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The mutagenic potential of cytotec was tested in several in vitro assays, all of which were negative.

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Information about Cytotec.

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

CYTOTECMISOPROSTOLADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTSABORTIONPREMATURE BIRTH OR UTERINE RUPTURE.

PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.

Cytotec can induce or augment uterine contractionsVaginal administration of Cytotecoutside of its approved indicationhas been used as a cervical ripening agentfor the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atonyA major adverse effect of the obstetrical use of Cytotec is uterine tachysystole which may progress to uterine tetany with marked impairment of uteroplacental blood flowuterine rupturerequiring surgical repairhysterectomyand/or salpingo-oophorectomyor amniotic fluid embolism and lead to adverse fetal heart changesUterine activity and fetal status should be monitored by trained obstetrical personnel in a hospital setting.

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

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