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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include females who are known to:    ο   smoke, if over age 35 [see boxed warning and warnings and precautions (5.1) ] ο   have current or history of deep vein thrombosis or pulmonary embolism. [see warnings and precautions (5.1) ]   ο   have cerebrovascular disease [see warnings and precautions (5.1) ]  ο   have coronary artery disease [see warnings and precautions (5.1) ]  ο   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) ]  ο   have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1) ] ο   have uncontrolled hypertension or hypertension with vascular disease [see warnings and precautions (5.5) ] ο   have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see warnings and precautions (5.7) ] ο   have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [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) ] - liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see warnings and precautions (5.2) ]. - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8) ] - 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 (5.4) ]. risk summary there is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets 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 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 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 (2.1) ].the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or the underlying maternal condition. safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have been established in women of reproductive age. safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. use of this product before menarche is not indicated.  levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. however, cocs may be poorly metabolized in patients with hepatic impairment. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see contraindications (4) and warnings and precautions (5.2) ]. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets how do i take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets? - take one pill every day at the same time. if you miss pills you could get pregnant. this includes starting the pack late. the more pills you miss, the more likely you are to get pregnant. - many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if it doesn't go away, check with 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, you could also feel a little sick to your stomach. - if you have trouble remembering to take levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control. before you start taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets - decide what time of day you want to take your pill. it is important to take it at about the same time every day. - look at your extended-cycle wallet. your wallet consists of blister strips that hold 91 individually sealed pills (a 13-week or 91-day cycle). the 91 pills consist of 84 orange pills and 7 mustard pills. blister strip 1 and 2 each contain 28 orange pills (4 rows of 7 pills). blister strip 3 contains 35 pills consisting of 28 orange pills (4 rows of 7 pills) and 7 mustard pills (1 row of 7 pills). 3.  also find: - where on the first strip in the pack to start taking pills (upper left corner at the start arrow) and - in what order to take the pills (follow the weeks and arrow). 4.  be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills. when to start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets - take the first orange pill on the sunday after your period starts, even if you are still bleeding. if your period begins on sunday, start the first orange pill that same day. - use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the sunday you start your first orange pill until the next sunday (first 7 days). if you are switching from another birth control method: if you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days. if you have recently given birth and have not yet had a period , use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days. how to take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets - take one pill at the same time every day until you have taken the last pill in the wallet. do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). do not skip pills even if you do not have sex very often. - do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). - do not skip pills even if you do not have sex very often. - when you finish a wallet after taking the last mustard pill, start taking the first orange pill from a new extended-cycle wallet the very next day (this should be on a sunday) regardless of when your period started. - after taking the last mustard pill, start taking the first orange pill from a new extended-cycle wallet the very next day (this should be on a sunday) regardless of when your period started. - if you miss your scheduled period when you are taking the mustard pills, contact your healthcare provider because you may be pregnant. if you are pregnant, you should stop taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. what to do if you miss pills if you miss 1 orange pill: - 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. - you do not need to use a back-up birth control method if you have sex. if you miss 2 orange pills in a row: - take 2 pills on the day you remember, and 2 pills the next day. - then take 1 pill a day until you finish the pack. - you could become pregnant if you have sex in the 7 days after you miss two pills. you must use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills. if you miss 3 or more orange pills in a row: - do not take the missed pills. keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. for example: if you resume taking the pill on thursday, take the pill under "thursday" and do not take the missed pills. you may experience bleeding during the week following the missed pills. - you could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. - you must use a non-hormonal birth control method (such as condoms or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. if you do not have your period when you are taking the mustard pills, call your healthcare provider because you may be pregnant. if you miss any of the 7 mustard pills: - throw away the missed pills. - keep taking the scheduled pills until the pack is finished. - you do not need a back-up method of birth control. finally, if you are still not sure what to do about the pills you have missed - use a back-up method anytime you have sex. - keep taking one pill each day until you contact your healthcare provider. 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. distributed by: lupin pharmaceuticals, inc. baltimore, maryland 21202 united states manufactured by: lupin limited pithampur (m.p.) - 454 775 india revised: september 2023                                                                              id#: 274539

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

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets usp and ethinyl estradiol tablets usp are indicated for use by women to prevent pregnancy. do not prescribe levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol 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            •  have deep vein thrombosis or pulmonary embolism, now or in the past            •  have cerebrovascular disease            •  have coronary artery disease            •  have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)            •  have hypercoagulopathies            •  have uncontrolled hypertension            •  have diabetes with vascular disease            •  have headaches with focal neurological symptoms or have migraine headaches with or without aura if ove

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

mayne pharma inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive age to prevent pregnancy. do not prescribe levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol 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 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 h

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

central texas community health centers - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets usp, 0.1 mg and 0.02 mg 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 ii 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, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. emergency contraceptive pills: the fda has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactation amenorrhea method: lam is a highly effective, temporary method of contraceptio

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets 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 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. contraceptive hormones and/or metabolites are present in human milk. cocs can red

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have the following conditions:

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel 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 2 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, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. table 2: percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. united states. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year3 method typical use1 perfect use2 (1) (2) (3) (4) chance4 85 85 spermicides5 26 6 40 periodic abstinence 2

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

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel and ethinyl estradiol tablets usp, 0.1 mg and 0.02 mg 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 ii 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, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. emergency contraceptive pills: the fda has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactation amenorrhea method: lam is a highly effective, temporary method of contraceptio

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel and ethinyl estradiol tablets usp, 0.1 mg and 0.02 mg 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 ii 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, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. emergency contraceptive pills: the fda has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactation amenorrhea method: lam is a highly effective, temporary method of contraceptio

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel and ethinyl estradiol tablets usp, 0.1 mg and 0.02 mg 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 ii 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, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. emergency contraceptive pills: the fda has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactation amenorrhea method: lam is a highly effective, temporary method of contraception.10 source: trussell j. contraceptive efficacy. in: hatcher ra, trussell j, stewart f, cates w, stewart gk, kowel d, guest f. contraceptive technology: seventeenth revised edition. new york ny: irvington publishers; 1998. 1 among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 the percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within one year. this estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 foams, creams, gels, vaginal suppositories, and vaginal film. 6 cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 with spermicidal cream or jelly. 8 without spermicides. 9 the treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. the fda has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10 however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. in a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. this represents an overall pregnancy rate of 0.84 per 100 woman-years. this rate includes patients who did not take the drug correctly. one or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: thrombophlebitis or thromboembolic disorders a history of deep-vein thrombophlebitis or thromboembolic disorders cerebrovascular or coronary artery disease (current or past history) valvular heart disease with thrombogenic complications thrombogenic rhythm disorders hereditary or acquired thrombophilias major surgery with prolonged immobilization diabetes with vascular involvement headaches with focal neurological symptoms uncontrolled hypertension current diagnosis of, or history of, breast cancer, which may be hormonesensitive carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia undiagnosed abnormal genital bleeding cholestatic jaundice of pregnancy or jaundice with prior pill use hepatic adenomas or carcinomas, or active liver disease known or suspected pregnancy hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol tablets. are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations (see warnings , risk of liver enzyme elevations with concomitant hepatitis c treatment ).