NORTREL 0.5/35 Rx
Generic Name and Formulations:
Norethindrone 0.5mg, ethinyl estradiol 35mcg (21 tabs); inert (7 tabs).
Indications for NORTREL 0.5/35:
28-day products: 1 tab daily for 28 days; repeat. 21-day product: 1 tab daily for 21 days, then 7 tablet-free days; repeat.
Pre-menarche: not applicable.
Thrombophlebitis or thromboembolic disorders. History of DVT. 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). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Depression. Fluid retention. 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.
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Nortrel prior to starting HCV regimen and restart 2wks after completion. Antagonized by rifampin, phenobarbital, phenytoin, carbamazepine, St. John's wort. Efficacy may be reduced by ampicillin, tetracycline, griseofulvin, phenylbutazone. May be potentiated by atorvastatin, acetaminophen, ascorbic acid. May potentiate cyclosporine, prednisolone, theophylline. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins).
Progestin + estrogen.
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, headache, intolerance to contact lenses; serious thromboembolic events, liver disease.
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