OXYTOCIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

OXYTOCIN

Composition:

OXYTOCIN 10 [USP'U] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

                                                                                     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.   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 whe

Product summary:

Oxytocin Injection, USP (synthetic) is supplied as follows:   NDC No. Strength Volume 55154-9577-5 10 USP Units/mL Overbagged with 5 x 1 mL fill in a 3 mL vial per bag  * Packaged in a plastic 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.

Authorization status:

New Drug Application

Summary of Product characteristics

OXYTOCIN- OXYTOCIN INJECTION, SOLUTION
CARDINAL HEALTH
----------
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
maternal reason