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

lupin pharmaceuticals, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel tablets, 0.75 mg are progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. to obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. the second tablet should be taken 12 hours later. levonorgestrel tablets, 0.75 mg are available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. levonorgestrel tablets, 0.75 mg are not indicated for routine use as a contraceptive. levonorgestrel tablets, 0.75 mg are contraindicated for use in the case of known or suspected pregnancy. many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. the few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. in general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth or development of the infant. however, isolated post-marketing cases of decreased milk production have been reported. small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. use of levonorgestrel tablets, 0.75 mg emergency contraception before menarche is not indicated. this product is not intended for use in postmenopausal women. no formal studies have evaluated the effect of race. however, clinical trials demonstrated a higher pregnancy rate in chinese women with both levonorgestrel tablets, 0.75 mg and the yuzpe regimen (another form of emergency contraception). the reason for this apparent increase in the pregnancy rate with emergency contraceptives in chinese women is unknown. no formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets, 0.75 mg. no formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets, 0.75 mg. levonorgestrel is not a controlled substance. there is no information about dependence associated with the use of levonorgestrel tablets, 0.75 mg.

Ireland - English - HPRA (Health Products Regulatory Authority)

imbat limited - levonorgestrel; ethinylestradiol; ethinylestradiol; levonorgestrel; levonorgestrel - tablet - *** awaiting value *** - progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - levonorgestrel , ethinylestradiol - tablets - levonorgestrel 0.05 mg/ethinylestradiol 0.03 mg, levonorgestrel 0.075 mg/ ethinylestradiol 0.04 mg, levonorgestrel 0.125mg/ ethinylestradiol 0.03 mg

Ireland - English - HPRA (Health Products Regulatory Authority)

famy care europe ltd - levonorgestrel ethinylestradiol - coated tablets - 100/20 microgram

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - ethinyloestradiol; levonorgestrel; levonorgestrel; ethinylestradiol; levonorgestrel; ethinylestradiol - coated tablet - . milligram(s) - progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol

Canada - English - Health Canada

bayer inc - levonorgestrel; ethinyl estradiol; levonorgestrel; ethinyl estradiol; levonorgestrel; ethinyl estradiol - tablet - 50mcg; 30mcg; 75mcg; 40mcg; 125mcg; 30mcg - levonorgestrel 50mcg; ethinyl estradiol 30mcg; levonorgestrel 75mcg; ethinyl estradiol 40mcg; levonorgestrel 125mcg; ethinyl estradiol 30mcg - contraceptives

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

physicians total care, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - seasonique® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. do not prescribe seasonique to women who are known to have the following: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]. have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.4)] . have diabetes with vascular

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

physicians total care, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - jolessa™ tablets 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 18-35 years of age during 809 completed 91-day cycles of jolessa™ 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. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic dis

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

allergan, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel 52 mg - liletta is indicated for prevention of pregnancy for up to 8 years.  liletta is indicated for the treatment of heavy menstrual bleeding for up to 5 years in patients who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed. liletta is contraindicated when one or more of the following conditions exist: pregnancy [see use in specific populations ( 8.1 ) ] for use as post-coital contraception (emergency contraception)  congenital or acquired uterine anomaly, including leiomyomas, that distorts the uterine cavity and would be incompatible with correct ius placement [see warnings and precautions ( 5.10 )] acute pelvic inflammatory disease (pid) [see warnings and precautions ( 5.4 )] postpartum endometritis or infected abortion in the past 3 months [see warnings and precautions ( 5.2 , 5.4 )] known or suspected uterine or cervical malignancy known or suspected breast cancer or other hormone-s

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

aurobindo pharma limited - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - simpesse® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. simpesse 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