英文药名: One-alpha(alfacalcidol capsules)
中文药名: 阿法骨化醇胶囊
生产厂家: Leo
药品名称
【药物名称】阿法骨化醇
【英文名】Alfacalcidol
【别名】 阿尔法D3; 阿尔法骨化醇, １α－羟基维生素Ｄ３
规格
胶囊剂：0.25μｇ, 1μｇ。
作用机理
1.增加小肠和肾小管对钙的重吸收，抑制甲状旁腺增生，减少甲状旁腺激素合成与释放，抑制骨吸收；
2.增加转化生长因子-β(TGF-β)和胰岛素样生长因子-I(IGF-I)合成，促进胶原和骨基质蛋白合成；
3.调节肌肉钙代谢，促进肌细胞分化，增强肌力，增加神经肌肉协调性，减少跌倒倾向。
药 动 学
口服经小肠吸收后在肝内经25羟化酶作用转化为1,25-(OH)2D3。现知成骨细胞也表达25羟化酶mRNA，也可将1α-OH-D3转化为活性形式。转化后的血1,25-(OH)2D3高峰出现于用药后8～12小时，半衰期(t1/2)17.6小时。
适应症
适用于防治骨质疏松症、肾原性骨病（肾病性佝偻病）、甲状旁腺功能亢进（伴有骨病者）、甲状旁腺功能减退、营养和吸收障碍引起的佝偻病和骨软化症、假性缺钙（Ｄ－依赖型Ⅰ）的佝偻病和骨软化症等。
不良反应
小剂量单独使用(＜1.0μg/d)一般无不良反应，长期大剂量用药或与钙剂合用可能会引起高钙血症和高钙尿症。
注意事项
1.用药过程中应注意监测血钙、血尿素氮、肌酐，以及尿钙、尿肌酐。
2.青年患者只限于青年特发性骨质疏松症及糖皮质激素过多引起的骨质疏松症。
3.出现高钙血症时须停药，并予有关处理，待血钙恢复正常，按末次剂量减半给药。
包装规格：
·0.25mcg*90胶囊
·0.5mcg*90胶囊
·1mcg*90胶囊
·0.25mcg*100胶囊
 |
One-Alpha®
Active ingredient: Each capsule contains 1 microgram of Alfacalcidol.
Therapeutic indications
One-Alpha® is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1 α-hydroxylation of vitamin D3 such as when there is reduced renal function.
The main indications are:
- Uraemic bone disease
- Hyperparathyroidism (with bone disease)
- Hypoparathyroidism
- Post-menopausal, senile and steroid-induced osteoporosis
- Nutritional and malabsorptive rickets and osteomalacia
- Pseudo-deficiency (D-dependent) rickets
- Hypophosphataemic vitamin D resistant rickets and osteomalacia
- Prophylactic and therapeutic use in neonatal hypocalcaemia
Posology and method of administration
Initial dosage for all indications is:
|
• Adults & children over 20 kg bodyweight |
1 microgram/day |
|
• Neonates and premature infants |
0.05 -0.1 microgram/kg/day |
|
• Children under 20 kg bodyweight |
0.05 microgram/kg/day |
|
• Elderly |
0.5 microgram/day may be sufficient |
Contraindications:
Hypercalcaemia.
Hypersensitivity to any of its constituents.
Undesirable Effects:
The most frequently reported undesirable effects are hypercalcaemia and various skin reactions such as rash.
