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The Mifepristone at home 24 hours before miso dosing starts
All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.
Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.
Drug: Mifepristone200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
Experimental: Mifepristone and first dose of misoprostol simultaneously.
Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.
Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
For patients using Mifeprex® tablets:
This medicine is given only by your doctor. You will not be allowed to take it at home. The entire treatment requires three visits to your doctor.
At the first visit, you will be given one mifepristone tablet. Two days later at the second visit, you will be given four tablets of another medicine called misoprostol. Two weeks later at the third visit, your doctor will check to make sure you are no longer pregnant. This may include an ultrasound exam (sonogram).
This medicine will cause you to bleed and have cramps for about 2 to 4 weeks. Call your doctor if you have little or no vaginal bleeding after receiving the medicine.
It is sometimes necessary to have a surgical abortion to completely end the pregnancy. You may also need to have surgery if there is any tissue left in your uterus after treatment with mifepristone.
Tell your doctor if you are using an intrauterine device (IUD). It must be removed first before using this medicine.
For patients using Karly™ tablets:
Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
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Swallow the tablet whole. Do not break, crush, or chew it. Take this medicine with a meal.
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Mifepristone is used in a regimen together with misoprostol to end a pregnancy that is less than 70 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.
Mifepristone is also used to control high blood sugar (hyperglycemia) in patients with Cushing’s syndrome who also have type 2 diabetes and have failed surgery or are not candidates for surgery.
This medicine is available only with your doctor’s prescription.
This product is available in the following dosage forms:
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
For termination of pregnancy (70 days or less) taken together with misoprostol:
Adults—200 milligrams (mg) as a single dose on Day 1. This is followed 2 days later by 800 micrograms (mcg) (four-200 mcg tablets) of misoprostol as a single dose placed in the cheeks.
Children—Use is not recommended.
For treatment of hyperglycemia in patients with Cushing’s syndrome:
Adults—At first, 300 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1200 mg per day.
Children—Use and dose must be determined by your doctor.

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