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THE PATIENT SHOULD NOT GIVE CYTOTEC TO ANYONE ELSECytotec has been prescribed for the patient’s specific conditionmay not be the correct treatment for another personand may be dangerous to the other person if she were to become pregnant.
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.
Cytotec is not fetotoxic or teratogenic in rats and rabbits at doses 625 and 63 times the human doserespectively.
Renal impairmentAvailable evidence indicates that no adjustment of dosage is necessary in patients with renal impairment.
Cytotec is predominantly metabolised via fatty acid oxidising systems and has shown no adverse effect on the hepatic microsomal mixed function oxidaseP450enzyme systemIn specific studies no clinically significant pharmacokinetic interaction has been demonstrated with antipyrine or diazepamA modest increase in propranolol concentrationsmean approximately 20in AUC30in C maxhas been observed with multiple dosing of misoprostolIn extensive clinical studies no drug interactions have been attributed to CytotecDrug interaction studies with misoprostol and several NSAIDs showed no clinically significant effect on the kinetics of ibuprofendiclofenacpiroxicamaspirinnaproxen or indomethacin.
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