Oxytocin

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. Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons.

Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use. Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor. Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane. An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.

Oxytocin injection (synthetic) is contraindicated in any of the following conditions: • Significant cephalopelvic disproportion, • Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies, • In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention, • In cases of fetal distress where delivery is not imminent, • Prolonged use in uterine inertia or severe toxemia, • Hypertonic uterine patterns, • Patients with hypersensitivity to the drug, • Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation…

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.

The following adverse reactions have been reported in the mother: • Anaphylactic reaction • Postpartum hemorrhage • Cardiac arrhythmia • Fatal afibrinogenemia • Nausea • Vomiting • Premature ventricular contractions • 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.

Store at 20° to 25°C (68° to 77°F). Do not permit to freeze.