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)
Drugs Generic
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