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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 >> 避孕药类 >> LO LOESTRIN FE(复方口服避孕药)

LO LOESTRIN FE(复方口服避孕药)

2011-05-22 10:03:57  作者:新特药房  来源:中国新特药网天津分站  浏览次数:965  文字大小:【】【】【
简介: LO LOESTRIN FE(复方口服避孕药)制造商: 华纳奇尔科特实验室 药理分类: 孕激素+雌激素。 活性成分(补): 醋酸炔诺酮1毫克,炔雌醇10mcg(24片),炔雌醇(2片)雌二醇10mcg;惰性+(2片); ...

LO LOESTRIN FE(复方口服避孕药)
制造商:

华纳奇尔科特实验室

药理分类:
孕激素+雌激素。

活性成分(补):
醋酸炔诺酮1毫克,炔雌醇10mcg(24片),炔雌醇(2片)雌二醇10mcg;惰性+(2片); +含有富马酸亚铁75毫克。
指示(补):
口服避孕药。

药理作用:
复方口服避孕药减少成为主要通过抑制排卵怀孕的危险。在子宫内膜和宫颈黏液变化可能发挥的作用以及在减少注入的可能性。

临床试验:
一个为期一年的,多中心,开放标签试验进行评估在预防怀孕本产品的功效。这项研究包括1270女性18-35岁,完成了12482暴露评估的周期相同。身体质量指数超过35kg/m2(BMI)的患者被排除在外。妊娠率(珍珠指数)为2.92,每100名妇女,使用,其中包括从这些妇女谁没有采取正确的药物数据年怀孕。

法律分类:
接收

成人:
1选项卡为28天;重复。以每天在同一时间,以正确的顺序。开始第一天的月经周期。允许产后至少4周,如果不是母乳喂养,开始循环;为第7天使用备份的方法。

儿童:
Premenarchal:不适用。

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,糖尿病血管病变,局灶性神经系统症状,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。未确诊的子宫异常出血。妊娠(Cat.X)。

警告/注意事项:
不适合女性使用的体重指数> 35kg/m2。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。胆囊疾病。糖尿病。糖尿病前期。不受控制的高脂血症。高甘油三酯血症。妊娠有关的胆汁淤积。抑郁症。评估重大变化,头痛,不规则子宫出血,闭经。监测血压。定期做完整的身体检查。哺乳母亲:不推荐。

互动(补):
可拮抗酶CYP3A4的诱导剂或其他(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,NNRTIs,阿托伐他汀对乙酰氨基酚,抗坏血酸,伊曲康唑,酮康唑。拉莫三嗪可拮抗。可能会影响实验室检查(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):
头痛,恶心,呕吐,出血不规则,痛经,体重改变,mastodynia,痤疮,腹痛,焦虑,抑郁,血管性水肿,黄褐斑,其他(见文献)。

如何提供:
包- 5

LO LOESTRIN FE

Manufacturer:

Warner Chilcott Laboratories

Pharmacological Class:

Progestin + estrogen.

Active Ingredient(s):

Norethindrone acetate 1mg, ethinyl estradiol 10mcg (24 tabs), ethinyl estradiol 10mcg (2 tabs); inert+ (2 tabs); +contains ferrous fumarate 75mg.

Indication(s):

Oral contraception.

Pharmacology:

Combination oral contraceptives reduce the risk of becoming pregnant primarily by the suppression of ovulation. Changes in the endometrium and cervical mucus may play a role as well in reducing the likelihood of implantation.

Clinical Trials:

A one-year, multicenter, open-label trial was conducted to assess the efficacy of this product in the prevention of pregnancy. The study included 1,270 women 18–35 years of age, completing the equivalent of 12,482 evaluable cycles of exposure. Patients with a body mass index (BMI) over 35kg/m2 were excluded. The pregnancy rate (Pearl Index) was 2.92 pregnancies per 100 women-years of use, which included data from those women who did not take the drug correctly.

Legal Classification:

Rx

Adults:

1 tab daily for 28 days; repeat. Take at the same time daily, in the correct order. Start Day 1 of menstrual cycle. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle; use backup method for first 7 days.

Children:

Premenarchal: not applicable.

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, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy (Cat.X).

Warnings/Precautions:

Not for use in women with BMI >35kg/m2. 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. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Pregnancy-related cholestasis. Depression. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Do regular complete physical exams. Nursing mothers: not recommended.

Interaction(s):

May be antagonized by CYP3A4 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, NNRTIs, atorvastatin, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

Adverse Reaction(s):

Headache, nausea, vomiting, bleeding irregularities, dysmenorrhea, weight change, mastodynia, acne, abdominal pain, anxiety, depression; angioedema, chloasma, others (see literature).

How Supplied:

Packs—5

Last Updated:

5/18/2011

责任编辑:admin


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