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 (oxytocin
injection) is not indicated for elective
induction of labor. Antepartum: Pitocin (oxytocin injection) 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 (oxytocin injection) is indicated to produce uterine
contractions during the third stage of labor and to control postpartum bleeding or hemorrhage. DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration
whenever solution and container permit. The dosage of oxytocin is determined by
the uterine response and must therefore
be individualized and initiated at a very
low level. The following dosage
information is based upon various
regimens and indications in general use. Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of parenteral
administration of Pitocin (oxytocin
injection) for the induction or stimulation
of labor. Accurate control of the rate of
infusion is essential and is best accomplished by an infusion pump. It is
convenient to piggyback the Pitocin
(oxytocin injection) infusion on a physiologic electrolyte solution, permitting the Pitocin (oxytocin
injection) infusion to be stopped abruptly
without interrupting the electrolyte
infusion. This is done in the following
way. Preparation a. The standard solution for infusion of
Pitocin (oxytocin injection) is prepared by
adding the contents of one 1- mL vial
containing 10 units of oxytocin to 1000
mL of 0.9% aqueous sodium chloride or Ringer's lactate. The combined solution
containing 10 milliunits (mU) of oxytocin/
mL is rotated in the infusion bottle for
thorough mixing. b. Establish the infusion with a separate
bottle of physiologic electrolyte solution
not containing Pitocin (oxytocin
injection) . c. Attach (piggyback) the Pitocin
(oxytocin injection) containing bottle
with the infusion pump to the infusion
line as close to the infusion site as
possible. Administration The initial dose should be 0.5-1 mU/min
(equal to 3-6 mL of the dilute oxytocin
solution per hour). At 30-60 minute
intervals the dose should be gradually
increased in increments of 1-2 mU/min
until the desired contraction pattern has been established. Once the desired
frequency of contractions has been
reached and labor has progressed to 5-6
cm dilation, the dose may be reduced by similar increments. Studies of the
concentrations of oxytocin in the
maternal plasma during Pitocin (oxytocin injection) infusion have shown that
infusion rates up to 6 mU/min give the
same oxytocin levels that are found in
spontaneous labor. At term, higher
infusion rates should be given with great
care, and rates exceeding 9-10 mU/min are rarely required. Before term, when
the sensitivity of the uterus is lower because of a lower concentration of
oxytocin receptors, a higher infusion rate
may be required. Monitoring a. Electronically monitor the uterine
activity and the fetal heart rate throughout the infusion of Pitocin
(oxytocin injection) . Attention should be
given to tonus, amplitude and frequency
of contractions, and to the fetal heart rate in relation to uterine contractions. If
uterine contractions become too
powerful, the infusion can be abruptly
stopped, and oxytocic stimulation of the
uterine musculature will soon wane (see PRECAUTIONS section). b. Discontinue the infusion of Pitocin
(oxytocin injection) immediately in the event of uterine hyperactivity and/or fetal distress. Administer oxygen to the mother, who preferably should be put in
a lateral position. The condition of mother and fetus should immediately be
evaluated by the responsible physician
and appropriate steps taken. Control of Postpartum Uterine Bleeding 1. Intravenous infusion (drip method). If the
patient has an intravenous infusion
running, 10 to 40 units of oxytocin may
be added to the bottle, depending on the
amount of electrolyte or dextrose solution remaining (maximum 40 units to
1000 mL). Adjust the infusion rate to
sustain uterine contraction and control uterine atony. 2. Intramuscular administration, (One mL) Ten (10) units of Pitocin (oxytocin
injection) can be given after the delivery
of the placenta. Treatment of Incomplete, Inevitable, or
Elective Abortion Intravenous infusion of 10 units of
Pitocin (oxytocin injection) added to 500
mL of a physiologic saline solution or 5% dextrose-in-water solution may help the
uterus contract after a suction or sharp
curettage for an incomplete, inevitable,
or elective abortion. Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea, etc., for midtrimester elective abortion,
the injection-to-abortion time may be
shortened by infusion of Pitocin (oxytocin
injection) at the rate of 10 to 20
milliunits (20 to 40 drops) per minute.
The total dose should not exceed 30 units in a 12-hour period due to the risk of
water intoxication. HOW SUPPLIED Pitocin (Oxytocin Injection, USP)
Synthetic is available as follows: NDC
60793-265-25 Packages of twentyfive
oversized 1-mL Steri-Vials®, each
containing 10 units of oxytocin. NDC
60793-267-01 A 10 mL multiple-dose Steri-ViaP containing 10 units of oxytocin
per mL (total = 100 units of oxytocin). Storage Store at 15°-25°C (59°-77°F).
