(mi fe' pri stone)
Serious or life-threatening vaginal bleeding may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. It is not known if taking mifepristone increases the risk that you will experience very heavy bleeding. Tell your doctor if you have or have ever had bleeding problems, an ectopic pregnancy ('tubal pregnancy' or pregnancy outside the uterus), anemia (less than normal number of red blood cells), or if you are taking anticoagulants ('blood thinners') such as warfarin (Coumadin), heparin, or aspirin. If you experience very heavy vaginal bleeding, such as soaking through two thick full-size sanitary pads every hour for two continuous hours, call your doctor immediately or seek emergency medical care.
Serious or life threatening infections may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. A small number of patients died due to infections that they developed after they used mifepristone and misoprostol to end their pregnancies. Some of these patients had used misoprostol vaginally; vaginal use of oral misoprostol tablets has not been approved by the Food and Drug Administration (FDA). It is not known if mifepristone and/or misoprostol taken vaginally or by mouth caused these infections or deaths.
If you develop a serious infection, you may not have many symptoms and your symptoms may not be very severe. You should call your doctor immediately if you experience any of the following symptoms: fever greater than 100.4 °F (38 °C) that lasts for more than 4 hours, severe pain or tenderness in the area below the waist, chills, fast heartbeat, or fainting.
You should also call your doctor immediately if you have general symptoms of illness such as weakness, nausea, vomiting, diarrhea, or feeling sick more than 24 hours after taking mifepristone even if you do not have a fever or pain in the area below your waist.
Your doctor will give you the manufacturer's patient information sheet (Medication Guide) to read before you begin treatment with mifepristone. You will also need to sign a patient agreement before taking mifepristone. Tell your doctor if you have questions about treatment with mifepristone or if you cannot follow the guidelines in the patient agreement.
Talk to your doctor and decide whom to call and what to do in case of an emergency after taking mifepristone. Tell your doctor if you do not think that you will be able to follow this plan or to get medical treatment quickly in an emergency during the first two weeks after you take mifepristone. Take your medication guide with you if you visit an emergency room or seek emergency medical care so that the doctors who treat you will understand that you are undergoing a medical abortion.
Keep all appointments with your doctor. These appointments are necessary to be sure that your pregnancy has ended and that you have not developed serious complications of medical abortion.
Talk to your doctor about the risks of taking mifepristone.
WHY is this medicine prescribed?
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.
HOW should this medicine 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.
Are there OTHER USES for this medicine?
Mifepristone is also sometimes used to end pregnancies when more than 49 days have passed since the woman's last menstrual period; as an emergency contraceptive after unprotected sexual intercourse ('morning-after pill'); to treat tumors of the brain, endometriosis (growth of uterus tissue outside the uterus), or fibroids (noncancerous tumors in the uterus); or to induce labor (to help start the birth process in a pregnant woman). Talk to your doctor about the possible risks of using this drug for your condition.
What SPECIAL PRECAUTIONS should I follow?
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.
- you should know that it is possible that mifepristone will not end your pregnancy. Your doctor will check to be sure that your pregnancy has ended when you return for your follow-up appointments after you take mifepristone. If your pregnancy has not ended, you may choose to have surgery to end the pregnancy. If you do not have this surgery, your baby may be born with birth defects.
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.
What SPECIAL DIETARY instructions should I follow?
Do not take mifepristone with grapefruit juice. Talk to your doctor about drinking grapefruit juice after taking this medication.
What should I do IF I FORGET to take a dose?
You will only take mifepristone in your doctor's office or clinic, so you do not have to worry about forgetting to take a dose at home.
What SIDE EFFECTS can this medicine 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
- pelvic pain
- vaginal burning, itching, or discharge
- difficulty falling asleep or staying asleep
- 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 Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Your doctor will store the medication in his or her office.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- blurred vision
- shortness of breath
- fast heartbeat
What OTHER INFORMATION should I know?
You should get mifepristone only from a doctor and use this medication only while under the care of a doctor. You should not buy mifepristone from other sources, such as the Internet, because you would bypass important safeguards to protect your health.
Do not let anyone else take your medication.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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