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Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
Combination oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Combination oral contraceptives should not be used in women with any of the following conditions:
The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis. Practitioners prescribing oral contraceptives should be familiar with information relating to these risks.
Risk information described in the full Prescribing Information includes:
The most serious reactions are discussed in detail in the full product labeling and include serious cardiovascular events and smoking, vascular events and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness and headache.
To achieve maximum contraceptive effectiveness, Aubra (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours.
Reference: Aubra® prescribing information, Charleston SC USA August 2017
Please see full Prescribing Information here.