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. 2020 May 14;35(8):2398–2405. doi: 10.1007/s11606-020-05836-9

Table 1.

Comparison of the US Food and Drug Administration (FDA) Labeling for Mifepristone Followed by Misoprostol 2000 vs. 2016

Original FDA-approved regimen (2000) Updated FDA-approved regimen (2016)
Gestational age limits 49 days’ gestation 70 days’ gestation
Mifepristone dose and administration 600 mg on day 1 in clinic 200 mg on day 1 in clinic
Misoprostol dose and administration 400 mcg orally in clinic on day 3 post-mifepristone 800 mcg buccally at home 24–48 h post-mifepristone
Timing of follow-up assessment 7–14 days post-mifepristone 7–14 days post-mifepristone
Location of follow-up assessment In clinic required In clinic not required