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Norethindrone Acetate/​Ethinyl Estradiol

    Brands

    DEA Class; Rx

    Common Brand Names; Femhrt, Jinteli, Loestrin 1.5/30, Loestrin 1/20, Microgestin 1.5/30, Microgestin 1/20, Junel 1.5/30, Junel 1/20, Larin 1/20, Larin 1.5/30, Fyavolv, Jevantique Lo, Hailey 1.5/30

    • Estrogens/Progestins; 
    • Contraceptives, Oral

    Combined oral contraceptive (COC) or hormone replacement therapy (HRT) depending on product; ethinyl estradiol is an estrogen; norethindrone acetate is a progestin of moderate androgenic and slight estrogenic activity
    COC products used for routine contraception in adolescent and premenopausal females; all COCs contain a boxed warning regarding the increased risk for thromboembolism in women who smoke
    HRT-oriented products used to treat symptoms of menopause or for osteoporosis prophylaxis in menopausal women; NOT effective as contraceptives; boxed warnings for HRT relate to cardiovascular, dementia, and cancer risks

    Indicated for routine contraception.
    For treatment of moderate to severe vasomotor symptoms (hot flashes) of menopause and/or related genitourinary symptoms including atrophic vaginitis, vulvar atrophy (kraurosis vulvae) in women with an intact uterus.
    For postmenopausal osteoporosis prophylaxis in women with an intact uterus.
    For the treatment of moderate acne vulgaris related to sebum overproduction in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
    For the treatment or adjuvant treatment of amenorrhea, abnormal uterine bleeding (dysfunctional uterine bleeding), hirsutism, hypermenorrhea, or polycystic ovary syndrome related to hypoestrogenic or hyperandrogenic conditions in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and have been evaluated for causes of the condition.
    For the treatment of endometriosis† to induce endometrial involution to a ‘resting’ phase and reduce the size and growth of endometrial tissue in females with no contraindications to hormonal contraceptives, have achieved menarche, and who desire contraception.

    Documented hypersensitivity

    Active or history of breast cancer

    Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

    Estrogen-dependent neoplasia

    Liver disease, liver tumors

    Undiagnosed abnormal vaginal bleeding

    Uncontrolled hypertension

    Diabetes mellitus with vascular involvement

    Jaundice with prior oral contraceptive use

    Edema

    Weakness

    Anorexia

    Amenorrhea

    Breakthrough bleeding

    Change in menstrual flow

    Spotting

    Deep vein thrombosis

    Thrombophlebitis

    Depression

    Dizziness

    Headache

    Nervousness

    Somnolence

    Breast tenderness

    Galactorrhea

    Abdominal pain

    Nausea

    Vomiting

    Weight change

    Cholestatic jaundice

    Acitretin inhibits contraceptive efficacy of norethindrone preparations

    Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

    Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

    Discontinue 4 week before major surgery or prolonged immobilization

    Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)

    Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk

    Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use

    Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy; studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy

    Small amounts of oral contraceptive steroids identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given in postpartum period may interfere with lactation by decreasing quantity and quality of breast milk

    Adults

    1 tablet (5 mcg estradiol with 1 mg norethindrone max dose)/day PO for menopausal symptoms or osteoporosis prevention. For oral contraception, 1 tablet/day PO as per product prescribed.

    Geriatric

    1 tablet (5 mcg estradiol with 1 mg norethindrone max dose)/day PO for menopausal symptoms or osteoporosis prevention.

    Adolescents

    For oral contraception, 1 tablet/day PO as per product prescribed.

    Children

    Not indicated in prepubescent females.

    Norethindrone acetate/ethinyl estradiol

    tablet, hormone replacement

    • 0.5mg/2.5mcg (Femhrt, Fyavolv, Jevantique Lo)
    • 1mg/5mcg (Jinteli, Fyavolv)

    tablet, monophasic

    • 1mg/20mcg (Larin 1/20, Loestrin 1/20, Microgestin 1/20, Junel 1/20)
    • 1.5mg/30mcg (Hailey 1.5/30, Larin 1.5/30, Loestrin 1.5/30, Microgestin 1.5/30, Junel 1.5/30)