Junel Fe 1/20 Generic Name & Formulations
Norethindrone acetate 1mg, ethinyl estradiol 20mcg (21 tabs); inert+ (7 tabs); +contains ferrous fumarate 75 mg.
Progestin + estrogen.
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). The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28 day regimen, are non-hormonal, and do not serve any therapeutic purpose.
Junel Fe 1/20 Indications
Junel Fe 1/20 Dosage and Administration
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.
Junel Fe 1/20 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 Fe 1/20 Boxed Warnings
Cigarette smoking increases risk of serious cardiovascular events.
Junel Fe 1/20 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 Fe 1/20 Pharmacokinetics
Renal, fecal. Half-life: 8-10 hours (norethindrone); 8.4±4.8 hours (ethinyl estradiol).
Junel Fe 1/20 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 Fe 1/20 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 Fe 1/20 Clinical Trials
Junel Fe 1/20 Note
Junel Fe 1/20 Patient Counseling