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Date: Tuesday, July 16, 2024 3:35

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Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 12.61
Fortekor 2.5 mg tablets for cats and dogs (GB)
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations, Renal preparations
Active ingredient: Benazepril Hydrochloride
Product:Fortekor® 2.5 tablets for Cats and Dogs
Product index: Fortekor 2.5 tablets for cats and dogs
Qualitative and quantitative composition
Active substance: Benazepril hydrochloride 2.5 mg
For a full list of excipients, see Pharmaceutical particulars section.
Pharmaceutical form
Beige, ovaloid, divisible, palatable tablet scored on both sides.
The tablets can be divided into halves.
Clinical particulars
Target species
Dogs and cats.
Indications for use, specifying the target species
Treatment of congestive heart failure.
Reduction of proteinuria associated with chronic kidney disease.
Do not use in known case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure.
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Do not use during pregnancy or lactation.
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
No evidence of renal toxicity of the veterinary medicinal product has been observed (in dogs or cats) during clinical trials, however, as is routine in cases of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy.
The efficacy and safety of the veterinary medicinal product has not been established in dogs and cats below 2.5 kg bodyweight.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician.
Pregnant women should take special care to avoid accidental oral exposure because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans.
Special precautions for the protection of the environment:
Not applicable
Adverse reactions (frequency and seriousness)

Rare (1 to 10 animals animals / 10,00 animals treated):
Diarrhoea, Vomiting,
Anorexia, Fatigue
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Elevated creatinine1
1These signs may be exhibited transiently.
Rare (1 to 10 animals / 10,000 animals treated):
Emesis, Diarrhoea, Anorexia, Dehydration, Lethargy
In double-blind clinical trials in dogs with congestive heart failure, the veterinary medicinal product was well tolerated with an incidence of adverse reactions lower than observed in placebo-treated dogs.
In cats and dogs with chronic kidney disease, the product 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.
The veterinary medicinal product may increase food consumption and body weight in cats.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
Use during pregnancy, lactation or lay
Do not use during pregnancy or lactation. The safety of the veterinary medicinal product has not been established in breeding, pregnant or lactating dogs and cats. Benazepril reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg body weight for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally non-toxic doses.
Interaction with other medicinal products and other forms of interaction
In dogs with congestive heart failure, the veterinary medicinal product has been given in combination with digoxin, diuretics, pimobendan and anti-arrhythmic veterinary medicinal products without demonstrable adverse interactions.
In humans, the combination of ACE inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of the product and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary.
Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using the veterinary medicinal product in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Amounts to be administered and administration route
This veterinary medicinal product should be given orally once daily, with or without food. The duration of treatment is unlimited.
This product is flavoured and is taken voluntarily by most dogs and cats.
This veterinary medicinal product should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table:
Weight of dog (kg)
Fortekor® 2.5 mg
Standard Dose
Double Dose
2.5 - 5
0.5 tablet
1 tablet
>5 - 10
1 tablet
2 tablets
The dose may be doubled, still administered once daily, to a minimum dose of 0.5 mg/kg (range 0.5-1.0), if judged clinically necessary and advised by the veterinary surgeon.
This veterinary medicinal product should be administered orally at a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight once daily according to the following table:
Weight of Cat (kg)
Fortekor® 2.5 mg
2.5 - 5
1 tablet
>5 - 10
2 tablets
Overdose (symptoms, emergency procedures, antidotes), if necessary.
The veterinary medicinal product reduced erythrocyte counts in normal cats when dosed at 10 mg/kg body weight once daily for 12 months and in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in cats or dogs.
Transient reversible hypotension may occur in cases of accidental overdose. Therapy should consist of intravenous infusion of warm isotonic saline.
Withdrawal period
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: ACE Inhibitors, plain.
ATCvet code: QC09AA07
Pharmacodynamic properties
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat. Benazeprilat is a highly potent and selective inhibitor of ACE, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone. Therefore, it blocks effects mediated by angiotensin II and aldosterone, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes).
The veterinary medicinal product causes long-lasting inhibition of plasma ACE activity in dogs and cats, with more than 95% inhibition at peak effect and significant activity (>80% in dogs and >90% in cats) persisting 24 hours after dosing.
The product reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.
In cats with experimental renal insufficiency, the veterinary medicinal product normalized the elevated glomerular capillary pressure and reduced the systemic blood pressure.
Reduction in glomerular hypertension may retard the progression of kidney disease by inhibition of further damage to the kidneys. Placebo controlled clinical field studies in cats with chronic kidney disease (CKD) have demonstrated that the product significantly reduced levels of urine protein and the urine protein to creatinine ratio (UPC); this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.
No effect of the veterinary medicinal product on survival in cats with CKD has been shown, but the product increased the appetite of the cats, particularly in more advanced cases.
Pharmacokinetic particulars
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour in dogs and within 2 hours in cats) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat. The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs, <30% in cats) and first pass metabolism.
In dogs, peak benazeprilat concentrations (Cmax of 37.6 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1.25 hours.
In cats, peak benazeprilat concentrations (Cmax of 77.0 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 2 hours.
Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=1.7 hours in dogs and t1/2=2.4 hours in cats) represents elimination of free drug, while the terminal phase (t1/2=19 hours in dogs and t1/2=29 hours in cats) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues. Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs. Repeated administration of the veterinary medicinal product leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs and R=1.36 in cats with 0.5 mg/kg), steady state being achieved within a few days (4 days in dogs).
Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs and 85% via the biliary and 15% via the urinary route in cats. The clearance of benazeprilat is not affected in dogs or cats with impaired renal function and therefore no adjustment of the dose of the product is required in either species in cases of renal insufficiency.
Pharmaceutical particulars
List of excipients
Cellulose microcrystalline
Povidone K30
Basic butylated methacrylate copolymer
Silicon dioxide anhydrous
Silica colloidal anhydrous
Sodium laurilsulphate
Dibutyl sebacate
Castor oil hydrogenated
Yeast powder
Not applicable.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 30 months.
Special precautions for storage
Do not store above 25 °C.
Store in a dry place.
Each time an unused half tablet is stored, it should be returned to the open blister space inserted back into the cardboard box and kept in a safe place out of the reach of children.
Nature and composition of immediate packaging
PVC/PE/PVdC-aluminium blisters with 14 tablets/blister. Cardboard box with:
1 blister
2 blisters
4 blisters
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
Vm 00879/5021
Significant changes
Date of the first authorisation or date of renewal
31 March 2003
Date of revision of the text
July 2024
Any other information
Legal category
Legal category: POM-V
GTIN description:FORTEKOR 2.5 FOR CATS AND DOGS 28 pack
GTIN description:FORTEKOR 2.5 FOR CATS AND DOGS 56 pack