About the Authorized Generic of Minastrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumerate tablets)
INDICATIONS AND USAGE
The Authorized Generic of Minastrin® 24 Feis an estrogen/progestin combination oral contraceptive (COC) indicated for use by females of reproductive age to prevent pregnancy. Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
IMPORTANT SAFETY INFORMATION
the Authorized Generic of Minastrin® 24 Feis contraindicated in pregnant patients, and those with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
Warnings and Precautions
Discontinue norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.
The Authorized Generic of Minastrin® 24 Feshould not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are prediabetic or diabetic, should be monitored while using the Authorized Generic of Minastrin® 24 Fe. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients usingthe Authorized Generic of Minastrin® 24 Fewho have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.
In the clinical trial for the Authorized Generic of Minastrin® 24 Fe, the most common adverse reactions (incidence ≥2%) were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Please see full Prescribing Information, including Boxed Warning.