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 NON-STEROIDAL 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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CYTOTEC SUMMARY
Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.
Misoprostol tablets are 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, e.g., 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 month duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
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NEWS HIGHLIGHTSMedia Articles Related to Cytotec (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 prepared with misoprostol. Misoprostol is widely used for cervical preparation before surgical abortion (vacuum aspiration), given that the drug is effective, easy to use, cheap and widely available...
Published Studies Related to Cytotec (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.
Clinical Trials Related to Cytotec (Misoprostol)
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP) [Not yet recruiting]
The primary goal of this study is to determine the clinical advantage of pre-treatment with
mifepristone in second trimester misoprostol induction abortion. This will be a randomized
controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus
misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Oral Titrated Misoprostol for Induction of Labour [Not yet recruiting]
The purpose of this study is to compare effectiveness and safety of an oral titrated
solution of misoprostol with vaginal misoprostol for induction of labour with an alive
fetus.
A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death [Recruiting]
Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the
United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by
the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past
several years, gained widespread acceptance to effect the medical termination of pregnancy
in the second trimester, either alone or after pretreatment with mifepristone. The primary
reasons for this prompt incorporation into standard practice include its low cost and the
lack of stringent storage requirements.
Vaginal administration seems to be more efficacious than when given orally. The use of
sublingual misoprostol for first trimester abortions has been extensively investigated as
evidenced by the large number of publications comparing sublingual to other routes of
misoprostol for first trimester pregnancy termination, on the assumption that the sublingual
route would have a similar efficacy of the vaginal route. In addition, the sublingual route
would combine an easier administration with the added advantage of no restriction of
mobility after administration. There has been no previous report in the literature comparing
the use of misoprostol given sublingually to that given vaginally for the second trimester
termination following intrauterine fetal death. Our aim is to compare efficacy, safety and
patient satisfaction with misoprostol given vaginally (the current standard) to that given
sublingually.
Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor [Recruiting]
Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue,
is a widely accepted induction agent, that has been proven safe and effective for induction
of labor. It stimulates both cervical ripening and uterine contractions, thus making it an
ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics
of different administration routes and effects on uterine contractility, side effects, and
safety. Vaginal misoprostol has been shown to be superior over oral administration however
patients often prefer a more tolerable route. Buccal administration has already been shown
to be as effective as vaginal misoprostol for cervical ripening and induction in both first
trimester and second trimester abortions. There is minimal research comparing buccal versus
vaginal for third trimester induction of labor. The investigators study is a prospective,
double blinded, randomized control trial comparing vaginal misoprostol and buccal
misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question
whether buccal misoprostol is as effective as vaginal misoprostol for third trimester
induction of labor.
Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) [Recruiting]
The primary goal of this study is to determine the clinical advantage of pre-treatment with
mifepristone in second trimester misoprostol induction abortion. This will be a randomized
controlled double-blinded trial of 120 women in each country comparing misoprostol alone to
mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Reports of Suspected Cytotec (Misoprostol) Side Effects
OFF Label USE (11),
Pyrexia (10),
Drug Ineffective FOR Unapproved Indication (8),
Bone Fissure (6),
Chills (5),
Maternal Exposure During Pregnancy (5),
Maternal Exposure Timing Unspecified (5),
Toxic Epidermal Necrolysis (4),
Diarrhoea (4),
Abdominal Pain (3), more >>
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Page last updated: 2012-03-09
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