Introduction

vet00501

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

Prilenal® tablets for dogs are presented as brown spotted, white round tablets, for oral administration containing 1, 2.5, 5, 10 and 20 mg of enalapril maleate.

Uses

For the treatment of mild, moderate or severe congestive heart failure, caused by mitral regurgitation or dilated cardiomyopathy, as an adjunctive therapy with diuretics (furosemide, whether associated or not with digoxin).

Dosage and administration

Prilenal® tablets for dogs should be administered orally at the recommended dose of 0.5 mg/kg of enalapril maleate per day (i.e. 0.38 mg/kg of enalapril base per day). Individual doses should be administered based on body weight using the most appropriate tablet size or combination of tablets. The dosage can be adapted according to the clinical response of the treated animal. In the absence of expected clinical response within 2 weeks following initiation of the therapy, the dose of 0.5 mg/kg of enalapril maleate can be administered twice a day. The increase in dose can be more rapid if the signs of heart failure require it. Dogs should be observed closely for 48 hours following initial dosing or an increase in dose.

Contra-indications, warnings, etc

Do not use in pregnant and lactating bitches.

Do not use in breeding dogs.

Do not use in cases of hypersensitivity to enalapril.

Do not use in dogs with evidence of cardiac output failure (e.g. aortic stenosis, mitral stenosis, obstructive cardiomyopathy).

Special warnings for each target species

Pre-renal azotemia generally results from hypotension due to cardio-vascular insufficiency. Substances that deplete blood volume, such as diuretics, or with a vasodilator effect, such as ACE inhibitors, may contribute to lowering systemic blood pressure. This may create a hypotensive state or exacerbate an existing hypotensive situation and result in pre-renal azotemia.

Dogs with no detectable renal disease may develop mild and transient increases in blood urea nitrogen or serum creatinine when the product is administered concomitantly with a diuretic.

The diuretic and/or enalapril dose should be reduced if clinical signs of hypotension or azotemia appear or if the blood concentration of urea nitrogen and/or creatinine increases significantly above the values observed before treatment. Should clinical signs of overdose occur (azotemia) after the dose is increased from once daily to twice daily, the dose should be decreased to once daily.

Overdose

Normal dogs dosed at 15 mg/kg/day for up to 1 year showed no adverse effects. This means that overdose symptoms generally appear at more than 30 times (at 0.5 mg/kg) or 15 times (at 1 mg/kg) the recommended dosage during one year.

Clinical signs reported include hypotension, azotemia, and increased concentration of urea and/or creatinine. Treat symptomatically.

Adverse reactions

Hypotension and its consequences (e.g. azotemia) can occur at the start of the therapy (in less than 2 % of the treated dogs). Diarrhoea, vomiting, lethargy, dizziness, disorientation and in-coordination can also occur.

Interaction with other medicinal products

Sodium chloride may decrease the hypotensive effect of enalapril.

Concurrent use with NSAIDs may increase the risk of renal toxicity.

Special precautions to be taken by the person administering the medicinal product to animals

Wash hands after use.

In case of accidental ingestion, seek medical advice showing the label to the doctor or medical practitioner.

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

No special precautions for storage.

Legal category

POM-V

Packaging Quantities

Box containing 4 blisters of 7 tablets

Box containing 12 blisters of 7 tablets

Box containing 24 blisters of 7 tablets

Not all pack sizes may be marketed

Further information

In case of hypokalaemia, potassium supplements can be administered concomitantly with Prilenal®. Plasma potassium should be assessed prior to treatment and periodic monitoring should be continued.

In humans, in cases of renal impairment, the concomitant use of enalapril with aldosterone-antagonists can lead to hyperkalaemia. Therefore, both the renal function and plasma potassium are closely monitored in such patients. In absence of data in dogs, such recommendations should be followed in the target species.

Therapy with diuretics should be started at least 1 day prior to initiating treatment with enalapril. Renal function should be assessed prior to, and for 2-7 days after starting treatment. Periodic monitoring of renal function should be continued.