Fortekor 2.5 mg tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Benazepril hydrochloride
For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM
Tablet. Beige, ovaloid, divisible, palatable tablet scored on both sides. 4. CLINICAL PARTICULARS Target species Dog and Cat. 4.2 Indications for use, specifying the target species
Treatment of heart failure in dogs. Treatment of chronic renal insufficiency in cats. 4.3 Contraindications
Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis. Do not use in animals known to be hypersensitive to the active substance. 4.4 Special warnings None. 4.5 Special precautions for use
i) Special precautions for use in animals 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. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use. Adverse reactions (frequency and seriousness) 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. Emesis, anorexia and lethargy have been reported very rarely in this species. 4.7 Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Pregnancy: Use only accordingly to the benefit/risk assessment by the responsible veterinarian. ACE inhibitors have been found to be teratogenic in the second and third trimesters in other species. Lactation: Use only accordingly to the benefit/risk assessment by the responsible veterinarian. Fertility: Do not use in breeding animals. FORTEKOR reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg for 52 weeks. 4.8 Interaction with other medicinal products and other forms of interaction 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, ß- 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 for example spironolactone, triamterene or amiloride 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. Amounts to be administered and administration route
For oral use only. Fortekor should be given orally once daily, with or without food. The duration of treatment is unlimited. In dogs, the recommended oral dose is 0.25-0.5mg benazepril hydrochloride/kg body, given according to the following regime:
FORTEKOR® 2.5
The dose may be doubled, still administered once daily, if judged clinically necessary and advised by the veterinary surgeon. 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:
FORTEKOR® 2.5
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
FORTEKOR is well tolerated in the target species. In normal dogs, overdosage up to 200-fold was asymptomatic. In normal cats, a 10-fold overdosage daily 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.
4.11 Withdrawal period(s) Not applicable. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: agent acting on the renin-angiotensin system, plain ACE inhibitor, ATCvet code: QC09AA07. 5.1 Pharmacodynamic properties Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat. Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II. Therefore, FORTEKOR blocks effects mediated by angiotensin II, 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 both cats and dogs, with more than 95% inhibition at peak effect and significant activity (>80% in dogs and >90% in cats) persisting 24 hours after dosing. FORTEKOR reduces the blood pressure and volume load on the
heart in dogs with heart failure. FORTEKOR 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 capillary 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. 5.2 Pharmacokinetic particulars
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (tmax 0.5 h in dogs, and within 2h in cats) and decline quickly (t1/2=1.4h in cats) as the drug is
partially metabolised by liver enzymes to benazeprilat. In dogs, unchanged benazepril and hydrophilic metabolites account for the remainder. In dogs, peak benazeprilat concentrations (Cmax of 38 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a tmax of 1.25 h. 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 2h. The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs and <30% in cats) and first pass metabolism. Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2= 1.7 h in dogs and t1/2=2.4h in cats) represents elimination of free drug, while the terminal phase (t1/2=19h in dogs and t1/2=29h 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, 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 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 FORTEKOR dose is required in either species in cases of renal insufficiency. 6. PHARMACEUTICAL PARTICULARS
6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: 30 months. 6.4. 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. 6.5 Nature and composition of immediate packaging
Not all pack sizes may be marketed. 6.6Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste materials should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Novartis Animal Health UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR 8. MARKETING AUTHORISATION NUMBER
Vm 12501/4129 9. RENEWAL OF THE AUTHORISATION
26 May 2009 10 DATE OF REVISION OF THE TEXT 14 December 2009 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE VETERINARY MEDICINAL PRODUCT QUALITATIVE AND QUANTITATIVE COMPOSITION
For a ful list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Tablet. Beige to light brown, ovaloid, divisible, tablet scored on both sides. The tablets can be divided into equal halves.
CLINICAL PARTICULARS Target species Indications for use, specifying the target species
Treatment of congestive heart failure in dogs.
Contraindications
Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis. Do not use in case of hypersensitivity to the active substance or to any of the excipients. See also section 4.7
4.4 Special warnings for each target species
4.5 Special precautions for use
i. Special precautions for use in animals
No evidence of renal toxicity to benazepril hydrochloride has been observed in dogs during clinical trials. As is routine in cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy. i . Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use. Pregnant women should take special care to avoid accidental exposure because ACE inhibitors have been found to affect the unborn child after oral exposure during pregnancy in humans. In case of accidental ingestion by children, seek medical advice immediately and show the doctor this warning.
Adverse reactions (frequency and seriousness)
In double-blind clinical trials in dogs with heart failure, benazepril hydrochloride was wel tolerated with an incidence of adverse effects statistical y lower than observed in placebo-treated dogs. A smal number of dogs may exhibit transient signs of fatigue or dizziness.
Use during pregnancy, lactation or lay
The safety of benazepril hydrochloride has not been tested in breeding, pregnant or lactating dogs. The product should therefore, be used only if justified clinical y, considering the risk/benefit ratio. ACE inhibitors have been found to be teratogenic in the second and third trimesters in other species.
Interaction with other medicinal products and other forms of interaction
None known. In dogs with heart failure, benazepril hydrochloride has been given in combination with digoxin, diuretics and anti-arrhythmic 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 benazepril hydrochloride 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 benazepril in combination with a potassium-sparing diuretic as life threatening reactions are a possibility.
4.9 Amounts to be administered and administration route
For oral use only. FORTEKOR Flavour 5 mg tablets are flavoured tablets which are taken voluntarily by dogs; they should be given oral y once daily, with or without food. The duration of treatment is unlimited. In dogs, the recommended oral dose is 0.25-0.5 mg benazepril hydrochloride/kg bodyweight, given according to the fol owing regime:
The dose may be doubled, stil administered once daily, if judged clinical y necessary and advised by the veterinary surgeon.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Benazepril hydrochloride is wel tolerated in the target species. In normal dogs, overdosage up to 200-fold was asymptomatic. Transient reversible hypotension may occur in cases of accidental overdosage. Therapy should consist of intravenous infusion of warm, isotonic saline.
4.11 Withdrawal period(s) PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Agent acting on the renin-angiotensin system, plain ACE inhibitor {group}, ATCvet code: QC09AA07
5.1 Pharmacodynamic properties
Benazepril hydrochloride is a pro-drug, hydrolysed in vivo to its active metabolite, benazeprilat. Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II. Therefore, it blocks effects mediated by angiotensin II, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodel ing effects (including pathological cardiac hypertrophy and degenerative renal changes). The product causes long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80% in dogs) persisting 24 hours after dosing. It reduces the blood pressure and volume load on the heart in dogs with heart failure. It 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.
5.2 Pharmacokinetic particulars
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (tmax 0.5 h) and decline quickly as the drug is partial y metabolised
by liver enzymes to benazeprilat. Unchanged benazepril and hydrophilic metabolites account for the remainder. Peak benazeprilat concentrations (Cmax of
50ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1 hour. The systemic bioavailability is incomplete in dogs (~13%) due to
incomplete absorption (38% in dogs) and first pass metabolism. Benazeprilat concentrations decline biphasical y: the initial fast phase (t½=1.7 h)
represents elimination of free drug, while the terminal phase (t½=19 h) reflects the
release of benazeprilat that was bound to ACE, mainly in the tissues. Benazepril and benazeprilat are extensively bound to plasma proteins 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 Flavour leads to slight bioaccumulation of benazeprilat (R=1.47 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 Flavour dose is required in cases of renal insufficiency.
PHARMACEUTICAL PARTICULARS List of excipients
Cel ulose microcrystal ine Crospovidone Povidone Basic butylated methacrylate copolymer Silicon dioxide anhydrous Sodium laurilsulphate Dibutyl sebacate Silica col oidal anhydrous Stearic acid Yeast powder Artificial powdered beef flavour
Incompatibilities Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life of tablet halves: 2 days
6.4. Special precautions for storage
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.
re and composition of immediate packaging
14 tablets per aluminium/aluminium blister. Cardboard box with:
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.MARKETING AUTHORISATION HOLDER
Novartis Animal Health UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR
8. MARKETING AUTHORISATION NUMBER(S) Vm 12501/4167
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE VETERINARY MEDICINAL PRODUCT QUALITATIVE AND QUANTITATIVE COMPOSITION
For a ful list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Tablet. Beige to light brown, ovaloid, divisible, tablet scored on both sides. The tablets can be divided into equal halves.
CLINICAL PARTICULARS Target species Indications for use, specifying the target species
Treatment of congestive heart failure in dogs.
Contraindications
Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis. Do not use in case of hypersensitivity to the active substance or to any of the excipients. See also section 4.7
4.4 Special warnings for each target species
4.5 Special precautions for use
i. Special precautions for use in animals
No evidence of renal toxicity to benazepril hydrochloride has been observed in dogs during clinical trials. As is routine in cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy.
i . Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use. Pregnant women should take special care to avoid accidental exposure because ACE inhibitors have been found to affect the unborn child after oral exposure during pregnancy in humans. In case of accidental ingestion by children, seek medical advice immediately and show the doctor this warning.
Adverse reactions (frequency and seriousness)
In double-blind clinical trials in dogs with heart failure, benazepril hydrochloride was wel tolerated with an incidence of adverse effects statistical y lower than observed in placebo-treated dogs. A smal number of dogs may exhibit transient signs of fatigue or dizziness.
Use during pregnancy, lactation or lay
The safety of benazepril hydrochloride has not been tested in breeding, pregnant or lactating dogs. The product should therefore, be used only if justified clinical y, considering the risk/benefit ratio. ACE inhibitors have been found to be teratogenic in the second and third trimesters in other species.
Interaction with other medicinal products and other forms of interaction
None known. In dogs with heart failure, benazepril hydrochloride has been given in combination with digoxin, diuretics and anti-arrhythmic 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 benazepril hydrochloride 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 benazepril in combination with a potassium-sparing diuretic as life threatening reactions are a possibility.
4.9 Amounts to be administered and administration route
For oral use only. FORTEKOR Flavour 20 mg tablets are flavoured tablets which are taken voluntarily by most dogs; they should be given oral y once daily, with or without food. The duration of treatment is unlimited. In dogs, the recommended oral dose is 0.25-0.5 mg benazepril hydrochloride/kg bodyweight, given according to the fol owing regime:
The dose may be doubled, stil administered once daily, if judged clinical y necessary and advised by the veterinary surgeon. When the 10 mg dose is required, veterinary surgeons should consider administering two 5 mg tablets to limit the use of half tablets.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Benazepril hydrochloride is wel tolerated in the target species. In normal dogs, overdosage up to 200-fold was asymptomatic. Transient reversible hypotension may occur in cases of accidental overdosage. Therapy should consist of intravenous infusion of warm, isotonic saline.
4.11 Withdrawal period(s) PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Agent acting on the renin-angiotensin system, plain ACE inhibitor {group}, ATCvet code: QC09AA07
5.1 Pharmacodynamic properties
Benazepril hydrochloride is a pro-drug, hydrolysed in vivo to its active metabolite, benazeprilat. Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II. Therefore, it blocks effects mediated by angiotensin II, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodel ing effects (including pathological cardiac hypertrophy and degenerative renal changes). The product causes long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80% in dogs) persisting 24 hours after dosing. It reduces the blood pressure and volume load on the heart in dogs with heart failure. It 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.
5.2 Pharmacokinetic particulars
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (tmax 0.5 h) and decline quickly as the drug is partial y metabolised
by liver enzymes to benazeprilat. Unchanged benazepril and hydrophilic metabolites account for the remainder. Peak benazeprilat concentrations (Cmax of
50ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1 hour. The systemic bioavailability is incomplete in dogs (~13%) due to
incomplete absorption (38% in dogs) and first pass metabolism. Benazeprilat concentrations decline biphasical y: the initial fast phase (t½=1.7 h)
represents elimination of free drug, while the terminal phase (t½=19 h) reflects the
release of benazeprilat that was bound to ACE, mainly in the tissues. Benazepril and benazeprilat are extensively bound to plasma proteins 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 Flavour leads to slight bioaccumulation of benazeprilat (R=1.47 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 Flavour dose is required in cases of renal insufficiency.
PHARMACEUTICAL PARTICULARS List of excipients
Cel ulose microcrystal ine Crospovidone Povidone Basic butylated methacrylate copolymer Silicon dioxide anhydrous Sodium laurilsulphate Dibutyl sebacate Silica col oidal anhydrous Stearic acid Yeast powder Artificial powdered beef flavour
Incompatibilities Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions. 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
14 tablets per aluminium/aluminium blister. Cardboard box with:
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.MARKETING AUTHORISATION HOLDER
Novartis Animal Health UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR
8. MARKETING AUTHORISATION NUMBER(S) Vm 12501/4168
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
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No evidence of renal toxicity to benazepril hydrochloride has been observed in dogs during clinical trials. As is routine in cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy. i . Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use. Pregnant women should take special care to avoid accidental exposure because ACE inhibitors have been found to affect the unborn child after oral exposure during pregnancy in humans. In case of accidental ingestion by children, seek medical advice immediately and show the doctor this warning.
Adverse reactions (frequency and seriousness)