中文药名:帕立骨化醇注射剂 Paricalcitol
英文药名: Zemplar (Paricalcitol Injection)
【其它名称】zemplar
药品介绍
美国FDA批准雅培公司的帕利骨化醇注射剂(paricalcitol,Zemplar)用于5~19岁儿童和青少年血液透析病人继发性甲状旁腺功能亢进(SHPT)。本品1998年上市,目前在美国主要用于治疗成人透析患者的SHPT。
肾衰竭患者体内不能产生活性维生素D。因而许多透析病人缺少维生素D,出现SHPT,造成骨疾病和影响包括骨、红细胞、心脏、神经和肌肉等许多器官和组织。
以29例5~19岁慢性肾衰竭血液透析儿童进行12周随机双盲设安慰剂对照研究本品的安全性和有效性,几乎所有患者研究前均接受过某种剂型的维生素D制剂。研究表明,Zemplar治疗组60%患者甲状旁腺激素浓度有2个连续的30%减少。而安慰剂组病人仅21%。较少的Zemplar组病人血清钙浓度较安慰剂组高(23%:31%)。在研究中,治疗组和安慰剂组均未出现高钙血症。
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
------------------------------------------------------------------- 原产地英文商品名: ZEMPLAR 10MCG/ML 2ML/VIAL 原产地英文药品名: PARICALCITOL 中文参考商品译名: ZEMPLAR 10微克/毫升 2毫升/瓶 中文参考药品译名: 帕立骨化醇 产地国家: 美国 所属类别: 激素内分泌药物->甲状腺激素类药及抗甲状腺激素药物 处方药:处方药 包装规格: 10微克/毫升 2毫升/瓶 计价单位: 瓶 ----------------------------------------------------------------- 原产地英文商品名: ZEMPLAR 2MCG/ML/VIAL 25VIALS/BOX 原产地英文药品名: PARICALCITOL 中文参考商品译名: ZEMPLAR 2微克/毫升/瓶 25瓶/盒 中文参考药品译名: 帕立骨化醇 产地国家: 美国 所属类别: 激素内分泌药物->甲状腺激素类药及抗甲状腺激素药物 处方药:处方药 包装规格: 2微克/毫升/瓶 25瓶/盒 计价单位: 瓶 ----------------------------------------------------------------- 原产地英文商品名: ZEMPLAR 5MCG/ML/VIAL 25VIALS/BOX 原产地英文药品名: PARICALCITOL 中文参考商品译名: ZEMPLAR 5微克/毫升/瓶 25瓶/盒 中文参考药品译名: 帕立骨化醇 产地国家: 美国 所属类别: 激素内分泌药物->甲状腺激素类药及抗甲状腺激素药物 处方药:处方药 包装规格: 5微克/毫升/瓶 25瓶/盒 计价单位: 盒
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