Trilotab 10 mg Chewable Tablets 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 product should be used with extreme caution in dogs with pre-existing anaemia
as further reductions in packed-cell volume and haemoglobin may occur. Regular
monitoring should be undertaken.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out
of reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Accidental ingestion of the product can cause gastrointestinal effects, such as
nausea and vomiting.
Avoid hand to mouth contact. To avoid accidental ingestion, especially by a child,
unused tablet parts should be placed back into the blister and carton and carefully
kept away from children. Part used tablets should be used at the time of the next
dose.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or carton to the physician.
Wash hands with soap and water after use.
Trilostane may decrease testosterone synthesis and has anti-progesterone
properties.
Women who are pregnant or are intending to become pregnant should avoid
handling the product.
The product may cause skin and eye irritation. After contact of the product with eyes
or skin, wash with plenty of water. If irritation persists, seek medical advice.
This veterinary medicinal product may cause hypersensitivity reactions. People with
known hypersensitivity to trilostane should avoid contact with the product. If you
develop allergic symptoms such as a skin rash, swelling of the face, lips or eyes
following exposure to the product, seek medical advice and show the package leaflet
or label to the physician.
Special precautions for the protection of the environment:
Not applicable.