(oxytocin injection, USP), Synthetic
Therapeutic Class: Oxytocics
This product is manufactured and distributed by JHP Pharmaceuticals, LLC
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Pitocin® (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection.
Indications and Usage
Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin® is not indicated for elective induction of labor.
Pitocin® is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. 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, preeclampsia at or near term, when delivery is in the best interests 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) as 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.
Pitocin® is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
Antepartum use of Pitocin® is contraindicated in any of the following circumstances:
- Where there is significant cephalopelvic disproportion;
- In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery;
- In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;
- In fetal distress where delivery is not imminent;
- Where adequate uterine activity fails to achieve satisfactory progress;
- Where the uterus is already hyperactive or hypertonic;
- In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord;
- In patients with hypersensitivity to the drug.
Pitocin®, when given for induction of labor or augmentation of uterine activity, should 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
- Hypertensive episodes
- Premature ventricular c ontractions
- Pelvic hematoma
- Subarachnoid hemorrhage
- Rupture of the uterus
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, 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 neonate:
Due to induced uterine motility:
- Premature ventricular contractions and other arrhythmias
- Permanent CNS or brain damage
- Fetal death
- Neonatal seizures
Due to use of oxytocin in the mother:
- Low Apgar scores at five minutes
- Neonatal jaundice
- Neonatal retinal hemorrhage
Please see the full prescribing information link above for additional information.