Ethinyl Estradiol And Levonorgestrel

1. INDICATIONS AND USAGE AMETHIA tablets are indicated for use by women to prevent pregnancy. AMETHIA tablets are an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 )

6. ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and smoking [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (≥5%) in clinical trials for levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets are irregular and/or heavy uterine bleeding, weight gain, and acne. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma. at 1-844 -825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. 5. WARNINGS AND PRECAUTIONS Vascular risks: Stop AMETHIA tablets if a thrombotic event occurs. Stop AMETHIA tablets at least 4 weeks before and through 2 weeks after major surgery. Start AMETHIA tablets no earlier than 4 weeks after delivery, in women who are not breastfeeding. ( 5.1 ) Liver disease: Discontinue AMETHIA tablets if jaundice occurs. ( 5.3 ) High blood pressure: Do not prescribe AMETHIA tablets for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.5 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking AMETHIA tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemias. ( 5.7 ) Headache: Evaluate significant change in headaches and discontinue AMETHIA tablets if indicated. 4. CONTRAINDICATIONS AMETHIA 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: ­Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] .