Mifepristone

Conditions Treated

Mifepristone is used alone or in combination with misoprostol (Cytotec) to end an early pregnancy. Early pregnancy means it has been 49 days or less since your last menstrual period began. Mifepristone is in a class of medications called antiprogestational steroids. It works by blocking the activity of progesterone, a substance your body makes to help continue pregnancy.

Possible Side Effects

What Side Effects Can This Cause?

Mifepristone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vaginal bleeding or spotting
• cramps
• pelvic pain
• vaginal burning, itching, or discharge
• headache
• tiredness
• difficulty falling asleep or staying asleep
• anxiety
• back or leg pain

Some side effects can be serious. If you experience any of the symptoms mentioned in the IMPORTANT WARNING section, call your doctor immediately.Mifepristone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Mifepristone comes as a tablet to take by mouth. It should be taken only in a clinic, medical office, or hospital under the supervision of a qualified doctor. You will take three tablets of mifepristone at one time on the first day. Two days later you must go back to your doctor. If your doctor is not certain that your pregnancy has ended, you will take two tablets of another medication called misoprostol. You may have vaginal bleeding for 9 to 30 days or longer. Fourteen days after taking mifepristone, you must go back to your doctor for an exam or ultrasound to make sure that the pregnancy has ended. Take mifepristone exactly as directed.

What Dietary Instructions Should I Follow

Do not take mifepristone with grapefruit juice. Talk to your doctor about drinking grapefruit juice after taking this medication.

Are There Any Special Instructions

Before taking mifepristone, tell your doctor if you are allergic to mifepristone; misoprostol (Arthrotec, Cytotec); other prostaglandins such as alprostadil, carboprost tromethamine (Hemabate), dinoprostone (Cervidil, Prepidil, Prostin E2), epoprostenol (Flolan), latanoprost (Xalatan), treprostinil (Remodulin); or any other medications. do not take mifepristone if you are taking any of the medications listed in the IMPORTANT WARNING section or corticosteroids such as beclomethasone (QVAR inhaler), betamethasone (Celestone), budesonide (Entocort, Pulmicort), cortisone (Cortone), dexamethasone (Decadron, Dexpak, Dexasone, others), fludrocortisone (Floriner), flunisolide (AeroBid); fluticasone (Advair, Flovent), hydrocortisone (Cortef, Cortenema, Hydrocortone), methylprednisolone (Medrol, Meprolone, others), prednisolone (Prelone, others), prednisone (Deltasone, Meticorten, Sterapred, others), and triamcinolone (Aristocort, Azmacort). tell your doctor what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Cordarone, Pacerone); astemizole; benzodiazepines such as alprazolam (Xanax), diazepam (Valium), midazolam (Versed), or triazolam (Halcion); buspirone (BuSpar); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Lexxel, Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular), nitrendipine , or verapamil (Calan, Isoptin, Verelan); carbamazepine (Tegretol); chlorpheniramine (antihistamine in cough and cold products); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), cerivastatin , lovastatin (Mevacor), or simvastatin (Zocor); cimetidine (Tagamet); cisapride; clarithromycin (Biaxin, Prevpac); cyclosporine (Neoral, Sandimmune); dicloxacillin; erythromycin (E.E.S., EM-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); haloperidol; furosemide; HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), or saquinavir (Fortovase, Invirase); itraconazole (Sporanox); ketoconazole (Nizoral); methadone (Dolophine, Methadose); nefazodone (Serzone); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); pimozide (Orap); propranolol (Inderal); quinidine; quinine; rifampin (Rifadin, Rimactane); rifabutin (Mycobutin); tacrolimus (Prograf, Protopic); tamoxifen (Nolvadex); trazodone; troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan, others); or vincristine (Vincasar). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor what herbal products you are taking, especially St. John's wort. tell your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section or any of the following: diabetes ; high blood pressure; porphyria (an inherited blood disease that may cause skin or nervous system problems); adrenal failure (problems with your adrenal glands); or heart, kidney, liver, or lung disease. tell your doctor if you have an intrauterine device (IUD) in place. It must be taken out before you take mifepristone. tell your doctor if you are breast-feeding. You may need to stop breast-feeding for a few days after taking mifepristone. if you are having surgery, including dental surgery, tell the doctor or dentist that you have taken mifepristone. you should know that mifepristone may make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you. tell your doctor if you smoke 10 or more cigarettes a dayor if you have a history of heavy smoking. you should know that after ending a pregnancy with mifepristone, you can become pregnant again right away, even before your period returns. If you do not want to become pregnant again, you should begin using birth control as soon as this pregnancy ends or before you start having sexual intercourse again.