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Fortekor is used for the management of heart problems in dogs.

Brand

Fortekor

Manufacturer

Elanco

Species

Dog

Prescription Type

POM-V (Written prescription required)

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£80.99
Reference : MED-00050
Delivery Between 2 and 3 days
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What is Fortekor and who is it for?

 

Fortekor is a palatable tablet that is used for:

 

The treatment of congestive heart failure in dogs.

 

This is a Prescription only medicine (POM-V).

Fortekor is only available with a prescription from your veterinary surgeon.

To check the most up to date information about this product, please read its Summary of Product Characteristics (SPC). It can be viewed here.

What is the active ingredient in Fortekor?

 

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).

FORTEKOR causes long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80%) persisting 24 hours after dosing.

FORTEKOR reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.

 

After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour) 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%) 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.

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) 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 FORTEKOR leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs 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. The clearance of benazeprilat is not affected in dogs with impaired renal function and therefore no adjustment of FORTEKOR dose is required in either species in cases of renal insufficiency.

28 tablets

What is in Fortekor?

 

Beige to light brown, ovaloid, divisible tablet scored on both sides. 

 

One tablet contains: 

Active substances:

Benazepril hydrochloride 20mg

 

Excipients:

Cellulose microcrystalline 

Crospovidone 

Povidone 

Basic butylated methacrylate copolymer 

Silicon dioxide anhydrous 

Sodium laurilsulphate 

Dibutyl sebacate 

Silica colloidal anhydrous 

Stearic acid 

Yeast powder 

Artificial powdered beef flavour

How do I use Fortekor?

 

Fortekor is a prescription product and must be used according to the instructions of your veterinary surgeon.

Please read the product leaflet thoroughly before administering to your pet.

Marketing Authorisation Holder

Elanco Europe Ltd
Lilly House
Priestley Road
Basingstoke
Hampshire
RG24 9NL

 

Marketing Authorisation Number

Vm 00879/4046

Is there any further advice I should know about Fortekor?

 

Contra-indications

 

Do not use in 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 precautions for use in animals

 

No evidence of renal toxicity of the veterinary medicinal product has been observed in dogs 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.

 

 

Special precautions to be taken by the person administering the 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.

 

Adverse reactions (frequency and seriousness)

 

In double-blind clinical trials in dogs with congestive heart failure, FORTEKOR Flavour was well tolerated with an incidence of adverse reactions lower than observed in placebo-treated dogs.

A small number of dogs may exhibit transient vomiting, incoordination or signs of fatigue.

In dogs with chronic kidney disease, FORTEKOR Flavour 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.

 

Use during pregnancy, lactation or lay

 

The safety of FORTEKOR Flavour has not been established in breeding, pregnant or lactating dogs.

Do not use during pregnancy or lactation.

Laboratory studies in rats have shown evidence of embryotoxic effects (foetal urinary tract malformation) at maternally non-toxic doses.

 

Interaction with other medicinal products and other forms of interaction

 

In dogs with congestive heart failure, FORTEKOR Flavour 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 FORTEKOR Flavour 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 FORTEKOR Flavour in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.

 

Overdose (symptoms, emergency procedures, antidotes), if necessary

 

FORTEKOR Flavour reduced erythrocyte counts 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 dogs.

Transient reversible hypotension may occur in cases of accidental overdose. Therapy should consist of intravenous infusion of warm isotonic saline.