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Junel Fe 1.5/30 Generic Name & Formulations
Legal Class
Rx
General Description
Norethindrone acetate 1.5mg, ethinyl estradiol 30mcg (21 tabs); inert+ (7 tabs); +contains ferrous fumarate 75mg.
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—5
Manufacturer
Junel Fe 1.5/30 Indications
Indications
Oral contraception.
Junel Fe 1.5/30 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 Fe 1.5/30 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 Fe 1.5/30 Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Junel Fe 1.5/30 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 Fe 1.5/30 Pharmacokinetics
See Literature
Junel Fe 1.5/30 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 Fe 1.5/30 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 Fe 1.5/30 Clinical Trials
See Literature
Junel Fe 1.5/30 Note
Not Applicable
Junel Fe 1.5/30 Patient Counseling
See Literature
