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、溉纯、三羟维D3、二羟维D3、1α，25-Dihydroxyvitamin D3、Rocaltrol   药物剂型 1.罗盖全，胶囊：0.25μg；0.5μg； 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。 Brand name: Rocaltrol Generic name: Calcitriol Why is Rocaltrol prescribed? Rocaltrol is a synthetic form of vitamin D used to treat people on dialysis who have hypocalcemia (abnormally low blood calcium levels) and resulting bone damage. Rocaltrol is also prescribed to treat low blood calcium levels in people who have hypoparathyroidism (decreased functioning of the parathyroid glands). When functioning correctly, these glands help control the level of calcium in the blood. Rocaltrol is also prescribed for hyperparathyroidism (increased functioning of the parathyroid glands) and resulting bone disorders in people with kidney disease who are not yet on dialysis. Most important fact about Rocaltrol While you are taking Rocaltrol, your doctor may want you to follow a special diet or take calcium supplements. This is an important part of your therapy. On the other hand, too high a calcium level can be harmful. If you are already taking any medications containing calcium or calcium supplements, make sure you doctor knows about it. How should you take Rocaltrol? Be sure to get enough fluids and avoid dehydration while taking Rocaltrol. If you miss a dose. If you take 1 dose every other day, and you remember before the next day, take the forgotten dose immediately, then go back to your regular schedule. If you do not remember until the next day, take the dose immediately, skip a day, then go back to your regular schedule. If you take 1 dose every day, take it as soon as you remember. Then go back to your regular schedule. If you do not remember until the next day, skip the dose you missed and go back to your regular schedule. If you take Rocaltrol more than once a day, take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once. Storage instructions. Keep capsules and oral solution away from heat and light. What side effects may occur? Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Rocaltrol. Side effects occurring early may include: Bone pain, constipation, dry mouth, extreme sleepiness, headache, loss of appetite, metallic taste, muscle pain, nausea, vomiting, weakness Side effects occurring later may include: Abnormal thirst, apathy, arrested growth, decreased sex drive, dehydration, elevated blood cholesterol levels, excessive urination, extremely high body temperature, high blood pressure, inflamed eyes, intolerance to light, irregular heartbeat, itchy skin, kidney problems, loss of appetite, nighttime urination, runny nose, sensory disturbances, urinary tract infections, wasting of muscles or other tissues, weight loss, yellowish skin Excessive amounts of vitamin D may cause abnormally high calcium levels in the blood. Why should Rocaltrol not be prescribed? You should not use Rocaltrol if you have high blood levels of calcium, or if you have vitamin D poisoning. You should also avoid Rocaltrol if it, or any similar drug, has given you an allergic reaction in the past. Special warnings about Rocaltrol You should not take additional doses of vitamin D while taking Rocaltrol. People who are on dialysis should not take antacids containing magnesium while taking Rocaltrol. Your doctor will monitor your calcium levels while you are taking Rocaltrol because excessive calcium levels can be very dangerous. If this problem develops, your doctor will need to stop Rocaltrol therapy temporarily and prescribe a lower dose when treatment resumes. While taking Rocaltrol, you should have an adequate daily intake of calcium (at least 600 milligrams a day), either from foods (such as milk and dairy products) or from a calcium supplement. Your doctor will estimate your daily calcium intake before you take this drug to see if you will require more calcium. Possible food and drug interactions when taking Rocaltrol If Rocaltrol 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 Rocaltrol with the following: Antacids containing magnesium Calcium supplements Cholestyramine Digitalis Ketoconazole Phenobarbital Phenytoin Steroid medications such as prednisone Thiazide diuretics such as hydrothiazdie Vitamin D supplements Special information if you are pregnant or breastfeeding The effects of Rocaltrol during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Pregnant women should use Rocaltrol only if the possible benefit outweighs any possible risk to the unborn baby. Rocaltrol may appear in breast milk. Because it may affect a nursing infant, you should not use Rocaltrol while you are breastfeeding. Recommended dosage for Rocaltrol ADULTS For People on Dialysis The suggested beginning dose is 0.25 microgram daily. Your doctor may increase the dose by 0.25 microgram daily at 4 to 8 week intervals if needed. Most people on dialysis require a dose of 0.5 to 1 microgram a day. People with normal or only slightly low blood calcium levels may find it helpful to take 0.25 microgram every other day. For Low Calcium Levels Due to Hypoparathyroidism The suggested beginning dose is 0.25 microgram daily, taken in the morning. Your doctor may increase the dose at 2 to 4 week intervals. For most adults, regular doses ranging from 0.5 to 2 micrograms daily are effective. For People Not Yet on Dialysis The recommended starting dose is 0.25 microgram a day, increased to 0.5 microgram if necessary. CHILDREN For Low Calcium Levels Due to Hypoparathyroidism The starting dose is 0.25 microgram, taken in the morning. For most children 6 years and older, doses ranging from 0.5 to 2 micrograms per day are effective. Children from 1 to 5 years old are usually given 0.25 to 0.75 microgram a day. Doses have not been established for hypoparathyroidism in infants under 1 year, or for pseudohypoparathyroidism (a special form of the disorder) in children under 6. For Children not yet on Dialysis The recommended starting dose for children 3 years and older is 0.25 microgram a day, increased to 0.5 microgram if necessary. For children less than 3 years old, the daily starting dose is 10 to 15 nanograms per 2.2 pounds of body weight. Overdosage Any medication taken in excess can have serious consequences. Severe overdosage of Rocaltrol may cause serious effects, such as extremely high blood levels of calcium. Warning signs include the symptoms listed under early side effects. If you suspect an overdose, seek medical help immediately. 附件： 200961021572132.pdf --------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买时请以电话咨询为准！ --------------------------------------------------------------- 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 --------------------------------------------------------------- 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 --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: ROCALTROL 0.5mcg/Capsule 100Capsules/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 100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 --------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: ROCALTROL 0.25mcg/Capsule 100Capsules/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 100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 ---------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: Generic ROCALTROL 0.25mcg/cap 30caps/box 原产地英文药品名: CALCITRIOL 中文参考商品译名: 罗盖全仿制药 0.25微克/胶囊 30胶囊/盒 中文参考药品译名: 骨化三醇