Prednidale

1 x 100 pc

Tablet

Active substance

Prednisolone : 25 mg

ATC code

QH02AB06 Prednisolone (Corticosteroids - weak (group I))

QH02AB Glucocorticoids

QH02A Corticosteroids for systemic use, plain

QH02 Corticosteroids for systemic use

QH Systemic hormonal preparations, excl. sex hormones and insulins

Species

Dogs.

Indications

For the treatment of inflammatory and allergic diseases, including some autoimmune diseases and some neoplastic conditions, in dogs. Inflammatory, allergic and autoimmune processes may be involved in cutaneous, alimentary, respiratory, musculo-skeletal and haematological manifestations of disease.

Dose to be administered and administration route

For oral administration in dogs.

0.1 - 2.0 mg per kg bodyweight per day.

A single administration may be sufficient for certain conditions such as anaphylaxis, but for more general treatment, administration for one to three weeks at the above dosage levels may be required. Dosage levels should be monitored carefully to ensure that the lowest effective dose is used. To minimise the risk of adrenal insufficiency, alternate day treatment may be implemented, using dose levels that adequately control the symptoms. Dogs should be dosed in the morning to coincide with the endogenous cortisol peak.

Higher dose levels may be used in animals with tumours responsive to corticosteroid therapy. In these cases, the dosage level is related to the surface area of the animal and dose levels of between 20 mg per m2 and 60 mg per m2 have been found to be useful. The potential risks associated with these high dose levels should be assessed before commencing treatment.

Adverse reactions

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.

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).