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Drug information for
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MISOPROSTOL (Systemic)
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Some commonly used brand names are:
In the U.S.—
Cytotec
In Canada—
Cytotec
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Category
Antiulcer agent
Gastric mucosa protectant
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Description
Misoprostol (mye-soe-PROST-ole) is taken to prevent stomach
ulcers in patients taking anti-inflammatory drugs, including
aspirin. Misoprostol may also be used for other conditions
as determined by your doctor.
Misoprostol helps the stomach protect itself against acid
damage. It also decreases the amount of acid produced by the
stomach.
This medicine is available only with your doctor's prescription,
in the following dosage form:
Oral
Tablets (U.S. and Canada)
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Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine
must be weighed against the good it will do. This is a decision
you and your doctor will make. For misoprostol, the following
should be considered:
Allergies—Tell your doctor if you have ever had any
unusual or allergic reaction to misoprostol. Also tell your
health care professional if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Pregnancy—Misoprostol must not be used during pregnancy
when used to prevent stomach ulcers caused by anti-inflammatory
medicines including aspirin. It has been shown to cause contractions
and bleeding of the uterus. Misoprostol may also cause miscarriage.
Before starting to take this medicine you must have had a
negative pregnancy test within the previous 2 weeks. Also,
you must start taking misoprostol only on the second or third
day of your next normal menstrual period. In addition, it
will be necessary that you use an effective form of birth
control while taking this medicine. Be sure that you have
discussed this with your doctor before taking this medicine.
Breast-feeding—It is not known whether misoprostol passes
into breast milk. However, misoprostol is not recommended
for use during breast-feeding because it may cause diarrhea
in nursing babies.
Children—Studies on this medicine have been done only
in adult patients, and there is no specific information comparing
use of misoprostol in children with use in other age groups.
Older adults—This medicine has been tested and has not
been shown to cause different side effects or problems in
older people than it does in younger adults.
Other medicines—Although certain medicines should not
be used together at all, in other cases two different medicines
may be used together even if an interaction might occur. In
these cases, your doctor may want to change the dose, or other
precautions may be necessary. Tell your health care professional
if you are taking any other prescription or nonprescription
(over-the-counter [OTC]) medicine.
Other medical problems—The presence of other medical
problems may affect the use of misoprostol. Make sure you
tell your doctor if you have any other medical problems, especially:
Blood vessel disease—Medicines similar to misoprostol
have been shown to make this condition worse
Epilepsy (uncontrolled)—Medicines similar to misoprostol
have been shown to cause convulsions (seizures)
Inflammatory bowel disease—Misoprostol may worsen diarrhea,
which could lead to dehydration
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Proper Use of This Medicine
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.
Dosing—The dose of misoprostol 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 misoprostol. If your dose is different, do
not change it unless your doctor tells you to do so.
To prevent stomach ulcers in patients taking anti-inflammatory
medicines including aspirin:
For oral dosage form (tablets):
Adults—200 micrograms (mcg) four times a day, with or
after meals and at bedtime. Or, your dose may be 400 mcg two
times a day with the last dose taken at bedtime. Your doctor
may reduce the dose to 100 mcg if you are sensitive to high
doses.
Children and teenagers—Dose must be determined by your
doctor.
Missed dose—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.
Storage—To store this medicine:
Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in
other damp places. Heat or moisture may cause the medicine
to break down.
Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of
children.
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Precautions While Using This Medicine
Misoprostol may cause miscarriage if taken during pregnancy.
Therefore, if you suspect that you may have become pregnant,
stop taking this medicine immediately and check with your
doctor .
This medicine may cause diarrhea, stomach cramps, or nausea
in some people. These effects will usually disappear within
a few days as your body adjusts to the medicine. However,
check with your doctor if the diarrhea, cramps, or nausea
is severe and/or does not stop after a week. Your doctor may
have to lower the dose of misoprostol you are taking.
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Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted
effects. Some side effects may occur that usually do not need
medical attention. These side effects may go away during treatment
as your body adjusts to the medicine. However, check with
your doctor if any of the following side effects continue
or are bothersome:
More common
Abdominal or stomach pain (mild); diarrhea
Less common or rare
Bleeding from vagina; constipation; cramps in lower abdomen
or stomach area; gas; headache; heartburn, indigestion, or
acid stomach; nausea and/or vomiting
Symptoms of overdose
Abdominal pain; convulsions (seizures); diarrhea; drowsiness;
fast or pounding heartbeat; fever; low blood pressure; slow
heartbeat; tremor; troubled breathing
Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your
doctor.
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Additional Information
Once a medicine has been approved for marketing for a certain
use, experience may show that it is also useful for other
medical problems. Although these uses are not included in
product labeling, misoprostol may be used in certain patients
with the following medical conditions:
Abortion, first trimester
Abortion, second trimester
Cervical ripening
Induction of labor
Postpartum hemorrhage
Other than the above information, there is no additional
information relating to proper use, precautions, or side effects
for these uses.
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