BENEVIA® Flavoured Tablets

Benazepril Hydrochloride Tablets

ACE Inhibitor for Dogs and Cats
For Veterinary Use Only

COMPOSITION

BENEVIA® 5 mg

Each flavoured tablet contains:

Benazepril Hydrochloride ........................ 5 mg
Excipients ................................................ q.s.

Other strengths may be developed according to the target market and dosing requirements.

PHARMACEUTICAL FORM

Beige to light-brown, scored, palatable tablets for oral administration.

TARGET SPECIES

• Dogs

• Cats

Veterinary benazepril tablets are authorised in Europe for oral use in dogs and cats, with indications differing by species.

INDICATIONS

Dogs

BENEVIA® is indicated for the treatment of congestive heart failure associated with cardiac insufficiency.

It may be administered as part of a comprehensive cardiac-treatment protocol alongside medicines such as:

• Pimobendan

• Furosemide

• Spironolactone

Cats

BENEVIA® is indicated for the reduction of proteinuria associated with chronic kidney disease.

The final species-specific indications must correspond to the approved registration dossier in the target country.

PHARMACOLOGICAL PROPERTIES

Benazepril hydrochloride is an angiotensin-converting enzyme inhibitor (ACE inhibitor).

After administration, it is converted to its active metabolite, benazeprilat, which inhibits the conversion of angiotensin I to angiotensin II.

This results in:

• Vasodilation

• Reduction of cardiac preload and afterload

• Reduced aldosterone secretion

• Reduced sodium and water retention

• Reduced intraglomerular pressure

• Reduction of protein loss through the kidneys

DOSAGE AND ADMINISTRATION

For oral administration once daily, with or without food.

Dogs

0.25–0.5 mg benazepril hydrochloride/kg body weight once daily.

The dose may be adjusted by the attending veterinarian according to clinical response.

Cats

0.5–1 mg benazepril hydrochloride/kg body weight once daily.

Treatment may be continued long-term according to veterinary assessment.

PROPOSED DOSING GUIDE

The definitive dosing table must be aligned with the approved dose, tablet divisibility and registration dossier.

CONTRAINDICATIONS

Do not use in animals with:

• Known hypersensitivity to benazepril or other ACE inhibitors

• Hypotension

• Hypovolaemia

• Hyponatraemia

• Acute renal failure

• Cardiac-output obstruction such as significant aortic or pulmonary stenosis

SPECIAL WARNINGS

Renal function and hydration status should be evaluated before treatment.

BENEVIA® may lower blood pressure, particularly in animals receiving:

• Diuretics

• Other vasodilators

• Antihypertensive medicines

Animals with congestive heart failure or chronic kidney disease should receive regular veterinary monitoring.

SPECIAL PRECAUTIONS FOR USE

During treatment, consider monitoring:

• Serum creatinine

• Blood urea nitrogen

• Serum potassium

• Hydration status

• Blood pressure

• Urinary protein levels in cats

• Cardiac and respiratory status in dogs

A moderate increase in creatinine may occur after initiation of ACE-inhibitor treatment because of reduced glomerular pressure. Clinical interpretation should be made by the attending veterinarian.

ADVERSE REACTIONS

Possible adverse reactions include:

• Vomiting

• Diarrhoea

• Reduced appetite

• Lethargy

• Hypotension

• Weakness

• Increased serum creatinine

In cats with chronic kidney disease, increased appetite and weight gain may occur as the clinical condition improves.

Discontinue treatment and consult a veterinarian if severe weakness, collapse, persistent vomiting or marked renal deterioration occurs.

USE DURING PREGNANCY AND LACTATION

Do not use during pregnancy or lactation because safety has not been established in pregnant or lactating dogs and cats.

Do not use in breeding animals unless specifically supported by the approved dossier.

DRUG INTERACTIONS

Use cautiously with:

• Furosemide and other diuretics

• Spironolactone

• Potassium supplements

• Potassium-sparing medicines

• NSAIDs

• Other antihypertensive agents

• Anaesthetic agents

Concurrent use with potassium-sparing diuretics may increase the risk of hyperkalaemia.

OVERDOSE

Overdose may result in:

• Excessive hypotension

• Weakness

• Lethargy

• Collapse

• Renal dysfunction

• Electrolyte abnormalities

Treatment should be symptomatic and supportive. Intravenous isotonic fluids may be required under veterinary supervision.

STORAGE

Store below 25°C.

Protect from moisture and direct sunlight.

Keep tablets in the original blister until use.

Return divided tablets to the opened blister cavity.

SHELF LIFE

36 months, subject to confirmation by stability studies.

The in-use period for divided tablets must be established in the final registration dossier.

PRESENTATION

Proposed strengths:

• BENEVIA® 2.5 mg

• BENEVIA® 5 mg

• BENEVIA® 20 mg

Proposed pack sizes:

• 14 tablets

• 28 tablets

• 30 tablets

• 100 tablets