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当前位置:药品说明书与价格首页 >> 激素类 >> 药品目录 >> 雌激素、黄体酮及相关合成药类 >> LoSEASONIQUE(避孕长效组合药)

LoSEASONIQUE(避孕长效组合药)

2011-04-26 11:51:35  作者:新特药房  来源:中国新特药网天津分站  浏览次数:104  文字大小:【】【】【
简介:制造商: Duramed制药公司 药理分类: 结合延长周期口服避孕药(孕激素+雌激素) 活性成分(补): 左炔诺孕酮炔雌醇20micrograms为0.1mg +(84橙色标签);炔雌醇10micrograms(7黄色标签)。 指示(补) ...

制造商
Duramed制药公司

药理分类:
结合延长周期口服避孕药(孕激素+雌激素)

活性成分(补):
左炔诺孕酮炔雌醇20micrograms为0.1mg +(84橙色标签);炔雌醇10micrograms(7黄色标签)。

指示(补):
口服避孕药。

药理作用:
复方口服避孕药通过抑制排卵的工作,并可能导致子宫颈癌和子宫内膜的变化,减少植入的可能性。扩展周期的口服避孕药提供的只有四个计划月经,每次约持续2-3天,每年的便利。然而,不定期出血和/或点状出血可能发生,特别是在最初的几个周期。这往往会随时间减少。

临床试验:
一名12个月,开放标签试验进行评估在防止怀孕的安全性和LoSeasonique疗效。有没有身体质量指数或体重排斥,并为2,185学科范围为87-381磅体重。妇女怀孕率在18至35岁为2.74,每100名妇女怀孕,年包括妇女谁没有采取正确的药物。

法律分类:
接收

成人:
1标签91天;重复。在同一时间以每天。使用周日开始第一周期;使用备份方法,直到橙色标签采取连续7天。允许产后至少4周,如果不是母乳喂养,开始循环。使用备份方法,如果连续2个橙色标签被错过(见文献)。

儿童:
Premenarchal:不推荐。

禁忌(补):
高风险的动脉或静脉血栓性疾病(如吸烟或偏头痛患者年龄超过35岁,深静脉血栓形成或栓塞,脑血管或冠状动脉疾病,血栓形成瓣膜病,心房颤动的历史,亚急性细菌性心内膜炎,hypercoagulopathies,不受控制高血压,高血压或糖尿病血管疾病,神经系统症状局灶性头痛)。乳腺癌雌激素或孕激素或其他敏感的肿瘤。肝脏疾病或肿瘤。妊娠(Cat.X)。

警告/注意事项:
如果停止血栓性事件,原因不明的视力改变,或出现黄疸,并至少有4周前通过2后的血栓风险增加有关手术星期。糖尿病。糖尿病前期。不受控制的高脂血症。妊娠有关的胆汁淤积。评估重大变化,头痛,不规则子宫出血,闭经。监测血压。哺乳母亲:不推荐。

互动(补):
可拮抗CPY3A4或其他酶诱导剂(如巴比妥酸盐,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)(使用备份避孕)。可能受蛋白酶抑制剂。拉莫三嗪可拮抗。可能会影响实验室测试(例如,凝血因子,血脂,血糖耐受性,结合蛋白)。可能需要调整剂量的甲状腺激素。

不良反应(补):
子宫不规则出血,恶心,mastodynia,头痛,痤疮,性欲降低,水肿,黄褐斑,高血糖,高甘油三酯血症,抑郁症,体重变化,其他的(见文献)。增加胆囊疾病,血栓栓塞疾病的危险。

如何提供:
掌柜- 2(2 ×91天周期)

最后更新:
2009年5月22日

Manufacturer:

Duramed Pharmaceuticals, Inc.

Pharmacological Class:

Combination extended-cycle oral contraceptive (progestin + estrogen)

Active Ingredient(s):

Levonorgestrel 0.1mg + ethinyl estradiol 20micrograms (84 orange tabs); ethinyl estradiol 10micrograms (7 yellow tabs

Indication(s):

Oral contraception.

Pharmacology:

Combination oral contraceptives work by suppressing ovulation and possibly by causing cervical and endometrial changes that reduce the likelihood of implantation. Extended-cycle oral contraceptives offer the convenience of only four planned menses, each lasting about 2–3 days, per year. However, unscheduled bleeding and/or spotting may occur, particularly in the first few cycles. This tends to diminish over time.

Clinical Trials:

A 12-month, open-label trial was conducted to assess the safety and efficacy of LoSeasonique in the prevention of pregnancy. There was no exclusion for body mass index or weight, and the weight range for the 2,185 subjects was 87–381 pounds. The pregnancy rate in women 18 to 35 years of age was 2.74 pregnancies per 100 women-years, including women who did not take the drug correctly.

Legal Classification:

Rx

Adults:

1 tab daily for 91 days; repeat. Take at the same time daily. Use Sunday start for 1st cycle; use backup method until orange tabs are taken for 7 consecutive days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle. Use backup method if 2 consecutive orange tabs are missed (see literature).

Children:

Premenarchal: not recommended.

Contraindication(s):

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, hypertension or diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy (Cat.X).

Warnings/Precautions:

Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Nursing mothers: not recommended.

Interaction(s):

May be antagonized by CPY3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be affected by protease inhibitors. May antagonize lamotrigine. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

Adverse Reaction(s):

Irregular uterine bleeding, nausea, mastodynia, headache, acne, decreased libido, fluid retention, melasma, hyperglycemia, hypertriglyceridemia, depression, weight changes; others (see literature). Increased risk of gallbladder disease, thromboembolic disorders.

How Supplied:

Dispensers—2 (2 X 91 day cycles)

责任编辑:admin


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