英文药名: Zemplar(Paricalcitol Injection)

中文药名: 帕立骨化醇注射剂

生产厂家: Abbott

ZEMPLAR INJECTION
Paricalcitol 2micrograms/mL; soln for IV inj; contains alcohol.

Legal Classification:
Rx

Pharmacological Class for ZEMPLAR INJECTION
Vit. D analogue.

Manufacturer of ZEMPLAR INJECTION
Abbott Laboratories
 
Indications for ZEMPLAR INJECTION
Secondary hyperparathyroidism due to chronic renal failure.

Adults and Children:
Give as IV bolus inj during dialysis. ≥5yrs: Initially 0.04–0.1microgram/kg (2.8–7micrograms) no more often than every other day; may increase in increments of 2–4micrograms at 2–4 week intervals; max 0.24microgram/kg (16.8micrograms). Titrate based on iPTH levels (see literature).

Also:
ZEMPLAR CAPSULES

Contraindications for ZEMPLAR INJECTION
Vit. D toxicity. Concurrent Vit. D or phosphate therapy. Hypercalcemia.

Warnings/Precautions for ZEMPLAR INJECTION
Severe hepatic impairment. Monitor serum calcium, phosphorus, and iPTH at least every 2 weeks for 3 months after starting or dose changes, then monthly for 3 months, then every 3 months. If hypercalcemia or elevated Ca x P product occurs, reduce dose or stop until normal; restart at lower dose. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions for ZEMPLAR INJECTION
Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole). Arrhythmias with digitalis if hypercalcemia occurs. Caps: cholestyramine may impair absorption.

Adverse Reactions for ZEMPLAR INJECTION
Hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, hypervitaminosis D.

How is ZEMPLAR INJECTION supplied?
Caps—30
Vial (1mL, 2mL, 4mL)—1

帕立骨化醇注射剂(paricalcitol injection，商品名Zemplar)获FDA批准，用于5~19岁的儿童及青少年血液透析患者的继发性甲状旁腺功能亢进症(SHPT)。
该产品在1998年问世，目前在美国被广泛应用于成人血液透析患者的SHPT。
在美国，大约有1400名5~19岁的儿童接受血液透析的治疗。这种治疗是通过人工肾对红细胞进行过滤，以去除其中的废物及额外的液体。由于肾衰患者的体内不能产生有活性的维生素D，多数透析患者会发展成为SHPT。SHPT可导致骨疾病的发生，还可累及多个器官及组织等，包括血液、心脏、神经及肌肉。
一项为期12周的随机、双盲、安慰剂对照试验考察了帕立骨化醇注射剂的安全性及有效性。该试验由29位5~19岁接受血液透析治疗的慢性肾衰患者参加。几乎每位患者在试验前都接受过各种形式的维生素D治疗。在帕立骨化醇注射剂治疗组中，60%的患者甲状旁腺激素水平连续两次下降30%，而对照组只有21%的患者取得此种疗效。治疗组中有23%的患者出现了血钙的升高，低于对照组（31%）。
在试验中，治疗组及对照组均未出现高钙血症患者。
但是，临床试验表明，治疗组不良反应的发生率高于对照组5%（无论该不良反应是否与药物有直接的相关性）。常见的不良反应有恶心、呕吐、水肿。
帕立骨化醇注射剂不宜用于维生素D中毒、高钙血症或对该药成分过敏者。