Label: OXYTOCIN- oxytocin injection injection, solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated January 12, 2016

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  • DESCRIPTION

    OXYTOCIN is a nonapeptide hormone prepared by synthesis.
    It is a sterile aqueous solution containing the equivalent of 20 USP Units of Oxytocin, less than 0.4 units of pressor activity per mL. The preservative is 0.5% Chlorobutanol.

    Each mL CONTAINS:
    Oxytocin (synthetic) 20 USP units
    Sodium chloride 0.9% w/v
    Chlorobutanol 0.5% w/v
    Water for Injection q.s.
    pH adjusted with Acetic Acid and/or Sodium Hydroxide.

    Oxytocin acts directly on the smooth musculature of the uterus in all species to produce rhythmic contractions although it has been demonstrated in some species that the uterine cervix will not respond to oxytocin. The degree of uterine activity elicited by oxytocin depends to a great extent on the stage of the reproductive cycle. Most authorities agree that the level of estrogen and progesterone in the various phases of pregnancy is the main controlling factor of the activity that oxytocin has on the uterus. During the early phases of normal pregnancy, the uterus is relatively insensitive to oxytocin. In the late phases, the sensitivity is increased.

    OXYTOCIN has the integral relationship with the letdown of milk. Some authorities refer to this as the galactogogic effect. The mechanism by which milk is discharged from the mammary glands is not definitely known, but Oxytocin is presumed to act on certain smooth muscle elements in the gland. It has been clearly demonstrated, however, that Oxytocin will promote a prompt milk-ejecting effect.

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  • INDICATIONS & USAGE

    INDICATIONS: Due to Oxytocin's specific action on 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 Cesarean section and control of uterine hemorrhage.

    Because of Oxytocin's milk ejecting effect, it will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: For obstetrical use. Oxytocin may be injected intravenously, intramuscularly or subcutaneously, under aseptic conditions as indicated.The following dosages are recommended and may be repeated as conditions require:

    CATS                      0.25 to 0.5 mL                 5 to 10 U.S.P. units
    DOGS                     0.25 to 1.5 mL                 5 to 30 U.S.P. units
    EWES, SOWS        1.5 to 2.5 mL                   30 to 50 U.S.P. units
    COWS, HORSES    5.0 mL                             100 U.S.P. units

    For augmenting the letdown of milk, intravenous administration is desirable.The following dosage is recommended and may be repeated as conditions require:

    COWS                     0.5 to 1.0 mL                   10 to 20 U.S.P. units
    SOWS                     0.25 to 1.0 mL                 5 to 20 U.S.P. units

    Use product within 60 days of the first puncture. Do not puncture the stopper more than 133 times.
    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • CONTRAINDICATIONS

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

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  • PRECAUTIONS

    PRECAUTIONS:Oxytocin is a potent preparation.Therefore, it should be administered with due caution. For prepartum usage, full dilation of the cervix should be accomplished either naturally or by administration of Estrogen prior to Oxytocin therapy.

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  • HOW SUPPLIED

    SUPPLIED: Oxytocin is available in 100 mL multiple dose vials.

    CAUTION: KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN

    Keep refrigerated at 36-46°F (5°±3°C). Do not freeze.

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  • INGREDIENTS AND APPEARANCE
    OXYTOCIN 
    oxytocin injection injection, solution
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:50989-140
    Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Oxytocin (UNII: 1JQS135EYN) (Oxytocin - UNII:1JQS135EYN) Oxytocin 20 [USP'U]  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-140-12 100 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA109305 10/05/2015
    Labeler - VEDCO (021634266)
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