High blood pressure-Women with well-controlled hypertension should be monitored closely.Hepatic adenomas and very rare hepatocellular carcinomas are associated with long-term (>8 years) of COC use. Liver disease-Discontinue COCs if jaundice develops.Carcinoma of the breast and cervix-Women with current or past history of breast cancer should not use COCs because breast cancer is a hormonally-sensitive tumor.Combined oral contraceptives should be used with caution in women with cardiovascular risk factors. Start COCs no earlier than 4 weeks after delivery, in women who are not breastfeeding. Thrombotic and other vascular events-Stop COCs if an arterial or venous thrombotic event occurs, or 4 weeks before through 2 weeks after major surgery or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (evaluate for retinal thrombosis immediately).Use hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.Pregnancy, because there is no reason to use COCs during pregnancy.Liver tumors, benign or malignant, or liver disease.Have headaches with focal neurological symptoms or migraine headaches with aura or women over age 35 with any migraine headaches.Have diabetes mellitus with vascular disease.Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation).Have inherited or acquired hypercoagulopathies.Have deep vein thrombosis or pulmonary embolism, now or in the past.A high risk of arterial or venous thrombotic diseases.For this reason, combination oral contraceptives, including Aubra EQ, Chateal EQ, Cyred EQ, Tarina Fe 1/20 EQ, Tri-VyLibra, Tri-VyLibra Lo, and VyLibra should not be used by women who are over 35 years of age and smoke.Ĭonsult the Package Insert or click below for Complete Prescribing Information:ĭo not prescribe COCs to women who are known to have the following conditions: This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTSĬigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra is indicated for use by females of reproductive potential to prevent pregnancy. IMPORTANT SAFETY INFORMATION for Aubra EQ ® (levonorgestrel and ethinyl estradiol tablets, USP 0.1 mg/0.02 mg), Chateal EQ ® (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Cyred EQ ® (desogestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Tarina Fe 1/20 EQ ® (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, 1.0 mg/20 mcg and 75 mg), Tri-VyLibra ® (norgestimate and ethinyl estradiol tablets, USP 0.180 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.250 mg/0.035 mg), Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol tablets, USP 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg), and VyLibra ® (norgestimate and ethinyl estradiol tablets, USP 0.250 mg/0.035 mg) 1-7 INDICATIONSĪubra EQ, Chateal EQ, Cyred EQ, Tarina Fe 1/20 EQ, Tri-VyLibra Lo, and VyLibra are indicated for use by females of reproductive potential to prevent pregnancy.