openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS All oxytocic agents are potentially dangerous. Mothers and infants have been injured, and some have died because of their injudicious use. Hyperstimulation of the uterus during labor may lead to uterine tetany with marked impairment of the uteroplacental blood flow, uterine rupture, cervical and perineal lacerations, amniotic fluid embolism, and trauma to the infant (e.g., hypoxia, intracranial hemorrhage). Because of these hazards, which result from overdosage, oxytocic agents must be administered under conditions of meticulous observation.
ADVERSE REACTIONS Nausea and vomiting may occur, but they are uncommon. Allergic phenomena, including shock, have been reported. Ergotism has also been reported. Elevation of blood pressure (sometimes extreme) may appear in a small percentage of patients, most frequently in association with regional anesthesia (caudal or spinal), previous administration of a vasoconstrictor, or the intravenous route of administration of an oxytocic. The mechanism of such hypertension is obscure, since it may occur in the absence of anesthesia, vasoconstrictors, and oxytocics. These elevations are no more frequent with Ergotrate ® than with other oxytocics. They usually subside promptly following intravenous administration of 15 mg of chlorpromazine. Postpartum use of ergotrates has been associated with rare cases of myocardial infarction.