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Nortrel 1/35–21 Generic Name & Formulations
Legal Class
Rx
General Description
Norethindrone 1mg, ethinyl estradiol 35mcg (21 tabs).
Pharmacological Class
Progestin + estrogen.
See Also
How Supplied
Packs—6
Manufacturer
Nortrel 1/35–21 Indications
Indications
Oral contraception.
Nortrel 1/35–21 Dosage and Administration
Adult
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.
Children
Pre-menarche: not applicable.
Nortrel 1/35–21 Contraindications
Contraindications
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.
Nortrel 1/35–21 Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Nortrel 1/35–21 Warnings/Precautions
Warnings/Precautions
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.
Nortrel 1/35–21 Pharmacokinetics
See Literature
Nortrel 1/35–21 Interactions
Interactions
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).
Nortrel 1/35–21 Adverse Reactions
Adverse Reactions
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, headache, intolerance to contact lenses; serious thromboembolic events, liver disease.
Nortrel 1/35–21 Clinical Trials
See Literature
Nortrel 1/35–21 Note
Not Applicable
Nortrel 1/35–21 Patient Counseling
See Literature
