NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

AbsorptionEthinyl estradiol and norethindrone are rapidly absorbed with maximum plasma concentrations occurring within 2 hours after norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets administration (see Table 1 ). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first-pass metabolism resulting in an absolute bioavailability of approximately 65 percent. Large intersubject variability is refl...

The data presented in Section 14 are from a clinical trial conducted with norethindrone 0.4 mg/ethinyl estradiol 35 mcg tablets. Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are bioequivalent to these norethindrone acetate/ethinyl estradiol tablets. In a multicenter open-label clinical trial, 1,970 women, 98% of whom were 16 to 39 years of age, were studied for up to 31 cycles (28 days per cycle) to assess the efficacy of norethindrone /ethinyl estradiol tablets, completing the equivalent of 20,230 cycles of exposure. The racial demographi...

6.2 Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC...

4. CONTRA IN DIC A TIONS Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg is 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) ] ▪ Have deep vein thrombosis or pulmonar...

Thrombotic Disorders and Other Vascular Problems: Stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if jaundice occurs ( 5.2 ) High b...

7. DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of ...