FEMCON Fe Rx
Generic Name and Formulations:
Norethindrone 0.4mg, ethinyl estradiol 35micrograms (21 tabs); inert+ (7 tabs); +contains ferrous fumarate; chew tabs; spearmint flavor.
Indications for FEMCON Fe:
1 tab daily for 28 days; repeat. Chew tabs: chew (follow with 8oz liquid) or swallow whole.
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.
Cigarette smoking increases risk of serious cardiovascular events.
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. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
Progestin + estrogen.
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Femcon 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, rifabutin, rufinamide, aprepitant, St. John’s wort); use backup contraception. May be potentiated by atorvastatin, rosuvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole, grapefruit juice). May be affected by HIV/HCV protease inhibitors. 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.
Irregular uterine bleeding, nausea, breast tenderness, headache; chloasma, serious thromboembolic events, liver disease.
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