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PREMARIN(conjugated estrogens tablets)

2016-07-18 03:56:05  作者:新特药房  来源:互联网  浏览次数:0  文字大小:【】【】【
简介: 英文药名: PREMARIN(conjugated estrogens tablets USP) 中文药名: 倍美力(结合雌激素片) 生产厂家: 辉瑞公司/惠氏制药药品名称和成分 适应症 1.治疗中-重度与绝经相关的血管舒缩症状。目前无资料 ...

 英文药名: PREMARIN(conjugated estrogens tablets USP)

中文药名: 倍美力(结合雌激素片)

生产厂家: 辉瑞公司/惠氏制药
药品名称和成分
适应症

1.治疗中-重度与绝经相关的血管舒缩症状。目前无资料表明,雌激素对绝经期出现的神经症状或抑郁症有效,故雌激素不用于治疗此类症状。
2.治疗外阴和阴道萎缩。
3.治疗因性腺功能减退、去势或原发性卵巢功能衰退所致的雌激素低下症。
4.治疗某些女性和男性的转移性乳房癌(只能减轻症状)。
5.治疗晚期雄激素依赖性前列腺癌(只能减轻症状)。
6.预防骨质疏松。
由于应用雌激素有一定风险,所以必须选择今后有骨质疏松危险倾向的病人。但不幸的是,无法识别哪些妇女会发生骨质疏松性骨折。在白人绝经妇女中对这一指征的有效性进行了许多前瞻性研究(未包括其他危险因素的分层分析),全球一致公认雌激素对骨的有益作用。
因此,选择病人必须根据病人的个体差异,权衡利弊。子宫切除妇女具最佳风险/利益比,因为她们没有患子宫内膜癌的危险性(见方框内警告)。雌激素替代治疗可降低骨吸收作用,延迟和停止绝经后的骨丢失。病例对照研究表明,在绝经后数年内即开始应用雌激素替代治疗的妇女,其髋部和腕部骨折减少60%。研究还表明雌激素可减少脊椎骨折。即使在绝经6年后才开始应用雌激素,只要坚持治疗,仍可防止骨质的进一步丢失。在停止雌激素治疗时,骨质丢失的速度与绝经初期相仿。雌激素替代治疗可使骨恢复至绝经前水平,尚无资料。在骨生成方面,骨总量和骨密度可因性别、人种而异,男性和黑人占优势。
因此,妇女发生骨质疏松的危险性高于男性,因为她们最初的骨质较男性少,在自然或诱发绝经后数年骨质下降率加快。亚洲妇女及白人较黑人的危险度更高。过早绝经是罹患骨质疏松的显著预兆之一。另外,其他与骨质疏松相关的影响因素包括遗传(矮小,家族史),内分泌(未产、甲状腺毒症、甲状旁腺功能亢进、柯兴氏综合征、高泌乳素血症、Ⅰ型糖尿病),生活方式(吸烟、酗洒、有久坐不活动的习惯)和营养因素(体重低于平均水平,钙摄取)。预防和治疗骨质疏松的主要方法是雌激素,终生足够的钙摄取和运动。绝经后妇女对饮食中钙的吸收较未绝经妇女差,平均每天需要1500mg元素钙以维持营养钙平衡。
与之相比,在美国,未绝经妇女每天需要约1000mg钙,而饮食中摄取钙为每天400-600mg。因此,若无禁忌,补充钙是有益的。负重运动和营养在协助预防和治疗骨质疏松中是重要的。不运动和长时间卧床休息可使骨迅速丢失。而负重运动不仅可减少骨丢失,还能增加骨质。尚未确立预防骨质疏松的最佳运动方法和运动量,但有2项研究表明,每周步行和跑步2-3次,每次1小时,可明显增加腰椎骨质。
用法用量
本品为处方药品,凭医生处方用药。
1.治疗中重度血管舒缩症,和/或与绝经相关的外阴及阴道萎缩,必须选择控制症状的最小剂量,用药尽量不要持续。血管舒缩症--每天0.625mg外阴和阴道萎缩--每天0.3mg-1.25mg,或更多,根据病人个体反应而定。倍美力治疗可不中断地进行,或根据病人的个体情况采用周期方案(例如25天用药,5天停药)进行适当治疗。如需停药或逐渐停药应隔3-6个月。
2.治疗因性腺功能减退、去势或原发性卵巢功能衰竭所致的女性雌激素过少女性性腺功能减退--每天0.3mg-0.625mg,周期性服.
如果您有任何疑问,请遵医嘱。
不良反应
以下报道的是雌激素治疗的其他不良反应(见警告中诱发肿瘤,对胎儿副作用,胆囊疾病,心血管疾病,血压升高和高钙血症发病率增加;见注意事项中有关的心血管疾病危险性)。
1.泌尿生殖系统阴道出血形式改变、异常撤退性出血、出血改变,突破性出血,点状出血,子宫平滑肌瘤体积增大;阴道念珠菌病;宫颈分泌物量的改变
2.乳房触痛,增大
3.胃肠道恶心,呕吐;腹绞痛,腹胀;胆汁郁积性黄疸;胆囊疾病发生率增加;胰腺炎
4.皮肤停药后黄褐斑或黑斑病持续存在;多形红斑;红斑结节;红斑疹;头发脱落;妇女多毛症
5.心血管静脉血栓栓塞;肺栓塞
6.眼角膜弯曲度变陡;对隐形眼镜耐受性下降
7.中枢神经系统头痛;偏头痛;头晕;精神抑郁;舞蹈病
8.其他体重增加或减轻;糖耐量下降;卟啉症加重;水肿;性欲改变
禁忌
下列患者不能应用雌激素:
1.已知或怀疑妊娠(见方框内警告)。孕妇使用雌激素可能对胎儿有害。
2.未确诊的异常生殖器出血。
3.已知或怀疑患有乳腺癌,除了治疗某些转移性癌的病人。
4.已知或怀疑患有雌激素依赖性肿瘤。
5.活动性血栓性静脉炎或血栓栓塞性疾病。以前患有与使用雌激素相关的血栓性疾病。
6.对本品过敏者。
孕妇及哺乳期妇女用药
妊娠期药物应用范畴X。在妊娠期间禁用雌激素。(见禁忌症和方框内警告)。哺乳母亲。作为一般原则,对任何药物,哺乳母亲仅在必须时才可服用,因为许多药物可分泌入乳汁。另外,已知哺乳母亲服用雌激素可降低乳汁的质量和数量。
老年患者用药
尚不明确。
药物相互作用
药物/实验室检查的相互关系
1.加速了凝血酶原时间,部分促凝血酶原激酶时间和血小板凝集时间;升高了血小板计数;增加了Ⅱ因子、Ⅶ因子抗原,Ⅷ因子抗原,Ⅷ因子凝集活性,Ⅸ、Ⅹ、Ⅻ、Ⅶ-Ⅹ因子复合物,Ⅱ-Ⅶ-Ⅹ因子复合物,β血小板球蛋白;降低了抗Xa和抗凝血酶Ⅲ水平,降低了抗凝血酶Ⅲ活性;增加了纤维蛋白原和纤维蛋白原活性;增加了纤溶酶原抗原和活性。
2.增加的甲状腺结合球蛋白(TBG)可使循环中总甲状腺激素增加,后者用蛋白结合碘(PBI)测定,增加了T4水平(用柱或放射免疫法)或T3水平(用放射免疫法测定)。而T3树脂摄取下降,反映TBG升高。游离T3和游离T4浓度则未变。
3.血清中其他结合蛋白,即皮质类固醇结合球蛋白(CBG)和性腺激素结合球蛋白(SHBG)可能升高,分别使循环中皮质类固醇和性类固醇升高。游离和具生物学活性的激素浓度不变。其他血浆蛋白亦可能升高(血管紧张素原/肾素底物,α1抗胰蛋白酶,血浆铜蓝蛋白)。
4.HDL和HDL-2浓度升高,LDL-胆固醇浓度降低,TG水平升高。
5.葡萄糖耐量降低。
6.对美替拉酮试验反应下降。
7.血清中叶酸盐浓度下降。
药物过量
儿童误摄入大量含有雌激素的口服避孕药后未见有严重不良反应。雌激素过量可导致恶心、呕吐,妇女可能发生撤退性出血。
贮藏
室温储藏(约25°C)。USP规定置于密封容器内。
----------------------------------------------
【原产地英文商品名】PREMARIN-0.625mg/Tablet,1000Tablets
【原产地英文药品名】CONJUGATED ESTROGENS
【中文参考商品译名】
注:以下产品不同的规格和不同的价格,采购以咨询为准!
·倍美力-0.3毫克/片,100片/瓶
·倍美力-0.45毫克/片,100片/瓶
·倍美力-0.625毫克/片,100片/瓶
·倍美力-0.625毫克/片,1000片/瓶
·倍美力-0.9毫克/片,100片/瓶
·倍美力-1.25毫克/片,100片/瓶
【中文参考药品译名】混合雌激素
【生产厂家中文参考译名】惠氏
【生产厂家英文名】Ayerst Laboratories,Inc

Premarin®Tablets(Conjugated Estrogens)  
Premarin® is a drug of the pharmacological group of antineoplastic hormonal agents and hormone antagonists, as well as of the pharmacological group of estrogens, progestins, their homologues and antagonists. Premarin® tablets for oral administration contains a mixture of conjugated estrogens that are obtained exclusively from natural sources. It is prescribed to the patients in case of malignant neoplasm of prostate, ovarian dysfunction, post menopause osteoporosis, in case of absence of menstruation or scanty and rare menstruation and other abnormal bleedings from the uterus and vagina, and in case of dysmenorrheal unspecified and menopausal status in women. Premarin® relieves or eliminates the menopausal symptoms (hot flashes, sweating, dizziness, irritability, depression). It also prevents the osteoporosis development and reproductive organs involution, normalizes the menstrual cycle in women of childbearing age. It also reduces the testosterone level in men.
Name of Drug
Premarin® Tablets:  Premarin® Tablets are also known as, Synthetic Conjugated Estrogen A and  Synthetic Conjugated Estrogens
PREMARIN Rx
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PREMARIN
Breast cancer 
Menopause and HRT 
Prostate and other male cancers  Only 4 drugs may be compared at once
Generic Name and Formulations:
Conjugated estrogens 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs.
Company:
Pfizer Inc.
Select therapeutic use: Breast cancer
Menopause and HRT
Prostate and other male cancers
Indications for PREMARIN:
Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
Adult:
10mg 3 times daily for at least 3 months.
Children:
Not applicable.
Contraindications:
Known, suspected, or history of breast cancer, except in appropriately selected patients being treated for metastatic disease. Known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Pulmonary embolism/DVT (active or history of). Arterial thromboembolism (eg, stroke, MI; active or history of). Liver dysfunction or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy (Cat.X).
Warnings/Precautions:
Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reevaluate periodically. Patients with an intact uterus should almost always receive a progestin with systemic estrogens to avoid endometrial hyperplasia. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 4–6 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Bone disease associated with hypercalcemia. Hereditary angioedema. Do initial complete physical and repeat annually (include BP, mammogram, PAP smear). Adolescents. Nursing mothers: not recommended.
Pharmacological Class:
Estrogen.
Adverse Reactions:
See literature. Increased risk of cardiovascular events, estrogen-dependent carcinoma, gallbladder disease, thromboembolic disorders, hepatic tumors. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, depression, anaphylactic reactions, angioedema, intolerance to contact lenses.
How Supplied:
Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100
Indications for PREMARIN:
Moderate to severe vasomotor symptoms of menopause. Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Postmenopausal osteoporosis prevention (consider alternative treatments). Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
Adult:
Menopausal symptoms or vaginal atrophy: 0.3mg/day. Osteoporosis: 0.3mg/day; supplement diet with calcium 1.5g/day and Vit. D 400–800IU/day. Give cyclically (25 days on, 5 days off) or continuously. Hypoestrogenism due to hypogonadism, castration, ovarian failure: 0.3–0.625mg/day, given cyclically (3 weeks on, 1 week off). Female castration, ovarian failure: 1.25mg/day, cyclically. For all: adjust as needed; periodically reassess need if dose is increased.
Children:
Not applicable.
Contraindications:
Known, suspected, or history of breast cancer, except in appropriately selected patients being treated for metastatic disease. Known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Pulmonary embolism/DVT (active or history of). Arterial thromboembolism (eg, stroke, MI; active or history of). Liver dysfunction or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy (Cat.X).
Warnings/Precautions:
Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reevaluate periodically. Patients with an intact uterus should almost always receive a progestin with systemic estrogens to avoid endometrial hyperplasia. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 4–6 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Bone disease associated with hypercalcemia. Hereditary angioedema. Do initial complete physical and repeat annually (include BP, mammogram, PAP smear). Adolescents. Nursing mothers: not recommended.
Pharmacological Class:
Estrogen.
Adverse Reactions:
See literature. Increased risk of cardiovascular events, estrogen-dependent carcinoma, gallbladder disease, thromboembolic disorders, hepatic tumors. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, depression, anaphylactic reactions, angioedema, intolerance to contact lenses.
How Supplied:
Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100
Cream—42.5g (w. applicator)
Indications for PREMARIN:
Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Adult:
1.25mg—2.5mg 3 times daily.
Children:
Not applicable.
Contraindications:
Known, suspected, or history of breast cancer, except in appropriately selected patients being treated for metastatic disease. Known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Pulmonary embolism/DVT (active or history of). Arterial thromboembolism (eg, stroke, MI; active or history of). Liver dysfunction or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy (Cat.X).
Warnings/Precautions:
Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reevaluate periodically. Patients with an intact uterus should almost always receive a progestin with systemic estrogens to avoid endometrial hyperplasia. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 4–6 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Bone disease associated with hypercalcemia. Hereditary angioedema. Do initial complete physical and repeat annually (include BP, mammogram, PAP smear). Adolescents. Nursing mothers: not recommended.
Pharmacological Class:
Estrogen.
Adverse Reactions:
See literature. Increased risk of cardiovascular events, estrogen-dependent carcinoma, gallbladder disease, thromboembolic disorders, hepatic tumors. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, depression, anaphylactic reactions, angioedema, intolerance to contact lenses.
How Supplied:
Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100

责任编辑:admin


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