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当前位置:药品说明书与价格首页 >> 综合药讯 >> 诺坤复-雌二醇阴道用药片|Vagifem (Estradiol Vaginal Tablets)

诺坤复-雌二醇阴道用药片|Vagifem (Estradiol Vaginal Tablets)

2011-05-24 17:27:51  作者:新特药房  来源:中国新特药网天津分站  浏览次数:561  文字大小:【】【】【
简介: 英文药名: Vagifem (Estradiol Vaginal Tablets) 中文药名: 雌二醇阴道用药片,诺坤复 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, ...
英文药名: Vagifem (Estradiol Vaginal Tablets)

中文药名: 雌二醇阴道用药片,诺坤复

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)。

【原产地英文商品名】VAGIFEM VAGINAL TAB 10mcg/tab 8tabs/box
【原产地英文药品名】ESTRADIOL
【中文参考商品译名】
注:以下产品不同规格和不同价格,购买时请以电话咨询为准!
·诺坤复阴道用药片 10微克/片 18片/盒
·诺坤复阴道用药片 10微克/片 8片/盒
【中文参考药品译名】雌二醇
【生产厂家中文参考译名】诺和诺德
【生产厂家英文名】NOVO NORDISK INC


Important information about Vagifem® (estradiol vaginal tablets)

 
This website provides a summary of the most important information about Vagifem®. If you would like more information, talk with your health care provider or pharmacist.

What is Vagifem®?
Vagifem® is a medicine that contains estradiol (an estrogen hormone) in a vaginal tablet.

What is Vagifem® used for?
Vagifem® is used after menopause to:
Treat menopausal changes in and around the vagina

You and your health care provider should talk regularly about whether you still need treatment with Vagifem® to control these problems.

Who should not use Vagifem®?
Do not start using Vagifem® if you:
Have unusual vaginal bleeding
Currently have or have had certain cancers
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have, have had or suspect cancer, talk with your health care provider about whether you should use Vagifem®.
Had a stroke or heart attack
Currently have or have had blood clots
Currently have or have had liver problems
Are allergic to Vagifem® or any of its ingredients
See the list of ingredients in Vagifem® in the next question.
Think you may be pregnant

Tell your health care provider:
If you have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find the cause.
About all of your medical problems
Your health care provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
About all the medicines you take
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Vagifem® works. Vagifem® may also affect how your other medicines work.
If you are going to have surgery or will be on bed rest
You may need to stop using Vagifem®.
If you are breast feeding
The hormone in Vagifem® can pass into your milk.

What are the ingredients in Vagifem®?
Vagifem® (estradiol vaginal tablets) are small, white, film-coated tablets containing estradiol. Each tablet also contains hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol.

Each Vagifem® tablet is contained in a disposable applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset tablets.

How should I use Vagifem®?
Vagifem® is a tablet that you place in your vagina with an applicator.
Take the dose recommended by your health care provider and talk to him or her about how well that dose is working for you
Estrogens should be used at the lowest dose possible for your treatment only as long as needed

You and your health care provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Vagifem®.

Dosage
Vagifem® therapy consists of the following dosing regimen: One (1) Vagifem® tablet inserted vaginally once daily for the first two (2) weeks, then one (1) tablet inserted twice weekly (for example Tuesday and Friday) for as long as you use Vagifem®.

What are the possible side effects of Vagifem®?
Vagifem® is only used in the vagina; however, the risks associated with oral estrogens should be taken into account.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious but less common side effects include:
Breast cancer
Cancer of the uterus
Stroke
Heart attack
Blood clots
Dementia
Gallbladder disease
Ovarian cancer
High blood pressure
Liver problems
High blood sugar
Enlargement of benign tumors of the uterus (“fibroids”)

Some of the warning signs of serious side effects include:
Breast lumps
Unusual vaginal bleeding
Dizziness and faintness
Changes in speech
Severe headaches
Chest pain
Shortness of breath
Pains in your legs
Changes in vision
Vomiting
Yellowing of the skin, eyes or nail beds

Call your health care provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.

Less serious, but common, side effects include:
Headache
Breast pain
Irregular vaginal bleeding or spotting
Stomach/abdominal cramps, bloating
Nausea and vomiting
Hair loss
Fluid retention
Vaginal yeast infection

These are not all the possible side effects of Vagifem®. For more information, ask your health care provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with Vagifem®?
Talk with your health care provider regularly about whether you should continue using Vagifem®
If you have a uterus, talk with your health care provider about whether the addition of a progestin is right for you
The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus. See your health care provider right away if you get vaginal bleeding while using Vagifem®.
Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your health care provider tells you something else
If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease

Ask your health care provider for ways to lower your chances for getting heart disease.

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