Do not change the dose or stop using this medicine without checking first with your doctor. This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions. Misoprostol is best taken with or after meals and at bedtime, unless otherwise directed by your doctor. To help prevent loose stools, diarrhea, and abdominal cramping, always take this medicine with food or milk.
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.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not use this medicine if you are pregnant or planning to become pregnant. Women returned to the clinic up to 8 days after mifepristone for ultrasonographic evaluation.
A second dose of misoprostol was administered if the abortion was not complete. Patients with continuing pregnancy, excessive bleeding, or retained pregnancy tissue 5 weeks later received an aspiration curettage.
Main Outcome Measures Effectiveness of the procedure ie, a complete medical abortion without surgical intervention , adverse effects, acceptability of the procedure based on patient questionnaires, reasons for surgical intervention, and adverse outcomes, compared among the study groups. Fifty-five subjects aborted before taking misoprostol, 9 had early surgery, and did not take misoprostol on their assigned day.
No blood transfusions were required. Cramping and nausea were the most common adverse effects reported, with similar percentages of patients in all 3 groups reporting such effects. Thirteen unexpected or serious adverse events occurred: 6 in those using misoprostol after 1 day; 4 in those using it after 2 days; and 3 in those using it after 3 days. Mifepristone, a synthetic antiprogesterone, has been shown to be an effective abortifacient when combined with a prostaglandin administered 2 days later, by competitively blocking the progesterone necessary to maintain a pregnancy.
Oral misoprostol is a synthetic prostaglandin widely marketed worldwide for prevention of nonsteroidal anti-inflammatory drug—induced gastric ulcer. Used 2 days after mifepristone, it increases the success rate of a medical abortion.
Conventional timing mandates misoprostol administration 48 hours after mifepristone, but no studies have investigated alternative schedules. The US Food and Drug Administration's labeling of mifepristone may require misoprostol to be used in a clinical setting 2 days after mifepristone, with clinical monitoring for up to 4 hours, as occurs in France.
In the United States, many clinicians likely would not want to administer mifepristone on a Thursday or Friday because they generally do not have office hours 2 days later during the weekend, when misoprostol would be taken. It is evident from US trials of methotrexate and misoprostol 7 , 8 and mifepristone and misoprostol 4 , 9 that women can safely self-administer misoprostol outside the clinic. We hypothesized that the 2-day protocol was unnecessarily restrictive and that misoprostol could be administered at home from 1 to 3 days after mifepristone administration, without compromising effectiveness.
This study was a prospective, open-label, randomized multicenter trial. Randomization was stratified by site. Sixteen sites participated, including hospital abortion services, abortion clinics, private family practice offices, and gynecology offices.
All sites had institutional review board approval and all participants provided written informed consent. Study drug was supplied by the Abortion Rights Mobilization. Participants were at least 18 years old, no more than 56 days pregnant, healthy, and desired an abortion of a confirmed intrauterine pregnancy. The inclusion and exclusion criteria and method of routine gestational dating by ultrasonography followed previously reported protocols.
On study day 1, women drew their concealed, computer-generated randomized assignments of misoprostol 1, 2, or 3 days after mifepristone. Women then received mifepristone, mg, in the office and were instructed to use the vaginal misoprostol between 7 AM and midnight on their assigned day.
Women in the group assigned to use misoprostol 1 day after mifepristone were instructed to wait at least 24 hours before using misoprostol but could administer it until midnight of the assigned day. Women had the option of inserting the misoprostol at home or returning to the office for administration by clinic staff. Women were provided with acetaminophen with codeine as analgesia. All women using misoprostol at home were required to have an emergency plan to seek medical care in case bleeding became excessive.
Women returned for their follow-up visit at their discretion anytime between 1 day after misoprostol use to 7 days after mifepristone administration ie, study day 8. At the first follow-up visit, if ultrasonography demonstrated that the gestational sac was no longer present, the abortion was considered complete. At the second follow-up visit, if the gestational sac was still present but there had been no interval growth, patients were permitted to keep waiting for a successful medical abortion and to return on or before study day If there had been interval growth, indicating an ongoing pregnancy, an aspiration curettage was performed.
An aspiration curettage was also performed if a gestational sac was still present at study day 36 or if excessive bleeding or other severe symptoms occurred at any time. At each visit, we interviewed patients about symptoms and use of medications. Patients who requested oral contraceptive pills started taking them on the first Sunday after vaginal bleeding started after a documented complete abortion.
Women reported by telephone or postcard the date when vaginal bleeding stopped. After the abortion was confirmed by ultrasonography, regardless of whether it was a successful medical abortion or an aspiration curettage following a failed medical abortion, participants completed an acceptability questionnaire.
It is a type of drug called a prostaglandin that is known to cause contractions of the womb, so it is not used for preventing or treating ulcers in women who are pregnant. Women who chose to have their labour induced after the late death of their unborn baby in the womb 24 weeks pregnant or more should be offered a drug called mifepristone which is taken by mouth as a tablet , followed by a drug that acts like the natural hormones that kick-start labour called a prostaglandin.
Misoprostol is a type of prostaglandin and is an option at this point. Prostaglandins should usually be inserted into the vagina as a gel, tablet or pessary. Women receiving oral misoprostol also were given a vaginal placebo vitamin B6 , whereas those receiving vaginal misoprostol were given an oral placebo.
If they failed to abort, a second course was given by the same route.
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