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

aurobindo pharma limited - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - aurovela 24 fe is indicated for use by women to prevent pregnancy [see clinical studies (14)] . the efficacy of aurovela 24 fe in women with a body mass index (bmi) of greater than 35 kg/m2 has not been evaluated. aurovela 24 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 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 precau

United States - English - 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 - minastrin 24 fe is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies (14) ] .  the efficacy of minastrin 24 fe in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. minastrin 24 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 acquire

United States - English - 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 1 mg - larin 24 fe is indicated for use by women to prevent pregnancy [see clinical studies (14)] . the efficacy of larin 24 fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. larin 24 fe is contraindicated in females 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 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

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - blisovi™ 24 fe is indicated for use by women to prevent pregnancy [see clinical studies (14)]. the efficacy of blisovi 24 fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. blisovi 24 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 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)] - 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)] - 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, blisovi 24 fe 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 blisovi 24 fe and any potential adverse effects on the breastfed child from blisovi 24 fe or from the underlying maternal condition. safety and efficacy of blisovi 24 fe 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. blisovi 24 fe has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of blisovi 24 fe 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 blisovi 24 fe has not been studied in women with renal impairment. the safety and efficacy of blisovi 24 fe 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)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - mibelas™ 24 fe is indicated for use by females of reproductive age to prevent pregnancy [see clinical studies (14)]. the efficacy of mibelas 24 fe in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. mibelas 24 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 warnings and precautions (5.1)] • have uncontrolled hypertension [see warnings and precautions (5.3)]   • have diabetes mellitus with vascular disease [see warnings and precautions (5.5)]   • have headaches with focal neurological symptoms or have migraine headaches with aura o    all women over age 35 with migraine headache [see warnings and precautions (5.6)] • liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2)] • undiagnosed abnormal uterine bleeding [see warnings and precautions (5.7)] • pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.8) and use in specific populations (8.1)] • current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.10)] • 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)] 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. when possible, advise the nursing mother to use other forms of contraception until she has weaned her child. 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 mibelas 24 fe 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. mibelas 24 fe has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of mibelas 24 fe has not been studied in subjects with renal impairment. the pharmacokinetics of mibelas 24 fe 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 safety and efficacy of mibelas 24 fe in women with a body mass index (bmi) greater than 35 kg/m2 has not been evaluated [see clinical studies (14)].

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

actavis pharma, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 1 mg

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

qualitest pharmaceuticals - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 1.5 mg

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

qualitest pharmaceuticals - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 1 mg

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

qualitest pharmaceuticals - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 1 mg

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

qualitest pharmaceuticals - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 1 mg