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 2021, it was the 52nd most commonly prescribed medication in the United States, with more than 12million 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.ref name="pmid16860174" />[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 2021 . ClinCalc . 14 January 2024 . 15 January 2024 . https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  5. Web site: Ethinyl Estradiol; Norethindrone - Drug Usage Statistics . ClinCalc . 14 January 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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