Vetoryl

1 x 30 pc

Capsule, hard

Active substance

Trilostane : 120 mg

ATC code

QH02CA01 Trilostane

QH02CA Anticorticosteroids

QH02C Antiadrenal preparations

QH02 Corticosteroids for systemic use

QH Systemic hormonal preparations, excl. sex hormones and insulins

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.

The starting dose for treatment is approximately 2 mg/kg, based on available combinations of capsule sizes. Administer once daily, with food.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Titrate the dose according to individual response, as determined by monitoring (see below). If a dose increase is required, use combinations of capsule sizes to slowly increase the once daily dose. A wide range of capsule 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. Do not divide or open capsules.

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.

A dose adjustment may be necessary if the dog is swapped from Vetoryl hard capsules to Vetoryl chewable tablets, or vice versa, as a strict interchangeability between the two products cannot be assured, as some dogs may respond differently to the change in pharmaceutical form.

Adverse reactions

Dogs:

Uncommon

(1 to 10 animals / 1,000 animals treated):

Lethargy^a,b, Anorexia^a,b Vomiting^a,b, Diarrhoea^a,b

Rare

(1 to 10 animals / 10,000 animals treated):

Hypoadrenocorticism^c

Hypersalivation^d, Bloated^d,

Ataxia^d, Muscle tremor^d

Skin disorders^d

Renal insufficiency^e

Arthritis^e

Weakness^a,b

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Adrenal necrosis^f Sudden death

^a associated with iatrogenic hypoadrenocorticism, particularly if monitoring is not adequate (see section 4.9); generally reversible within a variable period following withdrawal of treatment.

^b has been seen in dogs treated with trilostane in the absence of evidence of hypoadrenocorticism.

^c including Acute Addisonian Crisis (collapse) (see section 4.10).

^d mild

^e unmasked by treatment with the product due to a reduction in endogenous

corticosteroid levels.

^f may result in hypoadrenocorticism

Corticosteroid withdrawal syndrome or hypocortisolaemia should be distinguished from hypoadrenocorticism by evaluation of serum electrolytes.

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.