Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

nucare pharmaceuticals,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 postmenopau

Sjedinjene Američke Države - engleski - 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 .)

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

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

Sjedinjene Američke Države - engleski - 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 .)

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

a-s medication solutions - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol tablets should be discontinued during 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 chcs 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 percent and 15 to 20 percent, respectively. data human data a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone and ethinyl estradiol tablets in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. risk summary drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone and ethinyl estradiol tablets on the breast-fed infant. chcs 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. when possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding. [see also dosage and administration (2.2)]. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for drospirenone and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from drospirenone and ethinyl estradiol tablets or from the underlying maternal condition. data human data an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months postpartum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. safety and efficacy of drospirenone and ethinyl estradiol tablets has been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. drospirenone and ethinyl estradiol tablets are contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2)] . in subjects with creatinine clearance (clcr) of 50 to 79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of 30 to 49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see clinical pharmacology (12.3)] . drospirenone and ethinyl estradiol tablets are contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4)] . the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone and ethinyl estradiol tablets have not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3)] .

Sjedinjene Američke Države - engleski - 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

Sjedinjene Američke Države - engleski - 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:

Sjedinjene Američke Države - engleski - 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

Sjedinjene Američke Države - engleski - 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:

Sjedinjene Američke Države - engleski - 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