Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive age to prevent pregnancy.

• A high risk of arterial or venous thrombotic diseases ( 4 )
• Undiagnosed abnormal uterine bleeding ( 4 )
• Breast cancer ( 4 )
• Liver tumors or liver disease ( 4 )
• Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions:
• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )]. o Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ( 5.1 )]. o Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )]. o Have coronary artery disease [see Warnings and Precautions ( 5.1 )]. o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )]. o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )]. o Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions ( 5.5 )]. o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions ( 5.7 )]. o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see Warnings and Precautions ( 5.8 )].
• Current diagnosis of, or history of, breast cancer, which may be hormone sensitive [see Warnings and Precautions (5.11 )].