Mifegest (Mifepristone) Dosage for Medical Termination of Pregnancy
The recommended dose of Mifegest (mifepristone) is 200 mg orally as a single dose, followed 24-48 hours later by misoprostol, regardless of gestational age up to 70 days (first trimester) or between 14-27 weeks gestation.
First Trimester (≤70 days/10 weeks gestation)
For early pregnancy termination, administer mifepristone 200 mg orally on Day 1, followed by misoprostol 800 mcg buccally 24-48 hours later 1. This is the FDA-approved regimen and represents the standard of care.
Key Evidence Supporting 200 mg Dose:
The 200 mg dose is equally effective as the previously used 600 mg dose but uses less medication 2. Multiple high-quality randomized controlled trials demonstrate:
- No difference in efficacy: Complete abortion rates of 92-95% with both 200 mg and 600 mg doses 3, 4, 5, 6
- Similar abortion timing: Mean time to completion is identical (6.9 hours) regardless of dose 2
- A systematic review of 87 trials including 45,528 subjects showed 95.2% success rate with 200 mg mifepristone regimens 3
Critical Timing Considerations:
- 24-48 hour interval between mifepristone and misoprostol is essential 1
- Concurrent administration (taking both medications at the same time) results in significantly lower success rates (68.8% vs. 84.3%) and should be avoided 7
Second Trimester (14 0/7 to 27 6/7 weeks gestation)
For second trimester termination, use mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400 mcg sublingually or buccally every 3 hours 2.
Dosing Protocol:
- Mifepristone: 200 mg single oral dose (not 600 mg - the lower dose is equally effective) 2
- Misoprostol: 400 mcg every 3 hours via sublingual or buccal route
- Duration: Continue until complete expulsion, typically within 48 hours
- Maximum doses: Most patients complete abortion within 6 doses; no safety rationale exists for stopping after 5 doses if patient is otherwise stable 2
Superiority of Combination Regimen:
The mifepristone-misoprostol combination is significantly more effective than misoprostol alone for second trimester abortion 2:
- Ongoing pregnancy at 24 hours: 4% (combination) vs. 32% (misoprostol alone)
- Ongoing pregnancy at 48 hours: 2% (combination) vs. 10% (misoprostol alone)
- Mean abortion time: 5.8-8 hours (combination) vs. 11-12 hours (misoprostol alone)
Important Clinical Considerations:
Contraindications (from FDA label):
- Confirmed or suspected ectopic pregnancy 1
- Chronic adrenal failure 1
- Concurrent long-term corticosteroid therapy 1
- Hemorrhagic disorders or anticoagulant therapy 1
- IUD in place (must be removed first) 1
Common Pitfalls to Avoid:
- Do not use 600 mg dose: This wastes medication without improving efficacy 2, 3, 4, 5, 6
- Do not give medications concurrently: The 24-48 hour interval is critical for efficacy 7
- Do not stop misoprostol arbitrarily at 5 doses in second trimester: Continue if patient is stable and abortion incomplete 2
Safety Profile:
- Hospitalization rate: 0.3% 3
- Blood transfusion rate: 0.1% 3
- No evidence of teratogenicity if pregnancy continues (though this is rare with proper follow-up) 8
- Serious infections are very rare but can present atypically without fever 1
Mandatory Follow-Up:
Confirm complete termination at follow-up visit - this is essential to detect ongoing pregnancy or retained tissue requiring intervention 1. Patients must know to seek immediate care for sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope 1.