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Date: Tuesday, February 18, 2025 20:04

Description: Dechra
Release 5.117
Prednidale Tablets
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other steroids
Active ingredient: Prednisolone
Product:Prednidale Tablets
Product index: Prednidale Tablets
Incorporating:
Qualitative and quantitative composition
Prednidale 5 mg tablets for dogs and cats:
1 tablet contains: Active substance:
Prednisolone 5 mg
Prednidale 25 mg tablets for dogs:
1 tablet contains: Active substance:
Prednisolone 25 mg
Pharmaceutical form
Prednidale 5 mg tablets for dogs and cats:
Tablet. White, circular, flat faced tablets with a breakline and PL5 imprinted on one face and CP or DP on the reverse.
No data has been provided to demonstrate reproducible halving of the tablets.
Prednidale 25 mg tablets for dogs:
Tablet. White, 11 mm circular tablets.
Clinical particulars
Target species
Prednidale 5 mg tablets for dogs and cats:
Dogs and cats.
Prednidale 25 mg tablets for dogs:
Dogs.
Indications for use
Prednidale 5 mg tablets for dogs and cats:
For the treatment of inflammatory and allergic diseases, including some autoimmune diseases and some neoplastic conditions in cats and dogs.
Inflammatory, allergic and autoimmune processes may be involved in cutaneous, alimentary, respiratory, musculoskeletal and haematological manifestations of disease.
Prednidale 25 mg tablets for dogs:
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, musculoskeletal and haematological manifestations of disease.
Contraindications
Do not use in animals with renal insufficiency, diabetes mellitus or corneal ulceration.
Do not use in animals recieving vaccines containing live organisms.
Do not use in pregnant animals.
Special warnings for each target species
There are no special warnings required for either target species.
Special precautions for use in animals
Pharmacologically-active dose levels may lead to atrophy of the adrenal cortex, resulting in adrenal insufficiency. This may become apparent particularly after withdrawal of corticosteroid treatment.
Adrenal insufficiency may be minimised by institution of alternate-day therapy if practical. The dosage should be reduced and withdrawn gradually to avoid precipitation of adrenal insufficiency.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Gloves should be worn to administer the product and you should wash your hands immediately after administration of the product.
In the event of accidental ingestion, particularly by a child, seek medical advice and show the doctor the label or package leaflet.
Other precautions
No special precautions required.
Adverse reactions
Prednidale 5 mg tablets for dogs and cats:
Administration of single high doses are generally tolerated well, but medium to long-term use may provoke reactions.
Corticosteroid therapy may lead to increased time in the healing of wounds and to a reduction in the ability of the body to resist infection. Appropriate anti-infective therapy may be required.
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.
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 other 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).
Use during pregnancy and lactation
Corticosteroids are not recommended for use in pregnant animals. Studies in laboratory animals have shown that administration during early pregnancy may cause foetal abnormalities. Administration during the later stages of pregnancy may cause abortion or early parturition.
Insignificant amounts of prednisolone are generally eliminated in the milk of lactating animals, and therefore such use is not contraindicated.
Interactions
There are no known interactions of significance in veterinary medicine.
Amounts to be administered and administration route
For oral administration.
Dogs and cats: 0.1-2.0 mg per kg body weight per day.
A single administration may be sufficient for certain conditions such as anaphylaxis, but for more general treatment, treatment 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 and cats should be dosed at night 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.
Prednidale 5 mg tablets for dogs and cats: The tablets are divisible.
Overdose
Signs of overdosage should be treated symptomatically.
Pharmacological particulars
Pharmacotherapeutic group: Corticosteroid for systemic use.
ATCvet code: QH02AB06
Pharmacodynamic properties
Prednisolone is a synthetic glucocorticoid with anti-inflammatory and immunosuppressant properties. It possesses only slight mineralocorticoid activity. Prednisolone is used to suppress the clinical manifestations of a wide range of disorders.
Pharmacokinetic properties
Prednisolone is readily absorbed from the gastro-intestinal tract. Peak plasma concentrations are reached one to two hours after administration, with a plasma half-life of between two and three hours. It is extensively bound to plasma proteins. It is excreted in the urine as free and conjugated metabolites and parent compound. It has a biological half-life of several hours, making it suitable for alternate-day therapy.
Pharmaceutical particulars
Shelf life
Prednidale 5 mg tablets for dogs and cats:
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Prednidale 25 mg tablets for dogs:
Shelf life of the veterinary medicinal product as packaged for sale: 48 months.
Special precautions for storage
Do not store above 25°C. Store in tightly closed original container. Store in a dry place.
Immediate packaging
Prednidale 5 mg tablets for dogs and cats:
White polypropylene container with a white polyethylene tamper evident lid, containing 250 tablets.
Prednidale 25 mg tablets for dogs:
Polypropylene containers with low density polyethylene push-fit tamper evident closures containing 100 tablets.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Dechra Limited, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom.
Marketing Authorisation Number
Vm 10434/4009: 5 mg
Vm 10434/4008: 25 mg
Significant changes
Date of the first authorisation or date of renewal
Prednidale 5 mg tablets for dogs and cats:
14 August 1998
Prednidale 25 mg tablets for dogs:
19 November 2007
Date of revision of the text
Prednidale 5 mg tablets for dogs and cats:
August 2023
Prednidale 25 mg tablets for dogs:
June 2024
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Prednidale 5 mg Tablets for Dogs and Cats 250:
GTIN:05701170448429
GTIN description:Prednidale 25 mg Tablets for Dogs 100:
GTIN:05055031418916