Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older.
NGM is rapidly and completely metabolized by first pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of NGM. 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.
Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.Safety and efficacy of norgestimate and ethinyl estradiol have been established in women of reproductive age.
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. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see Do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions:Do not use norgestimate and ethinyl estradiol in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Norgestimate and ethinyl estradiol is contraindicated in women with benign and malignant liver tumors [see Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. Generic name: NORGESTIMATE 0.18mg, ETHINYL ESTRADIOL 0.025mg; NORGESTIMATE 0.215mg, ETHINYL ESTRADIOL 0.025mg; NORGESTIMATE 0.25mg, ETHINYL ESTRADIOL 0.025mg; Start on the same day that a new pack of the previous oral contraceptive would have started.Take the tablet as soon as possible.
NGMN is bound to albumin and not to SHBG, while NG is bound primarily to SHBG. Start on the same day that a new pack of the previous oral contraceptive would have started.Take the tablet as soon as possible. However, the risk of liver cancers in COC users is less than one case per million users.During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
Subsequent hepatic metabolism of NGMN occurs and metabolites include NG, which is also active and various hydroxylated and conjugated metabolites. Then take 1 pill …
Accumulation following multiple dosing of the 0.180 mg NGM / 0.025 mg EE dose is approximately 1.5 to 2 fold for NGMN and approximately 1.5 fold for EE compared with single dose administration, in agreement with that predicted based on linear kinetics of NGMN and EE. Use of this product before menarche is not indicated.Norgestimate and ethinyl estradiol has not been studied in postmenopausal women and is not indicated in this population.The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in subjects with hepatic impairment. Irregular vaginal bleeding or spotting may happen while you are taking Tri-Lo-EstaryllaThis Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.The brands listed are the registered trademark of their respective owners and are not trademarks of Xiromed, LLC.Manufactured by Laboratorios Leon Farma S.A., SpainThe easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
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