Prilben vet 20 mg for dogs over 20 kg 14 tablets
Treatment of congestive heart failure in dogs weighing more than 20 kg
PRILBEN vet 20 mg film-coated tablet for dogs
2. PRILBEN QUALITATIVE AND QUANTITATIVE COMPOSITION
Each divisible tablet contains:
Benazepril 18.42 mg
(equivalent to Benazepril Hydrochloride 20 mg)
Titanium dioxide (E171) 1.929 mg
Iron oxide yellow (E172) 0.117 mg
Iron oxide red (E172) 0.014 mg
Iron oxide black (E172) 0.004 mg
For a full list of excipients, see section 6.1
3. PRILBEN PHARMACEUTICAL FORM
Film-coated tablets. The tablets can be divided into equal halves.
Beige oblong biconvex film-coated divisible tablets
4. PRILBEN CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying target species
In dogs weighing more than 20 kg bw: Treatment of congestive heart failure.
Do not use in cases of known hypersensitivity to ACE inhibitors or to any ingredient of the product.
Do not use in any dog that has evidence of cardiac output failure, for example, due to aortic stenosis.
See also 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 benazepril has been observed in dogs. However, as is routine in cases of chronic renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Pregnant women should take special care to avoid accidental oral exposure, because ACE inhibitors have been found to affect the unborn child during pregnancy in humans.
Wash hands after use.
In case of accidental ingestion by children seek medical advice immediately and show the label to the doctor.
4.6 Adverse reactions (frequency and seriousness)
At the start of the treatment, a decrease of the blood pressure and a transient increase of plasmatic concentrations of creatinine may occur.
On rare occasions, transient signs of hypotension, such as lethargy and ataxia may occur.
4.7 Use during pregnancy , lactation or lay
Laboratory studies in rats have shown embryotoxic effects of Benazepril at non maternotoxic doses (urinary system abnormalities in foetus).
Safety of this product has not been tested in pregnant or lactating bitches.
Do not use in pregnant or lactating females.
Do not use in breeding dogs.
4.8 Interaction with other medicaments and other forms of interaction
Concomitant administration of potassium sparing diuretics may be considered. It is then recommended to regularly monitor potassium plasma levels.
The combination of this product with other anti-hypertensive agents (e.g. calcium channel blockers, b blockers or diuretics) anaesthetics or sedatives may lead to additive hypotensive effects. In man, the combination of ACE inhibitors and NSAIDs can lead to reduced anti-hypertensive efficacy or impaired renal function. Therefore the concurrent use of NSAIDs or medications with hypotensive effect should be considered with care.
4.9 Amounts to be administered and administration route
The dose is 0.23 mg benazepril /kg bw per day, corresponding to 0.25 mg of Benazepril hydrochloride / kg bw per day. It should be given orally once daily, with or without food. It corresponds to 1/2 tablet per 20 to 40 kg and 1 tablet for dogs of more than 40 kg given according to the following regime:
Weight of dog (kg); Number of tablets
20 - 40: 1/2 tablet
>40 - 80: 1 tablet
Dosage may be doubled, still administered once daily, if judged clinically necessary and advised by the veterinary surgeon.
Return any halved tablet to the blister pack and use within 1 day. The blister pack should be inserted back into the carboard box.
4.10 Overdose (symptoms, emergency procedures, antidotes)
Transient reversible signs of hypotension may occur in cases of accidental overdose. Symptomatic treatment consists of intravenous infusion of warm isotonic saline.
4.11 Withdrawal period
5. PRILBEN PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: ACE inhibitors, benazepril
ATCvet code: QC09AA07
5.1 Pharmacodynamic properties
Benazepril hydrochloride is a prodrug hydrolysed in vivo to benazeprilat. This active metabolite inhibits angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I into active angiotensin II. Therefore, benazeprilate inhibits all effects induced by angiotensin II, in particular, vasoconstriction of both arteries and veins and retention of sodium and water by the kidney. Benazepril hydrochloride causes long-lasting inhibition of plasma ACE in dogs, with significant inhibition persisting for 24 hours after a single dose.
In dogs with cardiac insufficiency, benazepril hydrochloride reduces the peripheral resistance, blood pressure of left ventricle and volume load on the heart.
5.2 Pharmacokinetic particulars
After oral administration, benazepril is rapidly absorbed from the gastrointestinal tract. One part of absorbed benazepril is hydrolyzed by hepatic enzymes to the active substance, benazeprilat; unchanged benazepril and hydrophilic metabolites account for the remainder. The absolute systemic bioavailability, calculated for oral benazepril versus intravenous benazepril is about 9%. Peak benazeprilat concentrations are achieved within about 2 hours, both in fasting and fed situations.
Benazepril and benazeprilat are extensively bound to plasma proteins. Repeated administration leads to slight accumulation of benazeprilat in plasma, steady state being achieved in less than 4 days.
In dogs, the major part of benazeprilat is rapidly eliminated, and it is excreted equally via hepatic and urinary routes.
After the administration of a single dose of the product (0.23 mg benazepril/ kg b.w.), peak benazeprilat concentrations (Cmax of 40.9 ng/ml) were achieved within about 1.5 h (Tmax of 1.5h), with AUC of 320.5 ng/ml.h and a half-life (t1/2) of 12.4 h.
6. PRILBEN PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Iron oxide yellow (E-172)
Iron oxide red (E-172)
Iron oxide black (E-172
Titanium dioxide (E-171)
Silica colloidal anhydrous
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life of divisions of the tablets: 24 hours
See 4.9 for storage precautions of the remaining half-tablet.
6.4 Special precautions for storage
Do not store above 25°C.
Store in a dry place
Protect from light.
6.5 Nature and composition of immediate packaging:
Blister made of clear film of PVC/PE/PVDC and aluminium film containing 14 tablets.
- 1 blister (14 tablets)
- 2 blisters (28 tablets)
- 4 blisters (56 tablets)
- 10 blisters (140 tablets)
Not all pack size 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.