MIBELAS 24 FE

AbsorptionIn a single-dose, two-way, crossover clinical study conducted in 35 healthy, non-smoking premenopausal women under fasting condition, Mibelas 24 Fe tablet chewed and swallowed was bioequivalent to norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablet (24-day regimen tablets) swallowed whole based on the exposure (AUC) and peak concentration (C max ) of norethindrone and ethinyl estradiol. Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone a...

The data presented in Section 14 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Mibelas 24 Fe is bioequivalent to these norethindrone acetate/ethinyl estradiol tablets. In a clinical study, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets, for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. The racial demographic of all enrolled women was: 70% Caucasian, 16% African-American, 10% Hispanic, 2% Asian and 2% Other. Wome...

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. ( 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 labeling: ...

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

Vascular risks: Stop Mibelas 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 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 Mibelas 24 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 ) Consult the labeling of the concurrently-used drug to obtain further information about interactions with C...