药品信息:
--------------------------------------------------------------- 部分中文Amethia® Lo处方资料(仅供参考) ---------------------------------------------------------------
美国:华生推出LoSEASONIQUE(R)仿制药 元培产业情报:华生公司当日宣称,根据与梯瓦制药工业有限公司(Teva Pharmaceutical Industries Ltd)(TEVA)(以下简称“梯瓦制药”)女性健康部门达成的协议,将推出Amethia® Lo药片。
Amethia® Lo药片的成分为左炔诺孕酮/炔雌醇(0.1 mg /0.02 mg)和炔雌醇(0.01 mg),是梯瓦制药公司女性健康部门避孕药LoSEASONIQUE®的仿制药。避孕药一般指口服避孕药,有女性口服避孕药和男性口服避孕药。它的避孕原理主要是通过抑制排卵,并改变子宫颈黏液,使精子不易穿透,或使子宫腺体减少肝糖的制造,让囊胚不易存活,或是改变子宫和输卵管的活动方式,阻碍受精卵的运送。使精卵无法结合形成受精卵,从而达到避孕目的的一种药物。
据悉,华生将获得为期180天的市场专有权,其他交易细节未公开,根据艾美仕市场信息调查数据显示:截至2011年9月30日的12个月内,LoSEASONIQUE®的销售额达2.8亿美元。
华生公司是一家综合的全球性专业制药公司,专业从事泌尿外科和妇女健康为重点非专利药品的研发,制造,营销和分销。华生的业务遍布全球多个已有及新兴市场。
Amethia Lo Amethia Lo is an extended-cycle oral contraceptive used to help prevent pregnancy. This birth control pill allows women to only have a period once every three months with a low level of hormones. It is a generic version of LoSeasonique, and works by stopping ovulation, altering the cervical mucus, and changing the lining of the uterus. Side effects include nausea, headaches, and back pain.
What Is Amethia Lo? Amethia™ Lo (levonorgestrel/ethinyl estradiol) is an oral contraceptive, commonly known as a birth control pill. It is a generic version of LoSeasonique®. Amethia Lo is a low-dose, extended-cycle oral contraceptive. With Amethia Lo, you will get your period once every three months (four times a year) with a low level of hormones. (Click What Is Amethia Lo Used For? for more information on what this medication is used for, including possible off-label uses.) Are There Side Effects? Just like any medicine, Amethia Lo may cause side effects. However, not everyone who takes the contraceptive will experience problems. In fact, most women tolerate it quite well. If reactions do occur, in most cases, they are minor and either require no treatment or are treated easily by you or your healthcare provider. Serious side effects are less common. Common side effects of Amethia Lo include but are not limited to: •Painful menstrual periods •Nausea •Headaches •Irregular or heavy uterine bleeding •Vomiting •Back pain. (Click Amethia Lo Side Effects to learn more, including potentially serious side effects you should report immediately to your healthcare provider.)
Important Information for Your Healthcare Provider You should talk with your healthcare provider prior to taking this contraceptive if you have: •High blood pressure (hypertension) •Diabetes •Migraines •Cancer (or if you have had cancer in the past) •A history of blood clots or a clotting disorder •Chest pain •A history of a heart attack or stroke •Liver disease, such as liver failure, cirrhosis, hepatitis, or liver tumors •Problems with your heart valves •Kidney disease, such as kidney failure (renal failure) •An irregular heart rhythm (arrhythmia) •Yellowing of the whites of the eyes or skin (jaundice) during a prior pregnancy or oral contraceptive use •Gallbladder disease •High cholesterol •Depression •Unexplained vaginal bleeding •Any allergies, including to foods, dyes, or preservatives. Also, let your healthcare provider know if you: •Are obese •Have an upcoming surgery •Smoke cigarettes •Are pregnant or thinking of becoming pregnant (see LoSeasonique and Pregnancy) •Are breastfeeding (see LoSeasonique and Breastfeeding). Make sure to tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements. (Click Precautions and Warnings With Amethia Lo to learn more, including information on who should not take this drug.)
How Does Amethia Lo Work? Amethia Lo belongs to a group of medications known as combined oral contraceptives. These birth control pills contain a combination of a progestin (levonorgestrel) and an estrogen (ethinyl estradiol). Combined oral contraceptives are the most commonly used type of birth control pill. In general, they are more effective than progestin-only birth control pills. Amethia Lo primarily prevents pregnancy by stopping ovulation (the maturation and release of eggs from the ovaries). However, it also prevents pregnancy in two other, minor ways. It alters the cervical mucus (the fluid of the cervix, which is the lower, narrow part of the uterus that is connected to the vagina), making it more difficult for sperm to enter the uterus. It also alters the lining of the uterus (the endometrium), making it less receptive to an embryo. With Amethia Lo, the hormone tablets are taken for 84 days, rather than the usual 21 days with most birth control pills. This allows for less frequent periods. There is no reason women need to have a monthly period while taking birth control pills. In fact, the "period" you experience while taking birth control pills isn't really a period at all. Because ovulation does not occur, the body does not prepare for a possible pregnancy by building up the lining of the uterus, so there is no need to shed the lining, as with a regular period. Instead, the "period" that occurs due to birth control pills is actually caused by a withdrawal of the hormones in the pills, which causes bleeding. When and How to Use It Some general considerations to keep in mind during treatment with Amethia Lo include the following: •Amethia Lo comes in tablet form. It is taken by mouth once a day. •You can take this medication with or without food. If it seems to bother your stomach, try taking the pills with food. •Each pack of Amethia Lo contains 91 pills. Make sure to take them in order. Once you finish a pack, start a new one the next day. You will probably start your period during the last seven days of the pack. •It is normal to experience breakthrough bleeding or spotting between periods while taking Amethia Lo. Keep taking the tablets as normal. •It is important to take Amethia Lo every day, at the same time each day. Try to pick a time that will be easy to remember, such as at bedtime or breakfast. If you have trouble remembering, please talk with your healthcare provider, as missing pills increases your risk of pregnancy. •Make sure you know exactly what to do if you miss any pills. In some circumstances, you may need to use a backup method of contraception, such as condoms, for seven days. •For the medication to work properly, it must be taken as prescribed.
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