ABD - İngilizce - 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

ABD - İngilizce - NLM (National Library of Medicine)

nucare 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

ABD - İngilizce - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - 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: - 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 - 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 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 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. 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 to determine whether those over 65 years of age differ from younger subjects in their response to estradiol transdermal system. 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 ( es" tra dye' ol) transdermal system read this instructions for use before you start using estradiol transdermal system 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. 1. determine your schedule for your twice-a-week application - decide upon which 2 days you will change your patch. - your estradiol transdermal system individual carton contains a calendar card printed on its inner flap. mark the 2-day schedule you plan to follow on your carton’s inner flap. - be consistent. - if you forget to change your patch on the correct date, apply a new one as soon as you remember. - no matter what day this happens, stick to the schedule you have marked on the inner flap of your carton (your calendar card). - apply patch to a dry area of the skin of the trunk of the body, including the lower abdomen, or buttocks. avoid the waistline, since clothing may cause the patch to rub off. - do not apply patch to breasts. - when changing your patch, based on your twice-a-week schedule, apply your new patch to a different site. do not apply a new patch to that same area for at least 1 week. make sure your skin is: - clean (freshly washed), dry and cool. - free of any powder, oil, moisturizer or lotion. - free of cuts or irritations (rashes or other skin problems). - each patch is individually sealed in a protective pouch. - tear open the pouch at the tear notch (do not use scissors). - remove the patch. - apply the patch immediately after removing from the pouch. - holding the patch with the rigid protective liner facing you, remove half of the liner, which covers the sticky surface of the patch. - avoid touching the sticky side of the patch with your fingers. - using the other half of the rigid protective liner as a handle, apply the sticky side of the patch to the selected area of the abdomen or buttocks. - press the sticky side of the patch firmly into place. - smooth it down. - while still holding the sticky side down, fold back the other half of the patch. - grasp an edge of the remaining protective liner and gently pull it off. - avoid touching the sticky side of the patch with your fingers. - press the entire patch firmly into place with the palm of your hand. - continue to apply pressure, with the palm of your hand over the patch, for approximately 10 seconds. - make sure that the patch is properly adhered to your skin. - go over the edges with your finger to ensure good contact around the patch. note: - showering will not cause your patch to fall off. - 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. - if you stop using your estradiol transdermal system 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 - when it is time to change your patch, remove the old patch before you apply a new patch. - 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. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 11-2021-01

ABD - İngilizce - 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

ABD - İngilizce - 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

ABD - İngilizce - 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

ABD - İngilizce - 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

ABD - İngilizce - 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

ABD - İngilizce - 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 .)

ABD - İngilizce - 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 .)