Download Active Constituent - Novartis Animal Health Inc.

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Tablets for Dogs and Cats (APVMA 56829)
Active Constituent:
Each tablet contains 2.5 mg benazepril hydrochloride
Tablets for Dogs and Cats (APVMA 61193)
Active Constituent:
Each tablet contains 5 mg benazepril hydrochloride
Tablets for Dogs (APVMA 61192)
Active Constituent:
Each tablet contains 20 mg benazepril hydrochloride
Indications
FORTEKOR is indicated for the treatment of heart failure in
dogs, chronic kidney disease in cats and dogs and
hypertrophic cardiomyopathy in cats.
phase. Benazeprilat is excreted approximately equally via
both biliary and urinary routes in dogs, and primarily via the
biliary route in cats. Repeated administration of FORTEKOR
leads to slight accumulation of benazeprilat in plasma;
steady state is attained within four days.
Because of its biliary excretion route, there is little risk of
bioaccumulation of benazeprilat in dogs or cats with
impaired renal function. For this reason no dose adjustment
of FORTEKOR is necessary in cases of renal insufficiency.
Dogs
FORTEKOR is indicated for the treatment of left-sided heart
failure in dogs, most commonly resulting from Mitral
Regurgitation (MR) (Endocardiosis) and Dilated
Cardiomyopathy (DCM). FORTEKOR, by inhibiting the renin
angiotensin aldosterone system (RAAS), minimises the
undesirable effects of vasoconstriction and sodium
retention mediated by this system. The end result is an
improvement in the clinical status of the dog. FORTEKOR
leads to an extension of the life span of dogs with heart
failure and also improves clinical signs, notably a reduction
in coughing, and improvement to the quality of life.
FORTEKOR is indicated for the treatment of chronic kidney
disease in dogs with proteinuria (urinary protein/creatinine
ratio (UPC) greater than 0.5). In such dogs, FORTEKOR
significantly reduced protein loss in the urine. Lower UPC
ratios may be associated with longer survival times.
FORTEKOR may be used in combination therapy with
diuretics (for example frusemide), digoxin and
antiarrhythmic drugs as necessary.
Contraindications
Contraindicated in animals known to be hypersensitive
to benazepril. This product is contraindicated in cases of
hypotension, hypovolaemia, hyponatraemia or acute renal
failure.
Precautions
Dogs
Use during Pregnancy and Lactation: The safety of
FORTEKOR has not been tested in breeding dogs.
FORTEKOR is therefore not recommended for use in
pregnant or lactating bitches. No data are available in
lactating bitches. ACE inhibitors have been found to be
teratogenic in the second and third trimesters in other species.
The efficacy and safety of FORTEKOR have not been
established in dogs below 2.5 kg bodyweight.
In dogs with chronic kidney disease, FORTEKOR may
increase plasma creatinine concentrations at the start of
therapy. A moderate increase in plasma creatinine
concentrations following administration of ACE inhibitors is
compatible with the reduction in glomerular hypertension
induced by these agents, and is therefore not necessarily a
reason to stop therapy in the absence of other signs.
It is recommended to check the hydration status of the
patient before starting treatment with FORTEKOR and to
monitor plasma creatinine and blood erythrocyte counts
during therapy.
In double blind clinical trials, FORTEKOR was well tolerated
with an incidence of adverse effects statistically lower than
observed in placebo treated dogs. A small number of dogs
may exhibit vomiting or transient signs of fatigue.
Interactions with potassium preserving drugs, like
spironolactone, triamterene or amiloride cannot be ruled
out. It is recommended to monitor plasma potassium levels
when using FORTEKOR in combination with a potassium
sparing diuretic due to the risk of hyperkalaemia. As with
other ACE inhibitors, the use of hypotensive medicinal
products or anaesthetics with a hypotensive effect may
add to the anti-hypertensive effects of benazepril. In man,
the combination of ACE inhibitors and NSAIDs can lead
to reduced anti-hypertensive efficacy of the ACE inhibitor
or impaired renal function. Therefore concurrent use of
NSAIDs should be considered with caution.
Overdose: FORTEKOR is well tolerated by the target
species. In normal dogs overdosage up to 200-fold was
without incident. Transient reversible hypotension may
occur in cases of accidental overdosage. Therapy should
consist of intravenous infusion of warm isotonic saline
solution. Signs of hypotension such as tiredness or
dizziness may appear in rare cases. Reduce the dose of the
diuretic if necessary.
910010
612739 AUS/NZL
Cats
FORTEKOR is indicated for the treatment of chronic kidney
disease in cats. In such cats, FORTEKOR reduces
protein loss in urine and lowers systemic and
intraglomerular blood pressure. FORTEKOR increases
quality of life, particularly in advanced cases. FORTEKOR
has been shown to increase the survival time in cats with a
urinary protein/creatinine ratio (UPC) equal to or exceeding
0.8 before treatment, and to improve the appetite in cats
with a UPC ratio exceeding 1.0. FORTEKOR has some
beneficial effects on clinical signs and cardiac remodelling
in cats with feline hypertrophic cardiomyopathy (HCM) and is
well tolerated. Most cases of HCM in cats will require other
medications in addition to FORTEKOR. The most commonly
prescribed of these medications will be a calcium channel
blocker, for example diltiazem.
Pharmacological Properties
FORTEKOR contains benazepril hydrochloride, a prodrug
hydrolysed in vivo to benazeprilat, which inhibits the
angiotensin converting enzyme (ACE), thus preventing the
conversion of inactive angiotensin I into active angiotensin II.
FORTEKOR reduces all effects mediated by angiotensin II,
including vasoconstriction of both arteries and veins and
retention of sodium and water by the kidney. FORTEKOR
causes long-lasting inhibition of plasma ACE in dogs and
cats, with significant inhibition persisting for 24 hours after
a single dose.
Benazepril is rapidly but incompletely absorbed from the
gastrointestinal tract following oral administration.
Absorbed benazepril is partially hydrolysed by hepatic
enzymes to the active substance, benazeprilat; unchanged
benazepril and hydrophilic metabolites account for the
remainder. Peak plasma benazeprilat concentrations are
attained within about two hours both in fasting and fed
situations. Benazepril and benazeprilat are bound to plasma
proteins, and in tissues are found mainly in the liver and
kidney. The major part of benazeprilat is rapidly eliminated,
although there is in addition a slow terminal elimination
Product
Format
Fortekor Flavour Pack Size
163 x 297 mm
Element
910010 Mat-Nr
PP Country
612739
AUS/NZL
Doc-Size 100% Print-Size 100%
Colors
Contact
o.G. SINR
Cats
FORTEKOR may increase plasma creatinine
concentrations at the start of therapy. This effect is
Nick Gesù
ARTWORK SPECIFICATION
Agency
Inhouse Program
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Additional Information
related to the therapeutic effect of the product in
reducing glomerular capillary blood pressure and therefore it is not necessarily a reason to stop therapy in the
absence of other signs. FORTEKOR reduced erythrocyte
counts in normal cats at high doses, but this effect was not
observed at the recommended dose during clinical trials in
cats with chronic kidney disease. Therefore, as is routine
in cases of chronic kidney disease, it is recommended
to check hydration status before therapy, and to monitor
plasma creatinine and erythrocyte counts during therapy.
The efficacy and safety of FORTEKOR have not been
established in cats below 2.5 kg bodyweight.
The safety of FORTEKOR has not been tested in breeding
cats, or pregnant or lactating queens. FORTEKOR should
therefore be used only if justified clinically, considering
the risk/benefit ratio. FORTEKOR reduced ovary/oviduct
weights when administered daily at 10 mg/kg for 52 weeks.
ACE inhibitors have been found to be teratogenic in the
second and third trimesters in other species.
There are no known interactions between FORTEKOR and
other medicaments in cats. The combination of ACE
inhibitors and other antihypertensive agents (e.g. calcium
channel blockers, beta-blockers or diuretics) may lead
to additive hypotensive effects. Concurrent use of ACE
inhibitors and NSAIDs shoud be considered with caution
as reduced efficacy of the ACE inhibitors or impaired renal
function have been reported with their concurrent use in
humans.
FORTEKOR has been shown to be effective and safe when
used in combination with diets containing low amounts of
protein and salt.
ACE inhibitors may increase blood potassium levels, which
may be beneficial where hypokalaemia occurs associated
with chronic kidney disease. It is recommended to
monitor plasma potassium levels when using FORTEKOR in
combinations with diuretics that may have additive
potassium sparing effects.
Overdose: FORTEKOR is well tolerated in the target species.
In normal cats, overdosage of 10 times for one year was
asymptomatic. Transient reversible hypotension may occur
in cases of accidental overdosage. Therapy should consist
of intravenous infusion of warm isotonic saline.
FIRST AID: If poisoning occurs, contact a doctor or
Poisons I­nformation Centre (Phone: Australia
13 1126; New Zealand 0800 764 766).
Disposal: Dispose of empty containers by wrapping in
paper and putting in garbage.
Storage: Store below 25°C (Air Conditioning). Protect
from moisture and heat. Unused half tablets should be
returned to the open blis­ter space, inserted back into the
carton, and used within 2 days.
WARRANTY
The manufacturer of this animal remedy extends /grants to
the purchaser a warranty that this animal remedy is
reasonably fit for the purposes for which its use is
recommended, provided that the purchaser uses the
remedy only for the purposes for which it is recommended
him and strictly in accordance with the directions on this
container.
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED
ACN 076 745 198
54 Waterloo Road, North Ryde NSW 2113
NOVARTIS CUSTOMER ASSISTANCE
☎ 1800 633 768 TOLL FREE from anywhere in Australia
8.30 am to 5.30 pm E.S.T. Monday to Friday
NEW ZEALAND NOVARTIS CUSTOMER ASSISTANCE
0800 588 001 TOLL FREE from anywhere in New Zealand
10.30 am to 7.30 pm Monday to Friday
☎
APVMA Approval Nos. 56829/52678, 61193/52680,
61192/52679
NEW ZEALAND INFORMATION
RESTRICTED VETERINARY MEDICINE
Registered pursuant to the ACVM Act 1997,
No.s A009195, A009859, A009858.
See www.foodsafety.govt.nz for registration conditions.
Registered to Novartis New Zealand Limited,
Building G, 5 Orbit Drive, Rosedale, AUCKLAND 0632
DIRECTIONS FOR USE
FORTEKOR should be given orally, once daily, with or
without food.
Unused half tablets should be returned to the open blister
space, inserted back into the carton and used within two
days.
® Registered trademark of Novartis AG, Basel, Switzerland
Heart failure and chronic kidney disease in dogs
The minimum recommended o­­ral daily dose is 0.25 mg/kg
bodyweight, given according to the following regime:
Weight of
dog (kg)
2.5 – 5
Standard Dose
Fortekor 2.5
Fortekor
Flavour 5
Fortekor
Flavour 20
–
–
/2 tablet
–
/2 tablet
1
> 5 – 10
1 tablet
11 – 20
–
1 tablet
21 – 40
–
–
41 – 80
–
–
1
–
/2 tablet
1
1 tablet
In dogs with heart failure, the above doses may be doubled,
still administered once daily, if judged clinically necessary
and advised by the veterinarian.
Chronic kidney disease and hypertrophic
cardio­myopathy in cats
The minimum recommended oral daily dose is 0.5 mg/kg
bodyweight, given according to the following regime:
Fortekor 2.5
2.5 – 5
1 tablet
> 5 – 10
2 tablets
Fortekor Flavour
5
/2 tablet
1
1 tablet
910010
612739 AUS/NZL
Weight of cat (kg)
Product
Format
Fortekor Flavour Pack Size
163 x 297 mm
Element
910010 Mat-Nr
PP Country
612739
AUS/NZL
schwarz Doc-Size 100% Print-Size 100%
Colors
Contact
o.G. SINR
Nick Gesù
ARTWORK SPECIFICATION
Agency
Inhouse Program
Version
Adobe InDesign CS6
3 Date 03.12.2012