estradiol tablet
INDICATIONS AND USAGE Estradiol tablets are indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6. Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies ). 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.
epic pharma, llc
ROUND WHITE E 89
E 89 ROUND WHITE
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HOW SUPPLIED
ESTRADIOL Tablets, USP, 0.5 mg are white to off-white, round, convex, bisected tablets, debossed “ Є ” above the bisect and “87” below the bisect on one side, and plain on the other side. NDC 42806-087-01 in bottles of 100 NDC 42806-087-05 in bottles of 500
ESTRADIOL Tablets, USP, 1 mg are white to off-white, round, convex, bisected tablets, debossed “ Є ” above the bisect and “88” below the bisect on one side and plain on the other side. NDC 42806-088-01 in bottles of 100 NDC 42806-088-05 in bottles of 500
ESTRADIOL Tablets, USP, 2 mg are white to off-white, round, convex, bisected tablets, debossed “ Є ” above the bisect and “89” below the bisect on one side and plain on the other side. NDC 42806-089-09 in bottles of 90 NDC 42806-089-01 in bottles of 100 NDC 42806-089-05 in bottles of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev. 09-2018-00 MF087REV09/18 OE1609
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