ARIXIL VET 20MG 28 TABLETS | Treatment of congestive heart failure.

ARIXIL vet 20 mg Treatment of congestive heart failure.

Angiotensin Converting Enzyme (ACE) Inhibitor Flavored Oral Tablet

Pharmaceutical form

Coated tablet (Comp.rec.)

Composition by tablet:

Benazepril hydrochloride 20 mg (equivalent to 18,42 mg benazepril).

Pharmacological properties

Benazepril hydrochloride is a prodrug hydrolyzed in vivo to its active metabolite, benazepril. Benazeprilat is a highly potent selective inhibitor

of angiotensin converting enzyme (ACE). Thus, it blocks arterial and venous vasoconstriction, sodium and water retention by the kidneys, and remodeling effects (including pathologic cardiac hypertrophy and degenerative renal changes).

The veterinary medicinal product causes long-term inhibition of plasma ACE activity, producing greater than 95% inhibition of the maximum effect and significant activity (>80% in dogs) persisting 24 hours after administration.

The veterinary medicinal product reduces blood pressure and the volume of load on the heart in dogs with congestive heart failure.

Interactions and incompatibilities

In dogs with congestive heart failure, the veterinary medicinal product has been administered in combination with digoxin, diuretics, pimobendan and antiarrhythmic veterinary medicinal products without demonstrable adverse interactions.

In humans, the combination of ACE inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) may lead to reduced antihypertensive efficacy or renal failure. The combination of the product and other antihypertensive agents (eg calcium channel blockers, ß-blockers or diuretics), anesthetics or sedatives may lead to an increased hypotensive effect. Therefore, the concomitant use of NSAIDs or other drugs with a hypotensive effect should be considered with caution. Renal function and signs of hypotension (lethargy, weakness, etc.) should be closely monitored and treated if necessary.

Interactions with potassium-sparing diuretics such as spironolactone, triamterene or amiloride cannot be excluded. Monitoring of plasma potassium levels is recommended when the veterinary medicinal product is used in combination with a potassium-sparing diuretic due to the risk of hyperkalaemia.

Indications

Dogs: Treatment of congestive heart failure.

Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cases of decreased cardiac output due to aortic or pulmonary stenosis.

Do not use in cases of hypotension, hypovolemia, hyponatremia or acute renal failure.

Do not use during pregnancy or lactation.

Adverse reactions

In double-blind clinical trials in dogs with congestive heart failure, the veterinary medicinal product was well tolerated, with a lower incidence of adverse reactions than was observed in placebo-treated dogs.

A small number of dogs may exhibit transient vomiting, incoordination, or signs of fatigue. In dogs with chronic kidney disease, the veterinary medicinal product could increase plasma creatinine concentrations at the start of treatment. A moderate increase in plasma creatinine concentrations after administration of ACE inhibitors is consistent with the reduction in glomerular hypertension induced by these agents, and not necessarily a reason to discontinue treatment in the absence of other signs.

Route of administration

Orally.

Posology

Dogs: Should be administered orally once daily, with or without food. The dose is 0,23 mg benazepril/kg weight once daily, which corresponds to 0,25 mg benazepril hydrochloride/kg weight per day, according to the following table:

> 20 – 40kg: ½ tablet

> 40 – 80kg: 1 tablet

The dose can be doubled, being administered once a day, if the veterinarian considers it clinically necessary.

Special precautions

No evidence of renal toxicity of the veterinary medicinal product has been observed during clinical trials in dogs, however, as is routine in chronic kidney disease, monitoring of plasma creatinine, urea and erythrocyte counts during treatment is recommended.

The efficacy and safety of the drug have been established in dogs weighing less than 2,5 kg.

Wait time

Not applicable.

conservation mode

Do not store at temperatures above 25 ºC.

Store in the outer carton in order to protect from light.

Store in a dry place.

Return either half of the tablet to the blister pack and use within one day. The blister must be put back in the box.

Comments

Medicine subject to a veterinary prescription. Administration under control or supervision of the veterinarian.

DATA SHEET 

ARIXIL