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当前位置:缺药登记 >> 长效孕激素单杆激素避孕药Nexplanon(依托孕烯植埋剂)

长效孕激素单杆激素避孕药Nexplanon(依托孕烯植埋剂)

ID号:471  发布日期: 2011-12-23    截止日期: 不限  地区:北京市 浏览次数:211

默克公司新型植埋式避孕药Nexplanon在美国上市
默克公司在美国推出了68毫克长效孕激素单杆激素避孕药Nexplanon(依托孕烯植埋剂)。
   
这种避孕药得到了FDA的认可,用来防止女人怀孕,有效期三年。
   
在Nexplanon植入后的第三年,如果还需要避孕应该用新的替换掉旧的,如果不需要就直接取出。
   
这种避孕药是成分柔软坚韧的医疗合成物,需要经过简单的外科处理,然后植入在手腕处。
   
Neplanon含有依托孕烯(一种孕激素),它可以抑制排卵,浓缩宫颈粘液,改变子宫内膜,从而达到避孕的目的。

制造商:
默克制药公司

类药物:
孕激素。

活性成分(S):
Etonogestrel 68mg,硫酸钡15毫克;不透X线;植入棒;无乳胶。

指示(S):
皮下避孕。

药理:
Nexplanon避孕效果是通过抑制排卵,增加宫颈粘液的粘度,并在子宫内膜的改变。

Nexplanon植入皮下插入后,etonogestrel被释放进入血液循环和生物利用度约为100%。


临床试验:
在临床试验中,为期三年,涉及923科目,在进入18-40岁的妇女和使用,不透X线etonogestrel植入(Implanon的)表示为28天的周期等值的贷款总额1756年学习一年以下内容:1年= 10866次;年2 = 8581个周期; 3年= 3442周期。试验权衡自己的理想体重超过130%,长期服用药物诱导肝酶的妇女排除在外。

在妇女,在进入18-35岁,六个怀孕期间20648使用周期分组报告。两次怀孕发生在1,2年,每年,3。每一个概念是,不久之前或2个星期内,可能有拆除不透X线etonogestrel植入后发生。这六个怀孕,累计明珠指数0.38%的怀孕妇女使用100年。

在临床试验与不透X线etonogestrel植入(Implanon的),etonogestrel血药浓度低于检测的灵敏度下降切除植入后一周。此外,怀孕,观察发生早搬迁后的7-14天。因此,避孕应重新开始立即去除植入后如果需要继续避孕保护。


法律分类:
接收

成人:
见文献。 subdermally(非上占主导地位)手臂内侧插入1植入。删除后没有超过3年后插入。

儿童:
Premenarchal:不适用。

禁忌(S):
血栓栓塞性疾病。肝肿瘤。活动性肝病。不明原因的异常生殖器出血。乳腺癌。怀孕。


警告/注意事项:
超重的妇女(可能不太有效)。插入前和每年至少完成体检。排除怀孕(见文献其他避孕方法的切换);使用后备避孕,如果适当。插入和删除技术的文献,只执行适当资格。取出植入物,如果出现黄疸或血栓性事件,或如果怀孕是保持长期固定在考虑取消植入。高血压。肾脏疾病。萧条。监控糖尿病,hyperlipidemias,视觉变化。哺乳母亲:第四产后一周后可以使用。

相互作用(S):
可能是拮抗其他肝酶诱导剂(如巴比妥类,波生坦,卡马西平,非氨酯,灰黄霉素,奥卡西平,苯妥英,利福平,圣约翰草,托吡酯,蛋白酶抑制剂,非核苷类逆转录酶抑制剂);使用非激素的避孕。酮康唑,伊曲康唑,其他肝酶抑制剂含量增高。可能会影响性激素结合球蛋白,甲状腺素的测量。

不良反应(S):
月经出血模式,头痛,阴道炎,重量增加,痤疮,乳房胀痛,腹部疼痛(排除宫外孕),咽炎,白带,流感样症状,头晕,背痛,情绪不稳,恶心,抑郁,插入部位疼痛的变化血栓事件,其他人(见文献)。

注:
提供足够的辅导。获得签署的书面同意(见文献)。

如何提供:
单杆植入(预加载一次性撒施)-1


最后更新:
二○一一年十一月三十〇日


NEXPLANON

Manufacturer:

Merck & Co., Inc.

Pharmacological Class:

Progestin.

Active Ingredient(s):

Etonogestrel 68mg, barium sulfate 15mg; radiopaque; implantable rod; latex-free.

Indication(s):

Subdermal contraception.

Pharmacology:

The contraceptive effect of Nexplanon is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.

After subdermal insertion of the Nexplanon implant, etonogestrel is released into the circulation and is approximately 100% bioavailable.

 

Clinical Trials:

In clinical trials up to three years duration involving 923 subjects, 18–40 years of age at entry, and 1,756 women-years of use with the non-radiopaque etonogestrel implant (Implanon), the total exposures expressed as 28-day cycle equivalents by study year were the following: Year 1 = 10,866 cycles; Year 2 = 8,581 cycles; and Year 3 = 3,442 cycles. The trials excluded women who weighed more than 130% of their ideal body weight and who were chronically taking medications that induce liver enzymes.

In the subgroup of women, 18–35 years of age at entry, six pregnancies during 20,648 cycles of use were reported. Two pregnancies occurred in each of Years 1, 2, and 3. Each conception was likely to have occurred shortly before or within 2 weeks after removal of the non-radiopaque etonogestrel implant. With these six pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use.

In clinical trials with the non-radiopaque etonogestrel implant (Implanon), the etonogestrel blood levels decreased below sensitivity of the assay by one week after the removal of the implant. In addition, pregnancies were observed to occur as early as 7–14 days after removal. Therefore, contraception should be re-started immediately after removal of the implant if continued contraceptive protection is desired.

 

Legal Classification:

Rx

Adults:

See literature. Insert 1 implant subdermally in the inner side of upper (non-dominant) arm. Remove no later than 3 years after insertion.

Children:

Premenarchal: not applicable.

Contraindication(s):

Thromboembolic disorders. Liver tumors. Active liver disease. Undiagnosed abnormal genital bleeding. Breast carcinoma. Pregnancy.

 

Warnings/Precautions:

Overweight women (may be less effective). Do complete physical exam before insertion and at least annually. Exclude pregnancy (see literature for switching from other contraceptive methods); use back-up contraception if appropriate. See literature for insertion and removal technique; perform only if properly qualified. Remove implant if jaundice or thrombotic event occurs, or if a pregnancy is maintained; consider removing implant in prolonged immobilization. Hypertension. Renal disease. Depression. Monitor diabetes, hyperlipidemias, visual changes. Nursing mothers: may use after 4th postpartum week.

Interaction(s):

May be antagonized by other hepatic enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate, protease inhibitors, non-nucleoside reverse transcriptase inhibitors); use non-hormonal contraception. Levels increased by ketoconazole, itraconazole, other hepatic enzyme inhibitors. May affect measurement of sex hormone-binding globulin, thyroxine.

Adverse Reaction(s):

Change in menstrual bleeding pattern, headache, vaginitis, weight increase, acne, breast pain, abdominal pain (exclude ectopic pregnancy), pharyngitis, leukorrhea, influenza-like symptoms, dizziness, back pain, emotional lability, nausea, depression, insertion site pain; thrombotic events, others (see literature).

Notes:

Provide adequate counseling. Obtain signed written consent (see literature).

How Supplied:

Single rod implant (in pre-loaded disposable applicator)—1

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