MIFEPRISTONE (mi FE pri stone) is a hormone-like drug. It is used in combination with other medicines to end an early pregnancy (usually during the first 7 weeks). This medicine is only available in a doctor's office, health clinic, or hospital.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
They need to know if you have any of these conditions:
adrenal gland problems
cannot easily get emergency medical help in the 2 weeks after you take this medicine
cannot return for follow up appointments after you take this medicine
have intrauterine device (IUD)
it has been more than 49 days (7 weeks) since your last menstrual period began
other medical problem
take medicines that treat or prevent blood clots like enoxaparin, warfarin
take steroid medicines like prednisone or cortisone
tubal or ectopic pregnancy
an unusual or allergic reaction to mifepristone, misoprostol, prostaglandins, or other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Before you take this medicine, read the information your doctor or health care provider gives you. Talk to your doctor about any questions you have. Take your medicine exactly as directed. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
This does not apply.
Do not take this medicine with any of the following medications:
certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
certain medicines that treat or prevent blood clots like enoxaparin, warfarin
steroid medicines like prednisone or cortisone
This medicine may also interact with the following medications:
certain medicines for seizures like carbamazepine, phenytoin, phenobarbital
certain medicines used in surgery for anesthesia
other medicines that prolong the QT interval (cause an abnormal heart rhythm)
St. John's wort or other herbal products
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
For your safety, you must visit your doctor as directed after taking this medicine. Report any unusual effects to your doctor. This medicine can cause birth defects. You will need surgery if this medicine fails to cause a full abortion.
After you take this medicine, some vaginal bleeding is normal. Heavy bleeding may be a sign that something is wrong. If you soak through 2 thick full-size sanitary pads each hour for 2 hours, get medical help right away. Tell the health care provider that you have taken this medicine.
Call your doctor if you have a fever, stomach pain or tenderness, nausea, vomiting, diarrhea, or feel weak. This may be a sign that something is wrong. You may have a serious infection or complication and need medical help.
Keep the MedGuide for this medicine. If you need emergency medical care, show your healthcare provider the MedGuide.
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
fast, irregular heartbeat
feeling faint, lightheaded
unusually weak or tired
vaginal discharge with bad smell
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
loss of appetite
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This drug is given in a hospital or clinic and will not be stored at home.