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Tri-norinyl 28 Generic Name & Formulations
Legal Class
Rx
General Description
Norethindrone 0.5mg, ethinyl estradiol 35micrograms (7 tabs); norethindrone 1mg, ethinyl estradiol 35micrograms (9 tabs); norethindrone 0.5mg, ethinyl estradiol 35micrograms (5 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—3, 6
Manufacturer
Tri-norinyl 28 Indications
Indications
Oral contraception.
Tri-norinyl 28 Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Not applicable.
Tri-norinyl 28 Contraindications
Contraindications
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). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Tri-norinyl 28 Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Tri-norinyl 28 Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age; not recommended. 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 rentention. 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.
Tri-norinyl 28 Pharmacokinetics
See Literature
Tri-norinyl 28 Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Tri-Norinyl 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 affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins).
Tri-norinyl 28 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.
Tri-norinyl 28 Clinical Trials
See Literature
Tri-norinyl 28 Note
Not Applicable
Tri-norinyl 28 Patient Counseling
See Literature
