Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

naari pte limited - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg 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) ] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2) ] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9) ] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9) and use in specific populations (8.1) ]. - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11)] - hypersensitivity to any of the components. - 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. 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) 0.4 mg/0.035 mg and ferrous fumarate tablets 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) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have 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) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in women with renal impairment. instructions for use important information about taking - take 1 pill every day at the same time. take the pills in the order directed on your blister pack. - the norethindrone and ethinyl estradiol tablets, usp may be swallowed whole or chewed. if norethindrone and ethinyl estradiol tablets, usp are chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. - do not skip your pills, even if you do not have sex often. if you miss pills (including starting the pack late) you could get pregnant . the more pills you miss, the more likely you are to get pregnant. - if you have trouble remembering to take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, talk to your healthcare provider. when you first start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, spotting or light bleeding in between your periods may occur. contact your healthcare provider if this does not go away after a few months. - you may feel sick to your stomach (nauseous), especially during the first few months of taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if your nausea does not go away, call your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills (see below), you could also feel a little sick to your stomach. - it is not uncommon to miss a period. however, if you miss a period and have not taken norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. - if you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. if you do not have an extra blister pack, take the next pill in your blister pack. continue taking all your remaining pills in order. start the first pill of your next blister pack the day after finishing your current blister pack. this will be 1 day earlier than originally scheduled. continue on your new schedule. - if you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. - stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. be sure to use other forms of contraception (like condoms and spermicide) during this time period. before you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets: - decide what time of day you want to take your pill. it is important to take it at the same time every day and in the order as directed on your blister pack. - have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed. when should i start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets ? if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you have not used a hormonal birth control method before: - there are 2 ways to start taking your birth control pills. you can either start on a sunday (sunday start) or on the first day (day 1) of your natural menstrual period (day 1 start). your healthcare provider should tell you when to start taking your birth control pill. - if you use the sunday start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. you do not need back-up contraception if you use the day 1 start. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from another birth control pill: - start your new norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletspack on the same day that you would start the next pack of your previous birth control method. - do not continue taking the pills from your previous birth control pack. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and previously used a vaginal ring or transdermal patch: - start using norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day you would have reapplied the next ring or patch. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from a progestin-only method such as an implant or injection: - start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day of removal of your implant or on the day when you would have had your next injection. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from an intrauterine device or system (iud or ius): - start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day of removal of your iud or ius. - you do not need back-up contraception if your iud or ius is removed on the first day (day 1) of your period. if your iud or ius is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. keep a calendar to track your period: if this is the first time you are taking birth control pills, read, “ when should i start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets? ” above.follow these instructions for either a sunday start or a day 1 start. sunday start: you will use a sunday start if your healthcare provider told you to take your first pill on a sunday. - take pill 1 on the sunday after your period starts. - if your period starts on a sunday, take pill “ 1 ” that day and refer to day 1 start instructions below. - take 1 pill every day in the order on the blister pack at the same time each day for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack (sunday). take the first pill in the new pack whether or not you are having your period. - use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. day 1 start: you will use a day 1 start if your doctor told you to take your first pill (day 1) on the first day of your period . - take 1 pill every day in the order of the blister pack, at the same time each day, for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack. take the first pill in the new pack whether or not you are having your period. instructions for using your pill pack: step 1 . look at your norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pill pack. see figure a. the norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pill pack has: - 21 white to off white (active) pills with hormone for week 1 through week 3. - 7 brown (inactive) pills without hormones for week 4. step 2. find: - where on your pack to start taking pills - in what order to take your pills (follow the arrows) - the week numbers step 3. remove the white to off white pill by pressing the pill through the foil in the bottom of the pill pack. see figure b . continue taking the white to off white pills for 21 days. figure b step 4. on the first day of week 4 start taking the brown pills. take the brown pill for 7 days . your period should start during this time. step 5. when you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the white to off white pills. - for a day 1 start: begin your next pill pack on the same day of the week as your first cycle pill pack. - for a sunday start: begin your next pill pack on sunday. what should i do if i miss any norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pills? if you miss 1 pill in weeks 1, 2, or 3, follow these steps : - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - then continue taking 1 pill every day until you finish the pack. - you do not need to use a back-up birth control method if you have sex. if you miss 2 pills in week 1 or week 2 of your pack, follow these steps: - take the 2 missed pills as soon as possible and the next 2 pills the next day. - then continue to take 1 pill every day until you finish the pack. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 pills in a row in week 3, or you miss 3 or more pills in a row during weeks 1, 2, or 3 of the pack, follow these steps: - if you are a day 1 starter: • throw out the rest of the pill pack and start a new pack that same day. - if you are a sunday starter: • keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - you may not have your period this month but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. this patient information and instructions for use has been approved by the u.s. food and drug administration. manufactured for: naari pte limited 36 robinson road, #13-01 city house, singapore 068877 issued december 2021

Združene države Amerike - angleščina - 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.

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.025 mg - norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets (chewable) 75 mg are indicated for use by women to prevent pregnancy. the efficacy of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets (chewable) 75 mg in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. 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. 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 weeks postpartum. when possible, advise the nursing mother to use other forms of contraception until she has weaned her child. estrogen-containing ocs 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 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 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) have not been studied in subjects with renal impairment. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable). 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)]. the safety and efficacy of norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) in women with a bmi > 35 kg/m2 have not been evaluated.

Združene države Amerike - angleščina - 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 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 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 norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets 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 tablets and ferrous fumarate tablets has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets has not been studied in subjects with renal impairment. the pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets 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 norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) greater than 35 kg/m2 has not been evaluated [see clinical studies (14)].

Združene države Amerike - angleščina - 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) ] .

Združene države Amerike - angleščina - 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