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avkare - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate tablets, usp is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets, usp are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - known or suspected pregnancy. there is no indication for norethindrone acetate, usp in pregnancy. (see precautions .) - undiagnosed vaginal bleeding - known, suspected or history of cancer of the breast - 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) - impaired liver function or liver disease - as a diagnostic test for pregnancy - hypersensitivity to any of the drug components

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

amneal pharmaceuticals llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate tablets, usp is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets, usp are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - known or suspected pregnancy. there is no indication for norethindrone acetate, usp in pregnancy. (see precautions .) - undiagnosed vaginal bleeding - known, suspected or history of cancer of the breast - 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) - impaired liver function or liver disease - as a diagnostic test for pregnancy - hypersensitivity to any of the drug components

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 1 mg - 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. 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 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 1 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. table 1 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 2

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mylan pharmaceuticals inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - 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. do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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 [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

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

warner chilcott (us), llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - 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. do not prescribe norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 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

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

aurobindo pharma limited - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate tablets, usp   norethindrone acetate tablets, usp  are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets, usp  are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - known or suspected pregnancy. there is no indication for norethindrone acetate tablets in pregnancy. (see precautions .) - undiagnosed vaginal bleeding. - known, suspected or history of cancer of the breast. - 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). - impaired liver function or liver disease. - as a diagnostic test for pregnancy. - hypersensitivity to any of the drug components. 

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

mylan pharmaceuticals inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.4 mg - norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are indicated for use by females of reproductive potential to prevent pregnancy. norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are contraindicated in females who are known to have or develop 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. do not use cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, 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 norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) have been established in women of reproductive age. efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) has not been studied in women 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 norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) has not been studied in women with renal impairment.

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

lupin pharmaceuticals, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.4 mg - norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg is 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 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and implants, 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 % of women method typical use1 perfect use2 emergency contraceptive pills : treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75%9 lactational amenorrhea method : lam is a highly effective, temporary method of contraception10 source: trussell j, stewart f, contraceptive efficacy. in hatcher ra, trussell j, stewart f, cates w

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

glenmark pharmaceuticals inc., usa - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.