Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
EPIC PHARMA, LLC
ESTRADIOL
ESTRADIOL 0.5 mg
ORAL
PRESCRIPTION DRUG
Estradiol tablets are indicated in the: 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. Estrogens should not be used in individuals with any of the following conditions:
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
Abbreviated New Drug Application
ESTRADIOL- ESTRADIOL TABLET EPIC PHARMA, LLC ---------- ESTRADIOL TABLETS, USP BOXED WARNING ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than “synthetic” estrogens at equivalent estrogen doses (See WARNINGS, Malignant neoplasms, Endometrial cancer). CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease (See WARNINGS, Cardiovascular disorders). The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (See CLINICAL PHARMACOLOGY, Clinical Studies). The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy (See CLINICAL PHARMACOLOGY, Clinical Studies). Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowe Lestu allt skjalið