KAITLIB FE (ethinyl estradiol)

AbsorptionNorethindrone and ethinyl estradiol are absorbed with maximum plasma concentrations occurring within 2 hours after Kaitlib Fe administration (see Table 1). Both are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol. The plasma norethindrone and ethinyl estradiol pharmacokinetics following single- and multiple-dose administrations of Kaitlib Fe in 17 healthy female volunteers...

14.1 Oral Contraceptive Clinical Trial In a one-year (thirteen 28-day cycles) multicenter, open-label clinical trial, 1,677 women 18 to 46 years of age were studied to assess the safety and efficacy of Kaitlib Fe. The ethnic origin of the 1,570 treated subjects who were evaluable for efficacy was: Caucasian (72.0 %), African-American (13.0 %), Hispanic (11.2 %) and Asian (1.8 %). The weight range was 74 to243 pounds with a mean weight of 148.8 pounds. Of treated women, 16.2 % were lost to follow-up, 8.9 % discontinued by withdrawing their consent and 8.5 % discontinued due to an adverse event....

The most common adverse reactions (≥ 2%) are nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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 labelin...

A high risk of arterial or venous thrombotic diseases. ( 4 ) Undiagnosed abnormal uterine bleeding. ( 4 ) Breast cancer. ( 4 ) Liver tumors or liver disease. ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Kaitlib Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) i...

Vascular risks: Stop Kaitlib Fe if a thrombotic event occurs. Stop at least 4 weeks before and 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. ( 5.3 ) High blood pressure: Do not prescribe for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.5 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Kaitlib Fe....

7 DRUG INTERACTIONS 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 contraception when enzyme inducers are used with COCs. ( 7.1 ) No drug-drug interaction studies were conducted with Kaitlib Fe. 7.1 Changes in Contraceptive Effectivene...