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Mimvey Blister Pack 0.5-1 Mg Tabs 28 By Teva Pharma

Image 0 of Mimvey Blister Pack 0.5-1 Mg Tabs 28 By Teva PharmaImage 1 of Mimvey Blister Pack 0.5-1 Mg Tabs 28 By Teva Pharma

Mimvey Blister Pack 0.5-1 Mg Tabs 28 By Teva Pharma

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Mimvey Blister Pack 0.5-1 Mg Tabs 28 By Teva Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4305561/RXB10011200/RXA321474
Size : 28
Selling UoM : EA
NDC: 00093-5455-28
UPC Barcode : 300935455280
Supplier: 0050001781 TEVA PHARMACEUTICALS USA
Supplier Material : 545528
Generic Code : 040888 ESTRADIOL/NORETHINDRONE ACET ORAL TABLET
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type :

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Product Description.:

B, 34
tablet , film-coated , white , round round
Debossed

Mimvey (estradiol and norethindrone acetate) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following inactive ingredients: lactose, colloidal silicon dioxide, copovidone, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, starch and titanium dioxide.

INDICATIONS AND USAGE

Mimvey (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg are indicated in women who have a uterus for the:

Treatment of moderate to severe vasomotor symptoms associated with menopause.
Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Mimvey is also indicated in women who have a uterus for the:
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

CONTRAINDICATIONS

Mimvey (estradiol and norethindrone acetate tablets, USP) should not be used in women with any of the following conditions:

Undiagnosed abnormal genital bleeding.
Known, suspected, or history of cancer of the breast.
Known or suspected estrogen-dependent neoplasia.
Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
Liver dysfunction or disease.
Known hypersensitivity to the ingredients of estradiol and norethindrone acetate 1 mg/0.5 mg or estradiol and norethindrone acetate 0.5 mg/0.1 mg.
Known or suspected pregnancy. There is no indication for estradiol and norethindrone acetate in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

WARNINGS
1. Cardiovascular Disorders

Estrogen-plus-progestin therapy has been associated with an increased risk of myocardial infarction as well as stroke, venous thrombosis and pulmonary embolism.

Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis (DVT). Should any of these events occur or be suspected, estrogens should be discontinued immediately.

Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

a. Stroke

In the estrogen plus progestin sub-study of the Women?s Health Initiative (WHI), a statistically significant increased risk of stroke was reported in women receiving CE/MPA 0.625 mg/2.5 mg daily compared to woman receiving placebo (31 vs. 24 per 10,000 women-years). The increase in risk was demonstrated after the first year and persisted. (See CLINICAL STUDIES.)

In the estrogen-alone sub-study of the WHI, a statistically significant increased risk of stroke was reported in women receiving CE 0.625 mg daily compared to women receiving placebo (44 vs. 32 per 10,000 women-years). The increase in risk was demonstrated in year one and persisted.

b. Coronary Heart Disease

In the estrogen-plus progestin sub-study of WHI, no statistically significant increase in CHD events (defined as non-fatal, MI, silent MI, or death, due to CHD) was reported in women receiving CE/MPA compared to women receiving placebo (39 vs. 33 per 10,000 women-years). An increase in relative risk was demonstrated in year one, and a trend toward decreasing relative risk was reported in years 2 through 5. (See CLINICAL STUDIES.)

In the estrogen-alone sub-study of WHI, no overall effect on coronary disease (CHD) events was reported in women receiving estrogen alone compared to placebo. (See CLINICAL STUDIES.)

In postmenopausal women with documented heart disease (n=2,763, average age 66.7 years), a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study (