部分中文罗盖全处方资料（仅供参考）
药品英文名
Calcitriol

药品别名
1α，25-二羟基维生素D3、1α，25-二羟胆钙化醇、钙三醇、钙化三醇、罗盖全、罗钙全、溉纯、三羟维D3、二羟维D3、1α，25-Dihydroxyvitamin D3、Rocaltrol
 
药物剂型
1.罗钙全，胶囊：0.25μg；
2.溉纯，注射剂：1μg(1ml)，2μg(1ml)。

药理作用
本品是维生素1α，25-D3的一种最重要的活性代谢物。此代谢物通常是在肾脏内形成的。近年来发现肾外也可以生成钙三醇，已证实胎盘、单核细胞、巨噬细胞、肿瘤细胞上清液、结节病患者淋巴结和角朊细胞均存在1α羟化酶而能产生钙三醇。钙三醇的前体是25-羟基胆钙化醇（阿法骨化醇)。本品具有促使小肠吸收钙并调节骨质中无机盐转运等作用。在有明显的肾功能不全的患者，特别是需要长期血液透析者，内源性钙三醇合成会大幅度的降低，甚至几乎停止合成，因而导致肾性骨营养不良。口服本品能使肠正常吸收钙，因而可纠正低血钙，减轻骨与肌肉的疼痛，使已增高的血浆碱性磷酸酶降低或趋于正常，降低已增高的血浆甲状旁腺浓度而使之趋于正常，从而促进骨质矿化。本品还有加速骨骼胶原成熟的作用。
近年来还发现其对细胞的增殖、分化以及对免疫系统都有重要的作用，国外已开始作为一种新的免疫调节激素应用于临床。

药动学
口服吸收迅速，血浆药物浓度达峰时间为3～6h，7h后尿钙水平会增加，生物反应与剂量有关，血浆半衰期为3.5～6h。经代谢后由胆汁及尿液中排泄。

适应证
用于慢性肾功能衰竭患者的肾性骨营养不良，特别是需要长期血液透析的患者。手术后自发性及假性甲状腺功能减退。维生素D3依赖性佝偻病以及血磷酸盐过少维生素D抗性佝偻病。近年来还用于治疗银屑病等皮肤病的治疗。
 
禁忌证
凡与高血钙有关的疾病禁用。

注意事项
1.孕妇、儿童慎用。
2.根据血钙情况调整用量。
3.勿与含镁制剂合用，用药期间注意补钙。

不良反应
如果剂量不超出许可范围，本品没有不良反应。由于本品具有维生素D的作用，因此其不良反应类似维生素D过量后的反应，如食欲缺乏、呕吐、腹泻、软组织异常、多尿、蛋白尿及高血钙综合征或钙中毒（这取决于高血钙的维持时间及严重程度)。用药过量可导致眩晕、恶心、呕吐、腹痛、肌无力、精神错乱、烦渴、多尿、骨痛、肾结石、肾钙质沉着、心律失常等症状，由于本品的血浆半衰期短，因此在减量或停药后的几天内，血浆钙即可恢复正常，和用维生素D或其衍生物治疗相比，本品血浆钙恢复正常时间要快得多。
 
用法用量
口服:本品的最适宜剂量应根据每个患者血浆钙的水平仔细地予以确定。首次剂量是一天0.25μg。如患者的血浆钙浓度正常或略低，则隔日给予0.25μg已足够。如果在2～4周内，病情及生化指标等方面均无明显的改善，可在2～4周的间期内把日剂量增加到0.5μg。在此期间至少2次测定血钙浓度，随时调整剂量。大部分患者在剂量为每天0.5～1.0μg的范围内有良好反应。日剂量为5μg或以上，必须倍加小心（每周需2次测定血浆钙和磷酸盐的浓度并进行临床观察)。给予足量的钙制剂（成人的每天剂量为0.8～1.0g)是本品发挥最佳疗效的一个先决条件。如有需要，可再给予额外的钙片，但是易发生高血钙的患者须控制钙用量。当最适剂量确定后，血浆钙的浓度也必须每天复查1次。一旦血浆钙浓度比正常值高出0.25mmol/L（平均为2.25～2.75mmol/L)，此时剂量必须大大减低或停止治疗直到血钙正常为止。如服用其他的钙制剂也应停止，这对于促使血浆钙恢复正常水平是有好处的。在此期间血浆及磷酸盐的浓度必须逐日测定，当血浆钙水平恢复正常后，可继续治疗，每天剂量应比前次剂量低0.25μg。
 
药物相应作用
1.本品是维生素D3的重要代谢产物之一，因此不能同时给予维生素D制剂及其衍生物（例如二氢速甾醇)。
2.如同时有巴比妥类药物或抗惊厥剂，会加速本品代谢，需要根据血钙、磷浓度调整增加剂量。
3.在服用本品时，不应同时服用含镁的制剂，以免引起高镁血症。
 
专家点评
在本品双盲对照试验中，187例慢性肾功能不全、血液透析患者以阿法骨化醇为对照，进行临床观察，结果表明二者有效性、安全性等方面均无差异。剂量为阿法骨化醇的一半时，有同样的疗效。应用1g含本品15μg的凡士林软膏，外用，每天1次，90%的银屑患者于4周内有显著改善。

Rocaltrol
Generic Name: calcitriol (oral) (kal si TRYE ol)
Brand Names: Rocaltrol
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What is calcitriol?
Calcitriol is vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.
Calcitriol is used to treat calcium deficiency with hypoparathyroidism (decreased functioning of the parathyroid glands) and metabolic bone disease in people with chronic
kidney failure.
Calcitriol may also be used for other purposes not listed in this medication guide.
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What is the most important information I should know about calcitriol?
Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood. Drink plenty of fluids unless your doctor has told you to restrict your fluid intake.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. Becoming dehydrated while taking calcitriol can lead to an electrolyte imbalance. Do not take other vitamin or mineral supplements unless your doctor has told you to.
Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different minerals and some types can cause serious side effects if you take them together with calcitriol.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
Calcitriol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.
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What should I discuss with my healthcare provider before taking calcitriol?
Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have: high levels of calcium in your blood (hypercalcemia); orhigh levels of vitamin D in your body (hypervitaminosis D).
Before taking calcitriol, tell your doctor about all of your medical conditions. You may not be able to take calcitriol, or you may need a dose adjustment or special tests to safely take this medication.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Calcitriol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
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How should I take calcitriol?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended.
Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Drink plenty of fluids unless your doctor has told you to restrict your fluid intake. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. Becoming dehydrated while taking calcitriol can lead to an electrolyte imbalance.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. You may need blood tests as often as twice a week when you first start taking calcitriol. Do not miss any scheduled appointments.
Calcitriol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.
If you need to be on bed-rest or have any type of surgery, your dose or testing needs may change. Follow your doctor's instructions. Store this medication at room temperature away from moisture, light, and heat.
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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include increased thirst or urination, uneven heart rate, weakness, behavior changes, bone pain, nausea, weight loss, decreased appetite, constipation, or a metallic taste in the mouth.
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What should I avoid while taking calcitriol?
Do not take other vitamin or mineral supplements unless your doctor has told you to.
Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different minerals and some types can cause serious side effects if you take them together with calcitriol.
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Calcitriol side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking calcitriol and call your doctor at once if you have any of these serious side effects:
increased thirst,urinating more than usual;
pain in your lower back;
fast, slow, or uneven heart rate;
weakness, drowsiness, changes in behavior;
bone pain, muscle weakness, loss of height;
nausea, constipation, loss of appetite, weight loss;
slow growth (in a child taking calcitriol); or
dry mouth or a metallic taste.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
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What other drugs will affect calcitriol?
Before taking calcitriol, tell your doctor if you are taking any of the following medicines:
digoxin (digitalis, Lanoxin, Lanoxicaps);
cholestyramine (Questran, Prevalite);
sevelamer (Renagel);
ketoconazole (Nizoral);
lanthanum (Fosrenol);
seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton);steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; ora (water pill) diuretic such as hydrochlorothiazide (HCTZ, Esidrix, Hydrodiuril, Microzide,Oretic), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.
This list is not complete and there may be other drugs that can interact with calcitriol.
Tell your doctor about all your prescription and over-the-counter medications, vitamins,
minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
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Where can I get more information?
Your pharmacist can provide more information about calcitriol.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that
effect.
Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement
to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If
you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
附件：

200961021572132.pdf

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注：以下产品不同规格和不同价格，购买时请以咨询为准！
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产地国家: 欧洲共同体国家
原产地英文商品名:
ROCALTROL 0.5mcg/Capsule 20Capsules/box
原产地英文药品名:
CALCITRIOL
中文参考商品译名:
罗盖全 0.5微克/胶囊 20胶囊/盒
中文参考药品译名:
骨化三醇
生产厂家中文参考译名:
罗氏
生产厂家英文名:
Roche Pharma AG, Aktiengesellschaft
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产地国家: 欧洲共同体国家
原产地英文商品名:
ROCALTROL 0.25mcg/Capsule 20Capsules/box
原产地英文药品名:
CALCITRIOL
中文参考商品译名:
罗盖全 0.25微克/胶囊 20胶囊/盒
中文参考药品译名:
骨化三醇
生产厂家中文参考译名:
罗氏
生产厂家英文名:
Roche Pharma AG, Aktiengesellschaft