帕立骨化醇 Paricalcitol
【其它名称】zemplar
规格
帕立骨化醇胶囊(1)1μg。(2)2μg。(3)4μg。
药品简介
FDA批准其活性维生素D治疗药物帕立骨化醇（paricalcitol，Zemplar）1、2和4 mcg胶囊剂用于预防和治疗继发性甲状旁腺功能亢进症（SHPT）。本品对接受透析和移植手术前的Ⅲ及Ⅳ期慢性肾脏疾病（CKD）患者的SHPT显示预防及治疗疗效。
本品为口服制剂，其活性成份帕立骨化醇的注射制剂于1998年上市，并已成为透析患者最广泛使用的SHPT预防及治疗药物。本品通过更为便利的口服途径给药降低甲状旁腺激素（PTH）水平，同时对血钙及血磷水平具有最小影响。PTH降低是SHPT治疗疗效的一个关键性指标。
3项Ⅲ期临床研究结果表明，本品能安全、有效地降低并发SHPT 的Ⅲ及Ⅳ期CKD患者PTH水平。在24周的治疗后，本品组91%的患者PTH水平明显且持续降低，而安慰剂组这一比例仅为13%。PTH水平明显且持续降低是指PTH至少连续2次降低30%以上（包括30%），并且在治疗第9周患者PTH平均降低30%以上。
本品常见的不良反应发生情况与安慰剂类似。另外，偶见治疗不当引发的维生素D中毒、血钙过多以及对本品成份过敏。

ZEMPLAR CAPSULES Rx Generic Name and Formulations:
Paricalcitol 1mcg, 2mcg, 4mcg; soft gel caps.
Company:
AbbVie
Indications for ZEMPLAR CAPSULES:
Secondary hyperparathyroidism due to chronic kidney disease (CKD) Stages 3 and 4, or with CKD Stage 5 in patients on hemodialysis or peritoneal dialysis.
Adult Dose for ZEMPLAR CAPSULES:
Take without regard to food. CKD Stages 3/4: base initial dose on baseline intact parathyroid hormone (iPTH) levels. iPTH ≤500pg/mL: 1mcg daily or 2mcg 3 times week (every other day). iPTH >500pg/mL: 2mcg daily or 4mcg 3 times weekly. CKD Stage 5: base initial dose on baseline iPTH level (pg/mL)/80; give 3 times a week (every other day); treat only after baseline serum calcium adjusted to ≤9.5mg/dL. Dose titration: see full labeling.
Children's Dose for ZEMPLAR CAPSULES:
Not established.
See Also:
ZEMPLAR INJECTION
Pharmacological Class:
Vit. D analogue.
Contraindications:
Vit. D toxicity. Hypercalcemia.
Warnings/Precautions:
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. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole); use with caution and monitor. Arrhythmias with digitalis if hypercalcemia occurs. Caps: cholestyramine or mineral oil may impair absorption. Avoid concomitant Vit. D, phosphate, calcium-containing products, or thiazide diuretics. Concomitant aluminum-containing preparations (eg, antacids, phosphate binder); may cause aluminum bone toxicity.

Adverse Reactions:
Diarrhea, hypertension, dizziness, vomiting; hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, adynamic bone disease, hypervitaminosis D.

Generic Availability:
YES
How Supplied:
Caps—30; Vial (1mL, 2mL, 4mL)—1

FDA批准雅培帕立骨化醇胶囊用于肾病并发症早期治疗
雅培公司（Abbott）5月27日宣布，FDA批准其活性维生素D治疗药物帕立骨化醇（paricalcitol，Zemplar）1、2和4 mcg胶囊剂用于预防和治疗继发性甲状旁腺功能亢进症（SHPT）。本品对接受透析和移植手术前的Ⅲ及Ⅳ期慢性肾脏疾病（CKD）患者的SHPT显示预防及治疗疗效。
本品为口服制剂，其活性成份帕立骨化醇的注射制剂于1998年上市，并已成为透析患者最广泛使用的SHPT预防及治疗药物。本品通过更为便利的口服途径给药降低甲状旁腺激素（PTH）水平，同时对血钙及血磷水平具有最小影响。PTH降低是SHPT治疗疗效的一个关键性指标。
3项Ⅲ期临床研究结果表明，本品能安全、有效地降低并发SHPT 的Ⅲ及Ⅳ期CKD患者PTH水平。在24周的治疗后，本品组91%的患者PTH水平明显且持续降低，而安慰剂组这一比例仅为13%。PTH水平明显且持续降低是指PTH至少连续2次降低30%以上（包括30%），并且在治疗第9周患者PTH平均降低30%以上。
本品常见的不良反应发生情况与安慰剂类似。另外，偶见治疗不当引发的维生素D中毒、血钙过多以及对本品成份过敏。
Zemplar
Generic name: Paricalcitol
Why is Zemplar prescribed?
Zemplar is used for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4. Zemplar is an active form of vitamin D that comes in a capsule. Your doctor has prescribed Zemplar to replace the active vitamin D that your kidneys can no longer make. Zemplar capsules are not the same as the vitamin D supplements you can buy in the supermarket.
Most important fact about Zemplar
Taking too much vitamin D, like the active ingredient in Zemplar, can cause increased calcium levels, calcium in your urine, and bone disease.
How should you take Zemplar?
Zemplar may be taken with or without food. Swallow the capsules whole with water.
Storage instructions.
Store at room temperature.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include:
Allergic reaction, back pain, chest pain, fever, flu, fungal/bacterial infections, headache, pain, stomach pain, viral infection
Symptoms of vitamin D overdose:
(Early) Bone pain, constipation, dry mouth, headache, nausea/vomiting, metallic taste, muscle pain, sleeplessness, weakness
(Late) Eye infection, itchiness, light sensitivity, nasal infection, weight loss/loss of appetite (anorexia)
Why should Zemplar not be prescribed?
Do not take Zemplar if you have elevated blood levels of calcium or vitamin D, or if you are allergic to any of its ingredients.
Special warnings about Zemplar
Do not take any medications or supplements—including over-the-counter drugs, herbal products, and dietary supplements—without talking to your doctor first.
Because treatment with Zemplar may raise blood calcium levels, it's important to watch for signs that indicate there may be a problem. High blood calcium levels (hypercalcemia) can increase the risk for irregular heartbeat and seizures among people who have a history of these conditions. Hypercalcemia can also increase the effects of digitalis. Let your doctor know right away if you develop any of the following symptoms while taking Zemplar:
Weakness or tiredness
Vomiting
Constipation
Metallic taste in the mouth
Headache
Nausea
Dry mouth
Muscle or bone pain
You can help prevent hypercalcemia by taking Zemplar exactly as directed by your doctor. Do not take any other forms of vitamin D, such as over-the-counter supplements or other vitamin D prescription medicines, unless directed by your doctor. Taking too much vitamin D can lead to hypercalcemia and other serious problems. Hypercalcemia caused by an overdosage of vitamin D can become severe and may require emergency medical attention. In addition, you should follow your doctor's recommendations for controlling your intake of calcium and phosphorus. High intake of calcium and phosphorus during treatment with Zemplar can also lead to hypercalcemia.
Possible food and drug interactions when taking Zemplar
If Zemplar is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Zemplar with the following:
Atazanavir
Clarithromycin
Indinavir
Itraconazole
Ketoconazole
Nefazodone
Nelfinavir
Ritonavir
Saquinavir
Telithromycin
Voriconazole
Special information if you are pregnant or breastfeeding
The effects of Zemplar during pregnancy and breastfeeding are unknown. Talk with your doctor before taking this drug if you are pregnant, plan to become pregnant, or are breastfeeding.
Recommended dosage for Zemplar
ADULTS
Zemplar capsules may be taken daily or three times a week. When treated three times weekly, the dose should be given no more frequently than every other day.
Overdosage
Return to top
Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.
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产地国家: 德国
原产地英文商品名:
ZEMPLAR 1MCG/CAP 28CAPS/BOTTLE
原产地英文药品名:
PARICALCITOL
中文参考商品译名:
ZEMPLAR 1微克/胶囊 28胶囊/瓶
中文参考药品译名:
帕立骨化醇
生产厂家中文参考译名:
雅培
生产厂家英文名:
ABBOTT
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产地国家: 德国
原产地英文商品名:
ZEMPLAR 2MCG/CAP 28CAPS/BOTTLE
原产地英文药品名:
PARICALCITOL
中文参考商品译名:
ZEMPLAR 2微克/胶囊 28胶囊/瓶
中文参考药品译名:
帕立骨化醇
生产厂家中文参考译名:
雅培
生产厂家英文名:
ABBOTT
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产地国家: 美国
原产地英文商品名:
ZEMPLAR 4MCG/CAP 30CAPS/BOTTLE
原产地英文药品名:
PARICALCITOL
中文参考商品译名:
ZEMPLAR 4微克/胶囊 30胶囊/瓶
中文参考药品译名:
帕立骨化醇
生产厂家中文参考译名:
雅培
生产厂家英文名:
ABBOTT
-----------------------------------------------------------
产地国家: 美国
原产地英文商品名:
ZEMPLAR 2MCG/CAP 30CAPS/BOTTLE
原产地英文药品名:
PARICALCITOL
中文参考商品译名:
ZEMPLAR 2微克/胶囊 30胶囊/瓶
中文参考药品译名:
帕立骨化醇
生产厂家中文参考译名:
雅培
生产厂家英文名:
ABBOTT
----------------------------------------------------------
产地国家: 美国
原产地英文商品名:
ZEMPLAR 1MCG/CAP 30CAPS/BOTTLE
原产地英文药品名:
PARICALCITOL
中文参考商品译名:
ZEMPLAR 1微克/胶囊 30胶囊/瓶
中文参考药品译名:
帕立骨化醇
生产厂家中文参考译名:
雅培
生产厂家英文名:
ABBOTT
该药品相关信息网址1:
http://www.zemplar.com/
该药品相关信息网址2:
http://www.drugs.com/zemplar.html
该药品相关信息网址3:
http://www.rxlist.com/zemplar-drug.htm