CONTRAINDICATIONS
See BOXED WARNING.
Misoprostol should not be taken by anyone with a history of allergy to prostaglandins.
WARNINGS
See BOXED WARNING.
PRECAUTIONS
Information for the Patient
Misoprostol is contraindicated in women who are pregnant, and should not be used in
women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory
drug (NSAID) therapy and is at high risk of complications from gastric ulcers associated
with the use of the NSAID, or is at high risk of developing gastric ulceration. Women of
childbearing potential should be told that they must not be pregnant when misoprostol
therapy is initiated, and that they must use an effective contraception method while taking
misoprostol.
See BOXED WARNING.
Patients should be advised of the following:
Misoprostol is intended for administration along with nonsteroidal
anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the chance of
developing an NSAID-induced gastric ulcer.
Misoprostol should be taken only according to the directions given by a physician.
If the patient has questions about or problems with misoprostol, the physician
should be contacted promptly.
THE PATIENT SHOULD NOT GIVE MISOPROSTOL TO ANYONE
ELSE. Misoprostol has been prescribed for the patient's specific condition, may
not be the correct treatment for another person, and may be dangerous to the
other person if she were to become pregnant.
The misoprostol package the patient receives from the pharmacist will include a
leaflet containing patient information. The patient should read the leaflet before
taking misoprostol and each time the prescription is renewed because the leaflet
may have been revised.
Keep misoprostol out of the reach of children.
SPECIAL NOTE FOR WOMEN: Misoprostol must not be used by
pregnant women. Misoprostol may cause miscarriage. Miscarriages caused
by misoprostol may be incomplete, which could lead to potentially
dangerous bleeding, hospitalization, surgery, infertility, or maternal or fetal
death.
Misoprostol is available only as a unit-of-use package that includes a leaflet
containing patient information.
See PATIENT PACKAGE INSERT at the end of this labeling.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
There was no evidence of an effect of misoprostol on tumor occurrence or incidence in
rats receiving daily doses up to 150 times the human dose for 24 months. Similarly, there
was no effect of misoprostol on tumor occurrence or incidence in mice receiving daily
doses up to 1000 times the human dose for 21 months. The mutagenic potential of
misoprostol was tested in severalin vitro assays, all of which were negative.
Misoprostol, when administered to breeding male and female rats at doses 6.25 times to
625 times the maximum recommended human therapeutic dose, produced dose-related
pre- and post-implantation losses and a significant decrease in the number of live pups
born at the highest dose. These findings suggest the possibility of a general adverse effect
on fertility in males and females.
Pregnancy Category X
See BOXED WARNING.
Nonteratogenic Effects: Misoprostol may endanger pregnancy (may cause miscarriage)
and thereby cause harm to the fetus when administered to a pregnant woman.
misoprostol produces uterine contractions, uterine bleeding, and expulsion of the
products of conception. Miscarriages caused by misoprostol may be incomplete. In
studies in women undergoing elective termination of pregnancy during the first trimester,
misoprostol caused partial or complete expulsion of the products of conception in 11%
of the subjects and increased uterine bleeding in 41%. If a woman is or becomes
pregnant while taking this drug, the drug should be discontinued and the patient apprised
of the potential hazard to the fetus.
Teratogenic Effects: Misoprostol is not fetotoxic or teratogenic in rats and rabbits at
doses 625 and 63 times the human dose, respectively.
Nursing Mothers
See CONTRAINDICATIONS. It is unlikely that misoprostol is excreted in human milk
since it is rapidly metabolized throughout the body. However, it is not known if the active
metabolite (misoprostol acid) is excreted in human milk. Therefore, misoprostol should
not be administered to nursing mothers because the potential excretion of misoprostol
acid could cause significant diarrhea in nursing infants.
Pediatric Use
Safety and effectiveness in children below the age of 18 years have not been established.