Introduction

Company name: Vétoquinol UK Ltd

Address: Vétoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

Telephone: 01280 814500

Fax: 01280 825460

Email: office@vetoquinol.co.uk

Website: www.vetoquinol.co.uk

Presentation

A fine white powder for oral solution. After reconstitution, the solution is limpid and colourless

Containing 75mg.150 mg or 300 mg of imidapril hydrochloride.

Uses

Imidapril is a pro-drug which is hydrolysed in vivo to form an active metabolite, imidaprilat. Imidaprilat inhibits the angiotensin-converting enzyme (ACE). This enzyme catalyses the conversion of angiotensin I to angiotensin II in the blood plasma and tissues and inhibits the breakdown of bradykinin. As angiotensin II has a potent vasoconstrictive action, while bradykinin is a vasodilator, the reduced formation of angiotensin II and the inhibition of bradykinin breakdown lead to vasodilation. Imidapril reduces heart preload and afterload, and decreases blood pressure without any compensatory increase in the heart rate in dogs. It is indicated in the treatment of moderate to severe heart failure by mitral regurgitation or by dilated cardiomyopathy

Dosage and administration

The recommended dose of imidapril is 0.25 mg/kg once a day per oral route,

0.1 ml/kg of PRILIUM 75mg for dogs weighing more than 2kg (1ml/10kg)

0.05 ml/kg of PRILIUM 150 mg for dogs weighing more than 4 kg (1ml/20kg).

0.025 ml/kg of PRILIUM 300 mg for dogs weighing more than 8 kg (1ml/40kg).

The product can be administered either directly into the mouth of the animal on an empty stomach or during the meals, or on food.

Preparation of the oral solution: Remove the nipple and the stopper of the vial containing the powder and fill with tap water up to the 30ml mark which is indicated by a raised ring around the body of the bottle, place the child proof cap and screw on tightly.

Administration: Unscrew the child proof cap, introduce the graduated syringe into the applicator, turn the assembly upside down and measure the quantity to administer using the syringe graduated in kg and mls. Once the product has been administered, replace the child proof cap onto the vial and rinse the syringe with water. Store the vial in the fridge.

Contra-indications, warnings, etc

Do not use in dogs with low blood pressure.

Do not use in dogs with acute renal insufficiency.

Do not use in dogs with congenital heart disease

Do not use in dogs hypersensitive to an ACE inhibitor

Do not use in dogs with haemodynamically relevant stenoses (aortic stenosis, mitral valve stenosis, pulmonal stenosis)

Do not use in dogs with obstructive hypertrophic cardiomyopathy

Diarrhoea, hypotension and related symptoms such as fatigue, dizziness or anorexia can occur in rare cases. Vomiting can also occur in very rare cases. In such cases treatment should be discontinued until the patient's condition has returned to normal.

The use of ACE inhibitors in dogs with hypovolaemia/dehydration can lead to acute hypotension. In such cases the fluid and electrolyte balance should be restored immediately and treatment suspended until it has been stabilised. Parameters used for monitoring renal function should be checked at the beginning of the treatment and at regular time intervals thereafter.

In the absence of data, do not use in pregnant or lactating bitches or in breeding dogs.

However diuretics and a low sodium diet potentiate the effect of ACE inhibitors by activating the renin-angiotensin-aldosterone system (RAAS). Diuretics used at high doses and a low sodium diet are thus not recommended during a treatment with ACE inhibitors in order to avoid hypotension with clinical signs such as apathy, ataxia, rare syncope and kidney failure. In case of joint administration with potassium retaining diuretics, potassium must be monitored because there is a risk of hyperkaliemia

Oral doses up to 5 mg/kg of imidapril (20 times the recommended dose) have been well tolerated in healthy dogs. Hypotension may occur as a symptom of overdosage with signs of apathy and ataxia. The treatment is symptomatic.

Withdrawal periods

Not applicable

Operator warnings

In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.

Wash hands after having administered the product. In case of contact with eyes, rinse immediately with plenty of water.

The vial must be closed using the child proof stopper before being stored in the fridge.

Pharmaceutical precautions

Before reconstitution: do not store above 25°C

After reconstitution: store at 2°C - 8°C (in the refrigerator) for 77days.

Any unused product or waste material should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Prilium 75mg: Box containing vial and a polypropylene syringe with blue graduations.

Prilium 150mg: Box containing vial and a polypropylene syringe with orange graduations.

Prilium 300mg: Box containing vial and a polypropylene syringe with mauve graduations.

Further information

Following oral administration in the dog, imidapril is rapidly absorbed by the gastrointestinal tract and reaches its maximum plasma concentration within less than one hour. The half-life of imidapril is about 2 hours. Imidapril is mainly hydrolysed in the liver and kidney to its active metabolite, imidaprilat. Maximum plasma concentrations of imidaprilat are reached within about 5 hours and decline with a half-life of more than 10 hours. The bioavailability of imidapril and imidaprilat is decreased by the joint administration of food. The protein binding of imidapril and imidaprilat is moderate (85% and 53%, respectively).

After oral administration of the radio-labelled compound, about 40% of total radioactivity is excreted in urine and about 60% in the faeces.

After multiple dosing, the plasma imidaprilat concentrations are about 3 times higher after the second administration than after the first administration, but no additional increase is observed after further administrations.