United States - English - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol and norethindrone acetate tablets are indicated for: limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol and norethindrone acetate tablets are contraindicated in women with any of the following conditions: • undiagnosed abnormal genital bleeding [see warnings and precautions (5.2) ]  • breast cancer or history of breast cancer [see warnings and precautions (5.2) ] • estrogen-dependent neoplasia [see warnings and precautions (5.2) ] • active dvt, pe, or history of these conditions [see warnings and precautions (5.1) ] • active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings a

United States - English - NLM (National Library of Medicine)

pharmpak, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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 mai

United States - English - NLM (National Library of Medicine)

pharmpak, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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 mai

United States - English - NLM (National Library of Medicine)

direct_rx - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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 pos

United States - English - NLM (National Library of Medicine)

direct_rx - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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 pos

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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. estrogens should not be used in individuals with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. - 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. - estradiol tablets should not be used in patients with known hypersensitivity to its ingredients. estradiol tablets 2 mg contain fd&c yellow no. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. although the overall incidence of fd&c yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. - known or suspected pregnancy. there is no indication for estradiol tablets 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. (see precautions .)

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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. estrogens should not be used in individuals with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. - 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. - estradiol tablets should not be used in patients with known hypersensitivity to its ingredients. estradiol tablets 2 mg contain fd&c yellow no. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. although the overall incidence of fd&c yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. - known or suspected pregnancy. there is no indication for estradiol tablets 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. (see precautions .)

United States - English - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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 mai

United States - English - NLM (National Library of Medicine)

asclemed usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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 decreasi

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - 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: