OXYTOCIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

OXYTOCIN

Composition:

OXYTOCIN 10 [USP'U] in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

IMPORTANT NOTICE Oxytocin 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 is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve early vaginal delivery. It is indicated for (1) induction of labo

Product summary:

Oxytocin Injection, USP (synthetic), 10 USP units per mL is packaged in single or multiple dose vial and supplied as follows: Store at 25°C (77°F); excursions permitted to 15–30°C (59-86°F) [See USP Controlled Room Temperature]. Do not freeze.  Do not use if solution is discolored or contains a precipitate. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutcial Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Authorization status:

New Drug Application

Summary of Product characteristics

OXYTOCIN- OXYTOCIN INJECTION
HIKMA PHARMACEUTICALS USA INC.
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OXYTOCIN INJECTION, USP (SYNTHETIC)
FOR INTRAVENOUS INFUSION OR INTRAMUSCULAR USE
RX ONLY
DESCRIPTION
Each mL of Oxytocin Injection sterile solution contains an oxytocic
activity equivalent to 10 USP
Posterior Pituitary Units, Chlorobutanol (a chloroform derivative),
0.5%, as a preservative, and acetic
acid to adjust pH (3.0 to 5.0). Oxytocin is intended for IM or IV use.
Oxytocin is a synthetic
polypeptide; it occurs as a white powder and is soluble in water. It
may be designated chemically as:
CLINICAL PHARMACOLOGY
The pharmacologic and clinical properties of oxytocin are identical
with those of naturally occurring
oxytocin principle of the posterior lobe of pituitary. Oxytocin 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.
When given in appropriate doses during pregnancy, oxytocin is capable
of eliciting graded increases in
uterine motility from a moderate increase in the rate and force of
spontaneous motor activity to sustained
titanic contraction. The sensitivity of the uterus to oxytocic
activity increases progressively throughout
pregnancy until term when it is maximal.
Oxytocin is distributed throughout the extracellular fluid. Small
amounts of this drug probably reach the
fetal circulation. Oxytocin has a plasma half-life of about 3 to 5
minutes. Following parenteral
administration, uterine response occurs within 3 to 5 minutes and
persists for 2 to 3 hours. Its rapid
removal from plasma is accomplished largely by the kidney and the
liver. Only small amounts oxytocin
are excreted in the urine unchanged.
INDICATIONS AND USAGE
IMPORTANT NOTICE
Oxytocin is indicated for the medical rather than the elective
induction of labor. Available data
and information are inadequate to d