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Mifeprex
mifepristone (gynecologic)
Black Box Warnings .
Appropriate Use
restricted distribution program (mifepristone REMS) due to serious infection and bleeding risk; prescribers, pharmacies must be certified and meet all requirements
Serious Infection Risk
serious and sometimes fatal infections occur very rarely after spontaneous, surgical, and medical abortions including mifepristone use; no causal relationship established b/w mifepristone and misoprostol and these events; atypical presentation of serious bacterial infections and sepsis include without fever, bacteremia, or significant findings on pelvic exam post-abortion; very rarely deaths reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with marked left shift, tachycardia, hemoconcentration, and general malaise; high index of suspicion needed to rule out serious infection and sepsis
Bleeding Risk
serious and sometimes fatal bleeding occurs very rarely after spontaneous, surgical, and medical abortions including mifepristone use; no causal relationship established b/w mifepristone and misoprostol and these events; prolonged heavy bleeding may be sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed; advise patients to seek immediate medical attention if prolonged heavy vaginal bleeding
Patient Information
inform patient of serious infection and bleeding risk and discuss medication guide and patient agreement before prescribing; ensure patient knows whom to call and what to do including go to ED if contacts not available if symptoms include sustained fever, severe abdominal pain, prolonged heavy bleeding, and syncope, or if abdominal discomfort/pain or general malaise including weakness, nausea, vomiting or diarrhea >24h after misoprostol dose
Adult Dosing .
Dosage forms: TAB: 200 mg
Restricted Distribution in US
- [1-877-432-7596 or www.earlyoptionpill.com for more info]
early pregnancy termination
- [200 mg PO x1 on day 1]
- Info: patient must be <71 days from 1st day of last menstrual period; use with misoprostol
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.