Predef 2X Sterile Aqueous Suspension (Canada)

Company: Zoetis

sterile aqueous suspension

isoflupredone acetate sterile suspension for injection - mfr. std.

2 mg/mL

Veterinary Use Only

DIN 00813869

Description

Medicinal ingredient: Each mL contains: isoflupredone acetate 2 mg.

Non-medicinal ingredients: sodium citrate 4.5 mg; polyethylene glycol 120 mg; polyvinylpyrrolidone 1 mg; myristyl-gamma-picolinium chloride (as preservative) 0.2 mg and water for injection q.s. When necessary, pH was adjusted with hydrochloric acid and/or sodium hydroxide. Predef 2X is intended 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 sterile aqueous suspension contains a potent corticosteroid developed in the Research Laboratories of Pfizer Animal Health which has greater glucocorticoid activity than an equal quantity of prednisolone. The glucocorticoid activity of isoflupredone 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.

Predef 2X Sterile Aqueous Suspension Indications

Bovine Ketosis. Predef 2X sterile aqueous suspension, 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 sterile aqueous suspension should be used concurrently with proper local and parenteral antibacterial therapy, infusion solutions, and other accepted treatments for the primary conditions.

Milk Fever. Predef 2X sterile aqueous suspension has been found to be excellent supportive therapy in the treatment of the stress associated with parturient paresis. It should be given intramuscularly, before or after the administration of the calcium infusion solutions commonly employed in treating the disease.

Predef 2X sterile aqueous suspension is not to be added to the infusion solutions.

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 sterile aqueous suspension 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 sterile aqueous suspension 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 treatments may be indicated.

Overwhelming Infections with Severe Toxicity. In animals moribund from overwhelmingly severe infections for which specific antibacterial therapy is available (e.g., critical pneumonia, peritonitis, endometritis, septic mastitis), intensive isoflupredone therapy may aid in correcting the circulatory defect by counter-acting 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. Isoflupredone 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 sterile aqueous suspension is indicated in adrenal failure and shock-like 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 and will give comfort to the animal and hasten complete recovery.

Predef 2X Sterile Aqueous Suspension Cautions

Isoflupredone acetate 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, isoflupredone 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 isoflupredone acetate, as with all corticoids, animals should be under close observation for possible untoward effects. If clinical signs of hypokalemia should occur, corticoid therapy should be discontinued and a solution of potassium chloride administered by continuous intravenous drip.

The following reaction is related to parenteral corticosteroid therapy: anaphylactoid reaction (such as bronchospasm, laryngeal edema, urticaria). In the event of a hypersensitivity reaction following administration of this drug, immediate appropriate therapy should be instituted.

Predef 2X Sterile Aqueous Suspension Dosage And Administration

Predef 2X sterile aqueous suspension 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 required. 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 isoflupredone therapy parallels that derived with prednisolone. Isoflupredone 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 (i.e., 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 140 kg animal. The dose for larger or smaller pigs is proportional to the weight of the animal.

Warnings

Treated animals must not be slaughtered for use in food for at least 5 days after the latest treatment with this drug. Milk taken from treated animals during treatment and within 72 hours after the latest treatment must not be used as food.

Storage

Store between 15 and 25°C. Once broached, contents should be used within 28 days.

Presentation

Predef 2X sterile aqueous suspension (isoflupredone acetate injection) 2 mg per mL is supplied in 100 mL vials.

Zoetis is a trademark and Predef is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc.

? 1-800-461-0917

Zoetis Canada Inc., Kirkland QC H9H 4M7

07/14 G1703114PAECA

1638-11-1

CPN: 1198304.5