Verenigde Staten - Engels - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol transdermal system is indicated for:   limitations of use: when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.   limitations 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 transdermal system is contraindicated in women with any of the following conditions: risk summary estradiol transdermal system is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy. in the u.

Verenigde Staten - Engels - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol transdermal system is indicated for: 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 transdermal system is 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 a history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.1)] - known anaphylactic reaction or angioedema, or hypersensitivity to estradiol transdermal system - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary estradiol transdermal system is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for estradiol transdermal system and any potential adverse effects on the breastfed child from estradiol transdermal system or from the underlying maternal condition. estradiol transdermal system is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. a total of 417 postmenopausal women 61 to 79 years old, with an intact uterus, participated in the osteoporosis trial. more than 50 percent of women receiving study drug, were 65 years of age or older. efficacy in older (≥ 65 years of age) and younger (<65 years of age) postmenopausal women in the osteoporosis treatment trial was comparable both at 12 and 24 months. safety in older (≥ 65 years of age) and younger (<65 years of age) postmenopausal women in the osteoporosis treatment trial was also comparable throughout the study. the women's health initiative studies in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.2)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.2)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.3)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8  [see warnings and precautions (5.3), and clinical studies (14.3)].

Verenigde Staten - Engels - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol gel is contraindicated in women with any of the following conditions: risk summary estradiol gel is not indicated for use in pregnant women. there are no data with the use of estradiol gel in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol gel and any potential adverse effects on the breastfed child from estradiol gel or from the underlying maternal condition. estradiol gel is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in studies utilizing estradiol gel to determine whether those over 65 years of age differ from younger subjects in their response to estradiol gel. the women's health initiative studies in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see warnings and precautions (5.1) and clinical studies (14.2)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see warnings and precautions (5.1, 5.2) and clinical studies (14.2)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.3)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.3)] .

Verenigde Staten - Engels - NLM (National Library of Medicine)

avpak - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.5 mg

Verenigde Staten - Engels - NLM (National Library of Medicine)

sandoz inc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - the estradiol transdermal system is indicated for: [enter generic section here] [enter generic section here] 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 transdermal system is contraindicated in women with any of the following conditions: the estradiol transdermal system is not indicated for use in pregnancy. there are no data with the use of the estradiol transdermal system in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. estrogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the estradiol transdermal system and any potential adverse effects on the breastfed child from the estradiol transdermal system or from the underlying maternal condition. in general, the estradiol transdermal system is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone metabolism and effects on epiphyseal centers is recommended during estrogen administration. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing the estradiol transdermal system to determine whether those over 65 years of age differ from younger subjects in their response to the estradiol transdermal system. in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.3)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.3)] . in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.4)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.4)] .

Verenigde Staten - Engels - NLM (National Library of Medicine)

pharmacia & upjohn company llc - estradiol cypionate (unii: 7e1dv054lo) (estradiol - unii:4ti98z838e) - estradiol cypionate 5 mg in 1 ml - depo-estradiol injection is indicated in the treatment of: estrogens should not be used in individuals with any of the following conditions: 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.) chlorobutanol anhydrous (chloral derivative) added as a preservative may be habit forming.

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 3 mg - natazia® is indicated for use by women to prevent pregnancy. the efficacy of natazia in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see clinical studies (14.2)]. natazia is contraindicated in females who are known to have or develop the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during pregnancy to treat threatened or habitual abortion. wo

Verenigde Staten - Engels - NLM (National Library of Medicine)

ax pharmaceutical corp - estradiol benzoate (unii: 1s4cjb5zgn) (estradiol - unii:4ti98z838e) -

Verenigde Staten - Engels - NLM (National Library of Medicine)

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.5 mg - 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:

Verenigde Staten - Engels - NLM (National Library of Medicine)

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 2 mg - 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 .)