| 简介：
部份中文盐酸司维拉姆处方资料（仅供参考）
英文名：Sevelamer Hydrochloride
商品名：Phoslock
中文名：盐酸司维拉姆
生产商：协和麒麟制药
药品介绍
肾衰竭透析新剂型Phoslock（Sevelamer Hydrochloride，フォスブロック錠，盐酸司维拉姆）是目前治疗肾病中高磷酸盐血症选择性最好的新药。
フォスブロック錠250mg
药物分类名称
高磷血症治疗剂（磷结合聚合物）
批准日期：2003年4月
商標名
PHOSBLOCK TABLETS 250mg
一般名
セベラマー塩酸塩(Sevelamer Hydrochloride)(JAN)
本質
〔英名〕Hydrochloride of prop-2-en-1-amine polymer with 1-chloro-2,3-epoxypropane
〔日本名〕プロプ-2-エン-1-アミンと1-クロロ-2,3-エポキシプロパンの重合物の塩酸塩
構造式
性状
它是白色至微黄色的白色粉末。
几乎不溶于乙腈，2-丙醇，0.1mol/L盐酸溶液，0.1 mol/L氢氧化钠溶液和水。
它极易吸湿。
药用药理学
1.作用与效果
（1）提高血清磷浓度和血清钙磷产物的作用
在正常大鼠和仓鼠中，施用司维拉姆饮食盐酸盐可降低血清磷浓度。此外，在部分肾切除术大鼠，阿霉素引起的和腺嘌呤引起的肾功能不全的大鼠中，抑制了血清磷浓度和血清钙磷产物的增加。此外，证实在单侧肾切除的Thy1肾功能不全大鼠中，显示出高值的血清磷浓度和血清钙磷产物降低。
（2）抑制异位钙化进展的作用
在腺嘌呤诱发的肾衰竭大鼠中，对照组每10例中有10例观察到胸主动脉钙化，其中重度7例，中度1例和轻度1例，但盐酸司维拉姆饮食控制为2％结果，尽管在10例中有1例观察到严重的钙化，但在9例中未观察到病变，表明该药物抑制异位钙化进展的作用。
（3）提高血清PTH浓度的效果
在部分肾切除的大鼠中，血清PTH浓度较高（平均789.4pg/mL），但通过在饮食中施用1％和3％的司维拉姆盐酸盐，平均分别为192.1pg/mL和68.7pg/mL，以及假手术组值（平均）。43.6pg/ mL）。此外，在阿霉素诱导，腺嘌呤诱导和单侧肾切除的Thy1肾衰竭大鼠中也观察到了类似的血清PTH升高或降低作用。
（4）抑制肾性骨营养不良的进展的作用
在腺嘌呤诱发的肾功能不全的大鼠中，类骨质，纤维质和孔隙率显示出较高的值，并表现出与血清PTH升高有关的高周转性骨疾病，但通过饮食方式施用1％和2％的司维拉姆盐酸盐，所有这些参数均被显着抑制。
2.作用机制
Sevelamer盐酸盐是一种聚阳离子聚合物，可与消化道中的磷结合并促进粪便中磷的排泄，从而抑制了磷从消化道中的吸收并降低了血磷浓度。
适应症
改善以下患者的高磷酸盐血症
慢性肾衰竭透析患者
用法与用量
通常，对于成年人，在饭前即刻每天口服1-2克司维拉姆盐酸盐3次。最大剂量为9g/天，尽管可以根据年龄，症状和血清磷水平进行调整。
包装
片
250mg：100片（PTP），1000片（PTP）
制造商和销售商
协和麒麟有限公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整资料附件：
https://medical.kyowakirin.co.jp/site/infopdf/notice/852.pdf
Brand name :PHOSBLOCK TABLETS 250mg
Active ingredient:Sevelamer hydrochloride
Dosage form:
white to faintly yellowish white tablet, diameter: 9 mm, thickness: 6.2mm
Print on wrapping:
フォスブロック250, PHOSBLOCK250, KR01
Effects of this medicine
This medicine binds to phosphorus contained in food in the gastrointestinal tract to promote the fecal excretion of phosphorus. It consequently suppresses gastrointestinal absorption of phosphorus and decreases blood phosphorus concentration.
It is usually used to improve hyperphosphatemia occurred in chronic renal failure patient on dialysis.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc)to any medicines.
If you have intestinal obstruction.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products.(Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is((to be written by a healthcare professional))
In general, for adults, take 4 to 8 tablets(1 to 2g of the active ingredient) at a time, 3 times a day just before meals. The dosage may be adjusted according to your age, symptoms and serum phosphorus concentration.However, the maximum daily dose is 36 tablets(9g).Strictly follow the instructions.
Take it with water or lukewarm water, without keeping in the mouth for a long time or chewing.If it is difficult to take all the tablets at once, take in several batches.
If you miss a dose and realize it during or just after meals, take the missed dose as soon as possible. Otherwise, skip the missed dose and take the next dose before the next meal. You should never take two doses at one time.
If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include constipation/ aggravated constipation, abdominal pain, abdominal distension, nausea, indigestion, and diarrhea/loose stool. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets.If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
severe constipation, persistent abdominal pain, vomiting[intestinal tract perforation, intestinal obstruction]
tenderness in lower abdomen, fever, melena[diverticulitis, ischemic enteritis]
vomiting of blood, melena, nausea/vomiting [gastrointestinal bleeding, gastrointestinal ulcer]
general malaise, loss of appetite, yellowing of the skin and the white of eyes[hepatic function disorder]
constipation, worsening of constipation, abdominal pain, abdominal bloating [constipation, aggravated constipation, abdominal pain, abdominal distension]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them.
Internal
Revised: 3/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority.Approval details may vary by country. Medicines have adverse reactions(risks)as well as efficacies(benefits).It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. |
