英文药名:Pletaal OD tablets(Cilostazol)
中文药名:西洛他唑口腔崩解片
日文药名:プレタールOD錠
生产厂家:大冢制药 类别名称 抗血小板剂 商標名 Pletaal powder 20% 一般名 シロスタゾール〔Cilostazol(JAN)〕 化学名 6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)butyloxy]-3, 4-dihydroquinolin-2(1H)-one 構造式
分子式 C20H27N5O2 分子量 369.46 融点 158~162℃ 性状 白细黄白色晶体或结晶性粉末。该产品是甲醇,乙醇(99.5),或在乙腈中微溶,并且几乎不溶于水。 操作注意事项 ·由于缺乏在使用自动包装机的情况下,要考虑在盒的设定位置。 ·由于这种药物是由高湿度中观察到的未包装的状态的影响,要在包装或小袋的情况下特别小心。 药效药理 1. 抗血小板作用 (1)体外 ·在人类血小板,抑制ADP,胶原蛋白,花生四烯酸,肾上腺素24),凝血酶的血小板聚集。另外,抑制由切应力诱发的血小板凝集 ·在人类血小板,ADP,也抑制肾上腺素血小板凝集原也,要分离,一旦聚集血小板凝块由于聚集诱导物质。 ·在人类血小板,抑制血栓素A2生产 为了抑制人血小板的血液凝固促进活动 (2)体内 小猎犬在狗的口服给药)和猪,ADP抑制由胶原血小板聚集。 ·连续口服给药至大鼠,对ADP的血小板聚集抑制效果不衰减。 • 在慢性动脉阻塞口服施用给患者和脑梗塞患者,抑制ADP,胶原蛋白,花生四烯酸,肾上腺素血小板聚集。 • 在人类血小板聚集作用的抑制是在给药后迅速表示,其效果不被重复施用衰减。 • 由药物,血小板聚集,用这种药物的血浆浓度的衰减沿48小时后抑制-此撤出是福利值在给药前,反弹现象(聚集增强)是不被发现。 2. 抗血栓作用 • 鼠标ADP,抑制胶原诱导的致死性肺栓塞静脉给药。 • 抑制诱导的钠月桂酸施用到狗的股动脉血栓后肢循环衰竭的发展。 • 狗在当时的股动脉,用人造血管替代,抑制在现场引起的血栓性闭塞。 • 禁止在猪颈动脉电刺激诱发血栓形成。 • 减少出现由兔子注射花生四烯酸的颈内动脉脑梗塞区域。 •减少已在短暂性脑缺血发作的患者被观察到。 3. 血管扩張作用 ·氯化钾,前列腺素狗孤立的股动脉,这是由F2α收缩,放松大脑中动脉,基底动脉。 ·麻醉狗大腿动脉,椎动脉,增大颈总动脉和颈内动脉的血流量。 ·增加麻醉狗和猫麻醉的大脑皮层的血流量。 ·为了提高大脑皮质,或血流在非麻醉大鼠的下丘脑。 在慢性动脉闭塞症的患者,脚踝,可以提高小牛腹部的组织血流量已经通过体积描记法识别。在四肢的皮肤温度进一步上升,在皮肤血流的增加已经通过热熔观察。 ·在缺血性脑血管疾病的患者,以增加脑血流量已经由氙吸入法观察。 4. 对血管平滑肌细胞的作用 ·抑制血管平滑肌细胞在人的培养的血管平滑肌的生长。 ·大鼠颈动脉内膜球囊后抑制损伤内膜增厚。 5. 对血管内皮细胞的影响 ·促进从人的培养的内皮细胞NO的产生。 ·为了抑制人的培养的内皮细胞的失败。 ·在培养的内皮细胞的人通过在高半胱氨酸或脂多糖刺激抑制乳酸脱氢酶的泄漏。 6. 作用机序 • 抑制兔血小板,血清素的血清素释放,掺入血小板腺苷不会影响。此外,它由血栓素A2抑制血小板聚集。 • 通过选择性抑制血小板和血管平滑肌的PDE3(cGMP-抑制磷酸二酯酶)活性,发挥抗血小板作用和血管舒张效应的药剂。 • 本剂的人血小板的血小板聚集的抑制作用是培养的人血管内皮细胞,或者在前列腺素E125的存在下,以提高。 • 在试剂的狗血小板的血小板凝集抑制作用在前列腺素,或腺苷的存在而增强。 适应病症 ・ 慢性动脉闭塞性疾病的溃疡,改善疼痛和冷感等缺血症状。 ・ 脑梗塞(不包括心源性脑栓塞)发病后抑制复发 用法用量 成人,每日给药2次,每次100毫克。该剂量可以根据年龄和症状进行调整。 包装规格 口腔崩解片:50毫克 [PTP] 100片(10片×10),500片(10片×50),700片(14片×50)
[塑料瓶] 500粒
口腔崩解片:100毫克: [PTP] 100片(10片×10),500片(10片×50),700片(14片×50)
[塑料瓶] 500粒
制造厂商 大冢制药有限公司 注:以上中文资料仅供参考,使用以原处方为准: http://www.info.pmda.go.jp/go/pack/3399002F3020_1_06/ Pletaal OD tablets 50mg(プレタールOD錠50mg) Brand name : Pletaal OD tablets 50mg Active ingredient: Cilostazol Dosage form: White tablet, diameter: 7.0 mm, thickness: 3.0 mm Print on wrapping: プレタールOD, 50mg, print on back sheet: プレタールOD錠50mg Pletaal OD tablets 100mg(プレタールOD錠100mg) Brand name : Pletaal OD tablets 100mg Active ingredient: Cilostazol Dosage form: White tablet, diameter: 9.0 mm, thickness: 3.9 mm Print on wrapping: indentification code: OG18, プレタールOD, 100mg, print on back sheet: プレタールOD錠100mg Effects of this medicine This medicine inhibits the platelet aggregation induced by thromboxane A2 and inhibits the phosphodiesterase 3 (PDE3) activity of platelets and vascular smooth muscle, thus exerting an antiplatelet and vasodilative action and consequently improving blood flow. It is usually used to improve symptoms such as ulcer, pain and coldness attributed to chronic arterial occlusion, and to prevent recurrence of cerebral infarction. 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 bleeding (hemophilia, capillary fragility, hemoptysis, intracranial bleeding, bleeding from the gastrointestinal tract or urinary tract, bleeding in vitreous body, etc.). If you have congestive heart failure. If you are scheduled to undergo surgery or tooth extraction. •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 1 tablets (100 mg of the active ingredient) at a time, twice daily. The dosage may be adjusted according to your disease, age or symptoms. Strictly follow the instructions. •You may swallow this medicine with saliva after soaking the tablet with saliva on the tongue and crushing it gently with the tongue. You may also take this medicine with a cup of cold or lukewarm water. •You should not take this medicine while in a lying-down position. •If you miss a dose, take the dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. 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 •Do not take this medicine with grapefruit juice since it may enhance the effects of this medicine. •This medicine makes it more difficult for blood to clot. If you are bleeding lasting for several hours or an injury involving a large area of your body, immediately visit a nearby hospital. •If you receive treatment by another doctor, including dental treatment, tell the doctor or dentist that you are taking this medicine. Possible adverse reactions to this medicine The most commonly reported adverse reactions include headache, headache dull, tachycardia, abdominal pain, nausea or vomiting, dizziness, palpitation, diarrhea, rash, hepatic dysfunction, anemia, arrhythmia such as atrial fibrillation, supraventricular tachycardia, supraventricular extrasystole or ventricular extrasystole, eruption, itch, hives, photosensitivity and erythema. 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. •Respiratory distress, general swelling, sudden onset of precordial chest pressure sensation or chest pain, pulse rate increased (more than 100 beats/min) [congestive heart failure, myocardial infarction, angina pectoris, ventricular tachycardia] •Headache, consciousness disorder, abdominal pain [bleeding (bleeding intracranial such as cerebral bleeding, pulmonary bleeding, gastrointestinal bleeding, nasal bleeding, fundal bleeding, etc.) ] •Headache, throat pain, muscular pain, high fever with chills and shivering [pancytopenia, agranulocytosis, thrombocytopenia] •Fever, dry cough, respiratory distress [interstitial pneumonia] •General malaise, loss of appetite, yellowing in skin and white of eyes [hepatic dysfunction, 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 and heat. •Store this medicine in a dry place as much as possible because it is susceptible to moisture. Do not remove the tablet from the press-through package (PTP) or single-dose packet until immediately before use. •If there is a remainder, this is to be discarded. Do not store it. Otsuka Pharmaceutical Co., Ltd.Internal Revised: 8/2012 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.
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