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  药店国别: 美国药房
产地国家: 美国
所属类别: 激素内分泌药物->孕激素类药
处方药:处方药
包装规格: 40毫克/毫升 240毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
百时美施贵宝
生产厂家英文名:
BRISTOL MYERS SQUIBB
该药品相关信息网址1:
http://www.drugs.com/pro/megace.html
该药品相关信息网址2:
http://www.rxlist.com/megace-drug.htm
该药品相关信息网址3:
http://www.netdoctor.co.uk/medicines/100001601.html
原产地英文商品名:
MEGACE ORAL SUSP 40mg/ml 240mls/bottle
原产地英文药品名:
MEGESTROL ACETATE
中文参考商品译名:
梅格施口服混悬剂 40毫克/毫升 240毫升/瓶
中文参考药品译名:
醋酸甲地孕酮
原产地国家批准上市年份:
1993/09/10
英文适应病症1:
Advanced breast cancer
英文适应病症2:
Endometrial cancer
英文适应病症3:
Irregular menstruation, dysfunctional uterine bleeding
英文适应病症4:
Endometriosis
英文适应病症5:
Contraception
临床试验期:
完成
中文适应病症参考翻译1:
晚期乳腺癌
中文适应病症参考翻译2:
子宫内膜癌
中文适应病症参考翻译3:
月经不调、功能失调性子宫出血
中文适应病症参考翻译4:
子宫内膜异位
中文适应病症参考翻译5:
避孕
药品信息:

友情提示:MEGACE已停产。

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(20114620342019.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文醋酸甲地孕酮处方资料(仅供参考)

分类名称
一级分类:抗肿瘤药物 二级分类:激素类   
 
药品英文名
Megestrol
 
药品别名
梅格施、佳迪、妇宁、美可治、醋酸甲地孕酮、去氢甲孕酮、甲孕环酯、孕素1号、Megace、Megestat、Minigest、Niagestin
 
药理作用
本药属于17α-羟孕酮类衍生物,是一种高效的合成孕激素,无雌激素或雄激素活性,无蛋白同化作用。口服时其孕激素效应约为黄体酮的75倍,注射时约为黄体酮的50倍。本药能抑制下丘脑促性腺激素释放激素(GnRH)的释放,并作用于腺垂体,降低其对GnRH的敏感性,从而阻断垂体促性腺激素释放,产生显著的排卵抑制作用,因而主要与炔雌醇合用作为短效避孕药。本药较大剂量单用时还能影响宫颈黏液性状与子宫内膜正常发育,使宫颈黏液黏稠,不利于精子通过,并抑制子宫内膜腺体的正常发育,阻止受精卵着床。此外,本药还有维持早孕蜕膜组织和抑制子宫肌肉收缩的作用。本药作为抗肿瘤激素类药时,药理作用与醋酸甲羟孕酮相似,请参见相关内容。
 
药动学
口服吸收迅速,血浆药物浓度达峰时间为2h,正常人口服本品剂量为20mg、40mg、80mg及0.2g时,血浆药物浓度达峰时间为2~3h,血浆药物浓度峰值分别为89ng/ml、190ng/ml、209ng/ml及465ng/ml,血浆半衰期为15~20h。主要以葡萄糖醛酸结合物的形式从尿液中排出(57%~78%),也可以从粪便中排出(8%~30%)。剂量与血浆浓度成线性关系。本品能影响子宫内膜发育,不利于孕卵着床。肌内注射能在局部组织中储存,缓慢吸收而达长效作用。本药在血液循环中85%以上与血浆蛋白结合,口服后生物半衰期明显比左炔诺孕酮和炔诺酮为短。
 
适应证
1.治疗月经不调、功能失调性子宫出血、子宫内膜异位。
2.晚期乳腺癌和子宫内膜癌。
3.作为短效复方口服避孕片的孕激素成分。
4.用于避孕,还可以治疗痛经、功能性子宫出血、子宫内膜异位等。本品也可用于晚期乳癌和子宫内膜癌作为姑息性治疗(即治疗复发性,不能手术的或已转移的癌症患者)。本品与炔雌醚配伍,可作为一种以孕激素为主的长效口服避孕药。
 
禁忌证
乳腺癌、生殖器官癌、肝功能异常或近期有肝病或黄疸史、肾病、深静脉血栓病、脑血管意外、高血压、心血管病、糖尿病、哮喘病、癫痫、未明确诊断的阴道出血、胆囊疾病、妊娠诊断实验、高脂血症、精神抑郁症及40岁以上妇女。妊娠前3个月的妇女禁用。
 
注意事项
1.慎用:(1)卟啉症患者;(2)有精神抑郁史者;(3)子宫肌瘤患者;(4)妊娠4个月内。
2.长期用药应按28天周期计算本药的用药日期。
3.长期用药的妇女不宜吸烟。
4.服药前半期发生突破性出血,可每晚加服炔雌醇0.01mg,直到服完这周期为止;如出血发生在服药后半期,可每天加服1片避孕药,到停药为止;如出血量似月经量,则应停药按行经对待。
5.在停药7天内仍未行经时,可开始服下一周期的药。连服两个周期未行经者,应查明闭经原因,排除妊娠。
6.每天服用避孕药的时间应相同,以免血药浓度波动大,影响避孕效果。
7.当出现怀疑妊娠、血栓栓塞性疾病、视觉障碍、原因不明的剧烈头痛或偏头痛、高血压、肝功能异常、精神抑郁、缺血性心脏病等应停止使用本药。
8.使用本药肌内注射避孕时,注意药液要摇匀、抽净,并用7号注射针头作臀部的深部肌内注射,以免大颗粒药物漏注或无法通过直径较小的注射针而导致剂量不足避孕失效。
9.药物对妊娠的影响:妊娠早期应用可能导致后代生殖道畸形,多见尿道下裂。
10.药物对哺乳的影响:(尚不明确)
11.用药前后及用药时应当检查或监测:(1)用药前应全面查体,特别要注意乳腺与盆腔检查,以及宫颈细胞学检查。(2)长期用药需注意检查肝功能。(3)如发生突破出血,应详细检查原因以除外器质性病变。
12.孕激素可引起一定程度的体液潴留,因此癫痫、偏头痛、哮喘、心肾功能不全的患者用药期间严密观察。
13.应严格按规定方法服药,漏服药不仅可发生突破性出血,还可导致避孕失败。
14.服药期限,以连续3~5年为宜,停药观察数月,体检正常者,可再服用。
15.当应用本品时,常规密切观察,适用于所有采用本品治疗的复发性或转移性癌肿患者。
 
不良反应
1.白带增多:为长效口服避孕药最常见的不良反应,多发生在服药3~6个周期之后。
2.类早孕反应:主要有恶心、呕吐、头晕、乏力等,和短效口服避孕药表现相似,但比较严重,开始服药的前几个周期表现较重,随后可逐渐减轻或消失。午饭后用药可减轻类早孕反应。
3.少数人可发生月经过多或闭经;部分妇女有月经周期缩短,尤以年轻妇女多见。
4.其他:可出现胃痛、水肿、乳房胀痛、头痛等。
5.有30%患者因水潴留而致下肢轻度水肿,用利尿剂可使水肿很快消退,但体重增加不受影响。其他不良反应是男子出现阳痿,女性阴道少量出血(2.7%~5%)、闭经(7%)。与其他激素治疗相同,有深静脉血栓形成的倾向。但血栓栓塞包括血栓性静脉炎及肺动脉栓塞罕见报道。
6.常见痤疮、水肿、体重增加、过敏性皮炎、精神压抑、乳房疼痛、女性性欲改变、月经紊乱以及不规则出血或闭经。
7.少见头痛,胸、臀、腿(特别是腓肠肌)疼痛,四肢无力、麻木或疼痛,以及突然或原因不明的呼吸短促、言语发音不清、视力改变、复视、不同程度失明等。
8.长期应用可引起肝功能、凝血功能异常以及缺血性心脏病发生率上升。
 
用法用量
口服:1.用于治疗功能性子宫出血:每8小时服1次(严重情况下,可每3小时服药1次),每次4mg,然后每3天递减1次,每次递减量不超过原剂量的1/2,直至减为每天4mg维持量,连续20天。流血停止后,每天加服炔雌醇0.05mg或己烯雌酚1mg,共20天。2.用于治疗闭经:每次4mg,每天2~3次,连续2~3天,停药2~7天。3.治疗不育症:每次甲地孕酮4mg及炔雌醇0.05mg,每天1次,共20天,连续3个月。4.治疗痛经:每天4mg,共20天,于月经来潮后第5~7天起初始服。5.治疗子宫内膜异位症:每次4mg,每天2次,连续7天,然后每天3次,每次4mg,共7天,再每天2次,每次8mg,连续共7天,然后每天20mg,共用6周。6.治疗子宫内膜增长过度,用法同治疗痛经。7.用于乳腺癌:每天0.16g,分1~3次服用。8.子宫内膜癌:每天40~320mg,一次或分次使用,至少连续治疗2个月,方能决定本品的有效性。9.对肿瘤患者厌食及恶液质:每天0.16g作为初始剂量,根据情况适当增减。10.避孕:探亲当天中午服2mg,当晚2mg,以后每晚2mg,直至探亲结束,次日再服2mg。
 
药物相应作用
与利福平、苯巴比妥、氨苄西林、非那西丁及吡唑酮类镇痛药(保泰松)等合用,可产生肝微粒体酶效应,加速甲地孕酮在体内的代谢,导致子宫内膜突破性出血。
 
专家点评
甲地孕酮是一种孕酮,原主要作为避孕药,因注意到它可使晚期癌症患者明显改善食欲和增加体重后,已作为恶液质的一种可能的治疗。已有3个随机的、安慰剂对照的临床试验证实甲地孕酮可使晚期恶性肿瘤患者改善食欲,增加摄食,一部分患者还有体重增加,其作用机制可能是改善代谢作用,从而使食欲和摄食增加。在一项多中心的临床试验中观察了本品对肺或结肠癌食欲缺乏和体重减轻患者的剂量和疗效。随机对300例患者进行三个药物剂量测试(每天0.16g、0.8g和1.6g)。初步结果显示,从每天0.16~0.8g组,食欲和摄食有正性剂量相关效应,但超过每天0.8g后无显著改善。可以用每天0.32g作为初始剂量,几周后达到适当的胃纳改善和体重增加再增减本品的剂量。一般几天后食欲改善,但体重增加需要几周时间。典型的表现是初始体重下降,以后稳定,几周后增加,这时推荐剂量每天不超过0.8g。本品雌激素含量少,胃肠道不良反应小,安全性较高。本品用于治疗绝经后的乳腺癌和晚期子宫内膜癌有效,对肾癌、前列腺癌和卵巢癌也有一定疗效,并可用于晚期肝癌患者增加体重,不主张用于乳腺癌的术后辅助治疗。

Megace (megestrol acetate)

How does it work?
Megace tablets contain the active ingredient megestrol acetate, which is a synthetic form of the naturally occurring female sex hormone, progesterone. It is used to treat women with certain hormone-dependant cancers.

Most breast cancers and cancers affecting the womb (endometrial cancers) are sensitive to the female sex hormone oestrogen, and their growth is increased in the presence of this hormone. Oestrogen binds to oestrogen receptors on the cancer cells and causes changes within the cells that result in faster growth of the cancer.

Megestrol opposes the action of oestrogen, which means that the growth and replication of cancer cells is disrupted.

Megace tablets must usually be taken for at least two months to see if they are being effective.

What is it used for?
Breast cancer.
Endometrial cancer.

Warning!
This medicine can cause abnormal blood clots in the blood vessels (for example deep vein thrombosis or pulmonary embolism), particularly during periods of immobilisation and following surgery. For this reason you should consult your doctor immediately if you experience any of the following symptoms during treatment: stabbing pains and/or unusual swelling in one leg, pain on breathing or coughing, coughing up blood, sudden breathlessness, sudden numbness affecting one side or part of the body, sudden or severe headache, fainting or sudden severe chest pain.
Women who could get pregnant should use an effective method of contraception to avoid pregnancy while taking this medicine, as it could be harmful to a developing baby.

Use with caution in
People with a history of inflammation of the veins associated with blood clots (thrombophlebitis).
Severely decreased liver function.
Hereditary blood disorders called porphyrias.

Not to be used in
Pregnancy.
Breastfeeding.
People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. (Megace tablets contain lactose)

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Seek medical advice from your doctor.
Women who could get pregnant should use an effective method of contraception to avoid pregnancy while taking this medicine, as it could be harmful to a developing baby.
This medicine may pass into breast milk. Mothers who need treatment with this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Increased appetite and weight gain.
Nausea and vomiting.
Swelling due to fluid retention.
Vaginal bleeding (breakthrough bleeding or spotting).
Difficulty breathing or shortness of breath (dyspnoea).
Heart failure.
High blood pressure.
Hot flushes.
Changes in mood.
High blood glucose level (hyperglycaemia).
Temporary stimulation of tumour growth (tumour flare).
Hair loss (alopecia).
Carpel tunnel syndrome.
Abnormal blood clots in the veins (thromboembolism – see warning section above).
Itchy rash (urticaria).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
There are no significant interactions reported with this medicine.

However, it is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain megestrol acetate as the active ingredient.

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 详细处方信息以本药内容附件PDF文件(20114620342019.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

2011-4-15更新

更新日期: 2014-08-19
附件:


20114620342019.pdf    



 
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