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 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 infusion on a
physiologic electrolyte solution, permitting the Pitocin infusion to be stopped
abruptly without interrupting the electrolyte infusion. This is done in the
The standard solution for infusion of Pitocin is prepared
by adding 1 mL (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
Establish the infusion with a separate bottle of
physiologic electrolyte solution not containing Pitocin.
Attach (piggyback) the Pitocin-containing bottle with the
infusion pump to the infusion line as close to the infusion site as possible.
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 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.
Electronically monitor the uterine activity and the fetal
heart rate throughout the infusion of Pitocin. 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).
Discontinue the infusion of Pitocin 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
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.
Intramuscular administration. 1 mL (10 units) of Pitocin
can be given after the delivery of the placenta.
Treatment Of Incomplete, Inevitable, Or Elective Abortion
Intravenous infusion of 10 units of Pitocin 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 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.
Directions For Dispensing
Pharmacy Bulk Package - Not for Direct Infusion
The pharmacy bulk package is for use in a pharmacy
admixture service only in a suitable work area, such as a laminar flow hood.
The closure should be penetrated only once utilizing an appropriate sterile transfer
device, which allows measured distribution of the contents. The transfer device
should be inserted into the Pharmacy Bulk Package using aseptic technique.
Contents should be used as soon as possible following
initial closure puncture. Discard any unused portion within 24 hours of first
entry. Following closure puncture, container should be maintained under labeled
storage conditions between 20° to 25°C (68° to 77°F) under a laminar flow hood
until contents are dispensed.
Pitocin (Oxytocin Injection, USP) Synthetic is available
NDC 42023-130-06 Packages of six 50 mL Pharmacy Bulk
Packages, each containing 10 units of oxytocin per mL (total = 500 units of oxytocin
Store between 20° to 25°C (68° to 77°F). See USP
Controlled Room Temperature.
1. Seitchik J, Castillo M: Oxytocin augmentation of
dysfunctional labor. I. Clinical data. Am J Obstet Gynecol 1982; 144:899-905.
2. Seitchik J, Castillo M: Oxytocin augmentation of
dysfunctional labor. II. Multiparous patients. Am J Obstet Gynecol 1983;
3. Fuchs A, Goeschen K, Husslein P, et al: Oxytocin and
the initiation of human parturition. III. Plasma concentrations of oxytocin and
13, 14-dihydro-15-keto-prostaglandin F2a in spontaneous and oxytocin-induced
labor at term. Am J Obstet Gynecol 1983; 145:497-502.
4. Seitchik J, Amico J, et al: Oxytocin augmentation of
dysfunctional labor. IV. Oxytocin pharmacokinetics. Am J Obstet Gynecol 1984;
5. American College of Obstetricians and Gynecologists:
ACOG Technical Bulletin Number 110- November 1987: Induction and augmentation
Manufactured and Distributed by: JHP Pharmaceuticals,
LLC, Rochester, MI 48307. Revised: Mar 2013.