Benakor 5 mg for dogs 98 tablets
Symptomatic treatment of congestive heart failure in dogs
Benakor 5 mg tablets for dogs
2. BENAKOR QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance: 4.6 mg benazepril (equivalent to 5 mg benazepril hydrochloride)
Excipient(s): Colourant: Iron oxides (E172) 0.5 mg
For a full list of excipients, see section 6.1.
3. BENAKOR PHARMACEUTICAL FORM
Yellow oblong divisible tablets, with a break mark on one side.
4. BENAKOR CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
Symptomatic treatment of congestive heart failure in dogs with or without adjunct therapy used in the treatment of heart failure.
Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis, mitral valve stenosis or pulmonary stenosis or in case of hypotension.
Do not use in case of known hypersensitivity to ACE inhibitors or to any of the ingredients of the product.
See section 4.7
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
No evidence of renal toxicity to the product has been observed in dogs during clinical trials. However, as is routine in cases of renal insufficiency, it is recommended to monitor plasma urea and creatinine levels. Do not abruptly stop or reduce therapy.
Special precautions to be taken by the person administering the 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 during pregnancy in humans.
In case of accidental ingestion by children, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
at the start of treatment a decrease of blood pressure may occur.
in rare cases fatigue or drowsiness may be observed.
benazepril hydrochloride may lead to increased plasma creatinine concentrations.
on rare occasions transient signs of hypotension, such as lethargy and ataxia may occur.
4.7 Use during pregnancy or lactation
Do not use in pregnant or nursing bitches or in bitches intended for breeding. Safety of the product has not been tested in breeding, pregnant or lactating dogs. Laboratory studies in rats have shown embryotoxic effects of benazepril at non-maternotoxic doses (urinary tract abnormalities in the foetus). In humans, ACE inhibitors have been found to be teratogenic during pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
In dogs with heart failure, benazepril has been given in combination with digoxin, diuretics and antiarrhythmic drugs without demonstrable adverse interactions.
In man, the combination of ACE inhibitors and NSAIDs can lead to reduced antihypertensive efficacy or impaired renal function. The combination of benazepril and other antihypertensive agents (e.g. calcium channel blockers, beta-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore concurrent use of NSAIDs or other medication 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.
4.9 Amounts to be administered and administration route
The recommended oral dose is 0.25 mg benazepril hydrochloride/kg body weight once daily. The dose may be doubled (still administered once daily), if judged clinically necessary and advised by the veterinary surgeon.
In case of using halved tablets: Put the remaining half of a divided tablet back in the blister pocket and store it in a dry place below 25°C. Use the remaining tablet half for the next administration.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Morphological changes such as hypertrophy and hyperplasia of the juxtaglomerular apparatus, increase of urea and lowered heart weight in healthy dogs due to involution has been observed after doses of more than 10 mg/kg.
Transient reversible hypotension may occur in cases of accidental overdosage. Symptomatic treatment consists of intravenous infusion of warm isotonic saline solution.
4.11 Withdrawal period(s)
5. BENAKOR PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: ACE inhibitors, plain
ATCvet code: QC09AA07
5.1 Pharmacodynamic properties
Benazepril hydrochloride is a pro-drug hydrolysed in vivo to benazeprilate. Benazeprilate 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 modelling effects (including pathological cardia 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.
Onset of clinical efficacy can be expected in approximately 1 week after initiation of therapy with benazepril hydrochloride.
5.2 Pharmacokinetic particulars
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (tmax 1.1 h in dogs) and decline quickly as the drug is partially metabolised by liver enzymes to benazeprilate. In dogs, unchanged benazepril and hydrophilic metabolites account for the remainder. In dogs, peak benazeprilate concentrations (Cmax of 384.16 ng/ml after a dose of 1.6 mg/kg of the product) are achieved with a tmax of 1.1 hither systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs).
Benazeprilate is eliminated with a t1/2 of 2.8 h in dogs. Benazepril and benazeprilate are extensively bound to plasma proteins, and in tissues are found mainly in the liver and the kidney.
There is no significant difference in the pharmacokinetics of benazeprilate when benazepril hydrochloride is administered to fed or fasted dogs.
Benazeprilate is excreted 54% via the biliary and 46% via the urinary route in dogs. The clearance of benazeprilate is not affected in dogs with impaired renal function and therefore no adjustment of the dose is required in cases of renal insufficiency.
6. BENAKOR PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Silica colloidal anhydrous (E551)
Microcrystalline cellulose (E460)
Colorcon Pigment Blend 22870 yellow (Iron oxides, E172)
Sodium cyclamate (E952) Sodium starch glycolate Type A Magnesium stearate (E470b).
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
PVC/PE/PVDC-Aluminium blister: 12 months.
Aluminium/Aluminium blister: 18 months.
6.4. Special precautions for storage
Do not store above 25ºCStore in the original package.
6.5 Nature and composition of immediate packaging
1 carton contains:
1, 2, 3, 4, 5, 6 or 7 PVC/PE/PVDC/Alu-foil blisters of 14 tablets each.
1,2,3,4,5,6,7 Alu/Alu-foil blisters of 14 tablets each.
Not all pack sizes may be marketed.
6.6 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.
7. MARKETING AUTHORISATION HOLDER
Le Vet B.V.
3421 GW Oudewater