USA - engelsk - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.45 mg - limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered premarin therapy is contraindicated in individuals with any of the following conditions: premarin should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. premarin should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the breast milk of mothers receiving estrogen-alone therapy. caution should be exercised when premarin is administered to a nursing woman. estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. safety and effectiveness in pediatric patients have not otherwise been established. large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short stature if treatment is initiated before the completion of physiologic puberty in normally developing children. 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. estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. in boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia. there have not been sufficient numbers of geriatric patients involved in studies utilizing premarin to determine whether those over 65 years of age differ from younger subjects in their response to premarin. the women's health initiative study 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 (14.5)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg]), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.5)] . 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 (14.6)] . 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 (14.6)]. the effect of renal impairment on the pharmacokinetics of premarin has not been studied. the effect of hepatic impairment on the pharmacokinetics of premarin has not been studied.

USA - engelsk - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 25 mg in 5 ml - premarin intravenous (conjugated estrogens, usp) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology. premarin intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels. premarin intravenous therapy should not be used in individuals with any of the following conditions:

USA - engelsk - NLM (National Library of Medicine)

u.s. pharmaceuticals - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: duavee is contraindicated in women with any of the following conditions: risk summary duavee is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential [see contraindications (4), warnings and precautions (5.15)]. conjugated estrogens (ce) there are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy. bazedoxifene there are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes. animal studies have shown that oral bazedoxifene administered during the period of organogenesis to pregnant rats or rabbits at 0.3 and 2 times, respectively, the exposure at the maxi

USA - engelsk - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: duavee is contraindicated in women with any of the following conditions: risk summary duavee is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential [see contraindications (4), warnings and precautions (5.15)]. conjugated estrogens (ce) there are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy. bazedoxifene there are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes. animal studies have shown that oral bazedoxifene administered during the period of organogenesis to pregnant rats or rabbits at 0.3 and 2 times, respectively, the exposure at the maximum recommended dose, can cause fetal harm [see data]. based on mechanism of action, bazedoxifene may block the important functions that estrogen has during all stages of pregnancy [see clinical pharmacology (12.1)] . data animal data bazedoxifene administration of bazedoxifene to rats at maternally toxic dosages ≥1 mg/kg/day (≥ 0.3 times the human area under the curve (auc) at the 20 mg dose) resulted in reduced numbers of live fetuses and/or reductions in fetal body weights. no fetal developmental anomalies were observed. in studies conducted with pregnant rabbits treated with bazedoxifene, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the fetuses were present at maternally toxic dosages of ≥ 0.5 mg/kg/day (≥ 2 times the human auc at the 20 mg dose). risk summary duavee is not indicated for use in females of reproductive potential [see warnings and precautions (5.15)] . conjugated estrogens estrogens are present in human milk and 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. bazedoxifene there are no data on the presence of bazedoxifene in either human or animal breast milk, the effect on the breastfed infant, or the effects on milk production. based on mechanism of action, bazedoxifene may block the important functions that estrogen has in mammary tissue during lactation [see clinical pharmacology (12.1)]. infertility bazedoxifene based on animal data, bazedoxifene administration may adversely affect female fertility. however, clinical fertility studies with bazedoxifene have not been conducted [see nonclinical toxicology (13.1)] . duavee is not indicated for use in children [see indications and usage (1)] . duavee is not recommended for use in women greater than 75 years of age [see dosage and administration (2.7) and clinical pharmacology 12.3)] . of the total number of women in phase 3 clinical studies who received duavee, 4.60% (n=224) were 65 years and over. duavee was not studied in women aged 75 and over. no overall differences in safety or effectiveness were observed between women 65–74 years of age and younger women, and other reported clinical experience has not identified differences in responses between the elderly and younger women, but greater sensitivity of some older women cannot be ruled out. an increased risk of probable dementia in women over 65 years of age was reported in the women's health initiative memory ancillary studies of the women's health initiative using daily conjugated estrogens (0.625 mg) [see clinical studies (14.6)]. duavee is not recommended for use in patients with renal impairment [see dosage and administration (2.6) and clinical pharmacology (12.3)]. the pharmacokinetics, safety, and efficacy of duavee have not been evaluated in women with renal impairment. duavee is contraindicated in patients with hepatic impairment [see contraindications (4) and clinical pharmacology (12.3)]. the pharmacokinetics, safety, and efficacy of duavee have not been evaluated in women with hepatic impairment. in a pharmacokinetics study of bazedoxifene 20 mg alone, the cmax and auc of bazedoxifene increased 67% and 143%, respectively, in women with mild hepatic impairment (child pugh class a), compared to healthy women. the cmax and auc of bazedoxifene increased 32% and 109%, respectively, in women with moderate hepatic impairment (child pugh class b). the cmax and auc of bazedoxifene increased 20% and 268%, respectively, in women with severe hepatic impairment (child pugh class c). no pharmacokinetic studies with conjugated estrogens were conducted in women with hepatic impairment. following duavee administration, the systemic exposures of conjugated estrogens and bazedoxifene were lower in obese subjects, compared to non-obese subjects [see pharmacokinetics (12.3)] . a single dose of duavee (conjugated estrogens 0.45 mg/bazedoxifene 20 mg) was administered to 12 obese bmi ≥ 30 [mean (sd) = 32.7 (2.7) kg/m2 ] and 12 non-obese bmi < 30 [mean (sd) 25.3 (2.6) kg/m2 ] postmenopausal women. in obese subjects, systemic exposures of total estrone, total equilin, and bazedoxifene were 2%, 32%, and 13% lower, respectively, compared to non-obese subjects. a greater reduction in bazedoxifene exposure compared to conjugated estrogens may be associated with decreased protection from endometrial hyperplasia. monitor and evaluate women with postmenopausal or unexplained genital bleeding for possible endometrial hyperplasia or malignancy [see warnings and precautions (5.3)] .

USA - engelsk - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg - premarin therapy is indicated in the: - treatment of moderate to severe vasomotor symptoms due to menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to 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 postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin d in

USA - engelsk - NLM (National Library of Medicine)

state of florida doh central pharmacy - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg - premarin therapy is indicated in the: - treatment of moderate to severe vasomotor symptoms due to menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to 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 postmenopausal 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 studies .) the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exe

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.3 mg - premarin therapy is indicated in the: - treatment of moderate to severe vasomotor symptoms due to menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to 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 postmenopausal 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 studies .) the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-b

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

pfizer australia pty ltd - conjugated estrogens, quantity: 0.625 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; carnauba wax; sucrose; hypromellose; lactose monohydrate; macrogol 400; hyprolose; calcium phosphate; powdered cellulose; titanium dioxide; propylene glycol; purified water; isopropyl alcohol; allura red ac aluminium lake; indigo carmine aluminium lake - oestrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. 1 premarin is indicated as replacement therapy for oestrogen deficiency states associated with climacteric manifested by: a) moderate to severe vasomotor symptoms associated with oestrogen deficiency in natural and surgical menopause (sweating, hot flushes). periodic re-evaluation with a view to short term treatment is recommended. b) atrophic vaginitis. when prescribing solely for the treatment of symptoms of vaginal atrophy, topical vaginal products should be considered. there is no evidence that oestrogens are effective for anxiety or depression without associated vasomotor symptoms, and they should not be used to treat such conditions. 2. premarin is indicated for the prevention of postmenopausal osteoporosis in select patients. when prescribed solely for the prevention of postmenopausal osteoporosis, therapy should only be prescribed for women who are at high risk of osteoporosis and 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 premarin 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). 3. hypoestrogenic states e.g. female hypogonadism, primary ovarian failure or female castration. see boxed warning, particularly when considering premarin for long-term usage.

USA - engelsk - NLM (National Library of Medicine)

creekwood pharmaceutical, inc, - methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif), estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768) - estrogens, esterified 1.25 mg - esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength are indicated in the treatment of: moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus (see boxed warning). estrogens should not be used in women with any of the following conditions: - known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. - known or suspected estrogen-dependent neoplasia. - known or suspected pregnancy (see boxed warning). - undiagnose

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - estrogens, conjugated 0.625 mg - prempro or premphase therapy should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding - known, suspected, or history of breast cancer - known or suspected estrogen-dependent neoplasia - active deep vein thrombosis, pulmonary embolism or a history of these conditions - active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions - known liver dysfunction or disease - known thrombophilic disorders (e.g., protein c, protein s, or antithrombin deficiency) - known or suspected pregnancy prempro and premphase should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. prempro and premphase should not be used during lactation. estrogen administration to nursing mothers has been shown to decrease the quanti