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Animal NDC 61133-6013-2 Oxytocin

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-6013-2
Proprietary Name Oxytocin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Oxytocin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Bimeda, Inc.
Product Type Prescription Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Oxytocin
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200328 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Oxytocin Images

Oxytocin Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



Oxytocin

(purified oxytocic principle)
INJECTION FOR HORSES, COWS, SOWS, & EWES

20 USP Units per mL

HAZARDOUS
Not for Use in Humans
KEEP OUT OF REACH OF CHILDREN

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

DESCRIPTION: Oxytocin injection is a sterile aqueous solution of highly purified oxytocic principle derived by synthesis or obtained from the posterior lobe of the pituitary gland of healthy domestic animals used for food by humans. 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.

ACTIONS: Oxytocin acts directly on the smooth musculature of the uterus in all species to induce rhythmic 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 know with certainty, but oxytocin is presumed to act on certain smooth muscle elements in the gland.


Indications & Usage



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



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


Precautions



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 & Administration



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 proper physiological state.


Adverse Reactions



To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.


How Supplied



HOW SUPPLIED:  100mL multiple dose vials.

Approved by FDA under ANADA # 200-328


Storage And Handling



Store at controlled room temperature.  Protect from freezing.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.