Drug Information for Aviane - 28 DAY (levonorgestrel and ethinyl estradiol tablets, USP) (Barr Laboratories Inc.): DETAILED PATIENT LABELING

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


    Any woman who considers using oral contraceptives (the “birth-control pill” or “the pill”) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your healthcare provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your healthcare provider's advice with regard to regular check-ups while you are on the pill.


    Oral contraceptives or “birth-control pills” or “the pill” are used to prevent pregnancy and are more effective than most other nonsurgical methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is approximately 1% per year (1 pregnancy per 100 women per year of use). Typical failure rates are approximately 5% per year (5 pregnancies per 100 women per year of use) when women who miss pills are included. The chance of becoming pregnant increases with each missed pill during each 28-day cycle of use.

    In comparison, average failure rates for other methods of birth control during the first year of use are as follows:

    IUD:0.1-2%Female condom alone: 21%
    Depo-Provera® (injectable progestogen):0.3%Cervical cap
    Norplant® System (levonorgestrel implants): 0.05%Never given birth: 20%
    Diaphragm with spermicides: 20%Given birth: 40%
    Spermicides alone: 26%Periodic abstinence: 25%
    Male condom alone: 14%No methods: 85%


  • 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.

  • Drug Information Provided by National Library of Medicine (NLM).