Generic Name and Formulations:
Norethindrone 0.5mg, ethinyl estradiol 35mcg (7 tabs); norethindrone 1mg, ethinyl estradiol 35mcg (9 tabs); norethindrone 0.5mg, ethinyl estradiol 35mcg (5 tabs); inert (7 tabs).
Indications for ARANELLE:
1 tab daily for 28 days; repeat.
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 adenoma or carcinoma. Pregnancy (Cat.X).
Cigarette smoking increases risk of serious cardiovascular events.
Increased risk of cardiovascular events (eg, MI, stroke, VTE). Smokers >35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Diabetes. Obesity. Gallbladder disease. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
Progestin + estrogen.
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels.
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.