Contraception:

Indications for: MINASTRIN 24 Fe

Oral contraception.

Adult Dosage:

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

Children Dosage:

Premenarchal: not recommended.

MINASTRIN 24 Fe 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. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

MINASTRIN 24 Fe 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. Postmenopausal women or nursing mothers: not recommended.

MINASTRIN 24 Fe Classification:

Progestin + estrogen.

MINASTRIN 24 Fe 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.

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.

Metabolism:

Hepatic. >95% serum protein bound.

Drug Elimination:

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

How Supplied:

Dispensers—5 (blister cards)