol-1-yl］-3,5-dihydroxyheptanoate｝trihydrate
分子式
C66H68CaF2N4O10・3H2O
分子量
1209.39
性状
阿托伐他汀钙水合物是一种白色至微黄白色结晶粉末。极易溶于甲醇，溶于二甲亚砜，极难溶于水或乙醇(99.5)。因光照逐渐变成黄白色。
化学構造式
处理注意事项
由于PTP产品的质量是通过使用铝袋来保持的，因此在打开铝袋后将其存放在远离潮湿的地方。不要让盖子打开，因为瓶装产品会被干燥以保持质量。
药效药理
作用机制
阿托伐他汀选择性和竞争性地抑制肝脏中的HMG-CoA还原酶，肝脏是调节血液中胆固醇含量的主要器官，并抑制肝脏中的胆固醇合成以及与阿托伐他汀具有相同活性的代谢物。..结果，阿托伐他汀增加了肝脏中LDL受体的数量，并通过抑制脂蛋白分泌来降低血脂的量。此外，阿托伐他汀可改善血脂动态并抑制与高胆固醇血症相关的动脉硬化的发生。
胆固醇合成抑制作用
在人肝癌细胞衍生的HepG2细胞中，阿托伐他汀选择性地和竞争性地抑制胆固醇生物合成途径中的限速酶HMG-CoA还原酶，并以浓度依赖性方式抑制从乙酸合成胆固醇。
此外，与同类药物相比，阿托伐他汀可长期抑制大鼠的肝脏胆固醇合成。
高脂血症模型动物的降脂作用
降胆固醇作用
在负载胆固醇的兔子和负载胆固醇的小型猪中，阿托伐他汀通过口服给药降低血浆总胆固醇水平并降低LDL-胆固醇和血浆 apoB水平。在LDL受体缺陷小鼠和WHHL兔中，阿托伐他汀降低了总血浆胆固醇和 LDL-胆固醇水平。
降低甘油三酯的作用
在载有胆固醇的小型猪和载有蔗糖的高甘油三酯血症大鼠中，阿托伐他汀降低了血液甘油三酯水平。
动脉粥样硬化进展抑制作用
在负载胆固醇的内皮损伤兔和WHHL兔中，阿托伐他汀降低了动脉硬化病变面积和血管壁胆固醇含量。
代谢物的药理作用
在大鼠肝微粒体中，人体内主要代谢物的酰胺结合位苯环的4位氢氧化物(M-1)和2位氢氧化物 (M-2) 分别为 1/2 至 1 /2 的阿托伐他汀显示出相同水平的HMG-CoA还原酶抑制活性。
对脂蛋白代谢的作用
在HepG2细胞中，阿托伐他汀降低细胞内胆固醇含量，增加肝LDL受体mRNA表达和肝LDL受体活性，并减少apoB分泌和甘油三酯分泌。在正常豚鼠中，阿托伐他汀增加肝脏LDL受体活性并减少apoB分泌。在载有胆固醇的小型猪中，阿托伐他汀降低了VLDL-apoB的产生率。在LDL受体缺陷小鼠中，阿托伐他汀降低了胆固醇分泌率。在负载蔗糖的高甘油三酯血症大鼠中，阿托伐他汀降低了甘油三酯的分泌率。
适应症
○高胆固醇血症
○家族性高胆固醇血症
用法与用量
<高胆固醇血症>
通常的成人剂量是每天一次口服10毫克阿托伐他汀。
剂量可根据患者的年龄和症状调整，但在严重的情况下，剂量可增加至每天20毫克。
<家族性高胆固醇血症>
通常的成人剂量是每天一次口服10毫克阿托伐他汀。
剂量可根据患者的年龄和症状调整，但在严重的情况下，剂量可增加至每天40毫克。
包装
片剂
5毫克：100片（10片×10片）、500片（10片×50片）、500片（玫瑰色、带干燥剂）、1000片（10片×100片）
10毫克：100片（10片×10片）、500片（10片×50片）、500片（含玫瑰花和干燥剂）、700片（14片×50片）、1000片（10片×100片）
制造和销售
安斯泰来制药
营销联盟:
辉瑞公司日本
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资资料书附件：
https://www.info.pmda.go.jp/go/pack/2189015F1023_2_01/
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Lipitor Tablets（Atorvastatin calcium hydrate）
Lipitor Tablets 5mg（リピトール錠5mg）
Brand name : Lipitor Tablets 5mg
　Active ingredient: Atorvastatin calcium hydrate
　Dosage form: pale pink tablet (φ: 5.6mm, thickness: 2.7mm)
　Print on wrapping: (Face) リピトール5mg, house-mark + 715, (Back) リピトール5mg, house-mark, company's name
Effects of this medicine
This medicine prevents production of cholesterol in the liver, and thus lowers the cholesterol levels in the blood.
It is usually used for the treatment of hypercholesterolaemia or familial hypercholesterolaemia.
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 liver or renal disorder.
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>>
?General dosage regimen:
For hypercholesterolaemia: For adults, take 1 tablet (10mg of atorvastatin) at a time, once daily. The dosage may be adjusted according to the patient's age and symptoms. For severe patients, the dosage may be increased up to a maximum dose of 2 tablets (20 mg) per day.
For familial hypercholesterolaemia: For adults, take 1 tablet (10mg of atorvastatin) at a time, once daily. The dosage may be adjusted according to the patient's age and symptoms. For severe patients, the dosage may be increased up to a maximum dose of 4 tablets (40mg) per day.
In either case, strictly follow the instructions of your doctor/pharmacist.
?If you have missed a dose, take the missed dose as soon as possible before bedtime. 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
Strictly follow the instructions on dietary/exercise therapy.
Intake of grapefruit juice may enhance the effect of this medicine. Refrain from taking the medicine together with grapefruit juice.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: stomach discomfort, itching, numbness of the fingers, loss of sleep, diarrhoea, heartburn, constipation, headache, general malaise, 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.
muscle pain, feeling of weakness, reddish brown urine  [rhabdomyolysis, myopathy]
?queasiness/vomiting, general malaise, yellowing of the skin and the whites of the eyes  [hepatitis fulminant, hepatitis, hepatic function disorder, jaundice]
pharynx pain/headache/heaviness of the head, general malaise, bleeding of nose/gums or under the skin  [agranulocytosis, pancytopenia, thrombocytopenia]
fever, loss of appetite, red rash  [oculomucocutaneous syndrome, toxic epidermal necrosis, erythema multiforme]
dry mouth, excessive drinking/urination, getting tired easily  [hyperglycaemia, diabetes mellitus]
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 infants and children. Store away from direct sunlight, heat and humidity.
Discard the remainder. Do not store them.
Astellas Pharama Inc.Internal
Revised: 1/2011
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/2189015F1023_1_30/