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(mifepristone) Tablet for Oral Use
TERMINATION OF PREGNANCY
Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.
Korlym (mifepristone) is a cortisol receptor blocker for oral administration. The chemical name of mifepristone is 11β-(4-dimethylaminophenyl)-17β-hydroxy-17α-(1-propynyl)-estra-4,9-dien-3-one. The chemical formula is C29H35NO2; the molecular weight is 429.60, and the structural formula is:
Mifepristone demonstrates a pH-related solubility profile. The greatest solubility is achieved in acidic media (~ 25 mg/mL at pH 1.5) and solubility declines rapidly as the pH is increased. At pH values above 2.5 the solubility of mifepristone is less than 1 mg/mL.
Each Korlym tablet for oral use contains 300 mg of mifepristone. The inactive ingredients of Korlym tablets are silicified microcrystalline cellulose, sodium starch glycolate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide, triacetin, D&C yellow 10 aluminum lake, polysorbate 80, and FD&C yellow 6 aluminum lake.
What are the possible side effects of Korlym (Korlym)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Korlym and call your doctor at once if you have a serious side effect such as:
- nausea, weakness, tired feeling, feeling like you might pass out;
- fever, chills, cough with yellow or green mucus;
- stabbing chest pain, wheezing, feeling short of breath;
- swelling in your hands or feet;
- unusual or irregular vaginal bleeding;
- low blood sugar (headache, hunger, weakness,...
Last reviewed on RxList: 11/24/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Korlym Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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