Prednicare Tablets (prednisolone)

Prednicare Tablets for Dogs and Cats

4.1 Target species

Dogs and Cats

4.2 Indications for use, specifying the target species

As an anti-inflammatory and anti-allergic agent for use in dogs and cats.

4.3 Contraindications

Do not use in animals with:
• Viral, mycotic or parasitic infections that are not controlled with an
appropriate treatment
• Diabetes mellitus
• Hyperadrenocorticism
• Osteoporosis
• Heart failure
• Severe renal insufficiency
• Corneal ulceration
• Gastro-intestinal ulceration
• Glaucoma
Do not use concomitantly with attenuated live vaccines.

Do not use during pregnancy (see section 4.7).
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
See also section 4.8.

4.4 Special warnings for each target species

Dosing should coincide with the endogenous cortisol peak (i.e., in the morning
with regard to dogs and in the evening with regard to cats).

4.5 Special precautions for use

Special precautions for use in animals

Caution is necessary when prescribing corticosteroids in animals with the
following conditions: epilepsy; hypertension; or previous steroid myopathy.
Anti-inflammatory steroids, 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 and when esters possessing a
long duration of action are administered. Dosage in medium to long term should
therefore generally be kept to the minimum necessary to control symptoms.
Consideration should therefore be given to means of minimising problems of
adrenal insufficiency following the withdrawal of treatment, e.g., dosing on
alternate days, dosing to coincide with the endogenous cortisol peak (i.e., in the
morning with regard to dogs and in the evening with regard to cats) and a
gradual reduction in dosage.
The immunosuppressant actions of corticosteroids may weaken resistance to or
exacerbate existing infections. In the presence of bacterial infection, anti

bacterial drug cover is usually required when steroids are used. In the presence
of viral infections, steroids may worsen or hasten the progress of the disease.

Special precautions to be taken by the person administering the veterinary
medicinal product to animals

Impermeable gloves should be worn when handling the veterinary medicinal
product.
Wash hands thoroughly with soap and water after handling this product.
In case of accidental ingestion, drink plenty of water and seek medical advice
immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to prednisolone should avoid contact with the
veterinary medicinal product.

4.6 Adverse reactions (frequency and seriousness)

Anti-inflammatory steroids are known to exert a wide range of side effects. Very
commonly, Cushingoid symptoms involving significant alteration of fat,
carbohydrate, protein and mineral metabolism, e.g., redistribution of body fat,
muscle weakness and osteoporosis may occur... Based on post marketing
experience and complementary data, lethargy, diarrhoea and emesis have been
observed very rarely.
During therapy, very commonly, effective doses suppress the Hypothalamic

Pituitary-Adrenal axis. Following cessation of treatment, symptoms of adrenal
insufficiency extending to adrenocortical atrophy can arise and this may render
the animal unable to deal adequately with stressful situations.
Systemically acting corticosteroids rarely can cause polyuria, polydipsia and
polyphagia, particularly during the early stages of therapy. Some corticosteroids
may cause sodium and water retention and hypokalaemia in long term use.
Systemic corticosteroids have caused deposition of calcium in the skin
(calcinosis cutis).
Corticosteroids rarely can delay wound healing and the immunosuppressant
actions may weaken resistance to or exacerbate existing infections.
Gastrointestinal ulceration has been reported very rarely in animals treated with
corticosteroids and usually with the concurrent use of non-steroidal antiinflammatory drugs (see section 4.8).
Steroids very rarely may cause enlargement of the liver (hepatomegaly) with
increased serum hepatic enzymes.
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).

4.7 Use during pregnancy, lactation or lay

Corticosteroids are not recommended for use during pregnancy (see section
4.3). Administration in early pregnancy is known to have caused foetal
abnormalities in laboratory animals. Administration in late pregnancy may cause
early parturition or abortion.

Prednisolone is likely to be present in milk in small quantities and may result in
growth impairment in suckling young animals. Consequently, the product should
be used only according to the benefit/risk assessment of the responsible
veterinary surgeon in lactating animals.

4.8 Interaction with other medicinal products and other forms of
interaction

The use of corticosteroids may render concurrent vaccinations inoperative.
Corticosteroid treated animals may succumb to infection if concurrently
vaccinated with live vaccines.
Gastro-intestinal tract ulceration may be exacerbated by steroids in patients
given non-steroidal anti-inflammatory drugs and in corticosteroid treated animals
with spinal cord trauma. Serum levels of concurrently administered salicylates
may increase considerably on withdrawal of corticosteroid therapy, with the
potential for toxic effects and/or increased gastro-intestinal tract ulceration.
Steroids may cause enlargement of the liver (hepatomegaly) with increased
serum hepatic enzymes.
The effectiveness of anticoagulants may be modified by concurrent corticosteroid
therapy.
The actions of hypoglycaemic agents will be antagonised by the hyperglycaemic
effects of corticosteroids.
Hypokalaemia may occur when amphotericin and corticosteroids are used
concurrently.
The simultaneous use of corticosteroids and methotrexate may increase
methotrexate toxicity.
The therapeutic effects of some barbiturates, phenytoin, and rifampicin may be
reduced by the concurrent use of corticosteroids.

4.9 Amounts to be administered and administration route

For oral administration.
Single dose treatment may be appropriate for some specific conditions
(anaphylaxis, etc), but for more general treatment, treatment may be given for
one to three weeks at doses between:
DOGS: 0.1-2.0 mg/kg/day
CATS: 0.1-2.0 mg/kg/day

The lowest effective dose must be used. Treatment should not be withdrawn
suddenly. Problems of adrenal insufficiency should be minimised by dosing on
alternate days, dosing to coincide with the endogenous cortisol peak (i.e. in the
morning with regard to dogs and in the evening with regard to cats) and a
gradual reduction in dosage.
For the treatment of cats and dogs with tumours responsive to corticosteroid
therapy, the balance between the risks of therapy and the benefits of treatment
may justify larger doses. In such cases, doses between 20 mg/m² every other
day and 60 mg/m²/day have been found to be useful. (Dose is related to the
animal’s estimated body surface area, in square metres.)

4.10 Overdose (symptoms, emergency procedures, antidotes), if
necessary

Overdose may result in disturbance of fat, carbohydrate, protein and mineral
metabolism, i.e. Cushingoid signs. Treatment should be symptomatic and
conservative.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Glucocorticoids.
ATC vet code: QH02AB06.

5.1 Pharmacodynamic properties

Prednisolone is a corticosteroid of the glucocorticoid class. It has anti

inflammatory activity, and has effects on tissue repair, the heart, kidneys, and
central nervous system. The other principal pharmacological actions are on
gluconeogenesis, glycogen deposition, and protein, lipid, and calcium
metabolism, and on inhibition of corticotrophin secretion.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose Monohydrate
Maize Starch
Dextrin
Stearic Acid

6.2 Major incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

Store in a tightly closed original container.
Do not store above 25°C. Store in a dry place. Protect from light.

6.5 Nature and composition of immediate packaging

500 or 1000 tablets in a grey or white polypropylene tub, with a white low density
polyethylene lid (snap-secure).
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.

Sizes:

1mg

5m