Lybrel — 第一个低剂量复合口服避孕药获美国FDA批准 全球著名制药公司惠氏制药有限公司近日宣布，美国食品药物管理局(FDA)已经批准该公司生产的口服避孕药Lybrel(90 mcg左炔诺孕酮/20 mcg炔雌醇)片剂，用于选择口服避孕药且对此种避孕方法没有禁忌的女性避孕。Lybrel是第一个也是目前唯一一个可以一年365天服用的低剂量复合避孕药，无需安慰剂阶段或者停药期。该药物为处方药，预计于2007年7月在美国上市。 Lybrel主要面向那些希望避孕并且能够自主控制月经周期的女性。Lybrel提供稳定的低剂量激素，从而使女性可长期避免月经周期。考虑服用Lybrel的女性应该了解，大多数临床试验对象出现过一些不规则出血和点状出血的现象，特别是在服药的前三到六个月。经研究分析，Lybrel不会推迟生育能力的恢复，也不会影响月经的恢复。 作为其上市后承诺的一部分，惠氏还将在服用Lybrel与服用含有20mcg炔雌醇周期性口服避孕药的女性之间进行血栓栓塞的对比试验研究. 惠氏制药女性健康护理部副总裁、医学博士Ginger Constantine称“对于那些选择避孕并且希望自主控制月经周期的女性来说，Lybrel可以是一个合适的选择。” 安全性与有效性研究 一项涉及2457名女性的全球临床试验证明了Lybrel的效果。与FDA批准的其他口服避孕药相比， Lybrel具有同样的避孕效果。试验评估了服用中出现的不规则出血和点状出血，结果显示这些症状随着时间推移而减少。在临床试验中，出血模式分为两类：一类是不规则出血，需使用卫生巾；另一类为点状出血，不需使用卫生巾。共有860名女性达到评估标准并完成了13板药片的服用。在服用13板药片(28天间隔)中： ● 59%女性没有出现月经症状(即未出现出血和点状出血)； ● 20%女性仅出现点状出血，无需使用卫生巾； ● 21%女性出现不规则性出血，需使用卫生巾。 Lybrel安全性与有效性的试验结果，已经在2006年12月份《避孕》期刊刊登。 在临床试验中，Lybrel严重副作用的发生率非常低，与FDA批准的其他口服避孕药相似。在服用Lybrel时，有可能出现不规则出血或者点状出血。但是，免于停经带来的便利要远远超过不规则出血或者点状出血所带来的不便。 由于服用Lybrel不会出现周期性的每月出血，因此很难发现意外怀孕。如果服用者怀疑有可能怀孕或已出现怀孕症状，如恶心、呕吐或者异常乳房胀痛，应进行怀孕检查并联系专业医疗人士。 口服避孕药并不适合所有女性。大部分副作用并不严重，严重的副作用也很少出现。所有控制生育的药物有可能产生的严重风险包括发生血栓、中风、心脏病等可危及生命的症状。这些风险在吸烟女性，尤其是35岁以上的吸烟女性中会有所提高。服用口服避孕药的女性不应吸烟。部分女性不应服用口服避孕药，尤其是患有心脏病、血栓、某些癌症或者肝病、原因不明的阴道出血以及怀孕或者可能怀孕的女性。同时，口服避孕药也并不能预防HIV感染(AIDS)或者性传播疾病。 Learn more about usage, cautions, and possible side effects . Disp Pack Chemical Name: LEVONORGESTREL (LEE-voe-nor-jess-trel) and ETHINYL ESTRADIOL (ETH-in-il ess-tra-DYE-ole) Common uses This medicine is an extended-cycle contraceptive pill (birth control pill) containing a progestin and an estrogen. This medicine is used topreventpregnancy. It may be used to treat other conditions as determined by your doctor. Before using WARNING: SMOKING CIGARETTES WHILE USING THIS MEDICINE INCREASES YOUR CHANCE OF HAVING SERIOUS HEART PROBLEMS. DO NOT SMOKE WHILE USING THIS MEDICINE. The risk of heart problems increases with age and with frequent smoking. Women older than 35 years of age and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. AN ADDITIONAL FORM OF BIRTH CONTROL (such as condoms) may be needed if you are also taking azole antifungal medicines (such as ketoconazole or itraconazole), aprepitant, bosentan, barbiturates (such as phenobarbital), carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (such as ritonavir), hydantoins (such as phenytoin), modafinil, nevirapine, oxcarbazepine, penicillin antibiotics (such as ampicillin), phenylbutazone, primidone, rifabutin, rifampin, tetracycline antibiotics (such as doxycycline), topiramate, troglitazone, or St. John's wort. An increased risk of pregnancy has been identified when taking these medicines with birth-control pills. Check with your doctor or pharmacist for more information. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking beta-blockers(such as metoprolol or carvedilol), corticosteroids (such as prednisolone), lamotrigine, theophylline, tizanidine, or troleandomycin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a history of abnormal mammogram, blood or bleeding problems (such as blood in the urine), breast problems(such as lumps or fibrocystic disease), chorea (jerky, involuntary movements of the face, arms, or legs), diabetes or high blood sugar, endometriosis, gallbladder problems, growths in the uterus, irregular menstrual periods, lupus, mental or mood problems (such as depression), persistent headaches or migraines, heart problems, high blood calcium levels, high cholesterol or triglyceride levels in the blood, high blood pressure, kidney or liver problems, obesity, pancreas problems, recent surgery, seizures, swelling problems, tobacco use, varicose veins, yellowing of the eyes or skin, allergies, pregnancy, breast-feeding, or if a family member has had breast cancer. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of blood clots (such as clots in the lungs, legs, or eyes); certain blood problems (such as porphyria); breast, endometrial, cervical, or vaginal cancer; certain heart problems (such as heart valve problems or irregular heartbeat); chest pain caused by angina; blood vessel problems (such as bleeding in the brain, heart attack, or stroke); certain types of severe headaches; diabetes that affects circulation; estrogen-dependent growths; active liver disease; liver tumors; uncontrolled high blood pressure; abnormal or undiagnosed vaginal bleeding; if you have given birth within the last 4 weeks; if you have had surgery and will be confined to a bed or chair for an extended period of time; or if you have a history of yellowing of the eyes or skin caused by pregnancy or prior hormonal contraceptive use. USE OF THIS MEDICINE IN CHILDREN who have not yet had their first menstrual period is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine. Directions Follow the directions for using this medicine provided by your doctor. THIS MEDICINE COMES with an additional patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about using this medicine. If stomach upset occurs, take this medicine with food to reduce stomach irritation. DO NOT REMOVE THE TABLET from the blister packaging until you are ready to take this medicine. BEGIN TAKING THIS MEDICINE during the first 24 hours of your period, unless otherwise directed by your doctor. TRY TO TAKE THIS MEDICINE at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day. IF YOU ARE SWITCHING FROM ANOTHER FORM OF HORMONAL BIRTH CONTROL TO THIS MEDICINE, be sure you know when you should start taking this medicine. Check with your doctor if you have any questions. BLEEDING OR SPOTTING may occur while taking this medicine. DO NOT STOP taking this medicine if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C), away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. FOR THIS MEDICINE TO BE EFFECTIVE IT MUST BE TAKEN EVERY DAY. Do not skip doses even if you are spotting, bleeding or nauseous, or even if you do not have sex very often. Check with your doctor if you have these side effects. IF YOU VOMIT WITHIN 4 HOURS OF TAKING THIS MEDICINE, followthedirections for what to do if you miss a pill. IF YOU MISS 1 DOSE OF THIS MEDICINE, TAKE IT AS SOON AS YOU REMEMBER. Take your next dose at the regular time. This means you may take 2 doses on the same day. IF YOU MISS MORE THAN 1 DOSE OF THIS MEDICINE, read the extra patient information leaflet that comes with this medicine or contact your doctor for instructions. IF YOU MISS 1 OR MORE DOSES OF THIS MEDICINE, you must use a backup form of birth control for 7 days after you start to take it again. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor. Cautions DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in the product. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure laboratory personnel and your doctors know you use this medicine. Laboratory and/or medical tests, including breast exams, Pap tests, physicals, and blood pressure may be performed to monitor your progress. EXAMINE YOUR BREASTS MONTHLY AS DIRECTED BY YOUR DOCTOR, and report any lumps immediately. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. If you will be having surgery or will be confined to a chair or bed for a long period of time (e.g., a long plane flight), notify your doctor 4 weeks beforehand. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. YOU COULD BECOME PREGNANT IF YOU MISS 2 OR MORE DOSES OF THIS MEDICINE or if you start the pack later than the proper day. If you have sex, you must use another form of birth control as a backup (eg, condoms) during the days that you miss doses and for the first 7 days after you begin to take it again. Talk with you doctor for more information. IF YOUR PERIOD DOES NOT COME when expected, or if you experience unusual breast tenderness or symptoms of morning sickness, call your doctor immediately. DO NOT SMOKE OR USE OTHER TOBACCO PRODUCTS while using this medicine. IF YOU WEAR CONTACT LENSES and you develop problems with them or with your vision, contact your doctor. THIS MEDICINE MAY CAUSE dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. You may experience a delay in being able to become pregnant after stopping this medicine. Check with your doctor if you have any concerns. THE EFFECTIVESS OF THIS MEDICINE may be decreased by certain medicines or conditions (such as antibiotics, medicines for seizures, St. John's wort, or prolonged vomiting or diarrhea). If any of these apply to you and you have sex, use an additional form of birth control to prevent pregnancy. If you have any questions, contact your doctor, nurse, or pharmacist. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while you are taking this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. Possible side effects SIDE EFFECTS that may occur while you are taking this medicine include breast tenderness, changes in appetite, dizziness, headache, mild hair loss, nausea, nervousness, vaginal spotting or breakthrough bleeding, vomiting, or weight gain. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience change in the amount of urine produced; persistent vaginal spotting; persistent, severe, or recurring headache or dizziness; swelling of fingers, hands, legs, or ankles; or vaginal irritation, discharge, or odor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (such as depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden severe headache or vomiting; unusual or severe vaginal bleeding; unusual tiredness or weakness; vision changes (such as sudden vision loss, double vision); or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. Drug interactions Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions If you take too much If overdose is suspected contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe dizziness, nausea, or vomiting; stomach pain; unusual drowsiness or tiredness; or unusual vaginal bleeding. Additional information USE OF THIS MEDICINE WILL NOT PREVENT the spread of sexually transmitted diseases (STDs) including HIV. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. 附件: 20082905294212.pdf    ------------------------------------------------------ 产地国家: 美国 原产地英文商品名: LYBREL DISP PACK 90-20mcg/Tablet 28Tablets/box 原产地英文药品名: LEVONORGESTREL/ETHINYL ESTRADIOL 中文参考商品译名: 利雷博尔板装 90-20微克/片 28片/盒 中文参考药品译名: 左炔诺孕酮/炔雌醇 生产厂家中文参考译名: 美国惠氏 生产厂家英文名: Wyeth 该药品相关信息网址1: http://www.Lybrel.com/