OXYTOCIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-Ward Pharmaceuticals Corp

INN (International Name):

OXYTOCIN

Composition:

OXYTOCIN 10 [USP'U] in 1 mL

Administration route:

INTRAMUSCULAR

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, USP (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

Product summary:

Oxytocin Injection, USP (synthetic) is supplied as follows: NDC 0143-9743-25 Package of 25. 1 mL fill in a 2 mL vial, 10 USP Units per mL. NDC 0143-9742-25 Package of 25. 10 mL fill in a 10 mL vial, 10 USP Units per mL. Discard unused portion. Use only if solution is clear and seal is intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Do not permit to freeze.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYTOCIN- OXYTOCIN INJECTION
WEST-WARD PHARMACEUTICALS CORP
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OXYTOCIN INJECTION, USP
(SYNTHETIC)
FOR INTRAVENOUS INFUSION OR INTRAMUSCULAR USE
RX ONLY
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 (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, USP 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, USP (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
m