What is this medication?
Estrogen and Progestin Combination
Estradiol+Norethindrone is officially indicated for hypoestrogenism, vasomotor symptoms associated with menopause, vulvar and vaginal atrophy associated with menopause and osteoporosis prevention.
“ALERT: US Boxed Warning
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg) alone, relative to placebo.
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.
The Women’s Health Initiative (WHI) estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.
Estrogen-alone therapy should not be used for the prevention of dementia. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years and older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg) alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Estrogen plus progestin therapy should not be used for the prevention of dementia. The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years or older during 4 years of treatment with daily conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Risk vs benefit:
In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens (with or without medroxyprogesterone acetate) and other dosage forms of estrogens (with or without progestins). Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.”
How does this medication work?
Estrogen is a female sex hormone that supports the development and function of the female reproductive system, secondary sex characteristics and urogenital structures. Estradiol is the principle female estrogen and inhibits the pituitary release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) thereby inhibiting ovulation through a negative feedback system.
Norethindrone is a progestin is a synthetic form of progesterone which is another female reproductive hormone. Progestin inhibits gonadotropin production which will prevent follicular maturation and subsequently ovulation. Progestin also reduces the risk of endometrial hyperplasia as it thins out the endometrial lining of the uterus.
How should I take this medication?
Vasomotor Symptoms Associated with Menopause
Activella, Activelle, Activelle LD, Lopreeza, Mimvey: Take one tablet daily.
Vulvar and Vaginal Atrophy Associated with Menopause
Activella, Activelle, Amabelz, Lopreeza, Mimvey: Take 1 tablet once daily.
Activella, Activelle, Activelle LD, Lopreeza, Mimvey: Take one tablet once daily.
*When treating symptoms of vulvar and vaginal atrophy, topical application should be considered.
How Do You Take the Tablet: You can take tablets with food or after a meal to reduce nausea. Take the medication exactly as prescribed by your doctor.
Contact Your Doctor if You Ever Experience: If you experience a sudden, intense, severe headache or chest pain; sudden loss of coordination; sudden loss of vision or speech disturbances; chest or calf pain; weakness in the extremities; sudden shortness of breath of pain with breathing (may indicate thromboembolic disorder); persistent or recurrent vaginal bleeding (may indicate endometrial cancer); edema; abdominal pain or jaundice (may indicate hepatitis or gallbladder disease).
What should I watch for while using this medication?
Do not use in women with an increased risk of invasive breast cancer
Do not use in women to prevent or treat dementia
Do not use unopposed estrogen in women with a uterus
Do not use in women with endometriosis
Use with caution in women with pre-existing hypertriglyceridemia
Use with caution in women with ovarian cancer
Use with caution in women with retinal vascular thrombosis
Use with caution in asthma, carbohydrate intolerance, cardiovascular disease, fluid retention, hepatic dysfunction, hypoparathyroidism, migraines, porphyria, and system lupus erythematosus
What if I miss a dose?
If you miss a dose, make sure to take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
The frequency of side effects is not well defined and some of the adverse reactions are dependent on the dosage form and combination therapy used:
Central Nervous System: Headache (23%)
Gastrointestinal: Abdominal pain (12%)
Genitourinary: Mastalgia (16%)
Neuromuscular and Skeletal: Back pain (12%)
Respiratory: Upper respiratory tract infection (21%), flu-like symptoms (11%)
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