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Junel 1/20 Generic Name & Formulations
Legal Class
Rx
General Description
Norethindrone acetate 1mg, ethinyl estradiol 20mcg (21 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—5
Manufacturer
Mechanism of Action
Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Junel 1/20 Indications
Indications
Oral contraception.
Junel 1/20 Dosage and Administration
Adult
28-day products: 1 tab daily for 28 days; repeat. 21-day products: 1 tab daily for 21 days, then 7 tablet-free days; repeat.
Children
Not applicable.
Junel 1/20 Contraindications
Contraindications
Thrombophlebitis or thromboembolic disease. History of DVT, cerebrovascular or coronary artery disease. Thrombogenic valvular disease. Severe hypertension. Diabetes with vascular disease. Headaches with focal neurologic symptoms. Major surgery with prolonged immobilization. Known or suspected breast carcinoma, endometrial or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Pregnancy-related cholestasis. Hepatic disease or tumors. Pregnancy (Cat.X).
Junel 1/20 Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Junel 1/20 Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, or headache/migraine occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during and after prolonged immobilization. Cardio- or cerebrovascular diseases. Gallbladder disease. Obesity. Diabetes. Prediabetes. Hypertriglyceridemia. Depression. Conditions aggravated by fluid retention; monitor. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Monitor BP. Do regular complete physical exams. Nursing mothers: not recommended.
Junel 1/20 Pharmacokinetics
Elimination
Renal, fecal. Half-life: 8-10 hours (norethindrone); 8.4±4.8 hours (ethinyl estradiol).
Junel 1/20 Interactions
Interactions
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels.
Junel 1/20 Adverse Reactions
Adverse Reactions
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.
Junel 1/20 Clinical Trials
See Literature
Junel 1/20 Note
Not Applicable
Junel 1/20 Patient Counseling
See Literature
