Prednidale 25 mg Tablets for Dogs

Anti-inflammatory corticosteroids, such as prednisolone, are known to exert a wide
range of side effects. Whilst single high doses are generally well tolerated, they may
induce severe side-effects in long term use. Dosage in medium to long term use
should therefore generally be kept to the minimum necessary to control symptoms.
The significant dose related cortisol suppression noticed during therapy is a result of
effective doses suppressing the hypothalamic-pituitary-adrenal-axis. Following
cessation of treatment, signs of adrenal insufficiency can arise, and this may render
the animal unable to deal adequately with stressful situations.
The significant increase in triglycerides noticed can be a part of possible iatrogenic
hyperadrenocorticism (Cushing’s disease) involving significant alteration of fat,
carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat,
increase in body weight, muscle weakness, wastage and osteoporosis may result.
Cortisol suppression and an increase in plasma triglycerides is a possible side-effect
of medication with corticoids. Weight gain has been reported in very rare cases, in
post-authorisation experience.
Changes in biochemical, haematological and liver parameters, such as significant
effects on alkaline phosphatase (increase), lactate dehydrogenase (decrease),
aspartate transaminase (decrease), albumin (increase), eosinophils, lymphocytes
(decrease), segmented neutrophils (increase), and serum hepatic enzymes
(increase) are probably associated with the use of prednisolone. Changes in
haematological parameters have been reported in rare cases and changes in
biochemical and liver parameters in very rare cases, in post authorisation experience.
Polyuria and polydipsia have been reported in rare cases and polyphagia in very rare
cases, in post authorisation experience and may be caused by systemically
administered corticosteroids, particularly during the early stages of therapy. Sodium
and water retention and hypokalaemia may be caused by some corticosteroids in
long term use. Hypokalemia has been reported in very rare cases, in post
authorisation experience.
Deposition of calcium in the skin (calcinosis cutis) has been caused by systemic
corticosteroids.

Revised: April 2025
AN: 04127/2024Page 3 of 5
Wound healing may be delayed during corticosteroid use and the
immunosuppressant actions may weaken resistance to, or exacerbate existing
infections.
Gastrointestinal ulceration has been reported in very rare cases in animals treated
with corticosteroids in post authorisation experience and may be exacerbated by
steroids in animals given non-steroidal anti-inflammatory drugs.
Inhibition of longitudinal growth of bones; skin atrophy; diabetes mellitus; behavioral
disorders (excitation and depression), pancreatitis, decrease in thyroid hormone
synthesis; and increase in parathyroid hormone synthesis are o. ther adverse
reactions that may occur. Excitation has been reported in very rare cases, in post
authorisation experience.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated )
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated
reports).