JUNEL Fe 1/20

Junel Fe 1/20 Generic Name & Formulations

Legal Class

General Description

Norethindrone acetate 1mg, ethinyl estradiol 20mcg (21 tabs); inert+ (7 tabs); +contains ferrous fumarate 75 mg.

Pharmacological Class

Progestin + estrogen.

How Supplied

Packs—5

Manufacturer

Teva Pharmaceuticals

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

Indications

Oral contraception.

Junel Fe 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 Fe 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 Fe 1/20 Boxed Warnings

Boxed Warning

Cigarette smoking increases risk of serious cardiovascular events.

Junel Fe 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 Fe 1/20 Pharmacokinetics

Metabolism

Hepatic. >95% serum protein bound.

Elimination

Renal, fecal. Half-life: 8-10 hours (norethindrone); 8.4±4.8 hours (ethinyl estradiol).

Junel Fe 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 Fe 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 Fe 1/20 Clinical Trials

See Literature

Junel Fe 1/20 Note

Not Applicable

Junel Fe 1/20 Patient Counseling