MINASTRIN 24 Fe Dosage & Rx Info

Minastrin 24 Fe Generic Name & Formulations

Legal Class

General Description

Norethindrone acetate 1mg, ethinyl estradiol 20micrograms (24 white chew tabs); inert+ (4 tabs); +contains ferrous fumarate 75mg.

Pharmacological Class

Progestin + estrogen.

How Supplied

Dispensers—5 (blister cards)

Manufacturer

AbbVie

Mechanism of Action

Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Minastrin 24 Fe Indications

Indications

Oral contraception.

Minastrin 24 Fe Dosage and Administration

Adult

Chew 1 tab daily for 28 days; repeat. Follow with 8oz of water.

Children

Premenarchal: not recommended.

Minastrin 24 Fe Contraindications

Contraindications

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or pulmonary embolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive cancer. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Minastrin 24 Fe Boxed Warnings

Not Applicable

Minastrin 24 Fe Warnings/Precautions

Warnings/Precautions

Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Cardiovascular disease. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias; consider alternative contraception. Hypertriglyceridemia. Pregnancy-related cholestasis. Depression. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Hereditary angioedema. Monitor blood pressure. Do regular complete physical exams. BMI >35kg/m²: not evaluated. Pregnancy: discontinue if occurs. Postmenopausal women or nursing mothers: not recommended.

Minastrin 24 Fe Pharmacokinetics

Distribution

Plasma protein bound: >95%.

Metabolism

Hepatic.

Elimination

Renal, fecal. Half-life: 8 hours (norethindrone); 14 hours (ethinyl estradiol).

Minastrin 24 Fe Interactions

Interactions

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Minastrin 24 Fe prior to starting HCV regimen and restart 2wks after completion. May be antagonized by CYP3A4 or other enzyme inducers (eg, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, St. John’s wort); use backup contraception. May be potentiated by atorvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole). May be affected by HIV/HCV protease inhibitors, NNRTIs. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones or cortisol therapy.

Minastrin 24 Fe Adverse Reactions

Adverse Reactions

Headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, weight gain; serious thromboembolic events, irregular uterine bleeding, liver disease.

Minastrin 24 Fe Clinical Trials

See Literature

Minastrin 24 Fe Note