英文药名：P-TOL Chewable Tab(Sucroferric oxyhydroxide)

中文药名：氢氧化亚铁咀嚼片

生产厂家：KISSEI药品
治疗类别名称
高磷血症治疗剂
欧文商標名
P-TOL Chewable Tab.250mg
P-TOL Chewable Tab.500mg
通用名称
Sukurookishi氢氧化铁
通用名（欧洲名）
Sucroferric oxyhydroxide
化学名称
铁氧化物氢氧化物（Ⅲ）/蔗糖/淀粉混合物
性状
粉末。作淀粉氧化铁（Ⅲ）的氢氧化物是几乎不溶于水。
适应病症
慢性肾病患者在透析高磷血症的改善
用法用量
成人，每日三次，每次250毫克的起始剂量，此后，根据血清磷浓度的程度的症状，但要调整，最高剂量为1天3000毫克
药效药理
1.药理作用
1）体外磷吸附能力
在使用标准的磷酸溶液中的磷吸附能力的确认试验，Sukurookishi铁氢氧化物表明在任何pH3.0,5.5和8.0的pH值的磷吸附能力。
血清磷浓度和钙磷乘积降低效应
在腺嘌呤诱发性肾功能衰竭大鼠，Sukurookishi铁氢氧化物显著由1.5％和5％的膳食给药降低血清磷浓度和钙磷乘积。
2）血管钙化的抑制作用
在腺嘌呤诱导的进行性肾功能衰竭大鼠，改进的主动脉钙化的组织病理学得分的的Sukurookishi氢氧化铁的5％的饮食管理，减少钙化程度，并观察在频率下降。
3）继发性甲状旁腺功能改进措施
在腺嘌呤诱导的进行性肾功能衰竭大鼠，Sukurookishi铁氢氧化物显著为5％的膳食给药降低了血清PTH浓度。
4）骨代谢异常的抑制作用
在腺嘌呤诱发性肾功能衰竭大鼠，股骨，纤维的重量和空隙面积比的骨样量显著通过饮食施用减少Sukurookishi铁氢氧化物，骨样形成骨组织，纤维化和多孔的5％的抑制的观察。
2.作用机序
Sukurookishi铁氢氧化物与磷酸在消化道结合，通过从消化道抑制磷的吸收，显示血清磷水平降低作用
包装规格
咀嚼片
250毫克
84片（PTP），420片（PTP）

500毫克
84片（PTP），420片（PTP）

制造厂商
KISSEI药品有限公司

P-TOL Chewable Tab（Sucroferric oxyhydroxide）

P-TOL Chewable Tab. 250mg（ピートルチュアブル錠250mg） 
Brand name : P-TOL Chewable Tab. 250mg
　Active ingredient: Sucroferric oxyhydroxide
　Dosage form: brown tablet, outside diameter: 16.5 mm, internal diameter: 5.5 mm, thickness: about 5.2 mm
　Print on wrapping: ピートル250, 高リン血症治療剤／食直前に噛み砕いて服用, KISSEI PA 250, 高リン血症治療剤, 食直前に服用
P-TOL Chewable Tab. 500mg（ピートルチュアブル錠500mg） 
Brand name : P-TOL Chewable Tab. 500mg
　Active ingredient: Sucroferric oxyhydroxide
　Dosage form: brown tablet, outside diameter: 20.5 mm, internal diameter: 6.0 mm, thickness: about 6.4 mm
　Print on wrapping: ピートル500, 高リン血症治療剤／食直前に噛み砕いて服用, KISSEI PA 500, 高リン血症治療剤, 食直前に服用
Effects of this medicine
This medicine absorbs phosphorous in the digestive tract and prevents absorption of phosphorous into the body. It therefore decreases blood phosphorous concentration.
It is usually used to improve hyperphosphatemia in the chronic kidney disease patients 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 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, start with 250 mg of iron at a time, 3 times a day immediately before meals. Then the dosage may be adjusted according to the symptoms and blood phosphorous concentration, however, the maximum daily dose is 3,000 mg. This preparation contains 500 mg of the iron in a tablet. Strictly follow the instructions.
•Chew the medicine in the mouth.
•If you miss a dose, skip the missed dose and continue your regular dosing schedule without changing the amount of the next dosage. 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
•Your stool may turn black due to components of this medicine.
•Transient discoloration (brownish-red) of the mouth may occur.
•If you are instructed to restrict intake of phosphorous-rich food, strictly follow the instructions of the dietary therapy.
•Serum concentrations of ferritin and hemoglobin may be checked periodically.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea. 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.
No pertinent entries.
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.
Kissei Pharmaceutical Co., Ltd.Internal
Published: 11/2015
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.
http://www.kegg.jp/medicus-bin/japic_med?japic_code=00065937