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mifepristone, combinations

G03XB51

Forms & Strengths

Mifepristone 200 mg oral tablet
Misoprostol 200 mcg buccal tablet (co-packaged)

Adult Dosing

Medical termination of intrauterine pregnancy through 70 days (10 weeks) gestation
Mifepristone 200 mg orally as a single dose on Day 1
Misoprostol 800 mcg buccally 24 to 48 hours after mifepristone

Pediatric Dosing

Safety and efficacy established in postmenarchal adolescents aged 17 and younger similar to adult females
Dosage is the same as adult dosing

Indications

Medical termination of intrauterine pregnancy through 70 days of gestation
Management of early pregnancy loss (off-label utilization)

Mechanism of Action

Competitive receptor antagonist of progesterone, binding to the progesterone receptor
Sensitizes the myometrium to the contraction-inducing action of prostaglandins
Causes decidual necrosis, cervical dilation, and detachment of the conception product

Contraindications

Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
IUD in place (must be removed before treatment)
Chronic adrenal failure
Concurrent long-term corticosteroid therapy
Known hypersensitivity to mifepristone, misoprostol, or other prostaglandins
Hemorrhagic disorders or concurrent anticoagulant therapy

Adverse Reactions

Uterine cramping and abdominal pain
Heavy uterine bleeding and hemorrhage
Nausea, vomiting, and diarrhea
Dizziness, fatigue, and headache
Fever, chills, and rigors
Serious bacterial infections (sepsis)

Drug Interactions

CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin) may decrease mifepristone metabolism
CYP3A4 inducers (e.g., rifampin, dexamethasone, St. John's wort) may increase mifepristone metabolism
Nonsteroidal anti-inflammatory drugs (NSAIDs) may theoretically decrease prostaglandin efficacy if used concurrently

Curated Content: Needs Vetting Before Put to Clinical Use