IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.
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warnings
WARNINGS Oxytocin injection (synthetic) when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.
ADVERSE REACTIONS The following adverse reactions have been reported in the mother: 1. Anaphylactic reaction 2. Postpartum hemorrhage 3. Cardiac arrhythmia 4. Fatal afibrinogenemia 5. Nausea 6. Vomiting 7. Premature ventricular contractions 8. Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus. The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred, and is associated with a slow oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water intoxication has been reported. The following adverse reactions have been reported in the fetus or infant: Due to induced uterine mobility: 1. Bradycardia 2. Premature ventricular contractions and other arrhythmias 3. Permanent CNS or brain damage 4. Fetal death Due to use of oxytocin in the mother: 1. Neonatal retinal hemorrhage 2. Low Apgar scores at five minutes 3. Neonatal jaundice