Indications for use, specifying the target species
Reduction of proteinuria associated with chronic kidney disease.
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 (see section Use during pregnancy, lactation or lay).
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
Efficacy and safety of benazepril have not been established in cats of weight less than 2.5 kg
No evidence of renal toxicity to the veterinary medicinal product has been observed in 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.
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 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 cats 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 therefore is not necessarily a reason to stop therapy in the absence of other signs.
The product may increase food consumption and body weight.
Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions.
Use during pregnancy, lactation or lay
Do not use during pregnancy or lactation. The safety of the product has not been established in breeding, pregnant or lactating cats. Benazepril reduced ovary / oviduct weights in cats when administered daily at 10 mg/kg for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Interaction with other medicinal products and other forms of interaction
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 product in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Amounts to be administered and administration route
The product should be given orally once daily, with or without food. The duration of treatment is unlimited. The product tablets are flavoured and are taken voluntarily by most cats. Cats: The 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:
2.5 - 5 kg cat
>5 - 10 kg cat
Number of 2.5 mg tablets
Number of 5 mg tablets
In case of use of half tablets: Put the remaining half of the tablet back into the blister pocket and use for the next administration.
Instruction on how to divide the tablet: Put the tablet on an even surface, with its scored side facing down (convex face up). With the tip of the forefinger, exert slight vertical pressure on the middle of the tablet to break it along its width into halves. Then, in order to obtain quarters, exert slight pressure on the middle of one half with the forefinger to break it into two parts.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The product reduced erythrocyte counts in normal cats when dosed at 10 mg/kg body weight once daily for 12 months but this effect was not observed at the recommended dose during clinical trials in cats.
Transient reversible hypotension may occur in cases of accidental overdose. Therapy should consist of intravenous infusion with warm isotonic saline.