Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - ethinyl estradiol 0.03 mg - drospirenone and ethinyl estradiol tablets usp are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following:      •      renal impairment      •      adrenal insufficiency       •      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) ]            

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - ethinyl estradiol 0.03 mg - drospirenone and ethinyl estradiol tablets usp are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following:      •      renal impairment      •      adrenal insufficiency       •      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) ]          

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

prasco laboratories - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only etonogestrel/ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. etonogestrel/ethinyl estradiol vaginal ring 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 warnin

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - drospirenone and ethinyl estradiol tablet usp is indicated for use by women to prevent pregnancy. drospirenone and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: - renal impairment - adrenal insufficiency  - 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

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - drospirenone and ethinyl estradiol tablet usp is indicated for use by females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: - renal impairment - adrenal insufficiency  - 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 (5.6) ] - ○        have diabetes mellitus with vascular disease [see warnings and precautions (5.8) ] - ○        have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and  precautions (5.9) ] - undiagnosed abnormal uterine      bleeding [see warnings and precautions      (5.10) ] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings      and precautions (5.3) ] - liver tumor (benign or      malignant) or liver disease [see warnings and      precautions (5.4) and use in specific      populations (8.7) ] - 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 (5.5) and drug      interactions (7.2) ]. risk summary there is no use for contraception in pregnancy, therefore drospirenone and ethinyl estradiol tablets should be discontinued during 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 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 a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone and ethinyl estradiol tablets usp in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. risk summary drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone and ethinyl estradiol tablets on the breast-fed infant. chcs 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 also dosage and administration (2.2)]. the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for drospirenone and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from drospirenone and ethinyl estradiol tablets or from the underlying maternal condition. data human data an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months post- partum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. safety and efficacy of drospirenone and ethinyl estradiol tablets have been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. drospirenone and ethinyl estradiol tablets are contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2) ]. in subjects with creatinine clearance (clcr) of 50 to 79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of   30 to 49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see clinical pharmacology (12.3) ]. drospirenone and ethinyl estradiol tablets are contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4) ]. the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone and ethinyl estradiol tablets have not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3) ].

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

a-s medication solutions - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only etonogestrel/ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. etonogestrel/ethinyl estradiol vaginal ring 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 (5.5)] have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - 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 (5.5)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - liver tumors, benign or malignant or liver disease [see warnings and precautions (5.3) and use in specific populations (8.6)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.11)] - pregnancy, because there is no reason to use chcs during pregnancy [see use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.14)] - hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of etonogestrel/ethinyl estradiol vaginal ring [see warnings and precautions (5.6) and adverse reactions (6)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for alt elevations [see warnings and precautions (5.4)] risk summary etonogestrel/ethinyl estradiol vaginal ring is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day). no adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). discontinue etonogestrel/ethinyl estradiol vaginal ring use if pregnancy is confirmed. data animal data in rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). no adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. when desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. no adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. risk summary small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. harmful effects have not been observed in breastfed infants exposed to chcs through breast milk. chcs 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. when possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for etonogestrel/ethinyl estradiol vaginal ring and any potential adverse effects on the breastfed child from etonogestrel/ethinyl estradiol vaginal ring or from the underlying maternal condition. safety and efficacy of etonogestrel/ethinyl estradiol vaginal ring have been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. etonogestrel/ethinyl estradiol vaginal ring has not been studied in postmenopausal women and is not indicated in this population. the effect of hepatic impairment on the pharmacokinetics of etonogestrel/ethinyl estradiol vaginal ring has not been studied. steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of chc use until markers of liver function return to normal. [see contraindications (4) and warnings and precautions (5.3).] the effect of renal impairment on the pharmacokinetics of etonogestrel/ethinyl estradiol vaginal ring has not been studied. instructions for use etonogestrel/ethinyl estradiol vaginal ring read these instructions for use before you start using etonogestrel/ethinyl estradiol vaginal ring and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your treatment. how should i start using etonogestrel/ethinyl estradiol vaginal ring? if you are not currently using hormonal birth control, you have 2 ways to start using etonogestrel/ethinyl estradiol vaginal ring. choose the best way for you: - first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. if you are changing from a birth control pill or patch to etonogestrel/ethinyl estradiol vaginal ring: if you have been using your birth control method correctly and are certain that you are not pregnant, you can change to etonogestrel/ethinyl estradiol vaginal ring any day. do not start etonogestrel/ethinyl estradiol vaginal ring any later than the day you would start your next birth control pill or apply your patch. if you are changing from a progestin-only birth control method, such as a minipill, implant or injection or from an intrauterine system (ius): - you may switch from a minipill on any day. start using etonogestrel/ethinyl estradiol vaginal ring on the day that you would have taken your next minipill. - you should switch from an implant or the ius and start using etonogestrel/ethinyl estradiol vaginal ring on the day that you remove the implant or ius. - you should switch from an injectable and start using etonogestrel/ethinyl estradiol vaginal ring on the day when your next injection would be due. if you are changing from a minipill, implant or injection or from an intrauterine system (ius), you should use an extra method of birth control, such as a male condom with spermicide during the first 7 days of using etonogestrel/ethinyl estradiol vaginal ring. if you start using etonogestrel/ethinyl estradiol vaginal ring after an abortion or miscarriage: - following a first trimester abortion or miscarriage: you may start etonogestrel/ethinyl estradiol vaginal ring within 5 days following a first trimester abortion or miscarriage (the first 12 weeks of pregnancy). you do not need to use an additional birth control method. - if you do not start etonogestrel/ethinyl estradiol vaginal ring within 5 days after a first trimester abortion or miscarriage, use a non-hormonal birth control method, such as male condoms and spermicide, while you wait for your period to start. begin etonogestrel/ethinyl estradiol vaginal ring at the time of your next menstrual period. count the first day of your menstrual period as "day 1" and start etonogestrel/ethinyl estradiol vaginal ring one of the following 2 ways below. first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. - first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. - following a second trimester abortion or miscarriage: you may start using etonogestrel/ethinyl estradiol vaginal ring no sooner than 4 weeks (28 days) after a second trimester abortion (after the first 12 weeks of pregnancy). if you are starting etonogestrel/ethinyl estradiol vaginal ring after childbirth: - you may start using etonogestrel/ethinyl estradiol vaginal ring no sooner than 4 weeks (28 days) after having a baby if you are not breastfeeding. - if you have not gotten your menstrual period after childbirth, you should talk to your healthcare provider. you may need a pregnancy test to make sure you are not pregnant before you start using etonogestrel/ethinyl estradiol vaginal ring. - use another birth control method such as male condoms with spermicide for the first 7 days in addition to etonogestrel/ethinyl estradiol vaginal ring. if you are breastfeeding you should not use etonogestrel/ethinyl estradiol vaginal ring. use other birth control methods until you are no longer breastfeeding. step 1. choose a position for insertion of etonogestrel/ethinyl estradiol vaginal ring. - choose the position that is comfortable for you. for example, lying down, squatting, or standing with 1 leg up (see figures a, b, and c) . positions for etonogestrel/ethinyl estradiol vaginal ring insertion step 2. open the pouch to remove your etonogestrel/ethinyl estradiol vaginal ring. - each etonogestrel/ethinyl estradiol vaginal ring comes in a re-sealable foil pouch. - wash and dry your hands before removing etonogestrel/ethinyl estradiol vaginal ring from the foil pouch. - open the foil pouch at either notch near the top. - keep the foil pouch so you can place your used etonogestrel/ethinyl estradiol vaginal ring in it before you throw it away in your household trash. step 3. prepare etonogestrel/ethinyl estradiol vaginal ring for insertion. - hold etonogestrel/ethinyl estradiol vaginal ring between your thumb and index finger and press the sides of the ring together (see figures d and e) . step 4. insert etonogestrel/ethinyl estradiol vaginal ring into your vagina. - insert the folded etonogestrel/ethinyl estradiol vaginal ring into your vagina and gently push it further up into your vagina using your index finger (see figures f and g) . - when you insert etonogestrel/ethinyl estradiol vaginal ring it may be in different positions in your vagina, but etonogestrel/ethinyl estradiol vaginal ring does not have to be in an exact position for it to work (see figures h and i) . - etonogestrel/ethinyl estradiol vaginal ring may move around slightly within your vagina. this is normal. although some women may be aware of etonogestrel/ethinyl estradiol vaginal ring in the vagina, most women do not feel it when it is in place. inserting etonogestrel/ethinyl estradiol vaginal ring (figure f, figure g) and positioning etonogestrel/ethinyl estradiol vaginal ring (figure h, figure i) note: - if the etonogestrel/ethinyl estradiol vaginal ring feels uncomfortable, you may not have pushed the ring into your vagina far enough. use your finger to gently push the etonogestrel/ethinyl estradiol vaginal ring as far as you can into your vagina. there is no danger of etonogestrel/ethinyl estradiol vaginal ring being pushed too far up in the vagina or getting lost (see figure g). - some women have accidentally inserted etonogestrel/ethinyl estradiol vaginal ring into their bladder. if you have pain during or after insertion and you cannot find etonogestrel/ethinyl estradiol vaginal ring in your vagina, call your healthcare provider right away. - regularly check that etonogestrel/ethinyl estradiol vaginal ring is in your vagina (for example, before and after intercourse) to ensure you are protected from pregnancy. step 5. how do i remove etonogestrel/ethinyl estradiol vaginal ring? - wash and dry your hands. - choose the position that is most comfortable for you (see figures a, b, and c). - put your index finger into your vagina and hook it through the etonogestrel/ethinyl estradiol vaginal ring. gently pull downward and forward to remove the etonogestrel/ethinyl estradiol vaginal ring and pull it out (see figure j).                                     figure j step 6. throw away the used etonogestrel/ethinyl estradiol vaginal ring. - place the used etonogestrel/ethinyl estradiol vaginal ring in the re-sealable foil pouch and put it in a trash can out of the reach of children and pets. - do not throw etonogestrel/ethinyl estradiol vaginal ring in the toilet. what else should i know about using etonogestrel/ethinyl estradiol vaginal ring? what if i leave etonogestrel/ethinyl estradiol vaginal ring in too long? - if you leave etonogestrel/ethinyl estradiol vaginal ring in your vagina for up to 4 weeks (28 days) you will still be getting pregnancy protection. remove your old etonogestrel/ethinyl estradiol vaginal ring for 1 week (7 days) and insert a new etonogestrel/ethinyl estradiol vaginal ring 1 week (7 days) later (see steps 1 through 4) . - if you leave etonogestrel/ethinyl estradiol vaginal ring in your vagina longer than 4 weeks (28 days), remove the ring and check to make sure you are not pregnant. if you are not pregnant, insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4) . you must use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row. what should i do if my etonogestrel/ethinyl estradiol vaginal ring comes out of my vagina? etonogestrel/ethinyl estradiol vaginal ring can slip or accidentally come out (expelled) of your vagina, for example, during sexual intercourse, bowel movements, use of tampons, or if it breaks. - etonogestrel/ethinyl estradiol vaginal ring may break causing the ring to lose its shape. if the ring stays in your vagina this should not lower etonogestrel/ethinyl estradiol vaginal ring's effectiveness at preventing pregnancy. if etonogestrel/ethinyl estradiol vaginal ring breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4). - if etonogestrel/ethinyl estradiol vaginal ring breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. - insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4). - you should pay attention when removing a tampon to be sure that your etonogestrel/ethinyl estradiol vaginal ring is not accidentally pulled out. be sure to insert etonogestrel/ethinyl estradiol vaginal ring before inserting a tampon. if you accidentally pull out your etonogestrel/ethinyl estradiol vaginal ring while using tampons, rinse your etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - be sure to insert etonogestrel/ethinyl estradiol vaginal ring before inserting a tampon. - if you accidentally pull out your etonogestrel/ethinyl estradiol vaginal ring while using tampons, rinse your etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - etonogestrel/ethinyl estradiol vaginal ring can be pushed out of (expelled from) your vagina, for example, during sexual intercourse or during a bowel movement. if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. if the expelled etonogestrel/ethinyl estradiol vaginal ring has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - if the expelled etonogestrel/ethinyl estradiol vaginal ring has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. - during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - if etonogestrel/ethinyl estradiol vaginal ring was out of the vagina for an unknown amount of time, you may not be protected from pregnancy. perform a pregnancy test prior to inserting a new ring and consult your healthcare provider. this patient information and instructions for use have been approved by the u.s. food and drug administration.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following: - renal impairment - adrenal insufficiency - 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 (5.5)] have d

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone and ethinyl estradiol tablets for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - 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  

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - 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 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 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