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雌二醇阴道用药片(诺坤复Vagifem)

2011-01-13 18:08:21  作者:新特药房  来源:中国新特药网天津分站  浏览次数:1319  文字大小:【】【】【
简介: 药品名称 中文通用名称:雌二醇 英文通用名称:Estradiol 中文其它名称:松奇, 求偶二醇, 诺坤复, 康美华, 妇舒宁, 得美素, 欧适可, 更乐, 雌二醇控释贴片, 雌二醇凝胶, 雌二醇片, 雌二醇每周用透皮贴 ...

 药品名称

中文通用名称:雌二醇
英文通用名称:Estradiol
中文其它名称:松奇, 求偶二醇, 诺坤复, 康美华, 妇舒宁, 得美素, 欧适可, 更乐, 雌二醇控释贴片, 雌二醇凝胶, 雌二醇片, 雌二醇每周用透皮贴片, 每周用雌二醇透皮贴片, 雌二醇阴道片, 伊司乐, 爱美特, 半水合雌二醇贴剂, 半水合雌二醇贴片, 雌二醇缓释透皮贴片, 雌二醇贴片, 乐复佳, 伊尔, 周效, 爱斯妥
英文其它名称:Oestradiol, Estraldine, Estrofem, FEM 7, Fem7, Aquadiol, Climara, Dermestril, Dihydrofollicullin, Dihydrotheclin, Diogyn, Estraderm TTS, Happier, Fematrix, Airmistor, Estradiol Hemihydrate Patches, Estradiol Tablets, Estradiol Hemihydrate, Estradiol Gel, Estradiol Patches, Estradiol SR Transdermal Patches, Estradiol Vaginal Tablets, Estreva, Vagifem, Oestrogel, Estradiol Controlled Delivery Patches
产品所属分类:女性生殖系统用药\雌激素类及抗雌激素类药
适应症

1.用于补充雌激素不足,如治疗萎缩性阴道炎、萎缩性尿道炎、女性性腺功能不良、围绝经期综合征,缓解卵巢切除或原发卵巢衰竭、非癌性疾病放射性去势后雌激素不足的症状。
2.用于垂体与卵巢内分泌失调引起的闭经、月经异常、功能性子宫出血、子宫发育不良。
3.预防骨质疏松症。
4.治疗晚期转移性乳腺癌(绝经期后妇女)。
5.用于前列腺增生、晚期前列腺癌,可明显改善晚期前列腺癌症状。
6.用作避孕药,与孕激素类药合用抑制排卵。
7.用于退乳。
8.治疗痤疮,在男性可用于较重的病例,在女性可选用雌-孕激素复合制剂。
用法用量

成人
•常规剂量
•肌内注射
1.雌二醇:
(1)雌激素替代治疗:一次0.5-1.5mg,一周2-3次,替代治疗剂量平均为一日0.2-0.5mg。
(2)功能性子宫出血:一日4-6mg,待血止后逐渐减量至每1-2日1mg,连用21日后停药。第14日开始加黄体酮注射,一日10mg。
(3)回乳:在乳房未胀前,一次4mg,一日1次,连用3-5日。
(4)人工月经周期:于出血第5日起一日1mg。注射第16日起,每日加用黄体酮10mg肌注,两药同时用完,下次出血第5日再重复疗程,一般需用2-3个周期。
2.戊酸雌二醇:
(1)补充雌激素不足:一次5-10mg,每1-4周1次。
(2)前列腺癌:一次30mg,每1-2周1次。可按需调整用量。
(3)替代治疗:一次5-10mg,每1-2周1次。平均每2周5-20mg。
(4)回乳:一次10mg。
3.苯甲酸雌二醇:
(1)围绝经期综合征:一次1-2mg,一周2-3次。
(2)子宫发育不良:一次1-2mg,每2-3日1次。
(3)功能失调性子宫出血:开始为一日4-6mg,待止血后逐渐减量至一日1mg,再减为隔日1mg,至止血后第21日停药。在止血后第14日开始加用黄体酮注射,一日10mg。一般一日最大量不超过12mg。
(4)回乳:一日2mg,不超过3日,其后减量至生效停药。
(5)前列腺增生、晚期前列腺癌:一次1-2mg,一周2-3次。
•口服给药
戊酸雌二醇:用于围绝经期综合征或卵巢切除及非癌性疾病放射性去势后的雌激素不足的症状,一日1mg,饭后服,可酌情增减,连用21日,停药至少1周后开始下一疗程。
•局部给药
1.控释贴片:揭除贴片上的保护膜后立即贴于清洁干燥、无外伤的下腹部或臀部皮肤。一周1片,连用3周,停用1周。并于使用贴片的最后5日加用醋酸甲孕酮4mg,一日1次,连续5日。
2.半水合贴片:打开包装后立即贴于干净、无油脂、干燥和无破损的皮肤。开始治疗时,一周1片;如症状缓解不佳,几个月之后可增加剂量至一次2片,一周1次。可连用3周,停用1周,或持续应用。最大剂量为一次2片,每周更换,不能超时。
3.外用凝胶:
(1)已绝经妇女:每日早晨或晚上涂2.5g于手臂、肩部、头颈部、腹部或大腿部及面部,涂后约2分钟即干。连用24日,自第13日开始加口服黄体酮一日100mg,连用12日,休息1周,再重复治疗。
(2)尚未绝经妇女:于月经周期第6日开始,一日2.5g涂于皮肤,连用25日,后13日加服黄体酮,一日100mg。
4.苯甲酸雌二醇软膏:一次1.5g(含1.35mg苯甲酸雌二醇或0.98mg雌二醇)涂于干净皮肤处(如手臂内侧、下腹部、腰部、臀和大腿等部位),一日1次,每月按月历1-24日连用,第15-24日每日合用口服安宫黄体酮片4mg。谨遵医嘱!
给药说明

1.应使用本药的最低有效量,时间尽可能缩短,以减少不良反应的发生。
2.男性患者以及子宫切除的女性患者,通常采用周期治疗,即用药3周停药1周,相当于自然月经周期中雌激素的变化情况。有子宫的女性,为避免过度刺激,可在月经周期的最后10-14日加用孕激素,模拟自然周期中的激素水平。
3.长期或大量使用本药者,停药或减量时须逐步进行。
4.使用本药贴片时,应经常更换贴片部位,同一部位皮肤不宜连续贴2次。最适合的部位是臀部、腰部和下腹部皮肤无皱褶处,不可贴于乳房或其附近。
5.本药凝胶剂不可口服。外用最佳部位为躯干部、上肢及腿内侧。忌用于乳房、外阴和阴道粘膜处。使用时间最好在每日早晨或晚间沐浴后。涂药后稍等片刻,待药物干后再穿内衣。
6.本药软膏禁涂于乳房及粘膜区域。
7.子宫内膜完整仍有生育能力的妇女,在使用本药和孕激素的治疗中,仍应采用非激素类药物避孕。
8.促进性征发育应在骨龄大于13岁以后开始用药,以免引起骨骺早闭。
9.研究显示,激素替代治疗可能会增加凝血的危险性(尤其是治疗的第1年),与未使用替代治疗的女性相比,主要是通过凝血因子Ⅲ发挥作用;在这些研究中还发现,肺栓塞危险性增加主要通过凝血因子Ⅱ起作用。
10.有证据显示,激素替代治疗可使绝经期和绝经后妇女发生乳腺癌的危险性相对增加。如果持续治疗5年以上,则必须认真权衡利弊,并进行定期的乳腺检查。
11.个别良性或恶性肝脏肿瘤患者,服用激素类药物后,可能发生危及生命的腹腔内出血。因此,若发生异常的上腹部症状,且短时间内不自行消失,应加以注意。
12.如出现乳房胀痛、水潴留、恶心和阴道突破出血,可能是剂量过高的表现,此时必须相应减少剂量。如发生子宫出血,应查明出血病因。
13.出现以下情况应立即停药:第1次发生偏头痛或频繁发作少见的严重头痛、突发性感觉障碍(如视觉或听觉障碍)、血栓性静脉炎或血栓栓塞的前兆指征(如异常的腿痛或腿肿、不明原因的呼吸或咳嗽时的刺痛感)、胸部疼痛及紧缩感、癫痫发作次数增加、血压显著升高及发生黄疸、肝炎、全身瘙痒。
14.肢体固定术(如事故后)前应停药,择期手术前应停药6周,以减少血栓发生的危险性,并防止卧床时间延长。
不良反应

1.较常见:恶心、纳差、腹部绞痛或腹胀、踝部及足背水肿、乳房胀痛或肿胀及体重增加或减少,但常在持续用药后减少。
2.少见或罕见:
(1)乳腺出现小肿块、不规则阴道流血、点滴出血、突破出血、长期出血不止或闭经、粘稠的白色凝乳状阴道分泌物(继发性念珠菌感染)。
(2)困倦、精神抑郁、严重的或突发的头痛、共济失调,不自主运动(舞蹈症),以及胸、上腹(胃)、腹股沟或腿痛(尤腓肠肌痛)、臂或腿无力或麻木、突然言语或发音不清。
(3)尿频或尿痛。
(4)突发的呼吸急促、血压升高。
(5)视力突然下降(眼底出血)、眼结膜或皮肤黄染、皮疹。
3.注射部位可出现红肿、疼痛。使用本药贴片处的皮肤可有轻度发红或瘙痒,偶见皮疹。
4.长期服药可刺激子宫内膜增生,增加子宫内膜癌的发病率。用药5-10年以上,乳腺癌发病率略有增加。
注意事项

1.禁忌症
(1)对本药过敏。
(2)疑有或患有乳腺肿瘤或有此病史(除外晚期转移性乳腺癌)。
(3)疑有或患有雌激素依赖性肿瘤。
(4)原因不明的阴道出血。
(5)中、重度子宫内膜异位症。
(6)活动性血栓性静脉炎或血栓栓塞。
(7)有因服用雌激素而致血栓性静脉炎或血栓形成等病史(但用于治疗晚期乳腺癌及前列腺癌时例外)。
(8)有胆汁淤积性黄疸史、Rotor综合征、Dubin-Johnson综合征或急、慢性(严重)肝脏疾病、肝脏疾病后肝功能未恢复到正常水平。
(9)严重肾脏疾病。
(10)镰刀细胞性贫血。
(11)伴有血管病变的严重糖尿病。
(12)先天性脂肪代谢异常。
(13)确诊或怀疑妊娠。
(14)哺乳妇女。
(15)儿童。
2.慎用
(1)有乳腺癌家族史。
(2)有乳腺结节、乳腺囊性纤维症及乳房X线检查异常。
(3)轻度子宫内膜异位症及子宫良性肿瘤(子宫肌瘤)。
(4)癫痫。
(5)抑郁症。
(6)偏头痛。
(7)手足抽搐。
(8)小舞蹈病。
(9)垂体肿瘤(下丘脑肿瘤)。
(10)严重高血压及心功能不全。
(11)脑血管或冠状动脉疾患。
(12)哮喘。
(13)皮肤过敏。
(14)糖尿病。
(15)代谢性骨病伴高血钙。
(16)血卟啉病。
(17)凝血危险性增大时(如凝血异常、长期卧床、静脉曲张、某些恶性疾病、某些心脏疾病)。
(18)内耳迷路骨性硬化伴有进行性听力丧失(耳硬化症)。
(19)轻中度肝、肾疾病。
(20)体液潴留(国外资料)。
(21)胆囊疾病(国外资料)。
(22)有高脂蛋白血症家族史(国外资料)。
3.药物对儿童的影响 易引起儿童早熟。
4.药物对妊娠的影响 妊娠期间使用雌激素,可能导致胎儿畸形。用药后所生女婴可能出现生殖道异常,女婴成年后发生阴道腺病、宫颈鳞状上皮发育不良或宫颈腺癌的危险性增加。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为X级。
5.药物对哺乳的影响 雌激素可随乳汁排泌,并可抑制泌乳,哺乳妇女禁用。用于回奶时需停止哺乳。
6.药物对检验值或诊断的影响
(1)美替拉酮(Metyrapone)试验反应减低。
(2)去甲肾上腺素导致的血小板凝集可增加。
(3)磺溴酞钠(BSP)潴留增加。
(4)用血清蛋白结合碘(PBI)测试甲状腺功能,T★4★的结合增加,T★3★血清树脂的摄取减低,这是由于血清甲状腺结合球蛋白(TBG)增多所致。放射性碘(☆131☆I)及血清促甲状腺素(TSH)则不受雌激素的影响。
7.用药前后及用药时应当检查或监测
(1)用药前应详细询问病史,并进行内科及妇科检查,包括血压、乳腺、腹腔、盆腔检查及宫颈细胞学检查。
(2)用药期间应监测:
①血压。
②肝功能。
③阴道脱落细胞。
④全面体检(每6-12个月1次),尤其是对子宫内膜的厚度和乳腺的检查。
⑤宫颈细胞学检查(一年1次)。
 
英文药名: Vagifem (Estradiol Vaginal Tablets)

中文药名: 雌二醇阴道用药片,诺坤复


生产厂家: Novo Nordisk Pharmaceuticals

VAGIFEM

Vagifem Information

Vagifem is a popular medicine that is generally prescribed to female patients who are suffering from vaginal area burning, dryness, and itching (menopause symptoms). Intake of this medicine has proved itself highly efficient in reducing irritation or urgency or urination.

Vagifem Indications

Vagifem is a well known drug that is generally prescribed to menopausal female patients. However, this medicine could also have some other purposes that have not been listed in this guide. Ask your physician for more information.

Vagifem Warnings

A treatment with Vagifem is known to increase the patient’s risk of developing endometrial hyperplasia. This medical disorder can sometimes trigger uterus cancer. This is why most patients who are following a long term treatment with this medicine should also use a progestin medicine. Prolonged intake of Vagifem could also trigger an unwanted Breast Cancer. Ask your personal physician to tell you more about the risk that a long term treatment with this medicine involves.

Some medical disorders are known to harmfully interact with a treatment with Vagifem. If you are suffering from any of the medical disorders that are listed below you might not be allowed to start taking this medicine or you might have to use a lower dose of Vagifem:

  • a blood-clotting or bleeding disorder;
  • a history of circulation problems or stroke;
  • unusual vaginal bleeding of unknown cause;
  • any type of uterine, breast, or any other cancer that is hormone dependent;
  • angina, high blood pressure, or heart disease;
  • high triglycerides or cholesterol;
  • kidney disease;
  • liver disease;
  • epilepsy;
  • asthma;
  • diabetes;
  • migraine;
  • Gallbladder disease;
  • depression;
  • if you have undergone Hysterectomy.

Vagifem is a category X FDA pregnancy drug. Therefore, it is known that intake of this medical product during pregnancy could trigger unwanted birth complications and / or birth defects. If you are pregnant, you should ask your personal physician if you may start using this drug. During your intake of Vagifem your personal health care specialists will probably ask you to use an effective non hormonal contraceptive method (such as condoms, diaphragm, etc). If you accidentally become pregnant during your treatment with this medicine you should alert your personal physician right away. Intake of this drug is known to sometimes decrease the patient’s natural milk flow production. It has not been determined whether this medicine’s components are able to pass into the breast milk.

Vagifem Intake Guidelines

You must use all your Vagifem doses exactly how your physician (or nurse, or pharmacist) has instructed you to. If you have any further questions about the treatment, you should discuss them with your doctor, a nurse or even a pharmacist. Read more about this medicine and its benefic effects from the medicine’s label. During your treatment with this product you should undergo physical medical exams on a regular basis. You might want to self-examine your breasts regularly (at least once a month). Store this product away from heat, moisture and direct sunlight. Do not keep it in a location that can be easily reached by pets or children in order to avoid unpleasant accidents.

Vagifem Dosage

Your doctor will give you the correct dosage of Vagifem because the needed dosage may vary from one person to another due to a great variety of factors (age, the severity of one’s medical condition, etc). You should not alter the dosage of this medicine that your personal physician has given you because this may alter the drug’s benefic effects and it also might lead to an accidental and unwanted overdose with Vagifem.

Vagifem Overdose

If you suspect that you might be suffering from an overdose with this medicine you should seek emergency medical care. An overdose with Vagifem could trigger vomiting, nausea, and vaginal bleeding.

Vagifem Missed Dose

It is not recommended that you miss your regular Vagifem doses. If you miss one, you should use it as soon as possible. If it is already about time for another scheduled dose, skip the one that you have missed and continue your normal dosing program. You should not use a double dose of Vagifem unless your doctor has specifically advised you to.

Vagifem Side Effects

You should stop your treatment with Vagifem at once and alert your personal health care specialist if you develop any of these severe side effects:

  • heavy feeling or chest pain, pain spreading to the shoulder or arm, sweating, nausea, general illness;
  • sudden weakness or numbness;
  • sudden headache, problems with vision, confusion, balance or speech;
  • swelling or pain in your lower leg;
  • unusual vaginal bleeding;
  • swelling, pain, or tenderness in your stomach;
  • jaundice;
  • a breast lump.

Intake of Vagifem could also trigger some other less severe side effects like:

  • vomiting, nausea, loss of appetite;
  • skin color changes or acne;
  • swollen breasts;
  • impotence, decreased sex drive, or problems having an orgasm;
  • dizziness or migraine headaches;
  • dryness, vaginal pain, or discomfort;
  • swelling of your feet or ankles;
  • depression;
  • break-through bleeding.

Vagifem Drug Reactions

During your treatment with Vagifem you should avoid using any of these medicines:

  • St. John's wort;
  • blood thinners;
  • phenobarbital (Solfoton, Luminal);
  • rifampin (Rifadin, Rifamate, Rifater, Rimactane);
  • carbamazepine (Tegretol, Carbatrol);
  • ritonavir (Norvir);
  • antibiotics like erythromycin (E-Mycin, Erythrocin, E.E.S., Ery-Tab), clarithromycin (Biaxin), ketoconazole (Nizoral), or itraconazole (Sporanox);

Buy Vagifem

Buy Vagifem through our Online Pharmacy Escrow Service or at any Canada Pharmacy where it is sold.

In some countries VAGIFEM may also be known as: Estrace, Farmacyrol, Gynoestryl, Oestrogel, Progynon, Aerodiol, Climara, Dermestril, Estradot, Femtran, Menorest, Primogyn Depot, Progynova, Sandrena, Vagifem, Delestrogen, Estring, Oesclim, Cutanum, Estrabeta, Sisare mono, Divigel, Alora, FemSeven, Elleste-Solo, Fematrix, depGynogen, Gynodiol, Estrapatch, Oestrodose, Oromone

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