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

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.1 mg in 1 g - estradiol vaginal cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. estradiol vaginal cream 0.01% should not be used in women with any of the following conditions:

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

remedyrepack inc. - 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)

remedyrepack inc. - 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 .)

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - medroxyprogesterone acetate - suspension for injection - medroxyprogesterone acetate 104 mg / 0.65 ml - medroxyprogesterone - medroxyprogesterone - * sayana is indicated for long-term female contraception. each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- 1 week). however, it should be taken into consideration that the return to fertility (ovulation) may be delayed for up to one year .since loss of bone mineral density may occur in females of all ages who use sayana long-term, a risk/benefit assessment, which also takes into consideration the decrease in bone mineral density that occurs during pregnancy and/or lactation, should be considered.* use in adolescents (12-18 years)in adolescents, use of sayana is only indicated when other contraceptive methods are considered unsuitable or unacceptable, due to unknown long-term effects of bone loss associated with sayana during the critical period of bone accretion.sayana has not been studied in women under the age of 18 years but data is available for intramuscular medroxyprogesterone acetate in this population.

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

kaiser foundation hospitals - 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 postmenop

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

lake erie medical dba quality care products llc - 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)

nucare pharmaceuticals, inc. - 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 postmeno

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

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.

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

viatris pty ltd - estradiol, quantity: 1 mg (equivalent: estradiol hemihydrate, qty 1.03 mg); dydrogesterone, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; hypromellose; maize starch; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - hormone replacement therapy (hrt) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uteri. prevention of postmenopausal bone mineral density loss in women. for initiation and continuation of treatment of postmenopausal symptoms, the lowest possible effective dose for the shortest duration should be used with the goal being short term use.,hormone replacement therapy (hrt) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. prevention of postmenopausal bone mineral density loss in women. for initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used with the goal being short term use (see dosage and administration and clinical trials). when prescribed solely for the prevention of postmenopausal bone mineral density loss in women, 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 osteoporosis. life style modifications and the risk benefit profile of femoston should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing( see precautions and dosage and administration).

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

teva pharmaceuticals usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - estradiol vaginal inserts is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)]. - breast cancer or a history of breast cancer [see warnings and precautions (5.3)]. - estrogen-dependent neoplasia [see warnings and precautions (5.3)]. - active dvt, pe, or history of these conditions [see warnings and precautions (5.2)]. - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.2)]. - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol vaginal inserts [see warnings and precautions (5.16)]. - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary estradiol vaginal inserts are not indicated for use in pregnancy. there are no data with the use of estradiol vaginal inserts in pregnant women; however, epidemiologic studies and meta-analyses have