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WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT
CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN
REPORTED WHEN CYTOTEC 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). CYTOTEC 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.
Cytotec 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, Cytotec 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 Cytotec only on the second or third day of the next normal
menstrual period.
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CYTOTEC SUMMARY
Cytotec oral tablets contain either 100 mcg or 200 mcg of
misoprostol, a synthetic prostaglandin E1 analog.
Cytotec (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, 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. Cytotec
has not been shown to reduce the risk of duodenal ulcers in patients taking
NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec 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 Cytotec (Misoprostol)
Safety and efficacy of misoprostol versus oxytocin for the prevention of
postpartum hemorrhage. [2014]
Postpartum hemorrhage (PPH) is the commonest cause of maternal death worldwide. Studies suggest that the use of misoprostol may be beneficial in clinical
settings where oxytocin is unavailable... Results
from this study indicate that it may be considered as an alternative for oxytocin
in low resource clinical settings.
A trial comparing the use of rectal misoprostol plus perivascular vasopressin
with perivascular vasopressin alone to decrease myometrial bleeding at the time
of abdominal myomectomy. [2013]
OBJECTIVE: To compare the efficacy of rectal misoprostol plus perivascular
vasopressin with perivascular vasopressin alone as hemostatic agents for the
reduction of blood loss during myomectomies... CONCLUSION(S): We conclude that perivascular vasopressin plus misoprostol caused
a significant reduction in blood loss compared with perivascular vasopressin
alone.
Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled
trial. [2013]
vaginal delivery... CONCLUSION: Use of a 200-microgram misoprostol vaginal inset significantly
Cervical priming before diagnostic operative hysteroscopy in infertile women: a
randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. [2013]
The aim of this study was to evaluate the efficacy of vaginal misoprostol for
cervical priming at doses of 200 mcg and 400 mcg, 12 to 15 hours before
diagnostic office hysteroscopy (OH) without anesthesia in patients with
infertility. Sixty infertile patients requiring a diagnostic office hysteroscopy
for investigation of infertility were included in the study...
Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy:
a randomized clinical trial. [2013]
vaginal) for cervical ripening before hysteroscopy... CONCLUSION: Sublingual route of misoprostol could be considered as an effective
Clinical Trials Related to Cytotec (Misoprostol)
Misoprostol Administration Before Operative Hysteroscopy [Completed]
The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no
misoprostol prior to operative hysteroscopy in premenopausal women.
Misoprostol for Cervical Priming Prior to Vacuum Aspiration [Completed]
Despite of the widespread use, and extensive studies, the optimal route of administration of
misoprostol before surgical abortion remains to be defined. Following administration of 400
mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours,
but the longer the interval the greater the risk or bleeding and expulsion of the uterine
contents before the surgical evacuation. Sublingual administration seems to give adequate
plasma concentration and cervical priming faster than oral or vaginal administration. This
may allow a shorter waiting time with maintained efficacy, less side effects and logistic
advantages.
Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination [Completed]
The aim of this study is to compare two misoprostol regimen in pregnancy termination.
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks [Recruiting]
Surgical abortion in the late first trimester and early second trimester is usually
performed with the aid of a cervical preparing agent, which helps to open up the uterine
cervix for the procedure. Routine use of cervical preparants is recommended by several
organizations during this period of pregnancy before surgical abortion, especially in
younger women or those who have not delivered a baby, because their cervices may be more
difficult to dilate without a preparant.
The standard medication used for cervical preparation is misoprostol. Unfortunately,
misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who
use it. Another medication called mifepristone has been shown to dilate the cervix better
than misoprostol in the first trimester, but little information exists about using
mifepristone in the late first trimester and early second trimester.
The investigators plan to perform a prospective, double-blind, randomized trial to evaluate
if mifepristone is a better cervical preparant than misoprostol. A total of 110
participants who are pregnant women desiring pregnancy termination 11 to 15 weeks
gestational age will be recruited. Half will receive mifepristone and the other half
misoprostol. The investigators will measure the amount of cervical dilation achieved right
before a surgical abortion to determine if mifepristone is significantly different than
misoprostol as a cervical preparant at this stage of pregnancy. The investigators expect
that mifepristone will work better than misoprostol for this purpose.
The investigators hope to generate information about mifepristone so that women and their
health care providers can know more about mifepristone as an option for cervical preparation
before surgical abortion.
Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) [Completed]
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: 2014-11-30
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