部份中文阿法骨化醇处方资料（仅供参考）
商品名：Alfarol Capsules
英文名：Alfacalcidol
中文名：阿法骨化醇软胶囊
生产商：中外制药
药品简介
Alfarol（Alfacalcidol）是骨化三醇类似物，用于改善维生素D代谢异常（见于慢性肾功能不全、甲状旁腺功能低下、抗维生素D性佝偻病和骨软化症）所致的症状（如：低钙血症、抽搐、骨痛及骨损害）及骨质疏松症。
アルファロールカプセル0.25μg／アルファロールカプセル0.5μg／アルファロールカプセル1μg
药效分类名称
Ca·骨代谢改善1α-OH-D3制剂
批准日期：1981年1月
商標名
ALFAROL Capsules
一般的名称
アルファカルシドール（Alfacalcidol）（JAN）
化学名
（5Z,7E）-9,10-Secocholesta-5,7,10（19）-triene-1α,3β-diol
分子式
C27H44O2
分子量
400.64
性状
白色结晶或结晶粉末。
易溶于甲醇、乙醇（99.5）、氯仿或二氯甲烷，略溶于丙酮或二乙醚，几乎不溶于水或己烷。
因空气或光而变化。
化学構造式
融点（一部分解）
135～138℃（日局　一般試験法）
137～142℃（日局　ビタミンD2測定法）
使用注意事项
铝枕包装开封后或玫瑰包装外箱开封后应遮光保存。
药效药理
作用机制
作用的表达（α-卡西多的25位氢氧化）
经口给药后，被血中吸收，肝的25-hydroxylase使侧链的25位被氢氧化，迅速地α,代谢成25-（OH）2D3。该肝中的25位氢氧化反应在四氯化碳或加拉沙明给药的肝损伤时也被保持（大鼠）。1α,25-（OH）2D3作用于骨、小肠，表现出促进骨形成作用、改善骨代谢作用、促进小肠吸收Ca的作用等。
作用、效果
骨钙化促进作用
对维生素D缺乏或低磷高Ca饮食饲养大鼠，具有抗克尔氏病作用，促进骨钙化前锋形成的作用。
骨吸收作用、重构作用
α－卡西多尔活性型代谢物1α,25-（OH）2D3具有骨吸收作用和骨重构作用（in vitro）。
骨形成促进作用
在骨形态测量中，通过给予α-辊，具有成骨细胞的类骨面比率增加，提示直接作用于成骨细胞促进骨形成（人骨质疏松症）。
肠道中Ca吸收作用
通过连日给药，血清1α,改善随着25-（OH）2D值的升高而降低的小肠中的Ca吸收率（人骨质疏松症）。
血清Ca上升作用
对于低Ca血症，通过促进从小肠吸收Ca的作用（人慢性肾功能不全、副甲状腺功能低下症）和骨盐溶出作用（肾或副甲状腺摘除大鼠）使血清Ca上升。中止给药后的血清Ca值显示迅速下降，据报告，由于血清Ca的推移，半衰期为3.4天（人）。
肾功能不全时的骨代谢改善作用
改善肾性骨萎缩症的骨吸收窝面、肥厚类骨层（人慢性肾功能不全、柴田肾炎大鼠，并降低肥大的副甲状腺重量及血中副甲状腺激素，抑制继发性的副甲状腺功能亢进。
1α,与25-（OH）2D的作用比较
经口给药的α-卡西多尔的作用为1α,与25-（OH）2D3相同或更高（人，柴田肾炎大鼠）。
适应症
○下述疾病中伴随维生素D代谢异常的各种症状（低钙血症、泰坦尼、骨痛、骨病变等）的改善
慢性肾功能不全、副甲状腺功能低下症、维生素D抵抗性骨质软化症.
○骨质疏松症
用法与用量
〈功效共通〉
本制剂在患者血清钙浓度的充分管理下调整给药量。
〈慢性肾功能衰竭、骨质疏松症〉
成人1天1次，作为α-卡西德尔为0.5～1.0μ口服给药g。但是，根据年龄、症状适当增减。
〈副甲状腺功能低下症、其他伴随维生素D代谢异常的疾病〉
成人1天1次，作为α-卡西德尔为1.0～4.0μ口服给药g。但是，根据疾病、年龄、症状、病型适当增减。
（儿童用量）
对于小儿，在骨质疏松症的情况下，1天1次，以α－卡西多计为0.01～0.03μmg/kg，其他疾病时，每日1次，以α－卡西多计0.05～0.1μ口服给药g/kg。但是，根据疾病、症状适当增减。
包装
软胶囊
0.25μg:100胶囊（PTP10胶囊×10）、500胶囊（PTP10胶囊×50）、500胶囊（含玫瑰、除臭剂）、700胶囊（PTP14胶囊×50）
0.5μg：100胶囊（PTP10胶囊×10）、500胶囊（PTP10胶囊×50）、500胶囊（含玫瑰、除臭剂）、700胶囊（PTP14胶囊×50）
1μg：100胶囊（PTP10胶囊×10）、500胶囊（PTP10胶囊×50）、500胶囊（含玫瑰、除臭剂）、700胶囊（PTP14胶囊×50）
制造供应商
中外制药株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明附件：
https://www.info.pmda.go.jp/go/pack/3112001M1046_1_10/
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ALFAROL Capsule（Alfacalcidol）
ALFAROL Capsule 0.5μg（アルファロールカプセル0.5μg）
Brand name : ALFAROL Capsule 0.5μg
　Active ingredient: Alfacalcidol
　Dosage form: opaque yellow capsule (φ: 5.6mm)
　Print on wrapping: アルファロール0.5
Effects of this medicine
This hepatically-metabolized medicine turns into activated vitamin D3 and promotes digestive tract absorption of calcium. It is usually used to treat osteoporosis as well as to improve bone disease and other symptoms caused by lack of vitamin D.
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 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: Your dosage of this medicine is adjusted under a fully controlled condition of serum calcium level.
To treat chronic renal failure: For adults, take 0.5-1.0μg of the active ingredient once a day. It should be adjusted according to your disease, age and symptoms.
To treat hypoparathyroidism and other disease caused by vitamin D metabolism abnormality: For adults, take 1.0-4.0μg of the active ingredient once a day. It should be adjusted according to your disease, age, symptoms and pattern of disease.
For children: In the case of osteoporosis, take 0.01-0.03 μg/kg of the active ingredient once a day. In the case of other diseases, take 0.05-0.1μg/kg of the active ingredient once a day. It should be adjusted according to your disease and symptoms.
1 capsule contains 3μg of the active ingredient. Strictly follow the instructions of your doctor in any case.
•Skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.
•If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
•Do not stop taking this medicine without the instructions of your doctor.
Precautions while taking this medicine
•If you take a large amount of calcium or vitamin D contained in OTC medicine or food while taking this medicine, you may have a higher risk of side effects. Check with your doctor about it beforehand.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: pruritus, loss of appetite, nausea, diarrhea.
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.
•decreased urinary volume, largely increased urinary volume, urinary retention, difficult urination, swollen body/legs/eyes, lassitude, easy fatigability, redden eyes, symptoms of hypercalcemia such as itch and irritation  [acute renal failure]
•yellowness in the skin and/or the white of the eye, lassitude [hepatic dysfunction, jaundice]
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 in a covered container, at room temperature (1-30℃). Keep away from light and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist how to discard.
Chugai Pharmaceutical Co., Ltd.Internal
Revised: 5/2007
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.