Generic
Mifepristone
4 brands available in the market
At a glance
Mifepristone is an anti-progestational steroid used for medical termination of pregnancy.
Description
Mifepristone is a progesterone antagonist that blocks the action of progesterone needed to sustain pregnancy. It breaks down the uterine lining and stops pregnancy growth.
Indications
- Medical termination of pregnancy (up to 70 days)
- Cervical softening and dilatation
- Preparation for prostaglandin analogues
- Labor induction for expulsion of dead fetus
Therapeutic class
Drugs acting on the Uterus
Pharmacological class
Anti-progestational Steroid
Pharmacology
Mifepristone binds to intracellular progesterone receptor and competitively inhibits progesterone attachment.
Mechanism of action
Blocks progesterone to terminate pregnancy.
Dosage
Adult Dose:
- Pregnancy Termination: 200 mg single oral dose (Day 1); followed by Misoprostol 800 mcg after 24-48 hours
- Cervical Softening: 200 mg
- Prostaglandin Preparation: 600 mg
- Fetal Death Expulsion: 600 mg/day for 2 days
Administration
- Take under physician supervision
- Swallow tablet whole
- Take with food
- Take Misoprostol after 36-48 hours
Missed dose
If you miss a dose consult your doctor.
Side effects
Common Side Effects:
- Nausea and vomiting
- Uterine contractions and cramping
- Diarrhea
- Vaginal bleeding
- Dizziness
- Skin rash and urticaria
Precautions & warnings
- Do not use if suspected ectopic pregnancy
- Caution in long-term corticosteroid therapy
- Contraindicated in adrenal failure
- Caution in bleeding disorders
- Contraindicated in pregnancy and lactation
Contraindications
- Confirmed or suspected ectopic pregnancy
- Chronic adrenal failure
- Long-term corticosteroid therapy
- Allergy to Mifepristone or Misoprostol
- Bleeding disorders or anticoagulant therapy
- Porphyria hepatic or renal impairment
- Pregnancy and lactation
- IUD in place
Drug interactions
- CYP3A4 Inhibitors: Increased serum levels
- CYP3A4 Inducers: Decreased serum levels
- Simvastatin and Lovastatin: Risk of adverse effects
- Glucocorticoids: Antagonizes effect
Food interactions
Alcohol with Mifepristone is unsafe.
Use in pregnancy
Use in Pregnancy: Highly unsafe (Category X). Contraindicated during pregnancy.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe. May pass into breast milk and harm the baby.
Pediatric use
Safety and efficacy in children not established.
Geriatric use
No specific dose adjustment for elderly.
Renal / hepatic impairment
Renal Impairment: Limited information available. Consult your doctor.
Hepatic Impairment: Limited information available. Consult your doctor.
Overdose effects
Single doses up to 2 gm caused no adverse reactions. Massive overdose may cause signs of adrenal failure.
Storage conditions
Store in a cool and dry place protected from light below 25°C.
Chemical structure
Mifepristone