Ethinylestradiol/norethisterone acetate
{{Short description|Pharmaceutical combination}}
{{Distinguish|Ethinylestradiol/norethisterone}}
{{Use dmy dates|date=October 2019}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| type = combo
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| component1 = Ethinylestradiol
| class1 = Estrogen
| component2 = Norethisterone acetate
| class2 = Progestogen
| tradename = Estrostep, Loestrin, Microgestin, others
| Drugs.com = {{drugs.com|ppa|ethinyl-estradiol-and-norethindrone}}
| MedlinePlus =
| DailyMedID = Norethindrone acetate and ethinyl estradiol
| pregnancy_AU =
| pregnancy_AU_comment =
| pregnancy_category =
| routes_of_administration = By mouth
| ATC_prefix = G03
| ATC_suffix = AB04
| ATC_supplemental =
| legal_AU =
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| legal_BR =
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| legal_CA = Rx-only
| legal_CA_comment = {{cite web | title=Lolo Product information | website=Health Canada | date=6 May 2024 | url=https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90215 | access-date=17 February 2025}}
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| legal_US = Rx-only
| legal_US_comment =
| legal_EU =
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| CAS_number = 8015-12-1
| CAS_supplemental =
| PubChem = 63020
| IUPHAR_ligand =
| DrugBank =
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| UNII =
| KEGG = D04483
| ChEBI =
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| 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
| StdInChI_comment =
| 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.{{cite web |title=Estrogen-Progestin Combinations Monograph for Professionals |url=https://www.drugs.com/monograph/estrogen-progestin-combinations.html |website=Drugs.com |publisher=AHFS |access-date=28 December 2018 }}{{cite journal | vauthors = Rowan JP, Simon JA, Speroff L, Ellman H | title = 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 | journal = Clin Ther | volume = 28 | issue = 6 | pages = 921–32 | date = June 2006 | pmid = 16860174 | doi = 10.1016/j.clinthera.2006.06.013 | url = }} EE is an estrogen, while norethisterone acetate (NETA) is a progestin. It is taken by mouth. Some preparations of EE/NETA used in birth control additionally contain an iron supplement in the form of ferrous fumarate.{{cite book| vauthors = Willihnganz M, Clayton AD |title=Basic Pharmacology for Nurses - E-Book|url=https://books.google.com/books?id=hO4LBAAAQBAJ&pg=PA648|date=1 May 2014|publisher=Elsevier Health Sciences|isbn=978-0-323-29309-9|pages=648–}}
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 8{{nbsp}}million prescriptions.{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=30 August 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}{{cite web | title = Ethinyl Estradiol; Norethindrone Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/EthinylEstradiolNorethindrone | access-date = 30 August 2024 }} It is available as a generic medication.{{cite web | title=Competitive Generic Therapy Approvals | website=U.S. Food and Drug Administration (FDA) | date=29 June 2023 | url=https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals | access-date=29 June 2023 | archive-date=29 June 2023 | archive-url=https://web.archive.org/web/20230629233651/https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals | url-status=live }}
Medical uses
Ethinylestradiol/norethisterone acetate is indicated for use by females of reproductive potential to prevent pregnancy.{{Cite web |title=Femlyv Full Prescribing Information |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218718s000lbl.pdf |access-date=17 January 2025 |website=Food and Drug Administration}}
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.{{cite web | title=Femhrt- norethindrone acetate/ethinyl estradiol tablet | website=DailyMed | date=14 November 2017 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fece0aa-2b9c-40a3-975e-1ef2c2ef72f2 | access-date=31 December 2019}}{{cite web |title=Drug Approval Package: Femhrt (Norethindrone Acetate & Ethinyl Estradiol) NDA #21065 |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21065_Femhrt.cfm |website=U.S. Food and Drug Administration (FDA) |access-date=28 December 2018}}
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.{{cite press release | title=FDA Roundup: July 23, 2024 | website=U.S. Food and Drug Administration (FDA) | date=23 July 2024 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-july-23-2024 | access-date=25 July 2024}} {{PD-notice}} 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,{{cite web | title=Junel 21 Day- norethindrone acetate and ethinyl estradiol tablet; Junel Fe 28 Day- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit | website=DailyMed | date=14 August 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b82ad14-580c-4145-b825-dce849f95363 | access-date=27 February 2024}} Larin, Leribane, Loestrin, Lo Loestrin (Lo Lo), Mibelas, Microgestin, Minastrin, Norlestrin, Primodos, Taytulla, and Tri-Legest, among others.{{cite web | title=Ethinyl Estradiol and Norethindrone (Professional Patient Advice) | website=Drugs.com | date=13 July 2019 | url=https://www.drugs.com/ppa/ethinyl-estradiol-and-norethindrone.html | access-date=10 April 2020}}
See also
References
{{Reflist}}
{{Birth control methods}}
{{Hormonal contraceptives}}
{{Estrogen receptor modulators}}
{{Progesterone receptor modulators}}
{{Portal bar | Medicine}}
{{Authority control}}
{{DEFAULTSORT:Ethinylestradiol Norethisterone Acetate}}