MSDS
Sheet
DESCRIPTION
Pitocin® (oxytocin injection, USP) is a sterile, clear, colorless
aqueous solution of synthetic oxytocin, for intravenous infusion or
intramuscular injection.
INDICATION AND USAGE
IMPORTANT NOTICE
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.
Antepartum:
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.
Postpartum:
Pitocin® is indicated to produce uterine contractions during the
third stage of labor and to control postpartum bleeding or hemorrhage.
CONTRAINDICATIONS
Antepartum use of Pitocin® is contraindicated in any of the following
circumstances:
1. Where there is significant cephalopelvic disproportion;
2. In unfavorable fetal positions or presentations, such as transverse lies,
which are undeliverable without conversion prior to delivery;
3. In obstetrical emergencies where the benefit-to-risk ratio for either the
fetus or the mother favors surgical intervention;
4. In fetal distress where delivery is not imminent;
5. Where adequate uterine activity fails to achieve satisfactory progress;
6. Where the uterus is already hyperactive or hypertonic;
7. 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;
8. In patients with hypersensitivity to the drug.
WARNINGS
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.
ADVERSE REACTIONS
The following adverse
reactions have been reported in the mother:
Anaphylactic reaction, Postpartum hemorrhage, Cardiac arrhythmia, Fatal
afibrinogenemia, Hypertensive episodes, Nausea, Vomiting, Premature ventricular
contractions, Pelvic hematoma, Subarachnoid hemorrhage, Rupture of the uterus.
The possibility of increased blood loss and Afibrinogenemia. 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. Excessive dosage or hypersensitivity to
the drug may result in uterine hypertonicity, spasm, tetanic contraction, or
rupture of the uterus.
The following adverse reactions have been reported in the fetus or neonate:
Due to induced uterine motility:
Bradycardia, 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
