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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) ] .

United States - English - 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

United States - English - 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

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

glenmark pharmaceuticals inc., usa - 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 are contraindicated in females who are known to have or develop the following conditions: risk summary 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 ( 2.2)] . the developmental and health benefits of breastfeeding should be

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

mylan pharmaceuticals inc. - 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 the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. combined oral contraceptives are highly effective for pregnancy prevention. table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the e

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actavis pharma, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - na/ee and fe is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies (14) ] .  the efficacy of na/ee and fe in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. na/ee and fe 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 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

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

teva pharmaceuticals usa, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - junel® fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is indicated for use by women to prevent pregnancy [see clinical studies (14)] . the efficacy of junel fe 24 in women with a body mass index (bmi) of >35 kg/m2 has not been evaluated. junel fe 24 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 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 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 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 [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - 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 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 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 [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - 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, junel fe 24 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 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 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 chcs before conception or during early pregnancy. risk summary contraceptive hormones and/or metabolites are present in human milk. chcs 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 (2.2).] the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and any potential adverse effects on the breastfed child from norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets or from the underlying maternal condition. safety and efficacy of junel fe 24 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. junel fe 24 has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of junel fe 24 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 [see contraindications (4) and warnings and precautions (5.2)]. the pharmacokinetics of junel fe 24 has not been studied in women with renal impairment. the safety and efficacy of junel fe 24 in women with a body mass index (bmi) > 35 kg/m2 has not been evaluated [see clinical studies (14)].

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 20 ug - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are 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. do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets to women who are known to have the following conditions: 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 preg

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

proficient rx lp - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1.5 mg - junel ® 21 and junel ® fe 28 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 combined progestin only 0.1 0.5 3 n/a‡ 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 parous 9 20 20 40 implant 0.05 0.05 injection: depot medroxyprogesterone acetate 0.3 0.3 iud progeste

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.02 mg - 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. % 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