Egyesült Államok - angol - 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

Egyesült Államok - angol - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - norgestimate and ethinyl estradiol tablets usp are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. norgestimate 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 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 migraine headaches with aura [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - 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 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 (5.8)] - 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)] - 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 administer 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 norgestimate and ethinyl estradiol tablets have been established in women of reproductive age. efficacy is expected to be the same for post pubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. norgestimate and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. the pharmacokinetics of norgestimate and ethinyl estradiol 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 pharmacokinetics of norgestimate and ethinyl estradiol tablets has not been studied in women with renal impairment.

Egyesült Államok - angol - NLM (National Library of Medicine)

a-s medication solutions - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel and ethinyl estradiol tablets, usp 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. % 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 25 63      calendar 9      ovulation method 3      sympto-thermal6 2      post-ovulation 1 cap7      parous women 40 26 42      nulliparous women 20 9 56 sponge      parous women 40 20 42      nulliparous women 20 9 56 diaphragm

Egyesült Államok - angol - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3) - ethinyl estradiol 0.02 mg - bekyree (desogestrel and ethinyl estradiol tablets usp and ethinyl estradiol tablets usp) 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 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, depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. adapted from hatcher et al., 1998, ref#1. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebral vascular or coronary artery disease - known or suspected carcinoma of the breast - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - un

Egyesült Államok - angol - 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 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. in a 1-year controlled clinical trial, 4 pregnancies occurred in women 18 to 35 years of age during 809 completed 91-day cycles of levonorgestrel and ethinyl estradiol tablets during which no backup contraception was utilized. this represents an overall use-efficacy (typical user efficacy) pregnancy rate of 1.98 per 100 women-years of use. oral contraceptives are highly effective for pregnancy prevention. 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 norplant® implant system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. source: trussell j, contraceptive efficacy. in hatcher ra, trussell j, stew

Egyesült Államok - angol - 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)] .

Egyesült Államok - angol - 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 ).

Egyesült Államok - angol - 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) ].

Egyesült Államok - angol - NLM (National Library of Medicine)

glenmark generics inc., usa - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - norgestimate and ethinyl estradiol tablets usp 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 for pregnancy prevention. 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 the norplant system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. method typical use§ perfect use¶ norgestimate and ethinyl estradiol tablets usp have not been studied for and are not indicated for use in emergency contraception. in clinical trials with norgestimate and ethinyl estradiol tablets, 1,651 subjects completed 24,272 cycles and the overall use-efficacy (typical user efficacy) pregnancy rate was approximately 1 pregnancy per 100 women-years. this rate includes patients who d

Egyesült Államok - angol - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg and norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)]. norgestimate and ethinyl estradiol tablets 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