英文药名: Loestrin 24 Fe (Norethindrone/Ethinyl Estradiol/Ferrous Fumarate Birth Control Pills)

中文药名: 炔诺酮~炔雌醇~富马酸亚铁避孕药

生产厂家: Warner Chilcott Laboratories

药品简介

美国FDA批准了Warner Chilcott公司的避孕药Loestrin 24 Fe上市，其包括了两种片剂，一种片剂含有醋酸炔诺酮与乙炔雌二醇，一种为延胡索酸铁片。
这是美国批准的一种新的用药方案，Loestrin 24 Fe需连续服用24天的醋酸炔诺酮与乙炔雌二醇片，之后服用4天的延胡索酸铁片。

LOESTRIN 24 iron is a combination birth control pills, estrogen and progesterone composition. Like all birth control pills, hormone in LOESTRIN 24 iron block by inhibiting ovulation (the egg maturation and release of) pregnancy. They also change the uterine lining and the thickness of cervical mucus, making it more difficult for the fertilized egg implanted in the uterus, the sperm to reach goals.

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Oral contraceptives, also known as "birth control pills" or "the pill", are taken to prevent pregnancy, and when taken correctly without missing any pills, have a failure rate of about 1% per year (1 pregnancy per 100 women per year of use). The typical failure rate of pill users is 5% (5 pregnancies per 100 women per year of use) when women who miss pills are included.

For the majority of women, oral contraceptives can be taken safely. But for some women oral contraceptive use is associated with certain serious medical problems that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you:

Smoke
Have high blood pressure, diabetes, high cholesterol, or are obese
Have or have had clotting disorders, heart attack, stroke, angina pectoris (severe chest pains), cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors
You should not take the pill if you are pregnant or have unexplained vaginal bleeding.

Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.

Most side effects of the pill are not serious. The most common are nausea, vomiting, bleeding or spotting between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may decrease or subside within the first three months of use.

The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill:

1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris), or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Women with migraine headaches also may be at increased risk of stroke when taking the pill.

2. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.

3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

The symptoms associated with these serious side effects are discussed in the DETAILED PATIENT INFORMATION leaflet given to you with your supply of pills. Notify your healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, and herbal preparations containing St. John's Wort (hypericum perforatum), may decrease oral contraceptive effectiveness.

Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use the pill. This very small increase in the number of breast cancer diagnoses gradually disappears during the 10 years after stopping use of the pill. It is not known whether the difference is caused by the pill. It may be that women taking the pill are examined more often, so that breast cancer is more likely to be detected. You should have regular breast examinations by a healthcare provider and examine your own breasts monthly. Tell your healthcare provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use hormonal contraceptives because breast cancer is usually a hormone-sensitive tumor.

Some studies have found an increase in the incidence of cancer or precancerous lesions of the cervix in women who use the pill. However, this finding may be related to factors other than the use of the pill.

Taking the combination pill provides some important noncontraceptive health benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The DETAILED PATIENT INFORMATION leaflet gives you further information which you should read and discuss with your healthcare provider.

DOSAGE AND ADMINISTRATION

HOW TO TAKE Loestrin 24 Fe

IMPORTANT POINTS TO REMEMBER

BEFORE YOU START TAKING YOUR PILLS:

BE SURE TO READ THESE DIRECTIONS:
Before you start taking your pills
Anytime you are not sure what to do
TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH WHILE TAKING THE FIRST 1 to 3 PACKS OF PILLS.If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even if you take these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
IF YOU HAVE VOMITING (within 3 to 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE CERTAIN MEDICINES, including some antibiotics, or the herbal supplement St. John's Wort, your pills may not work as well. Use a back-up method of birth control (such as condoms or spermicide) until you check with your healthcare provider.
IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare provider