DESCRIPTION
MIFEPREX™ (mifepristone) Tablets, 200 mg For Oral
Administration Only
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If Mifeprex* results in incomplete abortion, surgical intervention
may be necessary. Prescribers should determine in advance whether
they will provide such care themselves or through other providers.
Prescribers should also give patients clear instructions on whom
to call and what to do in the event of an emergency following administration
of Mifeprex.
Prescribers should make sure that patients receive and have an
opportunity to discuss the Medication Guide and the PATIENT AGREEMENT.
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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 11b-[p-(Dimethylamino)phenyl]-17b-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one.
Its empirical formula is C29H35NO2.
The compound is a yellow powder with a molecular weight of 429.6 and
a melting point of 191-196C. It is very soluble in methanol, chloroform
and acetone and poorly soluble in water, hexane and isopropyl ether.
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