Label: PREDEF- isoflupredone acetate injection, suspension

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

Drug Label Information

Updated December 28, 2017

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  • SPL UNCLASSIFIED SECTION

    For Intramuscular or Intrasynovial Use Only

    FOR USE IN ANIMALS ONLY

  • CAUTION

    Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

  • DESCRIPTION

    Each mL of PREDEF 2X contains 2 mg of isoflupredone
    acetate;also 4.5 mg sodium citrate hydrous;
    120 mg polyethylene glycol 3350;
    1 mg povidone; 0.201 mg myristyl-
    gamma-picolinium chloride added
    as preservative. When necessary,
    pH was adjusted with hydrochloric
    acid and/or sodium hydroxide.
    It is for intramuscular or intrasynovial
    injection in animals and is indicated in situations requiring glucocorticoid,
    anti-inflammatory, and/or supportive effect.

    Metabolic and Hormonal Effects

    PREDEF 2X, a potent corticosteroid, has greater glucocorticoid
    activity than an equal quantity of prednisolone.
    The glucocorticoid activity of PREDEF 2X is approximately 10
    times that of prednisolone, 50 times that of hydrocortisone, and 67
    times that of cortisone as measured by liver glycogen deposition in
    rats.

    The gluconeogenic activity is borne out by its hyperglycemic
    effect in both normal and ketotic cattle.

  • INDICATIONS


    Bovine Ketosis

    PREDEF 2X, by its gluconeogenic and glycogen deposition activity,
    is an effective and valuable treatment for the endocrine and metabolic
    imbalance of primary bovine ketosis. The stresses of parturition
    and high milk production predispose the dairy cow to this condition.
    This adrenal steroid causes a prompt physiological effect, with
    blood glucose levels returning to normal or above within 8 to
    24 hours following injection. There is a decrease in circulating
    eosinophils, followed by a reduction in blood and urine ketones.
    Usually the general attitude of the cow is much improved,
    appetite returns, and milk production rises to previous levels
    within 3 to 5 days. In secondary bovine ketosis, where
    the condition is complicated by pneumonia, mastitis,
    endometritis, traumatic gastritis, etc, PREDEF 2X
    should be used concurrently with proper local and
    parenteral antibacterial therapy, infusion solutions,
    and other accepted treatments for the primary conditions.

    Musculoskeletal Conditions

    As with other adrenal steroids, this preparation has been found useful in alleviating the pain and lameness
    associated with generalized and acute localized arthritic
    conditions in large animals. PREDEF 2X has been used successfully to
    treat laminitis, rheumatoid and traumatic arthritis, osteoarthritis,
    periostitis, tendinitis, tenosynovitis, bursitis, and myositis.
    Generalized muscular soreness, stiffness, depression, and anorexia
    resulting from overwork, shipping, unusual physical exertion, etc,
    respond promptly. Remission of symptoms may be permanent, or
    symptoms may recur, depending on the cause and extent of structural
    degeneration.

    Allergic Reactions

    PREDEF 2X is especially beneficial in treating
    acute hypersensitivity reactions resulting from treatment with a
    sensitizing drug or exposure to other allergenic agents. Usual manifestations
    are anaphylactoid reactions and urticaria. Less severe
    allergic manifestations, such as atopic and contact dermatitis, summer
    eczema, and conjunctivitis, may also be treated. Response is
    usually rapid and complete, although in severe cases with extensive
    lesions, more prolonged adrenocorticoid therapy and other appropriate
    treatment may be indicated.

    Overwhelming Infections with Severe Toxicity

    In animals moribund from overwhelmingly severe infections for which specific antibacterial
    therapy is available (eg, critical pneumonia, peritonitis, endometritis,
    septic mastitis), intensive PREDEF 2X therapy may aid
    in correcting the circulatory defect by counteracting the responsible inflammatory
    changes, thereby permitting the antibacterial agent to exert its full effect.
    As supportive therapy, this steroid combats the stress and improves the general 
    attitude of the animal being treated. All necessary procedures for the establishment of a bacterial
    diagnosis should be carried out whenever possible before institution
    of therapy. PREDEF 2X therapy in the presence of infection should be administered
    for the shortest possible time compatible with maintenance of an adequate response,
    and antibacterial therapy should be continued for at least three days after the hormone has been withdrawn.
    Combined hormone and antibacterial therapy does not obviate the
    need for indicated surgical treatment.

    Shock

    PREDEF 2X is indicated in adrenal failure and shocklike
    states occurring in association with severe injury or other trauma,
    emergency surgery, anaphylactoid reactions, and elective surgery in
    poor surgical risks. It is recommended as an adjuvant to standard
    methods of combating shock, including use of plasma expanders.
    Because of interrelated physiologic activities, beneficial effects may
    not be exhibited until all such procedures have been employed.

    Other Indications

    Exhaustion following surgery or dystocia,
    retained placenta, inflammatory ocular conditions, snakebite, and
    other stress conditions are also indications for use. Its employment
    in the treatment of these conditions is recommended as a supportive measure
    to standard procedures and time-honored treatments will
    give comfort to the animal and hasten complete recovery.

    PREDEF 2X has been found useful as supportive therapy in the
    treatment of the stress associated with parturient paresis ie, milk
    fever. It should be given intramuscularly, before or after the administration
    of the calcium infusion solutions commonly employed in
    treating the disease. PREDEF 2X is not to be added to the infusion
    solutions.

  • WARNINGS

    Animals intended for human consumption should not be slaughtered
    within 7 days of last treatment. Do not use in horses intended
    for human consumption. A withdrawal period has not been established
    for this product in preruminating calves. Do not use in calves to be
    processed for veal. Not for human use.

    Clinical and experimental data have demonstrated that corticosteroids
    administered orally or parenterally to animals may induce
    the first stage of parturition when administered during the last
    trimester of pregnancy and may precipitate premature parturition
    followed by dystocia, fetal death, retained placenta, and metritis.

    Additionally, corticosteroids administered to dogs, rabbits, and
    rodents during pregnancy have resulted in cleft palate in offspring.

    Corticosteroids administered to dogs during pregnancy have also
    resulted in other congenital anomalies, including deformed forelegs,
    phocomelia, and anasarca.

  • PRECAUTIONS

    PREDEF 2X exerts an inhibitory influence
    on the mechanisms and the tissue changes associated with inflammation.
    Vascular permeability is decreased, exudation diminished, and migration of the inflammatory
    cells markedly inhibited. In addition, systemic manifestations
    such as fever and signs of toxemia may also be suppressed. While
    certain aspects of this alteration of the inflammatory reaction may be
    beneficial, the suppression of inflammation may mask the signs of
    infection and tend to facilitate spread of microorganisms. However, in
    infections characterized by overwhelming toxicity, PREDEF 2X therapy
    in conjunction with appropriate antibacterial therapy is effective in
    reducing mortality and morbidity. Without concurrent use of an antibiotic
    to which the invader-organism is sensitive, injudicious use of the
    adrenal hormones in animals with infections can be hazardous. As
    with other corticoids, continued or prolonged use is discouraged.

    While no sodium retention nor potassium depletion has been
    observed at the doses recommended in animals receiving 9-fluoroprednisolone
    acetate, as with all corticoids, animals should be under
    close observation for possible untoward effects. If symptoms of
    hypopotassemia should occur, corticoid therapy should be discontinued
    and 5% solution of potassium chloride administered by
    continuous intravenous drip.

  • DOSAGE AND ADMINISTRATION

    PREDEF 2X is administered by deep intramuscular injection for systemic effect, or into joint cavity, tendon sheath, or bursa for local effect.

    Cattle

    The usual intramuscular dose for cattle is 10 to 20 mg,
    according to the size of the animal and severity of the condition.
    This dose may be repeated in 12 to 24 hours if indicated.

    Ketosis studies have demonstrated that relatively high initial doses
    of corticoids produce a more prompt recovery with a lower incidence
    of relapse than when relatively low doses are used, even when
    these are repeated. Response of ketosis to PREDEF 2X therapy
    parallels that derived with prednisolone. PREDEF 2X is 10 times
    more glucogenic than prednisolone. Thus, 10 mg of isoflupredone
    acetate therapeutically equals 100 mg of prednisolone.

    In the event of poor response or relapse, diagnosis should be
    reconfirmed by re-examining the animal for complications (ie, pneumonia,
    metritis, traumatic gastritis, mastitis).

    Horses

    The usual intramuscular dose for horses is 5 to 20 mg
    repeated as necessary. The usual intrasynovial dose in joint inflammation,
    tendinitis, or bursitis is 5 to 20 mg or more, depending on
    the size of the cavity to be injected.

    Swine

    The usual intramuscular dose for swine is 5 mg for a 300 pound animal. The dose for larger or smaller pigs is proportional to the weight of the animal.

  • HOW SUPPLIED

    PREDEF 2X, 2 mg per mL, is available in 100 mL vials.

    Store at controlled room temperature 20° to 25° C (68° to 77° F).

    NADA 011-789, Approved by FDA

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Revised: September 2017


    50576000

  • PRINCIPAL DISPLAY PANEL - 100 mL Vial Label

    100 mL Vial

    Predef® 2X
    isoflupredone acetate
    Sterile Aqueous Suspension

    2 mg per mL

    For intramuscular or
    intrasynovial use only

    For Use in Animals Only

    Caution: Federal (USA) law
    restricts this drug to use
    by or on the order of a
    licensed veterinarian.

    NADA 011-789,

    Approved by FDA

    zoetis

    Predef 2X - Label
  • INGREDIENTS AND APPEARANCE
    PREDEF 
    isoflupredone acetate injection, suspension
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-1620
    Route of AdministrationINTRAMUSCULAR, INTRASYNOVIAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOFLUPREDONE ACETATE (UNII: 55P9TUL75S) (ISOFLUPREDONE - UNII:HYS0B45Z2S) ISOFLUPREDONE ACETATE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 4.5 mg  in 1 mL
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POVIDONE (UNII: FZ989GH94E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1620-1100 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01178906/22/1959
    Labeler - Zoetis Inc. (828851555)