Label: OXYTOCIN- oxytocin injection, solution
- NDC Code(s): 61133-6013-2
- Packager: Bimeda Inc., Division of Cross Vetpharm Group
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
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(purified oxytocic principle)
INECTION FOR HORSES, COWS, SOWS, & EWES
20 USP Units per mL
Sterile Aqueous Solution
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) - Use Only as Directed
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA 200-328, Approved by FDA
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.Close
- 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.Close
CONTRAINDICATION: Do not use in dystocia due to abnormal presentation of the fetus until correction is accomplished.Close
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.Close
- DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION:
Obstetrical Use: Inject aseptically by the intravenous, intramuscular or subcutaneous route as follows:
1.5 to 2.5mL......................30 to 50 USP Units
5.0mL...............................100 USP Units
These dosages are recommended, and may be repeated as indicated.
Inject aseptically by the intravenous, intramuscular or subcutaneous route
0.5 to 1.0mL.....................10 to 20 USP Units
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.Close
- GENERAL PRECAUTIONS
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.Close
- HOW SUPPLIED
100mL multiple dose vials.Close
- STORAGE AND HANDLING
Store at controlled room temperature.
Protect from freezing.Close
- INGREDIENTS AND APPEARANCE
oxytocin injection, solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:61133-6013 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 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-6013-2 100 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200328 05/24/2004 Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923) Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923) Establishment Name Address ID/FEI Business Operations Bimeda - MTC Animal Health, Division of Cross Vetpharm Group 256232216 manufacture Establishment Name Address ID/FEI Business Operations GRINDEKS AS 644702888 api manufacture Establishment Name Address ID/FEI Business Operations Hemmo Pharmaceutical Pvt. Ltd. 650515294 api manufacture