Generic Name and Formulations:
Norethindrone 0.5mg, ethinyl estradiol 35micrograms (21 tabs); inert (7 tabs).
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Indications for BREVICON-28:
1 tab daily for 28 days; repeat.
Premenarchal: not applicable.
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic disease or tumors. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
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, and during and after prolonged immobilization. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Gallbladder disease. History of depression; monitor and discontinue if serious depression recurs. Fluid retention. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Brevicon prior to starting HCV regimen and restart 2wks after completion. May be antagonized by hepatic enzyme inducers (eg, rifampin, barbiturates, phenylbutazone, phenytoin, griseofulvin, ampicillin, tetracycline, St. John's wort). May affect lab tests (eg, coagulation factors, thyroid hormones, triglycerides, lipids, glucose tolerance, binding proteins, hormone binding globulins, serum folate).
Progestin + estrogen.
Nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, melasma, headache, intolerance to contact lenses; hypertension, serious thromboembolic events, liver disease.
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