Norelgestromin/ethinylestradiol

Norelgestromin/ethinylestradiol, sold under the brand name Ortho Evra among others, is a contraceptive patch containing the progestin norelgestromin and the estrogen ethinylestradiol.[3][4] As of December 2016, the product Ortho Evra has been discontinued in the U.S. while the product Xulane continues to be marketed.[5][3][6]

Norelgestromin/ethinylestradiol
Combination of
NorelgestrominProgestogen
EthinylestradiolEstrogen
Clinical data
Trade namesOrtho Evra, Xulane, Evra
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa602006
License data
Pregnancy
category
  • US: N (Not classified yet)
  • Contraindicated
Routes of
administration
Transdermal (patch)
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
  • None
UNII
KEGG
Chemical and physical data
FormulaC41H53NO4
Molar mass623.878 g·mol−1
3D model (JSmol)

The most common side effects include headache, nausea (feeling sick), breast tenderness, and irregular uterine bleeding.[4][3]

Norelgestromin/ethinyl estradiol was approved for medical use in the United States in November 2001, and in the European Union in August 2002.[7][4]

Norelgestromin/ethinyl estradiol is a transdermal patch (a patch that delivers a medicine across the skin).[4] 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.[4] The patch-free interval must not be longer than seven days; otherwise, additional non-hormonal contraceptive methods must be used, such as condoms.[4] Transdermal patches must always be applied on the same day of the week to the buttock, abdomen (belly), upper arm or upper back.[4] The same area of skin should not be used for two consecutive patches.[4] Norelgestromin/ethinyl estradiol may work less well in women weighing 198 pounds (90 kg) or more.[4]

Medical uses

In the United States norelgestromin/ethinyl estradiol 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.[3]

In the European Union, norelgestromin/ethinyl estradiol is indicated for use as female contraception.[4]

See also

References

  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. Retrieved 4 July 2020.
  3. "Xulane- norelgestromin and ethinyl estradiol patch". DailyMed. 7 April 2020. Retrieved 4 July 2020.
  4. "Evra EPAR". European Medicines Agency (EMA). Retrieved 4 July 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. "Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) Initial U.S. Approval: 2001". DailyMed. 12 July 2018. Retrieved 4 July 2020.
  6. "Ortho Evra: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 4 July 2020.
  7. "Drug Approval Package: Ortho EVRA (Norelgestromin/Ethinyl Estradiol Transdermal System NDA #21-180". U.S. Food and Drug Administration (FDA). Retrieved 4 July 2020.


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