Estradiol Norethindrone Acetate Estradiol 1 mg Norethindrone Acetate 0.5 mg
INDICATIONS AND USAGE Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 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 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg is also indicated in women who have a uterus for the: 3. 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.
Physicians Total Care, Inc.
ROUND WHITE B 474
B 474 ROUND WHITE
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HOW SUPPLIED Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg are white, convex, coated tablets debossed with "B" on one side and "474" on the other side (NDC 54868-4677-0). Estradiol/Norethindrone Acetate Tablets are supplied as: 28 tablets in a calendar blister pack dispenser. Store in a dry place protected from light. Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]
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