Adrestan 60 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trilostane

Available from:

Dechra Regulatory B.V.

ATC code:

QH02CA01

INN (International Name):

Trilostane

Dosage:

60 Milligrams per capsule

Pharmaceutical form:

Capsule, hard

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

trilostane

Authorization status:

Authorised

Authorization date:

2016-04-01

Summary of Product characteristics

Health Products Regulatory Authority
05 February 2021
CRN009V1P
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Adrestan 60 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains:
ACTIVE SUBSTANCE:
Trilostane 60 mg
EXCIPIENTS:
Titanium dioxide (E171) 1.19 mg
Yellow iron oxide (E172) 0.045 mg
Black iron oxide (E172) 0.672 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Ivory body and black cap with the capsule strength printed on the body
of the capsule.
4 CLINICAL PARTICULARS
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) in
dogs.
4.3 CONTRAINDICATIONS
Do not use in animals suffering from primary hepatic disease and/or
renal insufficiency.
Do not use in dogs weighing less than 10 kg.
Do not use in known 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.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for 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.
Health Products Regulatory Authority
05 February 2021
CRN009V1P
Page 2 of 5
Subsequent close monitoring during treatment should be carried out.
Particular attention should be paid to liver enzymes,
electrolytes, urea and creatini