Clinical Information
Gen. Code and Des.
62587 estradiol/norethindrone acet ORAL TABLET 0.5-0.1 MG
GCN and Des.
98362 estradiol/norethindrone acet ORAL TABLET 0.5-0.1 MG
Strength
0.5-0.1MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68160400 ESTROGENS
68320000 PROGESTINS
Active Ingredients
1265 estradiol 50282
1299 norethindrone acetate 51989
Inactive Ingredients
2432 lactose 64044515
2537 povidone 9003398
These highlights do not include all the information needed to use ESTRADIOL/NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL/ NORETHINDRONE ACETATE TABLETS.
ESTRADIOL / NORETHINDRONE ACETATE tablets, for oral use
Initial U.S. Approval: 1998
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER
See full prescribing information for complete boxed warning
Estrogen Plus Progestin Therapy
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) (5.1)
The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.2)
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.3)
Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia (5.1, 5.3)
Estrogen-Alone Therapy
There is an increased risk of endometrial cancer in a woman with a uterus who use unopposed estrogens (5.2)
The WHI estrogen-alone substudy reported increased risks of stroke and DVT (5.1)
The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.3)
Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia (5.2, 5.3)
RECENT MAJOR CHANGES
Boxed Warning 08/2021
INDICATIONS AND USAGE
Estradiol/Norethindrone Acetate Tablets are an estrogen and progestin combination indicated in a woman with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1)
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2)
Limitations of Use:
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
Prevention of Postmenopausal Osteoporosis (1.3)
Limitations of Use:
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
DOSAGE AND ADMINISTRATION
Take a single Estradiol/Norethindrone Acetate 1 mg/0.5 mg or 0.5 mg/0.1 mg tablet orally once daily for the Treatment of Moderate to severe Vasomotor Symptoms due to Menopause and for the Prevention of Postmenopausal Osteoporosis (2.1, 2.3)
Estradiol/Norethindrone Acetate 1 mg/0.5 mg tablets are taken orally once daily for the Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (2.2)
DOSAGE FORMS AND STRENGTHS
Estradiol/Norethindrone Acetate 1 mg/0.5 mg tablet (3)
Estradiol/Norethindrone Acetate 0.5 mg/0.1 mg tablet (3)
CONTRAINDICATIONS
Undiagnosed abnormal genital bleeding (4)
Breast cancer or a history of breast cancer (4, 5.2)
Estrogen-dependent neoplasia (4, 5.2)
Active DVT, PE, or history of these conditions (4, 5.1)
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.1)
Known anaphylactic reaction, angioedema, or hypersensitivity to Estradiol/Norethindrone Acetate Tablets (4)
Hepatic impairment or disease (4, 5.10)
Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (4)
WARNINGS AND PRECAUTIONS
Estrogens increase the risk of gall bladder disease (5.4)
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.5, 5.6, 5.9, 5.10)
Monitor thyroid function in women on thyroid replacement therapy (5.11, 5.18)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5 percent) with Estradiol/Norethindrone Acetate Tablets are: back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, emotional lability, upper respiratory tract infection, sinusitis, nasopharyngitis, weight increase, breast pain, post-menopausal bleeding, uterine fibroid vaginal hemorrhage, ovarian cyst, endometrial thickening, viral infection, moniliasis genital, and accidental injury. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. (7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2022
