Ethinylestradiol/norethisterone acetate explained

Type:combo
Component1:Ethinylestradiol
Class1:Estrogen
Component2:Norethisterone acetate
Class2:Progestogen
Tradename:Estrostep, Loestrin, Microgestin, others
Dailymedid:Norethindrone acetate and ethinyl estradiol
Routes Of Administration:By mouth
Atc Prefix:G03
Atc Suffix:AA05
Legal Us:Rx-only
Pubchem:63020
Kegg:D04483
Synonyms:EE/NETA
Smiles:CC(=O)OC1(CCC2C1(CCC3C2CCC4=CC(=O)CCC34)C)C#C.CC12CCC3C(C1CCC2(C#C)O)CCC4=C3C=CC(=C4)O
Stdinchi:1S/C22H28O3.C20H24O2/c1-4-22(25-14(2)23)12-10-20-19-7-5-15-13-16(24)6-8-17(15)18(19)9-11-21(20,22)3;1-3-20(22)11-9-18-17-6-4-13-12-14(21)5-7-15(13)16(17)8-10-19(18,20)2/h1,13,17-20H,5-12H2,2-3H3;1,5,7,12,16-18,21-22H,4,6,8-11H2,2H3/t17-,18+,19+,20-,21-,22-;16-,17-,18+,19+,20+/m01/s1
Stdinchikey:GEONECATAKDDLT-JDSZYESASA-N

Ethinylestradiol/norethisterone acetate (EE/NETA), or ethinylestradiol/norethindrone acetate, is a combination of ethinylestradiol (EE) and norethisterone acetate (NETA) which is used as birth control and menopausal hormone therapy.[1] [2] EE is an estrogen, while norethisterone acetate (NETA) is a progestin.[1] It is taken by mouth.[1] Some preparations of EE/NETA used in birth control additionally contain an iron supplement in the form of ferrous fumarate.[3]

Norethindrone acetate and ethinyl estradiol have been approved in the US for the prevention of pregnancy as a swallowable tablet since 1968. In 2022, the combination of ethinylestradiol with norethisterone or with norethisterone acetate was the 80th most commonly prescribed medication in the United States, with more than 8million prescriptions.[4] [5] It is available as a generic medication.[6]

Medical uses

Ethinylestradiol/norethisterone acetate is indicated for use by females of reproductive potential to prevent pregnancy.[7]

Ethinylestradiol/norethisterone acetate is also indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with the menopause; and for prevention of postmenopausal osteoporosis.[8] [9]

Society and culture

Legal status

In July 2024, the US Food and Drug Administration (FDA) approved Femlyv, the first orally disintegrating tablet for the prevention of pregnancy.[10] Norethindrone acetate and ethinyl estradiol have been approved in the US for the prevention of pregnancy as a swallowable tablet since 1968.

Brand names

Brand names include Anovlar, Blisovi, Cumorit, Estrostep, Femhrt, Femlyv, Fyavolv, Gildess, Junel,[11] Larin, Leribane, Loestrin, Lo Loestrin (Lo Lo), Mibelas, Microgestin, Minastrin, Norlestrin, Primodos, Taytulla, and Tri-Legest, among others.[12]

See also

Notes and References

  1. Web site: Estrogen-Progestin Combinations Monograph for Professionals . Drugs.com . AHFS . 28 December 2018 .
  2. Rowan JP, Simon JA, Speroff L, Ellman H . Effects of low-dose norethindrone acetate plus ethinyl estradiol (0.5 mg/2.5 microg) in women with postmenopausal symptoms: updated analysis of three randomized, controlled trials . Clin Ther . 28 . 6 . 921–32 . June 2006 . 16860174 . 10.1016/j.clinthera.2006.06.013 .
  3. Book: Willihnganz M, Clayton AD . Basic Pharmacology for Nurses - E-Book. 1 May 2014. Elsevier Health Sciences. 978-0-323-29309-9. 648–.
  4. Web site: The Top 300 of 2022 . ClinCalc . 30 August 2024 . 30 August 2024 . https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  5. Web site: Ethinyl Estradiol; Norethindrone Drug Usage Statistics, United States, 2013 - 2022 . ClinCalc . 30 August 2024 .
  6. Web site: Competitive Generic Therapy Approvals . U.S. Food and Drug Administration (FDA) . 29 June 2023 . 29 June 2023 . 29 June 2023 . https://web.archive.org/web/20230629233651/https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals . live .
  7. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218718s000lbl.pdf
  8. Web site: Femhrt- norethindrone acetate/ethinyl estradiol tablet . DailyMed . 14 November 2017 . 31 December 2019.
  9. Web site: Drug Approval Package: Femhrt (Norethindrone Acetate & Ethinyl Estradiol) NDA #21065 . U.S. Food and Drug Administration (FDA) . 28 December 2018.
  10. FDA Roundup: July 23, 2024 . U.S. Food and Drug Administration (FDA) . 23 July 2024 . 25 July 2024.
  11. Web site: Junel 21 Day- norethindrone acetate and ethinyl estradiol tablet; Junel Fe 28 Day- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit . DailyMed . 14 August 2023 . 27 February 2024.
  12. Web site: Ethinyl Estradiol and Norethindrone (Professional Patient Advice) . Drugs.com . 13 July 2019 . 10 April 2020.

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