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Norelgestromin/ethinylestradiol

From Wikipedia, the free encyclopedia
(Redirected from Ortho Evera)

Norelgestromin/ethinylestradiol
Combination of
NorelgestrominProgestogen
EthinylestradiolEstrogen
Clinical data
Trade namesOrtho Evra, Xulane, Evra, others
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa602006
License data
Pregnancy
category
  • Contraindicated
Routes of
administration
Transdermal (patch)
ATC code
Legal status
Legal status
Identifiers
PubChem CID
ChemSpider
  • None
KEGG
Chemical and physical data
FormulaC41H53NO4
Molar mass623.878 g·mol−1
3D model (JSmol)
  • CCC12CCC3C(C1CCC2(C#C)O)CCC4=CC(=NO)CCC34.CC12CCC3C(C1CCC2(C#C)O)CCC4=C3C=CC(=C4)O
  • InChI=1S/C21H29NO2.C20H24O2/c1-3-20-11-9-17-16-8-6-15(22-24)13-14(16)5-7-18(17)19(20)10-12-21(20,23)4-2;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/h2,13,16-19,23-24H,3,5-12H2,1H3;1,5,7,12,16-18,21-22H,4,6,8-11H2,2H3/b22-15-;/t16-,17+,18+,19-,20-,21-;16-,17-,18+,19+,20+/m01/s1
  • Key:KBFRRZPPJPKFHQ-WKXKRCMPSA-N

Norelgestromin/ethinylestradiol, sold under the brand name Ortho Evra among others, is a contraceptive patch containing the progestin norelgestromin and the estrogen ethinylestradiol.[4][6][7]

The most common side effects include headache, nausea (feeling sick), breast tenderness, and irregular uterine bleeding.[6][4]

Norelgestromin/ethinylestradiol is a transdermal patch (a patch that delivers a medicine across the skin).[6] For the first three weeks of the menstrual cycle a new patch should be applied every week, followed by a fourth week, which is patch-free.[6] The patch-free interval must not be longer than seven days; otherwise, additional non-hormonal contraceptive methods must be used, such as condoms.[6] Transdermal patches must always be applied on the same day of the week to the buttock, abdomen (belly), upper arm or upper back.[6] The same area of skin should not be used for two consecutive patches.[6] Norelgestromin/ethinylestradiol may work less well in women weighing 198 pounds (90 kg) or more.[6]

Norelgestromin/ethinylestradiol was approved for medical use in the United States in November 2001, and in the European Union in August 2002.[8][6] It is available as a generic medication.[4][9] In 2023, the combination was the 285th most commonly prescribed medication in the United States, with more than 600,000 prescriptions.[10][11]

Medical uses

[edit]

In the United States, norelgestromin/ethinylestradiol is indicated for the prevention of pregnancy in women with a BMI < 30 kg/m2 for whom a transdermal delivery system is an appropriate method of contraception.[4]

In the European Union, norelgestromin/ethinylestradiol is indicated for use as female contraception.[6]

See also

[edit]

References

[edit]
  1. "Evra Product information". Health Canada. 21 June 2018. Retrieved 17 February 2020.
  2. "Evra transdermal patch - Summary of Product Characteristics (SmPC)". (emc). 26 June 2020. Archived from the original on 24 October 2020. Retrieved 4 July 2020.
  3. "Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) Initial U.S. Approval: 2001". DailyMed. 12 July 2018. Retrieved 4 July 2020.
  4. 1 2 3 4 5 "Xulane- norelgestromin and ethinyl estradiol patch". DailyMed. 7 April 2020. Retrieved 4 July 2020.
  5. "Ortho Evra: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 30 April 2017. Retrieved 4 July 2020.
  6. 1 2 3 4 5 6 7 8 9 10 "Evra EPAR". European Medicines Agency (EMA). 5 August 2008. Retrieved 4 July 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. Graziottin A (2006). "A review of transdermal hormonal contraception : focus on the ethinylestradiol/norelgestromin contraceptive patch". Treatments in Endocrinology. 5 (6): 359–65. doi:10.2165/00024677-200605060-00004. PMID 17107221. S2CID 21033630.
  8. "Drug Approval Package: Ortho EVRA (Norelgestromin/Ethinyl Estradiol Transdermal System NDA #21-180". U.S. Food and Drug Administration (FDA). Archived from the original on 19 January 2017. Retrieved 4 July 2020.
  9. "Xulane (Norelgestromin and Ethinyl Estradiol Transdermal System), 150 mcg/35 mcg per day" (PDF). Abbreviated New Drug Application. U.S. Food and Drug Administration. 16 April 2014.
  10. "The Top 300 of 2023". ClinCalc. Archived from the original on 17 August 2025. Retrieved 17 August 2025.
  11. "Ethinyl Estradiol; Norelgestromin Drug Usage Statistics, United States, 2014 - 2023". ClinCalc. Retrieved 17 August 2025.