Solu-Delta-Cortef Sterile Solution (Canada)

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  • Solu-Delta-Cortef Sterile Solution Indications
  • Warnings and cautions for Solu-Delta-Cortef Sterile Solution
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Solu-Delta-Cortef Sterile Solution

This treatment applies to the following species:
Manufacturer: Zoetis

prednisolone sodium succinate for injection, USP

DIN 01990578

Veterinary Use Only

Sterile Powder for Solution

DESCRIPTION: Solu-Delta-Cortef® sterile solution (prednisolone sodium succinate) is a salt of prednisolone that is suitable for intravenous or intramuscular injection because it is highly water soluble, permitting administration of relatively large doses in a small volume of diluent. It is especially designed for intravenous use in situations requiring rapid and intense glucocorticoid and/or anti-inflammatory effect; however, it may be used by the intramuscular route in less acute conditions.

Metabolic and Hormonal Effects: Prednisolone, a derivative of hydrocortisone, has greater glucocorticoid activity, greater anti-inflammatory activity, less sodium-retaining effect, and less potassium-losing effect than the parent compound.

The glucocorticoid activity of prednisolone is approximately 4 times that of hydrocortisone and 5 times that of cortisone as measured in experimental animals in terms of liver glycogen deposition, eosinopenic response, and thymic involution.

The anti-inflammatory activity of prednisolone is at least 4 times that of hydrocortisone. Solu-Delta-Cortef sterile solution exerts an inhibitory influence on the cellular, fibrous, and amorphous components of connective tissue, and thereby suppresses the basic processes of inflammation. Vascular permeability is decreased, exudation diminished, and the migration of inflammatory cells markedly impaired.

Medicinal ingredients: Prednisolone (as prednisolone sodium succinate), 100 mg per 10 mL (when mixed)

Non-medicinal ingredients: Dibasic Sodium Phosphate, 0.75 mg, Monobasic Sodium Phosphate, 8.1 mg, Lactose Monodydrate, 196 mg, sodium hydroxide solution qs, water for injection qs and tyloxapol, 49 mg, per 10 mL (when mixed).

INDICATIONS: Solu-Delta-Cortef sterile solution is indicated for use in situations in which a rapid and intense adrenal glucocorticoid and/or anti-inflammatory effect is necessary for horses, cats or dogs. If the intravenous route is impractical or the need is not so urgent, the intramuscular route may be used.

Inflammatory Conditions: As with the other adrenal steroids, Solu-Delta-Cortef sterile solution has been found useful in alleviating lameness associated with acute localized and generalized inflammatory musculoskeletal conditions in horses, dogs, and cats. Treatment is usually required daily or on alternate days, depending on the severity or duration of the condition. Prednisolone sodium succinate has also been used successfully to treat bursitis, arthritis, tendinitis, and myositis. Remission of the clinical signs may be permanent, or clinical signs may recur, depending on the cause and the extent of structural degeneration.

Generalized muscular soreness, stiffness, depression, and anorexia as a result of overtraining, shipping, unusual physical exertion, etc., respond promptly to prednisolone sodium succinate.

Allergic Reactions: Solu-Delta-Cortef sterile solution 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. Recovery 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 (e.g., critical pneumonia, peritonitis, endometritis, mastitis), intensive prednisolone sodium succinate therapy (with Solu-Delta-Cortef) 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 product 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. In the presence of infection, prednisolone sodium succinate should be administered for the shortest possible time compatible with maintenance of an adequate clinical 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: For dogs, intravenous Solu-Delta-Cortef sterile solution is indicated in the prevention and treatment of 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. This hormone 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 visible until all such procedures have been employed. Solu-Delta-Cortef sterile solution is an invaluable emergency kit drug.

Other Indications: Solu-Delta-Cortef sterile solution has been found useful as supportive therapy in the treatment of stress-induced exhaustion, rattlesnake bite, toxemia, inflammatory ocular conditions and other stress conditions. Its use in the treatment of these conditions is recommended as a measure supportive to standard procedures and time-honored treatments, and will aid in recovery of the animal.

Dosage and Administration

Preparation Of Solution

Directions for using the Act-O-Vial* System

1. Press down on plastic activator to force diluent into the lower compartment.

2. Gently agitate to effect solution.

3. Remove plastic tab covering centre of stopper.

4. Sterilize top of stopper with a suitable germicide.

5. Insert a size 18 or less needle squarely through centre of stopper until tip is just visible (as illustrated). Invert vial and withdraw dose.

6. Amount of solution available for administration after reconstitution is 10 mL.

Reconstituted product should be used immediately. No additional diluent should be added, and the solution should be injected directly into the vein or muscle. If desired, the solution may be incorporated into the following infusion solutions: Dextrose 5% injection, Dextrose 5% and Sodium Chloride injection, Dextrose 10% injection, Dextrose 10% and Sodium Chloride injection, Ringer’s injection, Fructose 10%, and Lactated Potassic Saline injection (Darrow’s Solution), but must not be added to calcium infusion solutions. If the solution should become cloudy after reconstituting, it should not be used intravenously.

Horses: For the treatment of shock and shock-like states, an initial intravenous dose ranging from 0.25 to 1.0 mg/kg body weight is recommended. Treatments may be repeated at 1, 3, 6, or 10 hour intervals, according to the condition of the animal. For CPR (cardiopulmonary resuscitation) conditions, an intravenous dosage of 2.0 mg/kg could be used. For the treatment of inflammatory, allergic or other stress conditions, a dose ranging from 0.25 to 1.0 mg/kg body weight may be administered intravenously or intramuscularly and may be repeated at intervals of 12, 24 or 48 hours, depending upon the size of the animal, the severity of the condition, and the response to treatment.

When steroid therapy is to be prolonged beyond 48 hours, as for a chronic arthritic condition, Depo-Medrol® sterile aqueous suspension (methylprednlsolone acetate injectable suspension, USP) or Predef* 2X sterile aqueous suspension (isoflupredone acetate sterile suspension for injection - mfr. std.) may be injected intramuscularly and continued depending on the severity of the condition and response to treatment. See product insert for Depo-Medrol sterile aqueous suspension (methylprednlsolone acetate injectable suspension, USP) and Predef 2X sterile aqueous suspension (isoflupredone acetate sterile suspension for injection - mfr. std.). When continuing corticosteroid therapy with another product following the last administration of Solu-Delta-Cortef, the time of follow-up treatment should take into consideration the disease/condition under treatment and the pharmacodynamics and the pharmacokinetics of both Solu-Delta-Cortef and the follow on product.

Dogs and Cats: The usual intravenous dose in shock and shock-like states ranges from 5.5 to 11 mg/kg body weight as an initial dose, followed by equal maintenance doses at 1, 3, 6, or 10 hour intervals, as determined by the condition of the animal. The intramuscular dose in inflammatory, allergic, and less severe stress conditions, where immediate effect is not required, is usually 0.5 mg/kg body weight for dogs and 1.0 mg/kg body weight for cats. This may be repeated every 12 hours for a maximum of 3 to 5 days. For immunosuppression, a dosage ranging from 2.0 - 4.0 mg/kg body weight administered daily in divided doses for 3 days or more, as dictated by the condition, is recommended.

When steroid therapy is to be more prolonged, as in a chronic arthritic or dermal condition, Depo-Medrol sterile aqueous suspension (methylprednisolone acetate injectable suspension, USP) may be used. When continuing corticosteroid therapy with another product following the last administration of Solu-Delta-Cortef, the time of follow-up treatment should take into consideration the disease/condition under treatment and the pharmacodynamics and the pharmacokinetics of both Solu-Delta-Cortef and the follow on product.

Contraindications

Except when used for emergency therapy, prednisolone sodium succinate is contraindicated in animals with tuberculosis, Cushingoid syndrome, and peptic ulcer. Existence of congestive heart failure, diabetes, chronic nephritis, and osteoporosis are contraindications. In the presence of infection, appropriate antibacterial agents should also be administered and should be continued for at least 3 days after discontinuance of the hormone and disappearance of all signs of infection. Do not use in viral infections.

CAUTIONS: 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.

Solu-Delta-Cortef sterile solution may suppress systemic manifestations such as fever and also signs of toxemia. In some instances, this alteration of the inflammatory reaction may be beneficial; however, it may also mask the signs of infection and tend to facilitate the spread of microorganisms. In infections characterized by overwhelming toxicity, prednisolone sodium succinate therapy in conjunction with indicated antibacterial therapy is effective in reducing mortality and morbidity. It is essential that the causative organism be known and an effective antibacterial agent be administered concurrently. The injudicious use of adrenal hormones in animals with infections can be hazardous.

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, appropriate therapy should be instituted immediately.

Warnings

This drug must not be used in horses that are to be slaughtered for use in food. Keep out of reach of children.

Side Effects

The therapeutic use of Solu-Delta-Cortef sterile solution is unlikely to cause undesired accentuation of metabolic effects. However, if continued corticosteroid therapy is anticipated, a high protein intake should be provided to keep the animal in positive nitrogen balance. A retardant effect on wound healing has not been encountered, but such a possibility should also be considered when Solu-Delta-Cortef sterile solution is used in conjunction with surgery. Euphoria, or an improvement of attitude, and increased appetite are usual manifestations.

Undesirable effects of adrenocorticoid administration may be sodium and water retention, potassium loss, glycosuria, hyperglycemia, polyuria, and polydipsia.

Storage

Store at a temperature between 15 to 30°C. Protect from light.

PRESENTATION: Solu-Delta-Cortef sterile solution is available in 5x10 mL vials.

Pfizer Animal Health, Pfizer Canada Inc., Kirkland QC H9J 2M5

® Registered trademark of Pfizer Enterprises S.a.r.l.; Pfizer Canada Inc., Licensee.

* Registered trademark of Pharmacia & Upjohn Company LLC; Pfizer Canada Inc., Licensee.

PAA034885

1640-11-1

NAC No.: 1198308.4

ZOETIS CANADA
16,740 TRANS-CANADA HIGHWAY, KIRKLAND, QC, H9H 4M7
Order Desk:   800-663-8888
Technical Services Canada:   800-461-0917
Technical Services USA:   800-366-5288
Website:   www.zoetis.ca
Every effort has been made to ensure the accuracy of the Solu-Delta-Cortef Sterile Solution information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-12-03

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