Prilactone Next 100 mg Chewable Tablets for Dogs

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Spironolactone

Saadav alates:

Ceva Animal Health Ltd

ATC kood:

QC03DA01

INN (Rahvusvaheline Nimetus):

Spironolactone

Ravimvorm:

Chewable tablet

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Dogs

Terapeutiline ala:

Cardio Vascular diuretic

Volitamisolek:

Authorized

Loa andmise kuupäev:

2012-08-08

Toote omadused

Revised: October 2022
AN: 01683/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prilactone Next 100 mg Chewable Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
ACTIVE SUBSTANCE:
Spironolactone ....................................................100
mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Clover-shaped scored beige tablet. The tablet can be divided into four
equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use in combination with standard therapy (including diuretic
support, where
necessary) for the treatment of congestive heart failure caused by
degenerative
mitral valve disease in dogs.
4.3
CONTRAINDICATIONS
Do not use in animals used for or intended for use in breeding.
Do
not
use
in
dogs
suffering
from
hypoadrenocorticism,
hyperkalaemia
or
hyponatraemia.
Do not administer spironolactone in conjunction with NSAIDs to dogs
with renal
insufficiency.
Do not use in cases of hypersensitivity to spironolactone or any of
the excipients.
See section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: October 2022
AN: 01683/2022
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Kidney function and plasma potassium levels should be evaluated before
initiating
combined treatment with spironolactone and ACE inhibitors. Unlike in
humans, an
increased incidence of hyperkalaemia was not observed in clinical
trials performed in
dogs
with
this
combination.
However,
in
dogs
with
renal
impairment,
regular
monitoring of renal function and plasma potassium levels is
recommended as there
may be an increased risk of hyperkalaemia.
Dogs treated concomitantly with spironolactone and NSAIDs should be
correctly
hydrated.
Monitoring
of
their
renal
function
and
plasma
potassium
levels
is
recommended before initiation and during treatment with combined
therapy (see 4.3).
As spirono