OXYTOCIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

OXYTOCIN

Composition:

OXYTOCIN 10 [USP'U] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

  Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons.  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, pre-eclampsia at or near term, when delivery is in the best interest 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) 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. Oxytocin injection (synthetic) is indicated to produce uterine contractions during t

Product summary:

Oxytocin Injection, USP (synthetic) is supplied as follows: *Packaged in a plastic vial. †The container closure is not made with natural rubber latex. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

OXYTOCIN- OXYTOCIN INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
OXYTOCIN INJECTION, USP
_(SYNTHETIC)_
_FOR INTRAVENOUS INFUSION OR INTRAMUSCULAR USE_
DESCRIPTION
Each mL of Oxytocin Injection, USP (synthetic), intended for
intravenous infusion or
intramuscular injection, possesses an oxytocic activity equivalent to
10 USP Oxytocin
Units and contains chlorobutanol anhydrous (chloral derivative) 0.5%.
This product may
contain up to 12.5% decomposition products/impurities. Oxytocin
injection (synthetic) is
a sterile, clear, colorless solution of oxytocin in Water for
Injection prepared by
synthesis. Acetic acid may have been added for pH adjustment (pH
3.0-5.0). The
structural formula is:
CLINICAL PHARMACOLOGY
Oxytocin injection (synthetic) acts on the smooth muscle of the uterus
to stimulate
contractions; response depends on the uterine threshold of
excitability. It exerts a
selective action on the smooth musculature of the uterus, particularly
toward the end of
pregnancy, during labor and immediately following delivery. Oxytocin
stimulates
rhythmic contractions of the uterus, increases the frequency of
existing contractions
and raises the tone of the uterine musculature. Synthetic oxytocin
does not possess
the cardiovascular effects, such as elevation of blood pressure, as
exhibited by
vasopressin found in posterior pituitary injection.
INDICATIONS AND USAGE
IMPORTANT NOTICE:
Oxytocin Injection, USP (synthetic) is indicated for the medical
rather than the elective
induction of labor. Available data and information are inadequate to
define the benefits
to risks considerations in the use of the drug product for elective
induction. Elective
induction of labor is defined as the initiation of labor for
convenience in an individual with
a term pregnancy who is free of medical indications.
ANTEPARTUM
Oxytocin injection (synthetic) is indicated for the initiation or
improvement of uterine
contractions, where this is desirable and considered suitable, in
order to achieve early
vaginal delivery for fetal or matern