Life Issues: RU-486

 

 
RU 486 Label

 

MIFEPREX® (mifepristone) Tablets, 200 mg

For Oral Administration Only

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex* use. Before prescribing Mifeprex, inform the patient about the risk of these serious events and discuss the MEDICATION GUIDE and the PATIENT AGREEMENT. Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope.

  • Infection. Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination following an abortion. No causal relationship between the use of Mifeprex and misoprostol and these events has been established. A high index of suspicion is needed to rule out sepsis (see WARNINGS).

  • Bleeding. 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 (see WARNINGS).

Patients should be advised to take their MEDICATION GUIDE with them if they visit an emergency room or another health care provider who did not prescribe Mifeprex, so that provider will be aware that the patient is undergoing a medical abortion.

DESCRIPTION

Mifeprex tablets each contain 200 mg of mifepristone, a synthetic steroid with antiprogestational effects. The tablets are light yellow in color, cylindrical and biconvex, and are intended for oral administration only. The tablets include the inactive ingredients colloidal silica anhydrous, corn starch, povidone, microcrystalline cellulose, and magnesium stearate.

Mifepristone is a substituted 19-nor steroid compound chemically designated as 11ß-[p-(Dimethylamino)phenyl]-17ß-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one. Its empirical formula is C29H35NO2. Its structural formula is:


The compound is a yellow powder with a molecular weight of 429.6 and a melting point of 192-196°C. It is very soluble in methanol, chloroform and acetone and poorly soluble in water, hexane and isopropyl ether.

* Mifeprex is a registered trademark of Danco Laboratories, LLC.

11/12/04