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Information about Cytotec.
Cytotec is intended for administration along with nonsteroidal anti-inflammatory drugsNSAIDsincluding aspirinto decrease the chance of developing an NSAID-induced gastric ulcer.
In these trials there were no significant differences between Cytotec and placebo in relief of day or night abdominal painNo effect of Cytotec in reducing the risk of duodenal ulcers was demonstratedbut relatively few duodenal lesions were seen.
See boxed WARNINGSCytotec may endanger pregnancymay cause abortionand thereby cause harm to the fetus when administered to a pregnant womanCytotec may produce uterine contractionsuterine bleedingand expulsion of the products of conceptionAbortions caused by Cytotec may be incompleteIf a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID-induced ulcersthe drug should be discontinued and the patient apprised of the potential hazard to the fetus.
Adjustment of the dosing schedule in renally impaired patients is not routinely neededbut dosage can be reduced if the 200-mcg dose is not toleratedSee CLINICAL PHARMACOLOGY
There was no evidence of an effect of Cytotec on tumor occurrence or incidence in rats receiving daily doses up to 150 times the human dose for 24 monthsSimilarlythere was no effect of Cytotec on tumor occurrence or incidence in mice receiving daily doses up to 1000 times the human dose for 21 monthsThe mutagenic potential of Cytotec was tested in several in vitro assaysall of which were negative.
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