Estats Units - anglès - NLM (National Library of Medicine)

a-s medication solutions - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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 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. % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected* typical** (no contraception)  (85) (85) oral contraceptives  3       combined  0.1 n/a ***       progestin only  0.5 n/a *** diaphragm with spermicidal cream or jelly  6 20 spermicides alone (foam, creams, gels, vaginal suppositories and vaginal film)  6 26 vaginal sponge       nulliparous  9 20       parous 20 40 implant  0.05 0.05 inj

Estats Units - anglès - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 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 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. table i lowest expected and typical failure rates during the first year of continuous use of a method % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected* typical† (no contraception)  (85) (85) oral contraceptives  3       combined  0.1 n/a ‡       progestin only  0.5 n/a ‡ diaphragm with spermicidal cream or jelly  6 20 spermicides alone (foam, creams, gels, vaginal        suppositories, and vaginal film)  6 26 vaginal sponge       nulliparous  9 20       parous 20 40 implant  0.05 0.05 injection: depot medroxyprogesterone acetate  0.3 0.3 iud       progesterone t  1.5 2.0       copper t 380a  0.6 0.8       lng 20  0.1 0.1 condom without spermicides       female  5 21       male  3 14 cervical cap with spermicidal cream or jelly       nulliparous  9 20       parous  26 40 periodic abstinence (all methods)  1-9 25 withdrawal  4 19 female sterilization  0.5 0.5 male sterilization  0.10 0.15   oral contraceptives are contraindicated in women who currently have the following conditions:

Estats Units - anglès - NLM (National Library of Medicine)

a-s medication solutions - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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 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. % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected* typical** (no contraception)  (85) (85) oral contraceptives  3       combined  0.1 n/a ***       progestin only  0.5 n/a *** diaphragm with spermicidal cream or jelly  6 20 spermicides alone (foam, creams, gels, vaginal suppositories and vaginal film)  6 26 vaginal sponge       nulliparous  9 20       parous 20 40 implant  0.05 0.05 inj

Estats Units - anglès - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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 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. % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected * typical † (no contraception)  (85) (85) oral contraceptives 3       combined  0.1 n/a‡       progestin only  0.5 n/a‡ diaphragm with spermicidal cream or jelly  6 20 spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)  6 26 vaginal sponge       nulliparous  9 20       parous 20 40 implant  0.05 0.05 injectio

Estats Units - anglès - 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 0.0025 mg - 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. fyavolv is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a 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 and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, angioedema, or hypersensitivity to fyavolv. - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary norethindrone acetate and ethinyl estradiol is not indicated for use in pregnancy. there are no data with the use of norethindrone acetate and ethinyl estradiol 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 (estrogens and progestins) product 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 plus progestogens are present in human milk and can reduce milk production in breastfeeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for norethindrone acetate and ethinyl estradiol and any potential adverse effects on the breastfed child from norethindrone acetate and ethinyl estradiol or from the underlying maternal condition. norethindrone acetate and ethinyl estradiol is 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 norethindrone acetate and ethinyl estradiol to determine whether those over 65 years of age differ from younger subjects in their response to norethindrone acetate and ethinyl estradiol. the women's health initiative studies 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)] . 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 plus progestin or estrogen-alone 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)] .

Estats Units - anglès - NLM (National Library of Medicine)

xiromed, llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is indicated for use by females of reproductive age to prevent pregnancy [see clinical studies (14)] the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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 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 he

Estats Units - anglès - NLM (National Library of Medicine)

greenstone llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies ( 14 ) ] .  the efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules  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

Estats Units - anglès - NLM (National Library of Medicine)

northstar rx llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies (14) ] .  the efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 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 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 (5.4) ] ● have diabetes mellitus with vascular disease [see warnings and precautions (5.6) ] ● have headaches with focal neurological symptoms or have migraine headaches with aura       ● women over age 35 with any migraine headaches [see warnings and precautions (5.7) ] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2) ] - undiagnosed abnormal uterine bleeding [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) ] - 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 (5.3) ] risk summary there is no use for contraception in pregnancy; therefore, norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules should be discontinued during pregnancy. 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 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 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 dosage and administration (2.2)] . the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules and any potential adverse effects on the breast-fed child from norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules or from the underlying maternal condition. safety and efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules have been established in women of reproductive age. efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules has not been studied in subjects with renal impairment [see clinical pharmacology (12.3) ] .  the pharmacokinetics of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules has not been studied in subjects with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded [ s ee contraindications (4) and warnings and precautions (5.2) ] . the safety and efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (bmi) > 35 kg/m2 has not been evaluated [ s ee clinical studies (14) ] .

Estats Units - anglès - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see clinical studies (14)] . the efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 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

Estats Units - anglès - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by women to prevent pregnancy [see clinical studies (14)] . the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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 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 inherited or acquired hypercoagulopathies [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 th