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Rx only
LAB-0171-2.0
September 2006
WARNINGS
MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS and LABOR AND DELIVERY). MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.
Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, misoprostol may be prescribed if the patient
- has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
- is capable of complying with effective contraceptive measures.
- has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
- will begin misoprostol only on the second or third day of the next normal menstrual period.
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MISOPROSTOL SUMMARY
Misoprostol
Tablets
Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties.
Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, eg, the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
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NEWS HIGHLIGHTS
Published Studies Related to Misoprostol
[Benefit of misoprostol for prevention of postpartum hemorrhage in cesarean section: A randomized controlled trial.] [2009.10.13]
OBJECTIVES: To assess the benefit of sublingual misoprostol in addition to standard oxytocin in the prevention of post-partum hemorrhage at caesarean section... CONCLUSIONS: Sublingual misoprostol (in addition to oxytocin) is effective in prevention of post-partum hemorrhage at caesarean sections when compared to oxytocin alone, without major side-effects. Larger studies are needed to confirm our results.
A randomized controlled trial comparing powdery sublingual misoprostol and sublingual misoprostol tablet for management of embryonic death or anembryonic pregnancy. [2009.09]
OBJECTIVES: To compare complete abortion rate, duration of abortion, and side effects between 600 microg powdery sublingual misoprostol and 600 microg sublingual misoprostol tablet for management of embryonic death or anembryonic pregnancy... CONCLUSIONS: Single dose of 600 microg of powdery sublingual misoprostol does not improve its efficacy for management of embryonic death or anembryonic pregnancy when compared to sublingual misoprostol tablet.
Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. [2009.08]
OBJECTIVE: To evaluate the maternal and pregnancy characteristics that independently predict successful induction of labor, defined as vaginal delivery... CONCLUSION: Maternal characteristics such as BMI, parity, age, and race and neonatal birth weight are important variables to consider when predicting a successful induction of labor. The nearly 30% rate of cesarean delivery in this study underscores the importance of selecting appropriate candidates. LEVEL OF EVIDENCE: II.
Sublingual misoprostol after surgical management of early termination of pregnancy. [2009.08]
OBJECTIVE: To assess the efficacy of sublingual misoprostol after surgical management of early termination of pregnancy (ETP) regarding duration and amount of bleeding, presence of retained products of conception (RPOC), and endometrial thickness... CONCLUSION(S): In countries in which surgical management of ETP is still done, using sublingual misoprostol postoperatively may reduce the duration and amount of bleeding.
Sublingual versus oral misoprostol for uterine evacuation following early pregnancy failure. [2009.07]
CONCLUSION: The sublingual route was found to be as effective but faster than the oral route for uterine evacuation after early pregnancy failure.
Clinical Trials Related to Misoprostol
Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone [Completed]
A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and
acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will
include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The
second regimen will include two 800 mcg doses of buccal misoprostol. We hypthesize that both
methods work well, but that the mifepristone regimen will have an efficacy rate of
approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater
than 5% difference to be clinically meaningful.
Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion [Completed]
Background: In most countries in which abortion is legal, medical abortions are induced with
mifepristone and misoprostol. Since mifepristone is expensive and unavailable in many
countries, it is important to find other regimens. Methotrexate, which is used with
misoprostol in Canada, is also difficult to obtain in many countries. Misoprostol is
inexpensive and available in almost all countries. A report from Nigeria found that 98% of
100 women aborted within 24 hours of using misoprostol given both sublingually and
vaginally.
Method: This will be a randomized controlled trial of the usual regimen used in Canada,
methotrexate 50 mg/m2 intramuscularly (IM) followed three days later by 800 mcg vaginal
misoprostol to the Nigerian regimen of 400 mcg sublingual misoprostol with 400 mcg vaginal
misoprostol. The main outcome measure will be a completed abortion within the first week with
secondary outcome measures including total surgery rate, time to abortion, complications,
pain, side effects and patient satisfaction.
Rationale: If the investigators can find an inexpensive, easily available, method of medical
abortion, it will save many lives in third world countries.
Mifepristone and Misoprostol for Fetal Demise [Completed]
This is a pilot clinical trial to evaluate whether the medical management of early pregnancy
failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects
with early pregnancy failure receive mifepristone followed 24 hours later by vaginal
misoprostol for medical management. Subjects then return on study day 3 for a repeat
ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac
present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up
at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol,
and in person for those who received a second dose. Questionnaires are administered at the
beginning and end of the study to determine acceptability.
Misoprostol for the Treatment of Incomplete Abortion [Completed]
This randomized study will examine the efficacy, safety and acceptability of misoprostol for
treatment of incomplete abortion.
Women diagnosed with incomplete abortion will be randomized to receive one of the following
regimens:
In Tanzania and Mozambique:
1. 600 mcg of oral misoprostol in one dose, or
2. Standard surgical treatment (MVA)
In Moldova and Madagascar:
1. 600 mcg of oral misoprostol in one dose, or
2. 400 mcg of sublingual misoprostol in one dose.
We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual
misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation [Completed]
HYPOTHESIS: For women with pregnancies at <49, 50-56, and 57-63 days gestation who receive
mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete
abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within
each gestational age group.
This is a prospective clinical trial. Women will be enrolled such that 40 women are in each
of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment
is initiated. Once a gestational age range includes 40 subjects, enrollment in that group
will be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg
misoprostol tablets between the check and gum (2 tablets on each side). The women will be
instructed to keep the tablets in place for 30 minutes; any remaining portions of the tablets
will be swallowed after this time. Participants will follow-up 24 hours after receiving the
misoprostol. Vaginal ultrasonography will be performed to assess for expulsion of the
gestational sac. Women who have not aborted by the first follow-up visit will be given a dose
of vaginal misoprostol and will return for a follow-up visit in one week. Subjects who have
not aborted by the two-week follow-up will be offered a surgical abortion. At each visit,
data will be collected on bleeding, cramping, other side effects, and medication use.
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Page last updated: 2009-10-20
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