PREDEF- isoflupredone acetate injection, suspension

Predef by

Drug Labeling and Warnings

Predef by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PREDEF 
isoflupredone acetate injection, suspension

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 54771-1620
Route of Administration	INTRAMUSCULAR, INTRASYNOVIAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOFLUPREDONE ACETATE (UNII: 55P9TUL75S) (ISOFLUPREDONE - UNII:HYS0B45Z2S)	ISOFLUPREDONE ACETATE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)	4.5 mg  in 1 mL
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POVIDONE (UNII: FZ989GH94E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-1620-1	100 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA011789	06/22/1959

Labeler - Zoetis Inc. (828851555)