Solu Cortef

Prednisolone

Description

Composition                                                         

Each ml (when mixed) contains:

100 MG 500 mg
Prednisolone sodium succinate 10 mg 50 mg equivalent to prednisolone
Monobasic sodium phosphate (anh) 0.075 mg 0.075 mg
Dibasic sodium phosphate dried 0.81 mg 0.81 mg
Lactose hydrous 19.6 mg 19.6 mg
Tyloxapol 4.9 mg 4.9 mg
Chorobutanol anhydrous 3.08 mg 3.08 mg

(chloral deriv.) added as preservative

Characteristics
Solu (Delta) Cortef Sterile Powder contains prednisolone sodium succinate which is a salt of prednisolone that is particularly 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.

Indications
Solu Cortef is indicated  for use in situations in which a rapid an intense adrenal glucocorticoid and/or anti-inflammatory effect is necessary. If the intravenous route is impracticable or the need is not so urgent, the intramuscular route may be used.
Solu Cortef is indicated for animals (cats, dogs, horses) suffering from allergic reactions, shock, inflammatory conditions, overwhelming infections with severe toxicity, rattlesnake bite, toxaemia, inflammatory ocular conditions and other stress conditions.

Inflammatory Conditions:
As with the other adrenal steroids, Solu Cortef has been found useful in alleviating lameness associated with acute localized and generalized arthritic 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 been used successfully to treat bursitis, carpitis tendinitis and myositis. Remission of the symptoms may be permanent, or symptoms 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.
The intravenous administration is of particular value in treating acute laminitis (founder) in horses.

Allergic Reactions:
Especially beneficial in treating acute hypersensitivity reactions resulting from treatment with a sensitizing drug or exposure to other allergenic agents.

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 may aid in correcting the circulatory defect by counteracting the responsible inflammatory changes, thereby permitting the antibacterial agent to exert its full effect.

Shock:
For dogs, intravenous Solu Cortef 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.

Please see leaflet for more specific information.

Dosage and administration
Horses:
The dosage for horses is 50to 100mg as an initial dose. This may be given intravenously over a period of ½ to1 minute, or intramuscularly, and may be repeated in inflammatory, allergic, or other stress conditions 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.

Please see leaflet for continued use.
Dogs/Cats: see leaflet.

Adverse reactions
Undesirable effects of adrenocorticoid administration are sodium and water retention, potassium loss, glycosuria, hyperglycaemia and polyuria and polydipsia.

Precautions
Please see leaflet for continued use.

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 relative 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.

Warnings
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 partition followed by dystocia, foetal death, and retained placenta en 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.

Storage
Store at 15 – 25°C. Protect from light.
Use immediately, do not store reconstituted product.
Keep away from children.

Presentation
10ml Act-O-Vial system

Registration (International)
NADA 011-593