Trilotab 30 mg Chewable Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Trilostane

Available from:

CP Pharma Handelsgesellschaft mbH

ATC code:

QH02CA01

INN (International Name):

Trilostane

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anti Hormone Agent

Authorization status:

Authorized

Authorization date:

2023-09-18

Summary of Product characteristics

Issued: September 2023
AN: 02722/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trilotab 30 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Trilostane
30
mg
3.
PHARMACEUTICAL FORM
Tablet.
Off-white to light brown with brown spots, round and convex tablet
with a cross-
shaped break line on one side. Tablets can be divided into 2 or 4
equal parts.
4.
CLINICAL INFORMATION
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of pituitary-dependent and adrenal-dependent
hyperadrenocorticism (Cushing’s disease and syndrome).
4.3
CONTRAINDICATIONS
Do not use in animals suffering from primary hepatic disease and/or
renal
insufficiency.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
Issued: September 2023
AN: 02722/2021
Page 2 of 7
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for safe use in animals:
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