Oxytocin (Page 2 of 2)

ADVERSE REACTIONS

The following adverse reactions have been reported in the mother:

Anaphylactic reaction
Postpartum hemorrhage
Cardiac arrhythmia
Fatal afibrinogenemia
Nausea
Vomiting
Premature ventricular contractions
Pelvic hematoma

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, and is 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 infant:

Due to induced uterine mobility:

Bradycardia
Premature ventricular contractions and other arrhythmias
Permanent CNS or brain damage
Fetal death

Due to use of oxytocin in the mother:

Neonatal retinal hemorrhage
Low Apgar scores at five minutes
Neonatal jaundice

OVERDOSAGE

Overdosage with oxytocin injection (synthetic) depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H 2 O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, uteroplacental hypoperfusion and variable deceleration of fetal heart, fetal hypoxia, hypercapnia or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of oxytocin, is a serious complication that may occur if large doses (40 to 50 milliunits/minute) are infused for long periods. Management consists of immediate discontinuation of oxytocin, and symptomatic and supportive therapy.

DOSAGE AND ADMINISTRATION

Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use.

Induction or Stimulation of Labor

Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.

Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.

An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.

To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.

The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.

The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.

The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.

The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.

Control of Postpartum Uterine Bleeding

Intravenous Infusion ( Drip Method)—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.

Intramuscular Administration —1 mL (10 units) of oxytocin can be given after delivery of the placenta.

Treatment of Incomplete or Inevitable Abortion

Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Oxytocin Injection, USP (synthetic) is supplied as follows:

*Packaged in a plastic vial.
†The container closure is not made with natural rubber latex.

Product Code

Unit of Sale

Strength

Each

NP912011†

Overbagged with 5 vials per bag, NDC 55154-9584-5

10 USP
Units/mL

NDC 63323-012-17
1 mL fill in a
2 mL vial

Discard unused portion.

Use only if solution is clear and seal intact.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Do not permit to freeze.

Novaplus is a registered trademark of Vizient, Inc.

Manufactured by:

Fresenius Kabi USA, LLC
Lake Zurich, IL 60047

451126C

Distributed By:

Cardinal Health

Dublin, OH 43017

L56461790620

Revised: September 2019

Novaplus LogoNovaplus Logo

Package/Label Display Panel

Oxytocin Injection, USP

10 USP units /mL

Synthetic

5 x 1 mL Vials

bag label
(click image for full-size original)
OXYTOCIN
oxytocin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-9584(NDC:63323-012)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYTOCIN (OXYTOCIN) OXYTOCIN 10 [USP’U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL
ACETIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-9584-5 5 VIAL in 1 BAG contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BAG (55154-9584-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018248 08/10/2000
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 12/2022 Cardinal Health 107, LLC

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