Trilocur 50 mg/ml Oral Suspension for Dogs

An accurate diagnosis of hyperadrenocorticism is essential.
Where there is no apparent response to treatment, the diagnosis should be re-
evaluated. Dose increases may be necessary.
Veterinarians should be aware that dogs with hyperadrenocorticism are at increased
risk of pancreatitis. This risk may not diminish following treatment with trilostane.

Special precautions for safe use in the target species:
As the majority of cases of hyperadrenocorticism are diagnosed in dogs between the
ages of 10-15 years, other pathological processes are frequently present. It is
particularly important to screen cases for primary hepatic disease and renal
insufficiency as the product is contraindicated in these cases.
Subsequent close monitoring during treatment should be carried out. Particular
attention should be paid to liver enzymes, electrolytes, urea and creatinine.
The presence of diabetes mellitus and hyperadrenocorticism together requires
specific monitoring.
If a dog has previously been treated with mitotane, its adrenal function will have
been reduced. Experience in the field suggests that an interval of at least a month
should elapse between cessation of mitotane and the introduction of trilostane. Close
monitoring of adrenal function is advised, as dogs may be more susceptible to the
effects of trilostane.
The veterinary medicinal product should be used with extreme caution in dogs with
pre-existing anaemias as further reductions in packed-cell volume and haemoglobin
may occur. Regular monitoring should be undertaken.
The veterinary medicinal product contains the excipient xylitol which may be a cause
of adverse effects if administered at high doses. Administration of Trilocur 50 mg/ml
oral suspension for dogs at doses in excess of 10 mg trilostane/kg bodyweight has
the potential to result in xylitol toxicity. In dogs requiring doses higher than 10 mg
trilostane/kg, use an alternative trilostane product.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals

Trilostane may decrease testosterone synthesis and has anti-progesterone
properties. Women who are pregnant or are intending to become pregnant should
not handle this product.
The content of the product may cause skin and eye irritation and sensitisation. Take
care to avoid accidental contact with the skin and eyes. In case of accidental skin
contact, wash the affected area with soap and water. In case of accidental contact
with the eyes, immediately rinse with plenty of water.
If skin or eye irritation persists, seek medical advice.
People with known hypersensitivity to trilostane, vanillin, or sodium benzoate should
avoid contact with the veterinary medicinal product.
Accidental ingestion may cause harmful effects, including nausea, vomiting, and
diarrhoea. Care should be taken to avoid accidental ingestion, especially by a child.
Keep filled syringes away from children and store used syringes out of the sight and
reach of children. In case of accidental ingestion, seek medical advice immediately
and show the package leaflet or the label to the physician.
Wash hands with soap and water after use.
Special precautions for the protection of the environment:
Not applicable.