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Mifepristone information from DrugsUpdate  

See Available Brands of Mifepristone in India

P - Caution when used during pregnancy
L - Contraindicated in lactation

Mifepristone is a synthetic steroid compound used as a pharmaceutical. It is used as an abortifacient in the first two months of pregnancy, and in smaller doses as an emergency contraceptive. During early trials, it was known as RU-486, its designation at the Roussel Uclaf company, which designed the drug. The drug was initially made available in France, and other countries then followed—often amid controversy. It is marketed under tradenames Mifegyne and Mifeprex.

Pharmacodynamics

Pharmacokinetics

Mifepristone is a progesterone antagonist with antiglucocorticoid activity. It binds to the intracellular progesterone receptor where it competitively inhibits progesterone attachment. It is also a partial progesterone agonist.

Absorption

Peak plasma concentrations after 1.3 hours.

Distribution
Protein-binding: 98%.

Metabolism

Hepatic: Undergoes first-pass metabolism.

Excretion
Faeces (as metabolites); urine (small amounts); 18 hours (ellimination half-life).

Mifepristone Indications / Mifepristone Uses

Information Not Available

Mifepristone Adverse Reactions / Mifepristone Side Effects

Excessive vaginal bleeding; UTI; uterine haemorrhage; uterine infections; unusual tiredness or weakness; back pain; diarrhoea, nausea, vomiting; fever; dizziness; headache; anxiety; GI cramps.

Precautions

Warnings
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use.

Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination following abortion. A high index of suspicion is needed to rule out sepsis.

Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

Advise patients to take their Medication Guide with them if they visit an emergency room or another health care provider who did not prescribe mifepristone, so that provider will be aware that patient is undergoing a medical abortion.

Monitor

Qualified health care provider must supervise administration. Clinical examination is necessary to confirm complete termination of pregnancy 14 days after mifepristone administration.

Emergency treatment
Adequate access to medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusions, and emergency resuscitation must be assured during period from first visit until discharged by health care provider.

Special Precautions

Asthma, COPD; women smokers >35 yr; CV disease or risk factors; smoking; alcoholism; prosthetic heart valve; history of infective endocarditis.

Other Drug Interactions

Decreased efficacy with aspirin and NSAIDs. Efficacy of corticosteroids (including inhaled) decreased, monitor patients during co-admin and for several days afterwards.

Other Interactions

Information Not Available

Dosage

Oral
Termination of pregnancy (49 days or less duration)
Adult: 600 mg as a single dose followed 2 days later by 400 mcg of misoprostol as single dose.

Oral

Postcoital contraception
Adult: 600 mg single dose within 72 hours of unprotected intercourse.

Oral

Termination of pregnancy up to 63 days
Adult: 600 mg as a single dose followed by 1 mg gemeprost vaginally after 36-48 hours.

Oral
Induction of labour following intrauterine fetal death
Adult: 600 mg daily for 2 consecutive days.

Oral

Termination of pregnancy between 13-24 weeks of gestation
Adult: 600 mg as a single dose given 36-48 hours prior to prostaglandin therapy.

Oral

Softening and dilatation of cervix prior to surgical termination of pregnancy
Adult: 600 mg as a single dose given 36-48 hours prior to the procedure.

Food(before/after)

May be taken with or without food. (Avoid grapefruit juice.)

List of Contraindications

Mifepristone and Pregnancy

Caution when used during pregnancy

Mifepristone and Lactation

Contraindicated in lactation

Mifepristone and Children

Safety and efficacy not established

Mifepristone and Geriatic

Information Not Available

Mifepristone and Other Contraindications

Confirmed or suspected ectopic pregnancy, chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or other prostaglandin, haemorrhagic disorders or concurrent anticoagulant therapy, porphyria, hepatic or renal impairment; pregnancy and lactation; IUD in place; undiagnosed adnexal mass.

Storage

Information Not Available

Lab interference

Information Not Available

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