制造商：
拜耳医药保健
药理分类：
口服避孕药（孕激素+雌激素）
活性成分（补）：
戊酸雌二醇3毫克（2片）; dienogest 2毫克+戊酸雌二醇2毫克（5片）; dienogest 3毫克+戊酸雌二醇2毫克（17片）;戊酸雌二醇1毫克（2片），惰性（2片）。
指示（补）：
口服避孕药。
药理作用：
商品名Natazia是复方口服避孕药（COC）的，它包含的雌激素戊酸雌二醇和孕激素dienogest。这主要通过抑制排卵，也导致宫颈粘液和子宫内膜的变化，减少了植入式避孕的作品的可能性。
戊酸雌二醇转换由肝脏17β-雌二醇，这是进一步转化为雌二醇，雌酮和其他代谢产物。 Dienogest是一家具有19 nortestosterone衍生物的一些性质以及这些孕激素黄体酮的衍生物。
临床试验：
的安全性和疗效的商品名Natazia在两个多中心评估，开放标签，单臂临床试验：在北美，涉及490人18-35岁的受试者治疗达28次，并在欧洲18个学科之一，涉及1377 -50岁的处理20个周期。
珍珠指数是主要的疗效指标用于评估的避孕可靠性，并在这两个假设所有科目在怀孕风险周期的所有药物，除非备用避孕曾记载，每项研究进行评估。珍珠指数是根据怀孕，经过治疗初期发生，并在最后的药丸后7天的摄入量。在北美研究，珠江指数为1.64，而避孕失败率是0.016。为在18-35岁年龄组欧洲研究，珠江指数为1.04，而避孕失败率是0.010。
法律分类：
接收
成人：
体重指数> 30kg/m2：没有足够的数据。 1选项卡为28天;重复。使用第一天开始，用9天的第一非激素备份方法。不要跳过剂量或延迟剂量> 12小时。切换从其它的方法：见文献。
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。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。抑郁症。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。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）：
头痛，不规则子宫出血，mastodynia，胃肠不适，痤疮，体重增加，高血压，短暂的延迟排卵，停药后，水肿，黄褐斑。增加胆囊疾病，血栓栓塞疾病的危险。
如何提供：
制表- 84（3包）
额外的病人信息：
以每天在同一时间，以正确的顺序。错过丸，或如果采取12小时或更晚，或者呕吐或腹泻后发生在4小时内采取积极的片剂，或合并药物相互作用：使用备份避孕措施（见文献）。
最后更新：
二○一○年十二月一十四日
Manufacturer:
Bayer HealthCare
Pharmacological Class:
Oral contraceptive (progestin + estrogen)
Active Ingredient(s):
Estradiol valerate 3mg (2 tabs); dienogest 2mg + estradiol valerate 2mg (5 tabs); dienogest 3mg + estradiol valerate 2mg (17 tabs); estradiol valerate 1mg (2 tabs); inert (2 tabs).
Indication(s):
Oral contraception.
Pharmacology:
Natazia is a combined oral contraceptive (COC) that contains estradiol valerate as the estrogen and dienogest as the progestin. This type of contraceptive works primarily by suppressing ovulation and also by causing changes in cervical mucus and the endometrium, reducing the likelihood of implantation.
Estradiol valerate is converted by the liver to 17β-estradiol, which is further converted to estradiol, estrone, and other metabolites. Dienogest is a progestin with some properties of 19-nortestosterone derivatives as well as those of progesterone derivatives.
Clinical Trials:
The safety and efficacy of Natazia was evaluated in two multicenter, open-label, single-arm clinical trials: one in North America involving 490 subjects 18–35 years of age treated for up to 28 cycles, and one in Europe involving 1377 subjects 18–50 years of age treated for 20 cycles.
The Pearl Index was the primary efficacy endpoint used to assess contraceptive reliability and was assessed in each of the two studies assuming all subjects were at risk of pregnancy in all medication cycles unless back-up contraception was documented. The Pearl Index was based on pregnancies that occurred after the onset of treatment and within 7 days after the last pill intake. In the North American study, the Pearl Index was 1.64, and the contraceptive failure rate was 0.016. For the European study in the 18–35 year age group, the Pearl Index was 1.04, and the contraceptive failure rate was 0.010.
Legal Classification:
Rx
Adults:
BMI >30kg/m2: insufficient data. 1 tab daily for 28 days; repeat. Use Day 1 start; use non-hormonal backup method for first 9 days. Do not skip doses or delay dose >12 hours. Switching from other methods: see literature.
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. 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. Depression. 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 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. 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):
Headache, irregular uterine bleeding, mastodynia, GI upset, acne, increased weight; hypertension, transient delay of ovulation after discontinuation, edema, chloasma. Increased risk of gallbladder disease, thromboembolic disorders.
How Supplied:
Tabs—84 (3 packs)
Additional Patient Information:
Take at the same time daily, in the correct order. Missed pills, or if taken late by 12 hours or more, or if vomiting or diarrhea occurs within 4 hours after taking an active tablet, or concomitant interacting drug: use backup contraceptive measure (see literature).