部份中文羥基氢氧化亚铁处方资料（仅供参考）
英文名：Sucroferric oxyhydroxide
商标名：P-TOL Chewable
中文名：羥基氢氧化亚铁咀嚼片
生产商：Kissei Pharmaceutical
药品简介
P-TOL Chewable（sucroferric oxyhydroxide）是一种磷酸盐结合剂，以改善透析期间慢性肾病患者高磷血症的治疗。
ピートルチュアブル錠250mg/ピートルチュアブル錠500mg
药用分类名称
高磷血症治疗剂
批准日期：2015年11月
商標名
P-TOL Chewable Tab. 250mg
P-TOL Chewable Tab. 500mg
一般名：スクロオキシ水酸化鉄（Sucroferric oxyhydroxide）
化学名：酸化水酸化鉄（III）/スクロース/デンプン混合物
性状：
棕色粉末。 由氧化氢化铁（III）和淀粉组成的部分几乎不溶于水。
处理注意事项
该制剂在颗粒表面可能出现白色斑点，但由使用添加剂。
批准条件
制定并适当实施药品风险管理计划。
药效药理
1. 药理作用
（1） 体外磷吸附能力
在使用标准磷酸溶液的磷吸附能力的确认试验中，氢氧化铁在pH3.0、5.5和8.0的任何pH值中都表现出磷吸附能力。
（2） 血清磷浓度和钙磷减少作用
　在腺苷诱发的渐进性肾衰竭大鼠中，氯氧氢氧化铁通过混合施用1.5和5%，显著降低了血清磷浓度和钙磷。
（3） 血管钙化抑制作用
在腺苷诱发的渐进性肾衰竭大鼠中，通过混合施用5%的脱氧氢氧化铁，提高了主动脉钙化的病理学分数，观察到钙化程度的降低和频率的降低。
（4） 继发性甲状旁腺功能减退改善作用
　在腺苷诱发的肾衰竭大鼠中，氯氧氢氧化铁通过5%的混合给药显著降低了血清PTH浓度。
（5） 骨代谢异常抑制作用
在腺苷诱导的渐进肾衰竭大鼠中，通过混合施用5%的氯氧氢氧化铁，股骨的骨量、纤维量和孔隙度显著降低，骨组织的骨形成、纤维化和多孔抑制被观察到。
2. 操作机制
氢氧化铁在胃肠道中与磷酸结合，通过抑制胃肠道的磷吸收，表现出血清磷浓度降低的作用。
适应症
透析期间慢性肾病患者高磷血症的改善
用法与用量
通常，在成人中，一次250mg作为铁作为起始剂量，在每天三次饭前口服。此后，症状，但适当增加或减少根据血清磷浓度的程度，最高剂量为每天3000mg。
包装
咀嚼片
250mg： 84 片 （PTP）， 420 片 （PTP）
500mg： 84 片 （PTP）， 420 片 （PTP）
制造与销售
Kissei Pharmaceutical Co.Ltd.
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明附件：
https://www.info.pmda.go.jp/go/pack/2190036F1026_1_03/
P-TOL Chewable Tab（Sucroferric oxyhydroxide）
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