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)

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

USA - engelsk - NLM (National Library of Medicine)

dispensing solutions, inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - estrogens, conjugated 0.3 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

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 0.3 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

USA - engelsk - NLM (National Library of Medicine)

a-s medication solutions - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 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)

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)

a-s medication solutions - 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 dvt, pe, or a history of these conditions - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions - known anaphylactic reaction or angioedema to prempro/premphase - known liver dysfunction or disease - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - 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 women has been shown t

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - estrogens, conjugated synthetic a (unii: jm2621p2ls) (estrogens, conjugated synthetic a - unii:jm2621p2ls) - estrogens, conjugated synthetic a 0.45 mg - cenestin therapy is indicated for the: 1. treatment of moderate-to-severe vasomotor symptoms associated with the menopause. - 0.45 mg cenestin - 0.625 mg cenestin - 0.9 mg cenestin - 1.25 mg cenestin 2. 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. - 0.3 mg cenestin cenestin 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 deep vein thrombosis, pulmonary embolism or a 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. - cenestin therapy should not be used in patients with known hypersensitivity to its ingredients. - known or su

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 synthetic b (unii: 8l6lak9btr) (estrogens, conjugated synthetic b - unii:8l6lak9btr) - estrogens, conjugated synthetic b 0.9 mg - enjuvia tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with menopause. - treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. when prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. enjuvia tablets 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 deep vein thrombosis, pulmonary embolism or a 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. - known hypersensitivity to the ingredients of enjuvia tablets. - known or suspected pregnancy. there is no indication for enjuvia in pregnancy