Who should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy?Īn individual should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy if it has been more than 70 days since the first day of their last menstrual period, or if they: The labeling for the approved generic version of Mifeprex is consistent with the labeling for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation. The agency’s approval of this generic reflects the FDA’s determination that Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. FDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg, in April 2019. The FDA first approved Mifeprex (mifepristone) in September 2000 for medical termination of pregnancy through seven weeks gestation and this was extended to ten weeks gestation in 2016. When did the FDA approve mifepristone for medical termination of pregnancy? On day one: 200 mg of mifepristone taken by mouthĢ4 to 48 hours after taking mifepristone: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patientĪbout seven to fourteen days after taking mifepristone: follow-up with the health care provider The approved mifepristone dosing regimen is: Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation (70 days or less since the first day of the last menstrual period). Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. What is mifepristone and how does it work?
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