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

glenmark pharmaceuticals inc., usa - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - levonorgestrel and ethinyl estradiol tablets 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 or develop the following conditions: 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

New Zealand - English - Medsafe (Medicines Safety Authority)

carsl consulting - levonorgestrel 1.5mg - tablet - 1.5 mg - active: levonorgestrel 1.5mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate maize starch potato starch purified talc

Malta - English - Medicines Authority

gedeon richter plc gyomroi ut 19-21 1103 budapest, hungary - levonorgestrel - intrauterine delivery system - levonorgestrel 52 mg - other gynecologicals

Malta - English - Medicines Authority

gedeon richter plc gyomroi ut 19-21 1103 budapest, hungary - levonorgestrel - intrauterine delivery system - levonorgestrel 52 mg - other gynecologicals

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

jai pharma limited - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg

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 ).

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

actavis pharma, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - 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 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 implants, depend 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 sour

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - levonorgestrel, quantity: 1.5 mg - tablet, uncoated - excipient ingredients: maize starch; purified talc; potato starch; colloidal anhydrous silica; lactose monohydrate; magnesium stearate - emergency contraception within 72 hours of unprotected intercourse.