Amerika Syarikat - Inggeris - 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 are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel 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: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] . have current or history of deep vein thrombosis or pulmonary embolism [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 or hypertension with vascular disease [see warnings and precautions (5.4)] . have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see warnings and precautions (5.7)] . - smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] . - have current or history of deep vein thrombosis or pulmonary embolism [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 or hypertension with vascular disease [see warnings and precautions (5.4)] . - have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see warnings and precautions (5.7)] . - 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) and use in specific populations (8.6)].           undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9) ].           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, levonorgestrel 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 any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets or the underlying maternal condition. safety and efficacy of levonorgestrel 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 as for users 18 years and older. use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated. levonorgestrel and ethinyl estradiol tablet has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of levonorgestrel 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 is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see contraindications (4) and warnings and precautions (5.2)] .

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

remedyrepack inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - vienva tm (levonorgestrel and ethinyl estradiol tablets, usp) is 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. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year 3 method (1) typical use 1 (2) perfect use 2 (3) (4) chance 4 85 85 spermicides 5 26 6 40 periodic abstinence 25 63 calendar 9 ovulation method 3 sympto-thermal

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - oral contraceptives are 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 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 and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. na - not available a depending on method (calendar, ovulation, symptothermal, post-ovulation) adapted from hatcher ra et al, contraceptive technology : 17th revised edition . ny, ny: ardent media, inc., 1998. combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders. a past history of deep-vein thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. thrombogenic valvulopathies

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - emergency contraceptive for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use bir th control) - if you are already pregnant (because it will not work) - for regular birth control you are taking efavirenz (hiv medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). these medications may reduce the effectiveness of levonorgestrel.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

northstar rx llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - emergency contraceptive use for women to reduce the chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) •if you are already pregnant (because it will not work) •for regular birth control taking efavirenz (hiv medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). these medications may reduce the effectiveness of levonorgestrel. the sooner you take emergency contraception, the better it works. you should use new day® within 72 hours (3 days) after you have had unprotected sex. new day® is a backup or emergency method of birth control you can use when: •your regular birth control was used incorrectly or failed •you did not use any birth control method new day® should not be used: •as a regular birth control method, because it's not as effective as regular birth control. •if you are already pregnant, because it will not work. •if you are allergic to levonorgestrel or any other ingredients in new day®.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

afaxys pharma, llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - emergency contraceptive for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) - if you are already pregnant (because it will not work) - for regular birth control  taking efavirenz (hiv medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). these medications may reduce the effectiveness of levonorgestrel.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

aurohealth llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - emergency contraceptive for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) - if you are already pregnant (because it will not work) - for regular birth control  taking efavirenz (hiv medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). these medications may reduce the effectiveness of levonorgestrel.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

aurohealth llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - emergency contraceptive for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) - if you are already pregnant (because it will not work) - for regular birth control  taking efavirenz (hiv medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). these medications may reduce the effectiveness of levonorgestrel.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

cardinal health 110, llc. dba leader - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - emergency contraceptive for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - emergency contraception use for women to reduce the chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) the sooner you take emergency contraception, the better it works. you should use her style™ within 72 hour s (3 days) after you have had unprotected sex. her style™ is a backup or emergency method of birth control you can use when: •your regular birth control was used incorrectly or failed •you did not use any birth control method her style™ should not be used: •as a regular birth control method, because it's not as effective as regular birth control. •if you are already pregnant, because it will not work. •if you are allergic to levonorgestrel or any other ingredients in her style™.