Oxoject

Dosage Form: FOR ANIMAL USE ONLY
Oxoject Injection Oxytocin ANADA 200-328

Product Titles

Oxoject

Oxytocin Injection

Purified Oxytocic Principle

(20 USP Units per mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Description

Oxoject (Oxytocin injection) is a sterile aqueous solution of highly purified oxytocic principle derived by synthesis or obtained from the posterior lobe of the putuitary gland of healthy domestic animals used for food by humans.  Oxoject (Oxytocin injection) contains 20 USP Units of oxytocin and less than 0.4 units of presser activity per mL.  Each mL of sterile solution also contains 0.9% w/v sodium chloride, 0.5% w/v chlorobutanol (as a preservative), with water for injection q.s. and pH adjusted to 3.0 to 5.0 with acetic acid.

Action

Oxytocin acts directly on the smooth musculature of the uterus in all species to induce rythmic contractions, although in some species the uterine cervix does not respond to oxytocin.  The responsiveness of the uterine musculature to oxytocin varies greatly with the stage of the reproductive cycle.  During the early phases of pregnancy the uterus is relatively insensitive to the effects of oxytocin, while in the late phases the sensitivity is markedly increased.  Most authorities attribute this varying response to the varying levels of estrogen and progesterone during the course of pregnancy.  Oxytocin also has been shown to exert a milk ejecting effect, occasionally referred to as the galactogogic effect.  The actual mechanism by which oxytocin stimulates the release of milk from the mammary glands is not known with certainty, but oxytocin injection is presumed to act on certain smooth muscle elements in the gland.

Indications

Because of the specific action of oxytocin upon the uterine musculature, it is recommended as an aid in the management of the following conditions:


1)  To precipitate labor


2)  To accelerate normal parturition


3)  Postpartum evacuation of uterine debris


4)  Postoperative contraction of the uterus following a cesarean section and control of uterine hemorrhage.


Oxytocin will contract the smooth muscle cells of the mammary gland to induce milk let-down if the udder is in a proper physiological state.

Contraindications

Do not use in dystocia due to abnormal presentation of the fetus until correction is accomplished.

Do not use in dystocia due to abnormal presentation of the fetus until correction is accomplished.

Precautions

Oxytocin is a potent preparation, accordingly, it should be administered with due caution.  For prepartum usage full dilation of the cervix should be accomplished either naturally or through the administration of estrogen prior to oxytocin therapy.

Dosage and Administration

Obstetrical Use: Inject aseptically by the intravenous, intramuscular or subcutaneous route as follows:

EWES, SOWS:

1.5 to 2.5mL........30 to 50 USP Units

COWS, HORSES:

5.0mL.................100 USP Units

These dosages are recommended, and may be repeated as indicated.

Milk Let-down:

Inject aseptically by the intravenous, intramuscular or subcutaneous route.

COWS:

0.5 to 1.0mL............10 to 20 USP Units

SOWS:

0.25 to 1.0mL...........5 to 20 USP Units

These dosages are recommended and may be repeated as necessary.

Note:  Oxytocin will not induce milk let-down unless the udder is in the proper physiological state.

Caution

CAUTION:  Federal law restricts this drug to be used by or on the order of a licensed veterinarian.

How Supplied

100 mL multiple dose vials

Storage

Store at controlled room temperature.


Do Not Freeze.

Package Label Principle Display Panel

NDC # 11695-4015-1

Butler Animal Health Supply

Oxoject

Oxytocin Injection

Purified Oxytocic Principle

Sterile Aqueous Solution

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION:  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ANADA # 200-328, Approved by FDA

Net Contents:  100mL (3.4 fl. oz)

Distributed Exclusively by:  Butler Animal Health Supply-Dublin, OH  43017

Oxoject  oxytocin injection  injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 11695-4015 Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxytocin (Oxytocin) Oxytocin 20 [USP'U]  in 100 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11695-4015-1 100 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200328	10/15/2009

Labeler - Butler (017880659)

Revised: 12/2009Butler