LARIN 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 LARIN 24 Fe tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol occurring 1 to 4 hours postdose. Both are subject to first-pass metabolism after oral dosi...

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, for up to six 28-day cycles. The racial demographic of women randomized to norethindrone acetate and ethinyl estradiol 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/m2 were excluded from the study. The weight range for those women treated was 90 to 260 pounds, with a mean weight of 147 pounds. Among the women in the...

The most common adverse reactions (≥2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 Pr...

A high risk of arterial or venous thrombotic diseases (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Breast cancer (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4) Larin 24 Fe is contraindicated in females who are known to have the following conditions: A high risk of arterial or ve...

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

7 DRUG INTERACTIONS 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 contraception when enzyme inducers are used with COCs. ( 7.1 ) Consult the labeling of concurrently used drugs to obtain further information about interactions with o...