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Misoprostol (Misoprostol) - Summary

 
 



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.
 

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.


See all Misoprostol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Misoprostol

Misoprostol Lowers Risk Of Complications In Abortions
Source: Abortion News From Medical News Today [2012.03.09]
A new study, published Online First in The Lancet , reports that major complications during early surgical abortions are reduced by nearly a third in comparison with placebo, if the cervix is...

more news >>

Published Studies Related to Misoprostol

Oral misoprostol for labor augmentation: a randomized controlled trial. [2011.12]
OBJECTIVE: : To estimate the efficacy of oral misoprostol for labor augmentation... CONCLUSION: : Oral misoprostol is an effective agent for augmentation of labor. CLINICAL TRIAL REGISTRATION: : ClinicalTrials.gov, www.clinicaltrials.gov, NCT00906347. LEVEL OF EVIDENCE: : I.

Combination of misoprostol and mechanical dilation for induction of labour: a randomized controlled trial. [2011.12]
OBJECTIVE: To evaluate a combination of oral misoprostol (OM) and mechanical dilation of the cervix to improve efficacy in inducing labour... CONCLUSION: A combination of OM and a double-balloon catheter improves the efficacy of labour induction in term pregnancies, particularly in women without premature rupture of the membranes. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

A randomized, double-blind, placebo-controlled trial of misoprostol for oral mucositis secondary to high-dose chemotherapy. [2011.10.01]
PURPOSE: Misoprostol, a synthetic analog of prostaglandin E1, has anti-inflammatory and mucosa-protecting properties. The objective of this study was to evaluate the efficacy of misoprostol oral rinse in reducing the severity of oral mucosal injury caused by high-dose chemotherapy... CONCLUSIONS: Although this study did not find a beneficial effect of a misoprostol rinse in mucositis secondary to high-dose chemotherapy, the small sample size limits the strength of this conclusion. Given the proposed importance of the prostaglandin pathway in the pathogenesis of oral mucositis, additional studies are warranted.

Misoprostol in operative hysteroscopy: a systematic review and meta-analysis. [2011.10]
CONCLUSION: This review did not rule out a beneficial effect of misoprostol on cervical dilation or surgical complications. There was an increase in side effects in operative hysteroscopy patients treated with misoprostol. Current evidence does not support the routine use of preoperative misoprostol in operative hysteroscopy.

A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. [2011.10]
OBJECTIVE: To evaluate the efficacy and safety of vaginal misoprostol for cervical priming before diagnostic outpatient hysteroscopy (OH) without anesthesia.

more studies >>

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.

more trials >>

Reports of Suspected Misoprostol Side Effects

Haemorrhage (176)Abortion Incomplete (174)Anaemia (62)Muscle Spasms (44)Pain (41)Pregnancy (41)Menorrhagia (28)Dizziness (24)Vomiting (21)Syncope (18)more >>


Page last updated: 2012-03-09

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