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

a-s medication solutions - 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)

bryant ranch prepack - 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 .)

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

zydus pharmaceuticals usa inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol transdermal system is indicated for: limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. 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 transdermal system is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] - breast cancer or history of breast cancer [see warnings and precautions (5.2)] - estrogen-dependent neoplasia [see warnings and precautions (5.2)] - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.1)] - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol transdermal system - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary estradiol transdermal system is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens 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. risk summary estrogens 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 transdermal system and any potential adverse effects on the breastfed child from estradiol transdermal system or from the underlying maternal condition. in general, estradiol transdermal system is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone metabolism and effects on epiphyseal centers is recommended during estrogen administration. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol transdermal system to determine whether those over 65 years of age differ from younger subjects in their response to estradiol transdermal system. the women's health initiative studies 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 (14.3)] . 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 (14.3)] . 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 (14.4)] . 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 (14.4)] .

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

alvogen, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d -     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.     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. the estradiol transdermal system is contraindicated in women with any of the following conditions: the estradiol transdermal system 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 oral contraceptives inadvertently during early pregnancy. the estradiol transdermal system 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 b

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets 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, levonorgestrel and ethinyl estradiol tablets 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 cocs 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. contraceptive hormones and/or metabolites are present in human milk. cocs can red

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have the following conditions:

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

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets usp and ethinyl estradiol tablets usp are indicated for use by women to prevent pregnancy. do not prescribe levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets to women who are known to have the following conditions:    - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:            •  smoke, if over age 35            •  have deep vein thrombosis or pulmonary embolism, now or in the past            •  have cerebrovascular disease            •  have coronary artery disease            •  have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)            •  have hypercoagulopathies            •  have uncontrolled hypertension            •  have diabetes with vascular disease            •  have headaches with focal neurological symptoms or have migraine headaches with or without aura if ove

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. table 2: percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. united states. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year3 method typical use1 perfect use2 (1) (2) (3) (4) chance4 85 85 spermicides5 26 6 40 periodic abstinence 2

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, levonorgestrel 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 cocs 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. contraceptive hormones and/or metabolites are present in human milk. cocs can reduce milk production in breastfeeding females. this reduction can occur at any time but is less likely t

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include females who are known to:    ο   smoke, if over age 35 [see boxed warning and warnings and precautions (5.1) ] ο   have current or history of deep vein thrombosis or pulmonary embolism. [see warnings and precautions (5.1) ]   ο   have cerebrovascular disease [see warnings and precautions (5.1) ]  ο   have coronary artery disease [see warnings and precautions (5.1) ]  ο   have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1) ]  ο   have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1) ] ο   have uncontrolled hypertension or hypertension with vascular disease [see warnings and precautions (5.5) ] ο   have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see warnings and precautions (5.7) ] ο   have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see warnings and precautions (5.8) ] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11) ] - liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see warnings and precautions (5.2) ]. - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8) ] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.4) ]. risk summary there is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets 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 cocs 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. risk summary contraceptive hormones and/or metabolites are present in human milk. cocs can reduce milk production in breastfeeding females. this reduction can occur at any time but is less likely to occur once breastfeeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [see dosage and administration (2.1) ].the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or the underlying maternal condition. safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have been established in women of reproductive age. safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. use of this product before menarche is not indicated.  levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. however, cocs may be poorly metabolized in patients with hepatic impairment. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see contraindications (4) and warnings and precautions (5.2) ]. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets how do i take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets? - take one pill every day at the same time. if you miss pills you could get pregnant. this includes starting the pack late. the more pills you miss, the more likely you are to get pregnant. - many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if it doesn't go away, check with your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. - if you have trouble remembering to take levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control. before you start taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets - decide what time of day you want to take your pill. it is important to take it at about the same time every day. - look at your extended-cycle wallet. your wallet consists of blister strips that hold 91 individually sealed pills (a 13-week or 91-day cycle). the 91 pills consist of 84 orange pills and 7 mustard pills. blister strip 1 and 2 each contain 28 orange pills (4 rows of 7 pills). blister strip 3 contains 35 pills consisting of 28 orange pills (4 rows of 7 pills) and 7 mustard pills (1 row of 7 pills). 3.  also find: - where on the first strip in the pack to start taking pills (upper left corner at the start arrow) and - in what order to take the pills (follow the weeks and arrow). 4.  be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills. when to start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets - take the first orange pill on the sunday after your period starts, even if you are still bleeding. if your period begins on sunday, start the first orange pill that same day. - use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the sunday you start your first orange pill until the next sunday (first 7 days). if you are switching from another birth control method: if you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days. if you have recently given birth and have not yet had a period , use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days. how to take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets - take one pill at the same time every day until you have taken the last pill in the wallet. do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). do not skip pills even if you do not have sex very often. - do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). - do not skip pills even if you do not have sex very often. - when you finish a wallet after taking the last mustard pill, start taking the first orange pill from a new extended-cycle wallet the very next day (this should be on a sunday) regardless of when your period started. - after taking the last mustard pill, start taking the first orange pill from a new extended-cycle wallet the very next day (this should be on a sunday) regardless of when your period started. - if you miss your scheduled period when you are taking the mustard pills, contact your healthcare provider because you may be pregnant. if you are pregnant, you should stop taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. what to do if you miss pills if you miss 1 orange pill: - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - you do not need to use a back-up birth control method if you have sex. if you miss 2 orange pills in a row: - take 2 pills on the day you remember, and 2 pills the next day. - then take 1 pill a day until you finish the pack. - you could become pregnant if you have sex in the 7 days after you miss two pills. you must use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills. if you miss 3 or more orange pills in a row: - do not take the missed pills. keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. for example: if you resume taking the pill on thursday, take the pill under "thursday" and do not take the missed pills. you may experience bleeding during the week following the missed pills. - you could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. - you must use a non-hormonal birth control method (such as condoms or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. if you do not have your period when you are taking the mustard pills, call your healthcare provider because you may be pregnant. if you miss any of the 7 mustard pills: - throw away the missed pills. - keep taking the scheduled pills until the pack is finished. - you do not need a back-up method of birth control. finally, if you are still not sure what to do about the pills you have missed - use a back-up method anytime you have sex. - keep taking one pill each day until you contact your healthcare provider. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: lupin pharmaceuticals, inc. baltimore, maryland 21202 united states manufactured by: lupin limited pithampur (m.p.) - 454 775 india revised: september 2023                                                                              id#: 274539