Mifepristone/misoprostol

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Mifepristone/misoprostol
200 mg mifepristone (top) and 800 μg misoprostol (bottom), is the typical regimen for early medical abortion
Combination of
MifepristoneProgesterone receptor antagonist
MisoprostolProstaglandin E1
Names
Trade namesMifegymiso,[1] Medabon Combipack,[2] others
Clinical data
Main usesBring about abortion[3]
Side effectsNausea, upset stomach, uterine cramps, vaginal bleeding[4]
Routes of
use
By mouth, vaginally[4]
Typical doseMifepristone 200 mg[5]
Misoprostol 800 mcg[5]
Legal
Legal status

Mifepristone/misoprostol, also known as Mifeprex/Cytotec, are two medications packaged together and primarily used to bring about medical abortion.[3] It is a common method of abortions up to 11 weeks of pregnancy; though may also be used in the second trimester.[4][9] They can also be used for early pregnancy loss up to 12 weeks.[4] Pregnancy testing or ultrasound can confirm success.[4] They may be taken by mouth or placed under the tongue.[3][10] Use in the first trimester can generally take place at home and can be prescribed by a family doctor, including by telehealth; while in the second trimester hospitalization is recommended.[4][9]

Side effects may include nausea, upset stomach, and mild fever.[4] Uterine cramps and vaginal bleeding are expected.[4] Heavy bleeding, ongoing pregnancy, and infection may rarely occur.[4] It does not affect the risk of mental health problems, breast cancer, or infertility.[4] It contains mifepristone, a progesterone receptor antagonist which results in breakdown of the decidua; and misoprostol, a prostaglandin E1 that results in cervical ripening and uterine contractions.[4]

Mifepristone came into use in France in 1987 and the United States in 2000.[11][12] It became available as a generic medication in 2019.[12] Misoprostol was developed in 1973.[13] The combination is on the World Health Organization's List of Essential Medicines.[14] In the United States the medications can cost more than 500 USD as of 2023; though charities may provide for free or at low cost.[15][16][17] While in Canada it is about 300 to 450 CAD; though is covered for Canadians.[18] In low and middle income countries the cost ranged from 4 to 36 USD as of 2018.[19]

Medical uses

An ultrasound is only required before us in those who are at risk of an ectopic pregnancy or those in who the pregnancy dates are unclear.[4] For abortion effectiveness is greater than 95%.[4] For early pregnancy loss, the combination is better than misoprostol alone.[4]

It may also be used at 13–24 weeks of gestation, but it is generally recommended that this be done in hospital due to high risks of significant bleeding.[9] As the uterus is more sensitive to misoprostol often typical doses are sufficient.[9]

Rho(D) immune globulin may be given in those who are Rh negative but it is unclear if this is needed.[4]

Beta hCG should decrease by 80% after 1 week.[4]

Dosage

In the early first trimester it is taken as mifepristone 200 mg by mouth, followed one to two days later by misoprostol 800 mcg under the tongue or in the vagina.[5][10] While misoprostol can be placed under the tongue or in the vagina, under the tongue appears more effective.[4][10]

For those after 9 weeks a second dose of misoprostol may be used.[4] For those 13 to 24 weeks, the 800 ucg dose of misoprostol may be followed by 400 ucg every 3 hours up to 4 times.[9]

Side effects

Side effects may include nausea, mild fever, and upset stomach.[4] Uterine cramps and vaginal bleeding are expected.[4] These begin within a few hours and are significant for about 4 hours.[4] Some bleeding may occur for 16 days.[4] NSAIDs can help with these side effects.[4]

Heavy bleeding, ongoing pregnancy, and infection may rarely occur.[4] It does not affect the risk of mental health problems, breast cancer, or infertility.[4]

Society and culture

The combination became available in Canada in 2017.[20] Linepharma was the only company that sells the medication there as of 2023.[20] It is used about 50,000 to 80,000 times per year in Canada.[20]

References

  1. Linepharma International Limited (15 April 2019). "Mifegymiso Product Monograph" (PDF). Health Canada. Archived (PDF) from the original on 22 March 2023. Retrieved 10 September 2023.
  2. "Medabon - Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets - Summary of Product Characteristics (SmPC)". Electronic Medicines Compendium (EMC). 3 February 2020. Archived from the original on 9 June 2021. Retrieved 19 January 2021.
  3. 3.0 3.1 3.2 "eEML - Electronic Essential Medicines List". list.essentialmeds.org. Archived from the original on 4 June 2023. Retrieved 8 September 2023.
  4. 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 4.21 4.22 4.23 4.24 Macnaughton, H; Nothnagle, M; Early, J (15 April 2021). "Mifepristone and Misoprostol for Early Pregnancy Loss and Medication Abortion". American family physician. 103 (8): 473–480. PMID 33856168. Archived from the original on 19 October 2023. Retrieved 6 December 2023.
  5. 5.0 5.1 5.2 "Mifepristone and misoprostol: Recommended regimen". Ipas. Archived from the original on 22 April 2023. Retrieved 10 September 2023.
  6. "Mifepristone/misoprostol: List of nationally authorised medicinal products" (PDF). European Medicines Agency. 14 January 2021. PSUSA/00010378/202005. Archived (PDF) from the original on 16 September 2023. Retrieved 18 August 2023.
  7. "Medabon - Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets - Summary of Product Characteristics (SmPC)". Electronic Medicines Compendium (EMC). 3 February 2020. Archived from the original on 9 June 2021. Retrieved 19 January 2021.
  8. "The Abortion Pill | Get the Facts About Medication Abortion". Planned Parenthood. Archived from the original on 2023-08-16. Retrieved 2023-08-18.
  9. 9.0 9.1 9.2 9.3 9.4 Gemzell-Danielsson, K; Lalitkumar, S (May 2008). "Second trimester medical abortion with mifepristone-misoprostol and misoprostol alone: a review of methods and management". Reproductive health matters. 16 (31 Suppl): 162–72. doi:10.1016/S0968-8080(08)31371-8. PMID 18772097.
  10. 10.0 10.1 10.2 Zhang J, Zhou K, Shan D, Luo X (May 2022). "Medical methods for first trimester abortion". The Cochrane Database of Systematic Reviews. 2022 (5): CD002855. doi:10.1002/14651858.CD002855.pub5. PMC 9128719. PMID 35608608.
  11. Corey, E.J. (2012). "Mifepristone". Molecules and Medicine. John Wiley & Sons. ISBN 9781118361733. Archived from the original on 2017-09-08.
  12. 12.0 12.1 Research, Center for Drug Evaluation and (24 March 2023). "Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation". FDA. Archived from the original on 21 April 2023. Retrieved 10 September 2023.
  13. Paul, Maureen (2011). "Misoprostol". Management of Unintended and Abnormal Pregnancy: Comprehensive Abortion Care. John Wiley & Sons. ISBN 9781444358476. Archived from the original on 22 December 2015. Retrieved 20 December 2015.
  14. World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
  15. McCann, Allison (13 April 2023). "Inside the Online Market for Overseas Abortion Pills". The New York Times. Archived from the original on 30 October 2023. Retrieved 6 December 2023.
  16. "How Much Do Abortion Pills Cost?". GoodRx. Retrieved 10 September 2023.
  17. "How much does the abortion pill cost?". www.plannedparenthood.org. Archived from the original on 7 September 2023. Retrieved 10 September 2023.
  18. "FAQ: The Abortion Pill Mifegymiso | Action Canada for Sexual Health and Rights". www.actioncanadashr.org. Archived from the original on 2023-05-28. Retrieved 6 December 2023.
  19. Durocher, J; Kilfedder, C; Frye, LJ; Winikoff, B; Srinivasan, K (December 2021). "A descriptive analysis of medical abortion commodity availability and pricing at retail outlets in 44 countries across four regions globally". Sexual and reproductive health matters. 29 (1): 1982460. doi:10.1080/26410397.2021.1982460. PMID 34719353.
  20. 20.0 20.1 20.2 von Stackelberg, Marina (16 Feb 2023). "Doctors brace for a nationwide shortage of abortion pills". CBC. Archived from the original on 14 July 2023. Retrieved 6 December 2023.