部份中文依普黄酮处方资料（仅供参考） 药品英文名 Ipriflavone 药品别名 固苏桉、双锐安 药物剂型 1.依普黄酮片：200mg。贮法：密封，于室温保存，开封后注意防潮。 2.依普黄酮胶囊：200mg。贮法：密闭保存。 药理作用 有文献报道，本药属植物性促进骨形成药物，可直接作用于骨，能改善骨质疏松症所致的骨量减少，具有雌激素样的抗骨质疏松特性，但无雌激素对生殖系统的影响。其抗骨质疏松的机制为： 1.促进成骨细胞的增殖、骨胶原合成及骨基质的矿化，增加骨量。 2.减少破骨细胞前体细胞的增殖和分化，抑制成熟破骨细胞活性，从而降低骨吸收。 3.通过雌激素样作用增加降钙素的分泌，间接产生抗骨吸收作用。动物试验表明，本药无致畸、致突变性。对模型大鼠(因卵巢切除和泼尼松龙造成的实验性骨质疏松)有抑制骨量减少的作用。但缺乏临床有效性的随机对照临床研究报告的支持。 药动学 本药口服后在小肠形成7种代谢物，并与原药一起被吸收，约1.3小时原药达峰浓度，其中4种代谢物具有生物活性。药物主要分布在胃、肠、肝及骨中，经门静脉进入肝脏代谢。给予单剂量200mg口服，曲线下面积为632(ng·h)/ml，48小时内尿总排泄率为42.9%(均为代谢产物形式)，半衰期为9.8小时；如连续给药，1天600mg，连服6天，血药浓度可达稳态，曲线下面积为1455(ng·h)/ml，半衰期为23.6小时。继续服药后，原药及代谢物无体内蓄积，血药浓度不再升高。 适应证 用于改善原发性骨质疏松的症状，可能提高骨量减少者的骨密度。 禁忌证 1.对本药过敏者。 2.低钙血症患者。 注意事项 1.慎用： (1)重度食管炎患者。 (2)消化性溃疡及消化性溃疡史者。 (3)胃炎、十二指肠炎患者。 (4)胃肠功能紊乱者。 (5)中、重度肝肾功能不全者。 (6)高龄患者。 2.药物对儿童的影响：用药的安全性尚不确定，不宜服用本药。 3.药物对妊娠的影响：用药的安全性尚未确立，如必须使用应权衡利弊。 4.药物对哺乳的影响：用药的安全性尚不确定，动物试验表明，本药可分泌入大鼠乳汁中，故哺乳妇女应慎用。 5.用药前后及用药时应当检查或监测：用药期间，应周期性监测全血计数，如长期治疗应监测常规血生化。 6.用药后如出现消化性溃疡、胃肠道出血或恶化症状、黄疸、男子乳腺发育、出疹及皮肤瘙痒等，应立即停药，必要时给予对症处理。 7.服药期间需同时补钙。国外资料建议对绝经后骨质疏松症患者，可给予碳酸钙或葡萄糖酸钙1天1g。 8.本药多用于预防绝经后骨质疏松，对男性骨质疏松症目前尚无用药经验。 不良反应 1.中枢神经系统：偶见眩晕、轻微头痛等。 2.代谢/内分泌系统：罕见男子乳腺发育。 3.泌尿生殖系统：罕见尿素氮、肌酸酐升高。 4.肝脏： (1)重要的不良反应为黄疸(罕见)。 (2)偶见胆红素、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、乳酸脱氢酶(LDH)升高，罕见γ-谷氨酰转移酶(γ-GT)升高。 5.胃肠道： (1)重要的不良反应为消化性溃疡、胃肠道出血或恶化症状(均罕见)。 (2)偶见恶心、呕吐、食欲缺乏、胃部不适、反酸、腹痛、腹胀、腹泻、便秘、口腔炎、口干、舌炎、味觉异常等。 6.血液：偶见贫血、红细胞及白细胞减少。罕见粒细胞减少。 7.过敏反应：偶见出疹、皮肤瘙痒等。 8.其他：偶见水肿、倦怠感。罕见舌唇麻木。 用法用量 成人口服给药每次200mg，3次/d，餐后服用，应根据患者的年龄及症状适当调整剂量。 药物相应作用 1.与茶碱、香豆素类抗凝药合用，可增强后两者的作用，故合用时应减少其用量，并慎重给药。 2.对摘除卵巢的动物，合并使用雌酮，可增强雌激素的作用，故本药与雌激素制剂合用时应谨慎。 3.与他莫昔芬合用，可降低后者的疗效，对雌激素敏感型乳腺癌患者，在绝经后服用他莫昔芬治疗时，应避免服用本药。可使用其他药物替代依普黄酮以控制他莫昔芬的不良反应。进餐时服药，可提高本药的生物利用度。 OSTEN TABLETS(Ipriflavone) Brand name : OSTEN TABLETS 200mg. 　Active ingredient: Ipriflavone 　Dosage form: white to yellowish white tablets, φ8.6 mm, thickness 4.7 mm 　Print on wrapping: (Face) 347 200, (Back) オステン200mg Effects of this medicine This medicine suppresses reduction in bone mass by its bone resorption-inhibiting and bone formation-promoting effects. Usually, used for treatment of osteoporosis. Before using this medicine, be sure to tell your doctor and pharmacist •If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you have had peptic ulcer. •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>> •General dosage regimen: For adults, take 1 tablet (200 mg of the active ingredient) at a time, three times a day, after meals. The dosage should be adjusted according to your age and symptoms. Strictly follow the instructions of your doctor/pharmacist. •If you missed a dose, take the missed dose as soon as possible. If there is less than 4 hours to the next dose, skip the missed dose and take the next dose at your regular time. DO NOT take double doses to make up for the missed dose. •If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. •Do not stop taking the medicine without the instructions of your doctor. Precautions while taking this medicine • Possible adverse reactions to this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: rash, itching, nausea, vomiting, loss of appetite, abdominal discomfort, heart burn, gastralgia, abdominal pain, enlarged feeling of abdomen, diarrhea, constipation, stomatitis, dizziness, light-headed feeling, anemia, malaise, edema, gynecomastia, etc. 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. •pain in the pit of stomach, nausea, black stool [peptic ulcer, gastrointestinal bleeding] •yellowing of the skin or whites of the eyes, dullness, loss of appetite [jaundice] 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 humidity. •Discard the remainder. Do not store them. Takeda Chemical Industries, Ltd.Internal Revised: 11/2007 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. 原处方资料附件：http://www.info.pmda.go.jp/go/pack/3999008F1273_1_08/ --------------------------------------- 产地国家：日本  原产地英文商品名: OSTEN(オステン錠)200mg/TABLETS 100TABLETS/box 原产地英文药品名: Ipriflavone 中文参考商品译名: OSTEN(オステン錠)200毫克/片 100片/盒 中文参考药品译名: 依普黄酮 生产厂家中文参考译名: 武田 生产厂家英文名: Takeda