Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

mayne pharma inc - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - amethia tablets are indicated for use by women to prevent pregnancy. amethia tablets are contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: ­smoke, if over age 35 [see boxed warningand warnings and precautions (5.1)] . ­have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] . ­have cerebrovascular disease [see warnings and precautions (5.1)]. ­have coronary artery disease [see warnings and precautions (5.1)] . ­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)] . ­ have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] . ­ have uncontrolled hypertension [see warnings and precautions (5.5)] . ­have diabetes with vascular disease [see warnings and precautions (5.7)] . ­have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.8)] . - ­smoke, if over age 35 [see boxed warningand warnings and precautions (5.1)] . - ­have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] . - ­have cerebrovascular disease [see warnings and precautions (5.1)]. - ­have coronary artery disease [see warnings and precautions (5.1)] . - ­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)] . - ­ have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] . - ­ have uncontrolled hypertension [see warnings and precautions (5.5)] . - ­have diabetes with vascular disease [see warnings and precautions (5.7)] . - ­have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.8)] . - undiagnosed abnormal genital bleeding [see warnings and precautions (5.9)] . - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.2)] . - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.3)and use in specific populations (8.6)] . - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.10)and use in specific populations (8.1)] . - 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)]. there is little or no increased risk of birth defects in women who inadvertently use cocs during early 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 low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during pregnancy to treat threatened or habitual abortion. women who do not breastfeed may start cocs no earlier than four to six weeks postpartum. when possible, advise the nursing mother to use other forms of contraception until she has weaned her child. estrogen-containing cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of amethia 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 amethia tablets before menarche is not indicated. amethia tablets have not been studied in women who have reached menopause and is not indicated in this population. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of amethia tablets. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal. [see contraindications (4)and warnings and precautions (5.3)]. no studies have been conducted to evaluate the effect of renal disease on the disposition of amethia tablets.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - 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: 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 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 woman 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. however, steroid hormones may be poorly metabolized in patients with impaired liver function. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see contraindications (4) and warnings and precautions (5.2)]. levonorgestrel and ethinyl estradiol tablets usp, (0.15 mg/0.03 mg) and ethinyl estradiol tablets usp, (0.01 mg) how do i take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets? before you start taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 when to start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets how to take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets what to do if you miss pills if you miss 1 white to off-white pill: if you miss 2 white to off-white pills in a row: if you miss 3 or more white to off-white pills in a row: if you miss any of the 7 light peach pills: finally, if you are still not sure what to do about the pills you have missed this patient information and instructions for use has been approved by the u.s. food and drug administration. manufactured for: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured by: mylan laboratories limited ahmedabad- 382 213, india code no.: guj-drugs/g/28/1297 75102015 revised: 2/2024 fc:ot:7285:r10

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.02 mg - blisovi fe 1/20 is 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 i 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. adapted from ra hatcher et al, reference 7. oral contraceptives are contraindicated in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebral vascular or coronary artery disease - current diagnosis of, or history of, breast cancer, which may be hormone sensitive - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of pregnancy or jaundice with prior pill use - hepatic adenomas or carcinomas - are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ).

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. diagnosis is made by healthcare providers according to dsm-iv criteria, with symptomatology assessed prospectively over at least two menstrual cycles. in making the diagnosis, care should be taken to rule out other cyclical mood disorders. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been evaluated for the treatment of premenstrual syndrome (pms). drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for the treatment of moderate acne vulgaris in females of reproductive potential at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is contraindicated in females who are known to have or develop the following conditions: - renal impairment - adrenal insufficiency - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have cerebrovascular disease[see warnings and precautions (5.1)] have coronary artery disease[see warnings and precautions (5.1)] 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)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.6)] have diabetes mellitus with vascular disease [see warnings and precautions (5.8)] have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.9)] - smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] - have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] - have cerebrovascular disease[see warnings and precautions (5.1)] - have coronary artery disease[see warnings and precautions (5.1)] - 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)] - have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] - have uncontrolled hypertension [see warnings and precautions (5.6)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.8)] - have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.9)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.10)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.3)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.4) and use in specific populations (8.7)] - 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 (5.5) and drug interactions (7.3)]. risk summary there is no use for contraception in pregnancy; therefore, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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 breast-feeding. [see also dosage and administration (2.2)]. increase in folate concentration in milk is not expected (see data). the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets and any potential adverse effects on the breast-fed child from drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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 post-partum. 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. a study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416mcg/day [6s]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16 week period. studies to date indicate there is no adverse effect of folate on nursing infants. safety and efficacy of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been studied in postmenopausal women and is not indicated in this population. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has 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)].

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.03 mg - blisovi fe 1.5/30 is 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 i 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. adapted from ra hatcher et al, reference 7. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebral vascular or coronary artery disease - known or suspected carcinoma of the breast - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

afaxys pharma, llc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.02 mg - tarina fe 1/20 is 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 i 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. adapted from ra hatcher et al, reference 7. * the authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. ** this term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

allergan, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - lo minastrin fe is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies (14) ] .  the efficacy of lo minastrin fe in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. do not prescribe lo minastrin fe 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 [see boxed warning and  warnings and precautions (5.1) ] • have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1) ] • have cerebrovascular disease [see warnings and precautions (5.1) ] • have coronary artery disease [see warnings and precautions (5.1) ] • 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) ] • have inherited or acquired hypercoagulop

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3) - ethinyl estradiol 0.03 mg - enskyce 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant system depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. in a clinical trial with enskyce, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. this represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. this rate includes patients who did not take the drug correctly. emergency contraceptive pills: treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.4 lactation amenorrhea method: lam is a high

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.035 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 1 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. reproduced with permission of the population council from j. trussell, et al: contraceptive failure in the united states: an update. studies in family planning, 21(1), january-february 1990. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebrovascular or coronary artery disease - known or suspected carcinoma of the breast - carcinoma of th

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

allergan, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - lo loestrin® fe is indicated for use by women to prevent pregnancy [ see clinical studies (14) ] .   the efficacy of lo loestrin fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. lo loestrin fe 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 women who are known to: • smoke, if over age 35 [see boxed warning   and  warnings and precautions (5.1) ] • have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1) ] • have cerebrovascular disease [see warnings and precautions (5.1) ] • have coronary artery disease [see warnings and precautions (5.1) ] • 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) ] • have inherited or acquired hypercoagulopathies [see w