Estados Unidos - inglés - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 150 mg in 1 ml - medroxyprogesterone acetate injectable suspension is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate injectable suspension long-term [ see warnings and precautions ( 5.1) ]. the use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [ see warnings and precautions ( 5.2) ]. - known or suspected malignancy of breast [ see warnings and precautions ( 5.3) ]. - known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients [ see warnings and precautions ( 5.5)

Estados Unidos - inglés - NLM (National Library of Medicine)

cipla usa inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use: the use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see dosage and administration (2.1) and warnings and precautions (5.1)]. the use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: -   known or suspected pregnancy or as a diagnostic test for pregnancy. -   active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . -   known or suspected malignancy of breast [see warnings and precautions (5.3)] . -   known hypersensitivity to medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate) or any of its other ingredients [see warnings and precautions (5.5)] . -   sign

Estados Unidos - inglés - NLM (National Library of Medicine)

amphastar pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate long-term [see warnings and precautions (5.1)] . the use of medroxyprogesterone acetate is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)]. - known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients [see warnings and precautions (5.5)] . - significant liver disease [see warnings and precautions (5.6)]. - undiagnosed vaginal bleeding

Estados Unidos - inglés - NLM (National Library of Medicine)

northstar rxllc - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use : the use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see dosage and administration (2.1) and warnings and precautions (5.1)] . the use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)] . - known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients [see warnings and precautions (5.5)] . - significant liver disease [see warnings and p

Estados Unidos - inglés - NLM (National Library of Medicine)

remedyrepack inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate long-term [see warnings and precautions (5.1)] . the use of medroxyprogesterone acetate is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)]. - known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients [see warnings and precautions (5.5)] . - significant liver disease [see warnings and precautions (5.6)]. - undiagnosed vaginal bleeding [see warnings and precautions (5.9)] . medroxyprogesterone acetate should not be administered during pregnancy. [see contraindicationsand warnings and precautions (5.17).] detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate. [see warnings and precautions (5.13).] medroxyprogesterone acetate is not indicated before menarche. use of medroxyprogesterone acetate is associated with significant loss of bmd. this loss of bmd is of particular concern during adolescence and early adulthood, a critical period of bone accretion. in adolescents, interpretation of bmd results should take into account patient age and skeletal maturity. it is unknown if use of medroxyprogesterone acetate by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. other than concerns about loss of bmd, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women. this product has not been studied in post-menopausal women and is not indicated in this population. the effect of renal impairment on medroxyprogesterone acetate pharmacokinetics has not been studied. the effect of hepatic impairment on medroxyprogesterone acetate pharmacokinetics has not been studied. medroxyprogesterone acetate should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. [see contraindications (4)and warnings and precautions (5.7).]

Estados Unidos - inglés - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate tablets usp are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. medroxyprogesterone acetate is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen- or progesterone-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 medroxyprogesterone acetate. - known liver impairment or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

avera mckennan hospital - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. mpa tablets is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen- or progesterone-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 mpa. - known liver impairment or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

quality care products, llc - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. mpa tablets is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen- or progesterone-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 mpa. - known liver impairment or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol and norethindrone acetate tablets are indicated for:   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, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol and norethindrone acetate tablets are contraindicated in women with any of the following conditions: estradiol and norethindrone acetate tablets are not indicated for use in pregnancy. there are no data with the use of estradiol and norethindrone acetate tablets in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalities and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) 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% and 15% to 20%, respectively. estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol and norethindrone acetate tablets and any potential adverse effects on the breastfed child from estradiol and norethindrone acetate tablets or from the underlying maternal condition. estradiol and norethindrone acetate tablets are not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol and norethindrone acetate tablets to determine whether those over 65 years of age differ from younger subjects in their response to estradiol and norethindrone acetate tablets. in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), 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)] . 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 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 plus progestin or estrogen-alone when compared to placebo. it is unknown whether this finding applies to younger postmenopausal women [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)] .

Estados Unidos - inglés - NLM (National Library of Medicine)

mylan institutional llc - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use: the use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see dosage and administration (2.1) and warnings and precautions (5.1)]. the use of medroxyprogesterone acetate is contraindicated in the following conditions: medroxyprogesterone acetate should not be administered during pregnancy. [see contraindications and warnings and precautions (5.17) .] detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate. [see warnings and precautions (5.13) .] medroxyprogesterone acetate is not indicated before menarche. use of medroxyprogesterone acetate is associated with significant loss of bmd. this loss of bmd is of particular concern during adolescence and early adulthood, a criti