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See Boxed Warnings.

Caution should be employed when administering Cytotec (misoprostol) to patients with pre-existing cardiovascular disease.

Information for patients

Women of childbearing potential using Cytotec (misoprostol) to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when Cytotec (misoprostol) therapy is initiated, and that they must use an effective contraception method while taking Cytotec.

See Boxed Warnings.

Cytotec (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.

Cytotec (misoprostol) should be taken only according to the directions given by a physician.

If the patient has questions about or problems with Cytotec (misoprostol) , the physician should be contacted promptly.

THE PATIENT SHOULD NOT GIVE CYTOTEC (misoprostol) TO ANYONE ELSE. Cytotec (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 Cytotec (misoprostol) package the patient receives from the pharmacist will include a leaflet containing patient information. The patient should read the leaflet before taking Cytotec (misoprostol) and each time the prescription is renewed because the leaflet may have been revised.

Keep Cytotec (misoprostol) out of the reach of children.

SPECIAL NOTE FOR WOMEN: Cytotec (misoprostol) may cause abortion (sometimes incomplete), premature labor, or birth defects if given to pregnant women.

Cytotec (misoprostol) is available only as a unit-of-use package that includes a leaflet containing patient information. See PATIENT INFORMATION at the end of this labeling.

Carcinogenesis, mutagenesis, impairment of fertility

There was no evidence of an effect of Cytotec (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 Cytotec (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 Cytotec (misoprostol) was tested in several in 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: Pregnancy Category X.

Teratogenic effects: See Boxed Warnings. Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient, but the drug's teratogenic mechanism has not been demonstrated. Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy with skull defects, cranial nerve palsies, facial malformations, and limb defects.

Cytotec (misoprostol) is not fetotoxic or teratogenic in rats and rabbits at doses 625 and 63 times the human dose, respectively.

Nonteratogenic effects: See Boxed Warnings. Cytotec (misoprostol) may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman. Cytotec (misoprostol) may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by Cytotec (misoprostol) may be incomplete. If a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID-induced ulcers, the drug should be discontinued and the patient apprised of the potential hazard to the fetus.

Labor and delivery

Cytotec (misoprostol) can induce or augment uterine contractions. Vaginal administration of Cytotec (misoprostol) , outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony. A major adverse effect of the obstetrical use of Cytotec (misoprostol) is the hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported.

There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher doses of Cytotec (misoprostol) , including the manufactured 100 mcg tablet. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.

The effect of Cytotec (misoprostol) on later growth, development, and functional maturation of the child when Cytotec (misoprostol) is used for cervical ripening or induction of labor has not been established. Information on Cytotec (misoprostol) 's effect on the need for forceps delivery or other intervention is unknown.

Nursing mothers

Misoprostol is rapidly metabolized in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol. Caution should be exercised when misoprostol is administered to a nursing woman.

Pediatric use

Safety and effectiveness of Cytotec (misoprostol) in pediatric patients have not been established.

Last reviewed on RxList: 12/20/2010
This monograph has been modified to include the generic and brand name in many instances.