Predno-Leucotropin (PLT) Tablets

Presentation

Fawn coloured tablets marked with PLT on one side and double scored on the other. Each tablet contains:

Uses

PLT Tablets are indicated for the treatment of osteoarthritis in the dog.

Dosage and administration

Recommended dosage is based on 25 mg cinchophen/kg bodyweight and 0.125 mg prednisolone/kg bodyweight. This equates to a dose of:

The dose should be administered with food.

The length of treatment with PLT Tablets depends on the condition treated and the rapidity of response. If there is no improvement within the first 3 days, the dog should be re-examined by the veterinary surgeon. However, an initial treatment period should not exceed 14 days after which the dog's condition should be re-assessed by a veterinary surgeon and a 14 day treatment-free interval must be observed before continuing with further treatment. During a course of treatment the situation should be reviewed frequently by close veterinary supervision.

Owing to the prednisolone content, at the end of a treatment period, dose levels should be reduced gradually.

Contra-indications, warnings, etc

Interaction with other medicinal products and other forms of interaction - none known.

Not for use in any animal species other than the dog.

Not to be used in animals with the following conditions: Pregnancy, severe nephrosis, circulatory congestive conditions, hepatitis, previous adverse reaction to a steroid or NSAID treatment, concurrent diuretic therapy or treatment with other NSAIDs or steroids.

Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus. Should any treated animal show signs of vomiting, diarrhoea, dullness or jaundice, or show no evidence of improvement after 3 days of treatment, discontinue therapy.

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 and when esters possessing a long duration of action are administered. Dosage in medium to long term use should generally be kept to the minimum necessary to control symptoms.

Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result. During therapy effective doses suppress the Hypothalamo-Pituitreal-Adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocorticol atrophy can arise and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. a gradual reduction of dosage (for further discussion see standard texts).

Systemically administered corticosteroids may 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 may delay wound healing and the immunosuppressant actions 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.

Gastro-intestinal ulceration has been reported in animals treated with corticosteroids and g.i.t. ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in corticosteroid treated animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.

Gastro-intestinal upsets have been reported. Should inappetance or vomiting occur, medication should be discontinued and the dog re-examined by a veterinary surgeon.

For animal treatment only.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Protect from light. Keep out of reach of children.

Disposal

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Nature and composition of immediate packaging

Polypropylene tablet container containing 100 or 1000 tablets closed with polyethylene child-resistant closure.

Not all pack sizes may be marketed.

Further information

Pharmacological Properties

Pharmacotherapeutic group: Corticosteroids for systemic use, combinations.

ATC Vet Code: QH02BX

Pharmacodynamic Properties

Prednisolone is a glucocorticoid, with widespread anti-inflammatory properties. Cinchophen is a non-steroidal anti-inflammatory drug thought to act principally by inhibition of the cyclooxygenase enzyme responsible for conversion of arachidonic acid into the inflammatory mediators prostaglandins.

Pharmacokinetic Particulars

No information supplied.

Shelf Life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months

Marketing authorisation number

Vm 12501/4127.