美時 學名藥軟膠囊Paricalcitol 美FDA核可 (CKD之低血鈣引發副甲狀腺機能亢進)

學名藥 美時藥獲FDA核可 2015-07-27 04:47:23 經濟日報 黃文奇特殊學名藥廠美時化學製藥上周公告，旗下學名藥中之用於治療次發性副甲狀腺機能亢進之維生素D衍生物Paricalcitol，獲得美國FDA之審查核可通知，待2016年1月所有專利到期後，即可取得該藥證之正式核可。美時表示，Paricalcitol係為維生素D衍生物，主要用於治療慢性腎衰竭病患之次發性副甲狀腺機能亢進，由於其劑量極為微小且為高致敏軟膠囊產品，在處方開發與生產製造上皆有一定難度的技術門檻。

Paricalcitol is used to treat and prevent high levels of a certain natural substance made by the body (parathyroid hormone) in patients with long-term kidney disease. In these patients, the high level of parathyroid hormone is caused by a low level of calcium and a certain kind of vitamin D. Too much parathyroid hormone can cause serious problems such as bone disorders. Paricalcitol is a man-made form of vitamin D. It helps to reduce parathyroid hormone levels and may help your body absorb calcium and phosphorus. Paricalcitol, USP, the active ingredient in Zemplar Capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism in chronic kidney disease. Zemplar is available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxytoluene. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, glycerin, titanium dioxide, iron oxide red (2 microgram capsules only), iron oxide yellow (2 microgram and 4 microgram capsules), iron oxide black (1 microgram capsules only), and water. Paricalcitol is a white, crystalline powder with the empirical formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula:

亞培腎骨樂膠囊 英文名稱： Zemplar 2mcg/Cap成分及含量：Paricalcitol 2 mcg/Cap 亞培腎骨樂膠囊藥品類別：口服藥 作用：次發性副甲狀腺機能亢進用藥方法：1.空腹或與食物併服皆可。2.慢性腎臟疾病（CKD）第三、四期可以每日服藥一次或一星期服藥三次，每隔一天給藥。3.CKD第五期則一星期服藥三次，每隔一天給藥。特別用藥指示：1.本藥可能會使血鈣升高，正使用含鈣之磷結合劑病人，劑量需降低或中斷用藥。2.可能加強毛地黃的毒性，與毛地黃併用時，需特別小心。3.高鈣飲食、高劑量含鈣製劑或thiazide利尿劑可能會增加高血鈣的風險。4.避免和含鎂或鋁製劑（如制酸劑）長期併服，以免發生高血鎂或鋁中毒。5.和ketoconazole及其他CYP3A4強烈抑制劑併用時，需要特別注意。6.本藥品含少量乙醇(少於100毫克)，酒精中毒病人應注意。7.會降低腸道對脂溶性維生素吸收的藥物，如cholestyramine，可能會干擾本藥的吸收。