Trilotab (15 kg)
Active substance
ATC code
Species
Dogs.
Indications
For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing’s disease and syndrome).
Dose to be administered and administration route
For oral use.
Administer once daily with a meal.
The starting dose for treatment is approximately 2 mg trilostane /kg bodyweight, based on available combinations of (divided) tablet sizes. This tablet strength is therefore not appropriate for dogs weighing less than 3.75 kg.
Titrate the dose according to individual response, as determined by monitoring (see below). If a dose increase is required, use combinations of (divided) tablet sizes to slowly increase the once daily dose. A wide range of divisible tablet sizes enables optimum dosing for the individual dog. Administer the lowest dose necessary to control the clinical signs.
Ultimately, if symptoms are not adequately controlled for an entire 24 hour inter-dose period, consider increasing the total daily dose by up to 50% and dividing it equally between morning and evening doses.
A small number of animals may require doses significantly in excess of 10 mg per kg body weight per day. In these situations appropriate additional monitoring should be implemented.
Monitoring:
Samples should be taken for biochemistry (including electrolytes) and an ACTH stimulation test pre-treatment and then at 10 days, 4 weeks, 12 weeks, and thereafter every 3 months, following initial diagnosis and after each dose adjustment. It is imperative that ACTH stimulation tests are performed 4 – 6 hours post-dosing to enable accurate interpretation of results. Dosing in the morning is preferable as this will allow your veterinary surgeon to perform monitoring tests 4-6 hours following administration of the dose. Regular assessment of the clinical progress of the disease should also be made at each of the above time points.
In the event of a non-stimulatory ACTH stimulation test during monitoring, treatment should be stopped for 7 days and then re-started at a lower dose. Repeat the ACTH stimulation test after a further 14 days. If the result is still non-stimulatory, stop treatment until clinical signs of hyperadrenocorticism recur. Repeat the ACTH stimulation test one month after re-starting treatment.
Adverse reactions
Dogs:
|
Rare (1 to 10 animals / 10,000 animals treated): |
Ataxia, Muscle tremor Hypersalivation, Bloated Generalised skin reaction |
|
Undetermined frequency (cannot be estimated from the available data) |
Adrenal gland disorders, Hypoadrenocorticism1,2 and Addison disease3 Sudden death Lethargy4, Anorexia4 Vomiting4, Diarrhoea4 |
1: Signs associated with iatrogenic hypoadrenocorticism, including weakness, lethargy, anorexia, vomiting and diarrhoea (particularly if monitoring is not adequate, see section 4.9 ‘Amount(s) to be administered and administration route’. Signs are generally reversible within a variable period following withdrawal of treatment.).
2: possible result from adrenal necrosis
3 : Acute Addisonian crisis (collapse) (see section 4.10 ‘Overdose symptoms, emergency procedures, antidotes, if necessary’).
4 : in the absence of evidence of hypoadrenocorticism.
Corticosteroid withdrawal syndrome or hypocortisolaemia should be distinguished from hypoadrenocorticism by evaluation of serum electrolytes.
Subclinical renal dysfunction may be unmasked by treatment with the product.
Treatment may unmask arthritis due to a reduction in endogenous corticosteroid levels.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
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