HAILEY 24 FE

AbsorptionNorethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, because the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate and ethinyl estradiol are rapidly absorbed from norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol occurring 1 to 4 hours postdo...

In an active-controlled clinical trial, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, for up to six 28-day cycles. The racial demographic of women randomized to norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets was: 69.5% Caucasian, 15.5% African-American, 10.4% Hispanic, 2.3% Asian and 2.3% Native American/Other. Women with body mass index (BMI) greater than 35 mg/m 2 were excluded from the study. The weight range for those women treated was 90 to 260 pound...

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 (≥ 2%) were: headache, vagi...

Hailey 24 Fe 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 pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )]
• Have inh...

• Thrombotic Disorders and Other Vascular Problems: Stop Hailey 24 Fe 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 Hailey 24 Fe if jaundice occurs. ( 5.2 )
• High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Hailey 24 Fe if blood pressure rises significantly. ( 5.4 )
• Carbo...

7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with oral contraceptives or the potential for enzyme alterations.

• Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of c...