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, USP (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. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.

In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Postpartum Oxytocin Injection, USP (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

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 or prolapse, total placenta previa, and vasa previa.

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.