estradiol 0.5 MG Oral Tablet
INDICATIONS AND USAGE Estradiol tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 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.
Teva Pharmaceuticals USA, Inc.
OVAL WHITE 899 1 2 b
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HOW SUPPLIED
ESTRADIOL Tablets, USP are available as: 0.5 mg: white to off-white, oval, flat-faced, beveled-edge, scored tablet. debossed with 899 / 1/2 on the scored side and stylized b on the other side, packaged in bottles of 100 (NDC 0555-0899-02). 1 mg: Light purple, oval, flat-faced, beveled-edge, scored tablet. debossed with 886 / 1 on the scored side and stylized b on the other side, packaged in bottles of 100 (NDC 0555-0886-02) and 500 (NDC 0555-0886-04). 2 mg: green, oval, flat-faced, beveled-edge, scored tablet. debossed with 887 / 2 on the scored side and stylized b on the other side, packaged in bottles of 100 (NDC 0555-0887-02) and 500 (NDC 0555-0887-04). Store at 20º to 25º C (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense 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. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 2/2024
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