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aidarex pharmaceuticals llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1 mg - estradiol tablets usp 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 postmenop

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preferred pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1 mg - estradiol tablets usp are indicated in the: estrogens should not be used in individuals with any of the following conditions:

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a-s medication solutions - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1 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 .)

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prasco laboratories - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol vaginal cream, usp, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. estradiol vaginal cream, usp, 0.01% should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast. - known or suspected estrogen-dependent neoplasia. - active dvt, pe or history of these conditions. - active arterial thromboembolic disease (for example, stroke, mi) or a history of these conditions. - known anaphylactic reaction or angioedema to estradiol vaginal cream, usp, 0.01% - known liver dysfunction or disease. - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. - known or suspected pregnancy.

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pd-rx pharmaceuticals, 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

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

pd-rx pharmaceuticals, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1 mg

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xiromed, llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol gel 0.1% 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 history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (e.g, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] - known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1% - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary estradiol gel 0.1% is not indicated for use in pregnant women. there are no data with the use of estradiol gel 0.1% 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. animal studies to evaluate embryo/fetal toxicity were not conducted with estradiol gel, 0.1%. 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 0.1% and any potential adverse effects on the breastfed child from estradiol gel 0.1% or from the underlying maternal condition. estradiol gel 0.1% 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 0.1% to determine whether those over 65 years of age differ from younger subjects in their response to estradiol gel 0.1%. 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 women 8 [see warnings and precautions  (5.3), and clinical studies  (14.3)] .

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zydus pharmaceuticals usa inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol transdermal system, usp (twice-weekly) 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 (twice-weekly) is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a 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 and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol transdermal system (twice-weekly) - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary estradiol transdermal system (twice-weekly) is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system (twice-weekly) 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 transdermal system (twice-weekly) and any potential adverse effects on the breastfed child from estradiol transdermal system (twice-weekly) or from the underlying maternal condition. estradiol transdermal system (twice-weekly) 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 maturation and effects on epiphyseal centers is recommended during estrogen administration. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol transdermal system (twice-weekly) to determine whether those over 65 years of age differ from younger subjects in their response to estradiol transdermal system (twice-weekly). 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 (14.3)]. 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 warnings and precautions (5.1), and clinical studies (14.3)]. 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 (14.4)]. 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)]. estradiol transdermal system, usp (twice-weekly) (es″ tra dye′ ol) read this instructions for use before you start using estradiol transdermal system (twice-weekly) and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. note: 1.      showering will not cause your patch to fall off. 2.      if your patch falls off reapply it. if you cannot reapply the patch, apply a new patch to another area and continue to follow your original placement schedule. 3.      if you stop using your estradiol transdermal system (twice-weekly) patch or forget to apply a new patch as scheduled, you may have spotting, or bleeding, and recurrence of symptoms. 5.         throwing away your used patch 1.         when it is time to change your patch, remove the old patch before you apply a new patch. 2.         to throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash. used patches should not be flushed in the toilet. this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured by: zydus lifesciences ltd. ahmedabad, india distributed by: zydus pharmaceuticals (usa) inc. pennington, nj 08534 rev.: 03/24

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energique, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), estriol (unii: fb33469r8e) (estriol - unii:fb33469r8e), estrone (unii: 2di9ha706a) (estrone - unii:2di9ha706a) - for temporary relief of symptoms associated with estrogen imbalances such as excessive bleeding, irregular menses, fertility issues, difficulties in labor and breast-feeding, depression, hot flashes and vaginal dryness and irritation.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration. for temporary relief of symptoms associated with estrogen imbalances such as excessive bleeding, irregular menses, fertility issues, difficulties in labor and breast-feeding, depression, hot flashes and vaginal dryness and irritation.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration.

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

energique, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), estriol (unii: fb33469r8e) (estriol - unii:fb33469r8e), estrone (unii: 2di9ha706a) (estrone - unii:2di9ha706a) - may temporarily relieve excessive bleeding, irregular menses, breast tenderness, dry skin, moodiness, hot flashes, and vaginal dryness and irritation.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve excessive bleeding, irregular menses, breast tenderness, dry skin, moodiness, hot flashes, and vaginal dryness and irritation.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.