英文药名:Hysron-H Tab(Medroxyprogesterone Acetate)
中文药名:醋酸甲羟孕酮片
日文药名:ヒスロンH錠
生产厂家:协和发酵麒麟 类别名称 抗肿瘤口服促黄体激素制剂 欧文商標名 Hysron-H Tab. 200mg 一般名 メドロキシプロゲステロン酢酸エステル Medroxyprogesterone Acetate 化学名 17-Hydroxy-6α-methyl-4-pregnene-3, 20-dione acetate 略名 MPA 分子式 C24H34O4 分子量 386.52 化学構造式
性状 白色至淡黄白色结晶性粉末,无臭味。 可溶性 它易溶于氯仿中,易溶略微丙酮或1,4-二恶烷,稍稍溶于乙腈或正丁基氯化铵,甲醇,乙醇(99.5),或微溶于乙醚,并在水或己烷几乎不溶。 熔点 204〜209℃ 药效药理 1. 抗肿瘤作用 (1)预防乳腺癌的抗肿瘤活性 对DMBA诱发的大鼠乳腺癌,观察到由24,60,120mg/kg的口服给药剂量依赖性的抗肿瘤作用。 使用培养的人乳腺癌细胞MCF-7和其他莫昔芬耐药株的R-27的结果检查两种菌株的E2(雌二醇)的存在下的集落形成能力,10-8〜10-5mol/L的效果而不管在它显示出浓度依赖性的细胞生长抑制作用。 如对人乳腺癌细胞的ZR-75-1的影响的结果,研究了细胞计数,而不管E2的存在,显示出浓度依赖性细胞抑制效应在10-10和10-5mol/ L时,一效果是在存在比E2不存在的E2更强。 (2) 对子宫内膜癌的抗肿瘤效果 作用对子宫内膜腺癌细胞的AD-30移植到裸鼠0.1,10,100mg/千克/调查经口给药的日经结果的肿瘤倍增时间显著延长每个治疗组中观察到,所述组织与细胞的萎缩崩溃的组织学,没有观察到流体成分的腺腔的贮存器。 2. 作用机序 DNA合成抑制作用,据表达该抗肿瘤作用是由于抑制作用和抗雌激素作用的垂体 - 肾上腺 - 性腺系统上。 适应症 乳腺癌,子宫内膜癌 用法用量 乳腺癌, 成人每日口服600〜1200毫克。 子宫内膜癌 成人每日口服400〜600毫克,以2-3倍的醋酸甲羟孕酮。此外,根据症状进行调整 包装规格 片剂:200毫克: 100片(10片×10)[PTP]
制造商 协和发酵麒麟有限公司 完整处方资料附件:http://www.info.pmda.go.jp/go/pack/2478002F3056_3_04/ Hysron-H Tab 200mg(Medroxyprogesterone Acetate) Brand name:Hysron-H Tablets 200 mg Active ingredient: Medroxyprogesterone acetate Dosage form: White tablets, diameter 9.0 mm, thickness 3.5 mm Print on wrapping: KH405 HYSH 200 mg Effects of this medicine This medicine, a type of female hormone (luteal hormone), inhibits proliferation of hormone-dependent tumor cells by suppressing secretion of hormones that act on the pituitary gland and stimulate ovaries. It is usually used in the treatment of breast cancer and uterine body cancer (endometrial cancer). 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 within 1 week after surgery. If you have thrombotic disease (cerebral infarction, myocardial infarction, thrombophlebitis) (including history of the disease), arteriosclerosis, heart disease (heart valve disease, atrial fibrillation, endocarditis, heart failure, etc.). If you are administering hormones. If you have undiagnosed genital bleeding, urinary tract bleeding or breast lesion, liver disorder or hypercalcaemia. •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>> •Breast cancer: In general, for adults, take 1 to 2 tablets [200 to 400 mg of the active ingredient] 3 times daily. Uterine body cancer (endometrial cancer): In general, for adults, take 400 to 600 mg of the active ingredient in 2 or 3 devided doses daily. This preparation contains 200 mg of the active ingredient in a tablet. The dosage may be adjusted according to the symptoms. Strictly follow the instructions. •If you miss a dose, skip the missed dose and continue 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 • Possible adverse reactions to this medicine The most commonly reported adverse reactions include weight gain, moon face, uterine bleeding, edema, thrombosis, menstruation disorder and vision disorder. 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. •foot pain/swelling, chest pain, vomiting blood [thrombosis] •shortness of breath/breathing difficulty, general swelling, general malaise [congestive heart failure] •shortness of breath/breathing difficulty, swelling around eyes and lips, hives [anaphylactoid symptoms] •reduced visual acuity, bulging eyes, double vision, migraine [papilledema] 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. Kyowa Hakko Kirin Co.,LtdInternal Published: 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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