Kelapril 20mg film coated Tablets for Dogs

Kelapril 20mg film coated tablets Tablets for Dogs.

Uses:
Dogs: treatment of congestive heart failure.
Cats: Reduction of proteinuria associated with chronic kidney disease. (Kelapril 2.5 mg and 5 mg, tablets for dogs and cats only)

Dosage and administration:
Oral use
The product should be given orally once daily, with or without food. The duration of treatment is unlimited.
Dogs:
The product should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following tables:

Contra-indications, warnings, etc
Contraindications:
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 in pregnancy or lactation. (see further information below)

Special warnings for each target species:
None

Special precautions for use:
i. Special precautions for use in animals
No evidence of renal toxicity of the veterinary medicinal product has been observed (in dogs or 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.
The efficacy and safety of the product has not been established in dogs and 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.

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, the product 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 cats and dogs 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 is therefore not necessarily a reason to stop therapy in the absence of other signs.

The product may increase food consumption and body weight in cats.
Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions in cats.

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 dogs and cats. Benazepril reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg body weight for 52 weeks.

Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally non-toxic doses.
Interaction with other medicinal products and other forms of
interaction

In dogs with congestive heart failure, the product 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 the product and other anti-hypertensive agents (eg. 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 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.

Pharmaceutical precautions
Shelf life of the veterinary medicinal product as packaged for sale:
Kelapril 2.5mg tablets for dogs and cats: 2 years
Kelapril 5 mg tablets for dogs and cats: 30 months
Kelapril 20 mg tablets for dogs: 3 years
Tablet halves should be used within 2 days
Store below 25°C in the original package (Kelapril 2.5 mg tablets for dogs and cats)
Store below 30°C in the original package (Kelapril 5 mg tablets for dogs and cats and Kelapril 20 mg tablets for dogs)
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.
For animal treatment only- to be supplied only on veterinary prescription.
Keep out of the sight and reach of children
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category:
Legal category: POM-V

Packaging quantities:
PVC/PCTFE- aluminium blister containing 14 film-coated tablets.
Cardboard box with
- 2 blisters (28 tablets)
- 7 blisters (98 tablets)
Not all pack sizes may be marketed.