Norethindrone Acetate And Ethinyl Estradiol Tablets And Ferrous Fumarate Tablets

1 INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is an estrogen/progestin COC indicated for use by women to prevent pregnancy ( 1 ) The efficacy in women with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast Tenderness Headache The most common adverse reactions in clinical trials (greater than or equal to 2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.

8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. 5 WARNINGS AND PRECAUTIONS Vascular risks: Stop norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 ) Liver disease: Discontinue if jaundice occurs ( 5.2 ) High blood pressure: Do not prescribe for women with uncontrolled hypertension or hypertension with vascular disease ( 5.3 ) Carbohydrate and lipid metabolic effects: monitor prediabetic and diabetic women taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets. 4 CONTRAINDICATIONS Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets, are contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases.