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

direct_rx - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.5 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 postmenopausal ost

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

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

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

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:

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

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 .)

United States - English - 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 .)

Australia - English - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - estradiol, quantity: 1 mg/g - gel - excipient ingredients: trolamine; propylene glycol; ethanol; purified water; carbomer 934p - short-term treatment of climacteric symptoms after natural or surgical menopause. whenever possible the lowest effective dose should be used. review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment (including cardiovascular disease and breast cancer, see section 5.1 pharmacodynamic properties - clinical trials and section 4.4 special warnings and precautions for use). sandrena should only be continued for as long as the benefit outweighs the risks.

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.32 mg (equivalent: estradiol, qty 2.25 mg) - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; isopropyl palmitate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

besins healthcare sa-nv - estradiol hemihydrate 0,775 mg/dose - eq. estradiol 0,75 mg/dose - transdermal gel - 0,75 mg/dose - estradiol hemihydrate 0.775 mg/dose - estradiol

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - estradiol hemihydrate 1.64mg - transdermal patch - 100 mcg/24h - active: estradiol hemihydrate 1.64mg excipient: acrylic adhesive dipropylene glycol oleyl alcohol pegoterate polyolefin povidone silicone adhesive - estradiol is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - estradiol hemihydrate 0.41mg - transdermal patch - 25 mcg/24h - active: estradiol hemihydrate 0.41mg excipient: acrylic adhesive dipropylene glycol oleyl alcohol pegoterate polyolefin povidone silicone adhesive - estradiol is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis.