部份中文利塞膦酸钠处方资料（仅供参考） 药品英文名 Risedronate Sodium 药品别名 Actonel 药物剂型 利塞膦酸钠胶囊剂：5mg/粒。 利塞膦酸钠薄膜包衣片剂：5mg/片；30mg/片；35mg/片。20～25℃保存。 アクトネル錠：17.5mg 药理作用 本品是第三代双膦酸盐类药物，主要通过直接或间接影响破骨细胞而抑制骨吸收，从而增加骨矿物密度(BMD)，减少骨折发生率。 它对破骨细胞的影响，现在认为主要有以下四种途径： ①阻碍破骨细胞与骨基质的结合； ②抑制破骨细胞的骨吸收活性； ③抑制破骨细胞的更新和修复； ④加速破骨细胞凋亡，缩短破骨细胞的生存期。 药动学 口服本品能快速地吸收，生物利用度为62%～65%。平均达峰时间(Tmax)为0.81～0.87h。其吸收率与剂量呈正相关，与剂型和吸收部位无关，但受食物及钙、镁、铝等物质的影响。稳态表观分布容积为6.3L/kg，被吸收的本品大部分贮存在骨骼中，其他组织中的含量甚微，在体内的消除半衰期较长，大约为480h。由静脉注入体内的本品87%以原形通过肾脏清除，其中约50%在24h内滤入尿液中。终末半衰期为480h。 适应证 1.预防和治疗绝经后妇女骨质疏松和糖皮质激素诱导的骨质疏松。 2.用于湿疹样癌(佩吉特病)，适用于血浆碱性磷酸酶高于正常值2倍以上者，或有临床症状者，或有引起并发症危险者。 禁忌证 1.本品过敏者禁用。 2.低钙血症患者禁用。 3.不能直立或静坐30min以上者禁用。 4.本品生殖毒性分级为C，不建议孕妇使用。 5.尚不知本品是否经乳汁分泌，哺乳期妇女禁用或用药期间停止哺乳。 注意事项 1.在治疗前和治疗期间应适量补充钙和维生素。但应与本品相隔一定时间服用，不宜同时服用，否则可影响本品的吸收。 2.肌酐清除率＞20ml/min的中度或轻度肾功能不全者无需监护，而严重肾功能不全患者(肌酐清除率＜20ml/min)有必要进行监护并适当调整药物剂量。 3.尚无儿童用药安全性资料。 4.药物过量可致低钙血症，可给予钙及含钙的拮抗药与本品结合，以减少药物吸收。低钙血症可静脉给予钙制剂。 用法用量 1.预防和治疗绝经后妇女的骨质疏松症 口服，每次5mg，1次/d；或每次35mg， 1次/周。在每日早上进食(水除外)前至少30min服用，服用时取站立位，用凉水冲服。 2.预防和治疗糖皮质激素诱导的骨质疏松症口服,5mg/次，1次/d。 3.佩吉特病 口服，30mg/次，1次/d，用药2个月。 アクトネル錠17.5mg 治疗类别名称 骨质疏松症治疗剂 骨治疗剂的佩吉特氏病 商標名 Actonel Tab. 17.5mg 一般名 リセドロン酸ナトリウム水和物 （Sodium Risedronate Hydrate）［JAN］ 化学名 Monosodium trihydrogen 1-hydroxy-2-（pyridin-3-yl）ethane-1,1-diyldiphosphonate hemipentahydrate 分子式 C7H10NNaO7P2・21/2H2O 分子量 350.13 構造式 性状 氢氧化钠利塞膦是一种白色结晶粉末。微溶于水，并在乙醇（99.5）几乎不溶。溶于稀的稀氢氧化钠TS（1→20）。 条件批准 骨佩吉特氏病 由于在日本试验病人是非常有限的，上市后，直至有关一定数量的病例数据集成，通过实现对一切案件的使用，结果调查显示，该药物这使得能够早期识别患者的背景信息，数据收集这些药物的安全性和有效性，采取必要的措施在正确使用这种药物。 包装规格 日本药典利塞膦酸钠片 包装：骨质疏松症 片：17.5mg 20片（2片×10）·100片（2片卡×50） 日本药典利塞膦酸钠片 包装：骨佩吉特氏病 片：17.5mg 56片（7片×8） 制造厂商 味之素制药有限公司[联盟]卫材有限公司 Actonel Tablets 17.5 mg [Osteoporosis/Paget's disease of bone]（アクトネル錠17.5mg［骨质疏松症，佩吉特骨症］） Brand name : Actonel Tablets 17.5 mg [Osteoporosis] 　Active ingredient: Sodium risedronate hydrate 　Dosage form: Salmon-pink tablet, major axis: approx. 8.1 mm, minor axis: approx. 4.6 mm, thickness: approx. 3.3 mm 　Print on wrapping: アクトネル 17.5mg AJ4 Effects of this medicine This medicine increases bone density and bone strength, and reduces the risk of bone fracture by suppressing bone resorption by osteoclasts. It is usually used for the treatment of osteoporosis. 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: esophageal transitional disorder, esophagitis, gastric ulcer, duodenal ulcer, hypocalcemia and renal disorder. If you cannot keep your upper body raised up for at least 30 minutes at the time of taking the medicine. •If you are pregnant, possible 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 1 tablet (17.5 mg of the active ingredient) once a week at the time of rising, with a glass of water (about 180 mL) prior to consuming any beverage or food. Avoid lying down for at least 30 minutes after taking the medicine. Avoid drinking any beverages (including mineral water with particularly high content of calcium, magnesium, etc.) other than water, and do not take any food and other medicines for at least 30 minutes after taking the medicine. Strictly follow the instructions. •This medicine may irritate your mouth and throat. Avoid chewing and sucking this medicine. Do not take this medicine before going to bed, or while lying in bed. •If you take nothing to eat or drink by the time when you remembered that you missed a dose, take the missed dose as soon as possible. If you remembered that you missed a dose after you take something to eat and drink, skip the missed dose on the day. Take a dose at the time of rising on the next day. Thereafter, take a dose on a preliminarily scheduled day of the week. You should never take two doses at one time. •If you accidentally took 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 •Abnormality in jaw bone may occur in receiving dental treatment such as tooth extraction while taking bisphosphonates including this medicine. You need to receive an adequate explanation about the following points from doctors or pharmacists: If possible, receive dental treatment such as tooth extraction prior to taking the medicine, after consultation with your doctor. Undergo an oral or dental checkup regularly while taking the medicine. Avoid any treatments such as tooth extraction while taking the medicine. Keep your mouth clean by brushing of teeth while taking the medicine. Inform your dentist that you are taking the medicine when you receive dental treatment. Possible adverse reactions to this medicine The most commonly reported adverse reactions include gastric discomfort, constipation and epigastric pain. 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. •chest pain, abdominal pain, difficulty in swallowing, tarry stool  [upper gastrointestinal disorder] •nausea, vomiting, loss of appetite, yellowing of the skin or white of the eye  [hepatic dysfunction, jaundice] •pains in teeth, gingiva and jaw; gingival swelling; pus discharge; loose tooth  [necrosis of the jaw bone, osteomyelitis of the jaw] •The pain of the thigh or an inguinal region [atypical subtrochanteric and diaphyseal femoral fractures] 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. Ask the pharmacist how to discard them. Eisai Co., Ltd.Internal Revised: 11/2011 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.eisai.co.jp/news/news200724.html http://www.info.pmda.go.jp/go/pack/3999019F2022_2_12/