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Fortekor flavour 5MG (Elanco Animal Health)

42

Description
Potent ACE inhibitor, for the treatment of heart failure which contains Benazepril HCL 5mg per tablet.

Primary Package
Carton 28 tablets

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SKU: 20 Categories: ,

Description

Potent ACE inhibitor, for the treatment of heart failure which contains Benazepril HCL 5mg per tablet.

Disclaimer
This information summarizes the current status of our knowledge and may differ from the legally binding, country specific use instructions provided with the product. Novartis Animal Health Inc. is not liable for damages or injury caused by the use of its products different from those specified on the pack label.

Product Type
Oral tablet for the treatment of heart failure in dogs and chronic renal insufficiency in cats

Description and Composition
Film coated tablets of 2 strengths are available:
FORTEKOR 5 contains 5.00 mg, FORTEKOR 20 contains 20.00 mg benazepril hydrochloride.

Properties
FORTEKOR contains benazepril hydrochloride, a pro-drug hydrolyzed in vivo to benazeprilat, which inhibits 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.FORTEKOR reduces the blood pressure and volume load on the heart in dogs with heart failure and leads to an extension of the life span of dogs with heart failure and also improves clinical signs, notably reduction in coughing, and improvement to the quality of life.In cats with experimental renal insufficiency, FORTEKOR normalized the elevated glomerular capillarly pressure (GCP) and reduced the systemic blood pressure. Reduction in glomerular hypertension retards the progression of kidney disease by inhibition of further damage to the kidneys. In a large clinical trial in cats with chronic kidney insufficiency, FORTEKOR significantly reduced protein loss in the urine; this effect is probably mediated via reduced GCP and beneficial effects on the glomerular basement membrane. FORTEKOR also increased the appetite, quality of life and the survival time of the cats, particularly in more advanced cases.

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 FORTEKOR dose is required in either species in cases of renal insufficiency.

Indications
• Treatment of heart failure in dogs.
• Treatment of chronic renal insufficiency in cats.
Dosage and Administration In dogs, the recommended oral dose is 0.25-0.5mg/kg body weight, given according to the following regime:

FORTEKOR5 FORTEKOR20
Weight of dog (kg) Standard Dose Double Dose Standard Dose Double Dose
5 – 10 0.5 tablet 1 tablet
11 – 20 1 tablet 2 tablet
21 – 40 0.5 tablet 1 tablet
41 – 80 1 tablet 2 tablet

In cats, FORTEKOR should be administered orally at a dose of 0.5-1.0 mg benazepril hydrochloride/kg body weight once daily according to the following table:

Weight of cat (kg) FORTEKOR 5
2.5 – 5 0.5 tablet
>5 – 10 1 tablet

FORTEKOR should be given orally once daily, with or without food. The duration of treatment is unlimited. The dose may be doubled, still administered once daily, if judged clinically necessary and advised by the veterinary surgeon.

Special Precautions and Warnings
None known in cats. Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis.

Undesirable effects
In double-blind clinical trials in dogs with heart failure, 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 transient signs of fatigue or dizziness.In cats with chronic renal insufficiency, FORTEKOR may increase plasma creatinine concentrations at the start of therapy. This effect is related to the therapeutic effect of the product in reducing blood pressure, and therefore is not necessarily a reason to stop therapy in the absence of other signs. As is routine in cases of chronic renal insufficiency, it is recommended to monitor plasma creatinine during therapy.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 renal insufficiency. As is routine in cases of chronic renal insufficiency, it is recommended to monitor erythrocyte counts during therapy.FORTEKOR may increase food consumption and body weight in cats.

Special precautions for use
No evidence of renal toxicity to FORTEKOR has been observed in dogs or cats during clinical trials. As is routine in cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy. The efficacy and safety of FORTEKOR has not been established in cats below 2.5 kg body weight.

Use during pregnancy and lactation
The safety of FORTEKOR has not been tested in breeding, pregnant or lactating dogs or cats. FORTEKOR should therefore be used only if justified clinically, considering the risk/benefit ratio. FORTEKOR reduced ovary/oviduct weights in cats 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.

Interaction with other medicaments
None known in dogs or cats. In dogs with heart failure, FORTEKOR has been given in combination with digoxin, diuretics and anti-arrythmic drugs without demonstrable adverse interactions. In man, the combination of ACE inhibitors and NSAIDs can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of FORTEKOR and other anti-hypertensive agents (e.g. calcium channel blockers, -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, triamteren or amilorid cannot be ruled out. It is recommended to monitor plasma potassium levels when using benazepril in combination with a potassium sparing diuretic as life threatening reactions are a possibility. As with other ACE inhibitors, the use of hypotensive medicinal products or anaesthetics with a hypotensive effect may add to the anti-hypertensive effect of benazepril.

Overdose
FORTEKOR is well tolerated in the target species. In normal dogs, overdosage up to 200 fold was asymptomatic. 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.

Formulations and Packages
The 2 tablet strengths are available in packs containing 1 or 10 blisters, each with 14 color-coded tablets.

Storage Recommendations and Shelf Life
4 years if stored in a dry place.

 

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