Prednicortone – veterinary medicine recommended for the symptomatic treatment or as an adjuvant treatment of inflammatory and immune-mediated diseases in dogs and cats.
1 tablet contains:
Active substance: Prednisolone 5 mg
Active substance: Prednisolone 20 mg
Light brown tablet, with brown dots, round and convex, flavored, with a cross-shaped line on one side, for
breaking the tablet.
The tablets can be divided into 2 or 4 equal parts.
TARGET SPECIES
Dogs and cats.
WITHDRAWAL TIME
Not applicable.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Shelf life of divided tablets: 4 days.
Any unused portion of the tablet should be returned to the opened blister.
This medicine does not require any special temperature storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
SPECIAL WARNINGS
Special precautions for each target species
The administration of corticosteroids induces an improvement in clinical signs rather than a cure. Treatment should be combined with treatment of the underlying disease and/or environmental control.
Special precautions for use in animals
In cases where a bacterial infection is present, the product should be used in combination with appropriate antibacterial therapy.
Due to the pharmacological properties of prednisolone, caution should be exercised when using the veterinary medicinal product in animals with a weakened immune system.
Corticosteroids, such as prednisolone, exacerbate protein catabolism. Consequently, the product should be administered with caution to elderly and malnourished animals.
Corticosteroids, such as prednisolone, should be used with caution in animals with hypertension.
Pharmacologically active doses may lead to atrophy of the adrenal cortex, leading to adrenal insufficiency. This may be observed particularly after discontinuation of corticosteroid treatment. Adrenal insufficiency may be reduced by initiating therapy every other day, if practical. Doses should be reduced and administration should be discontinued gradually to avoid accelerating adrenal insufficiency (see section on: Amounts to be administered and route of administration).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to prednisolone or other corticosteroids, or to any of the excipients, should avoid contact with the veterinary medicinal product.
Corticosteroids may cause foetal malformations; therefore, it is recommended that pregnant women avoid contact with the veterinary medicinal product. Wash hands thoroughly immediately after handling the tablets.
Use during pregnancy and lactation
Do not use in pregnant animals. Studies in laboratory animals have shown that administration during early pregnancy may cause foetal abnormalities. Administration during later stages of pregnancy may cause abortion or premature birth. See also section on contraindications.
Use during lactation only according to the benefit/risk assessment by the responsible veterinarian.
Overdose (symptoms, emergency procedures, antidotes) (if applicable)
Overdose does not cause adverse reactions other than those mentioned in the adverse reactions section. There is no known antidote.
Interactions with other medicinal products and other forms of interaction
Phenytoin, barbiturates, ephedrine and rifampicin may accelerate the metabolic clearance of corticosteroids, leading to decreased blood concentrations and reduced physiological effect.
Concomitant use of the veterinary medicinal product with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal ulceration. Since corticosteroids may reduce the immune response to vaccination, prednisolone should not be used in conjunction with vaccines or within two weeks of vaccination.
Administration of prednisolone may induce hypokalaemia and therefore may increase the risk of cardiac glycoside toxicity. The risk of hypokalaemia may be increased if prednisolone is administered concomitantly with potassium-depleting diuretics.
CONTRAINDICATIONS
Do not use in animals with viral or fungal infections.
Do not use in animals with diabetes mellitus or hyperadrenocorticism.
Do not use in animals with osteoporosis.
Do not use in animals with cardiac or renal dysfunction.
Do not use in animals with corneal ulcers.
Do not use in animals with gastrointestinal ulceration.
Do not use in animals with burns.
Do not use concomitantly with live attenuated virus vaccines.
Do not use in cases of glaucoma.
Do not use during pregnancy (see also section: Special warnings; Use during pregnancy and lactation).
Do not use in cases of known hypersensitivity to the active substance, to corticosteroids or to any of the excipients.
See also section: Interactions with other medicinal products and other forms of interaction.
ADVERSE REACTIONS
Anti-inflammatory corticosteroids, such as prednisolone, are known to cause a wide range of adverse reactions. While single administration of high doses is generally well tolerated, they can induce severe adverse reactions with long-term use.
Therefore, doses for medium to long-term use should be kept to the minimum necessary to control symptoms.
The significant dose-related suppression of cortisol observed during treatment is the result of suppression of the hypothalamic-pituitary-adrenal axis at effective doses. Signs of adrenal insufficiency may occur after cessation of treatment, which may progress to atrophy of the adrenal cortex, and this may render the animal unable to cope adequately with stressful situations.
Therefore, means of mitigating the problems associated with adrenal insufficiency following discontinuation of treatment should be considered.
The significant increase in triglycerides observed may be part of a possible iatrogenic hyperadrenocorticism (Cushing’s disease) involving significant alterations in fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, weight gain, muscle weakness and wasting, and osteoporosis. Cortisol suppression and increased plasma triglyceride levels are very common adverse reactions to corticosteroid medication (more than 1 in 10 animals).
Glucocorticoid-induced increases in alkaline phosphatase may be associated with liver enlargement (hepatomegaly) accompanied by increases in serum liver enzymes.
Other changes in blood biochemical and haematological parameters, possibly associated with the use of prednisolone, were reflected by significant effects observed on lactate dehydrogenase (decrease) and albumin (increase), as well as on eosinophils, lymphocytes (decrease) and segmented neutrophils (increase).
A decrease in aspartate aminotransferase is also observed.
Systemically administered corticosteroids may cause polyuria, polydipsia and polyphagia, especially in the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalemia with long-term use. Systemic corticosteroids cause calcium deposition in the skin (calcinosis cutis).
The use of corticosteroids may delay wound healing, and the immunosuppressive action may weaken resistance or exacerbate existing infections. In the presence of viral infections, corticosteroids may worsen the disease or hasten its progression.
Gastrointestinal ulceration has been reported in animals treated with corticosteroids, and gastrointestinal ulceration may be exacerbated by steroids in animals receiving nonsteroidal anti-inflammatory drugs and in animals with spinal cord trauma.
Other adverse reactions that may occur include: inhibition of longitudinal bone growth; skin atrophy; diabetes mellitus; euphoria, pancreatitis, decreased thyroid hormone synthesis; increased parathyroid hormone synthesis.
See also the section on Special warnings: Use during pregnancy and lactation.
If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.
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