The following information is a summary about RU-486. It is not intended to replace a doctor's instructions.
ACTIVE INGREDIENT:
Mifepristone (mif-i-PRIS-tone)
COMMON BRAND NAME(S):
Ru-486
USES:
Mifepristone is used to end a pregnancy that is less than 49 days in duration. It works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled.
HOW TO USE:
To terminate a pregnancy of 49 days or less duration: Adults—600 milligrams (mg) (three 200 mg tablets) as a single oral dose followed two days later by 400 micrograms (mcg) (two 200 mcg tablets) of misoprostol as a single oral dose as needed.
SIDE EFFECTS:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- Less common
- Excessively heavy vaginal bleeding; unusual tiredness or weakness
- Incidence not known
- Chest pain or discomfort; confusion ; cough or hoarseness; fast, weak pulse; fever or chills; lower back or side pain; pain or discomfort in arms, jaw, back or neck; painful or difficult urination ; pale, cold, clammy skin; shortness of breath; sudden increase in abdominal or shoulder pain; sweating; unusual or large amount of vaginal bleeding.
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.
- More common
- Abdominal pain or uterine cramping; back pain; diarrhea; dizziness ; headache; nausea or vomiting.
- Less common
- Acid or sour stomach; anxiety; belching; cough; fainting or light-headedness when getting up from a lying or sitting position; fever; flu-like symptoms; headache; heartburn ; increased clear or white vaginal discharge; indigestion; itching of the vagina or genital area; lack or loss of strength; pain during sexual intercourse; pain or tenderness around eyes and cheekbones; pale skin; shaking chills; shortness of breath or troubled breathing; sleeplessness or trouble sleeping; stomach discomfort, upset, or pain; tightness of chest or wheezing; troubled breathing, exertional; unusual bleeding or bruising; stuffy or runny nose.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
PRECAUTIONS:
You must have 3 visits to your physicians office during the treatment procedure. It is extremely important that you attend all three visits. Check with your physician if the vaginal bleeding becomes severe or seems to last longer than expected (i.e., soaking through two thick full-size sanitary pads per hour for two consecutive hours) . You may need to have a surgical procedure to stop excessive vaginal bleeding or to terminate a pregnancy that was not terminated with the medical treatment procedure. You should check with your physician immediately if signs or symptoms of serious infection (i.e., continuing fever = 100.4 °F, severe stomach pain, pelvic tenderness, weakness, nausea, vomiting, diarrhea, or abnormally fast heartbeat) occur.
DRUG INTERACTIONS:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking mifepristone, it is especially important that your doctor and pharmacist know if you are taking any of the following:
- Carbamazepine (e.g., Tegretol) or
- Dexamethasone (e.g., Decadron) or
- Phenobarbital (e.g., Luminal) or
- Phenytoin (e.g., Dilantin) or
- Rifampin (e.g., Rifadin) or
- St. John's Wort — May decrease the concentration of mifepristone in the blood
- Erythromycin (e.g., E-Mycin) or
- Grapefruit juice or
- Itraconazole (e.g., Sporanox) or
- Ketoconazole (e.g., Nizoral) — May increase the concentration of mifepristone in the blood
- Anticoagulants, such as warfarin (e.g., Coumadin) — May increase the risk of bleeding
- Corticosteroids (cortisone-like medicine)—Mifepristone may not work as well
Teenagers Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.
Older adults This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking a progestin, it is especially important that your health care professional know if you are taking any of the following:
- Aminoglutethimide (e.g., Cytadren) or
- Carbamazepine (e.g., Tegretol) or
- Phenobarbital or
- Phenytoin (e.g., Dilantin) or
- Rifabutin (e.g., Mycobutin) or
- Rifampin (e.g., Rifadin, Rimactane)—These medicines may decrease the effects of progestins and increase your chance of pregnancy, so use of a second form of birth control is recommended
OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Symptoms of overdose may include severe vaginal bleeding.
NOTES:
Do not share this medication with others. Laboratory and/or medical tests (e.g., ultrasound) may be performed to monitor your progress. Keep all scheduled medical appointments (at least three will be required); vaginal bleeding is not proof that the abortion was successful.
MISSED DOSE:
You must follow the dosing schedule as directed by your doctor. If you miss an appointment, contact your doctor immediately.
STORAGE:
Store at room temperature; 77 degrees F (25 degrees C) away from light and moisture.
