Enacard (5 mg) (Canada)

(enalapril maleate)

Tablets for Dogs

Veterinary Use Only

For the Treatment of Heart Failure in Dogs

DIN 02060531 (1 mg), 02060558 (2.5 mg), 02060566 (5 mg), 02060574 (10 mg), 02060582 (20 mg)

Description

ENACARD (enalapril maleate) is the maleate salt of enalapril, a derivative of two amino-acids, L-alanine and L-proline. Following oral administration, enalapril is rapidly absorbed and then hydrolyzed to enalaprilat, which is a highly specific, long-acting, non-sulphydryl angiotensin converting enzyme (ACE) inhibitor. ENACARD tablets are round, non-scored, and available in five colour-coded dosage strengths.

Enacard (5 mg) Indications

ENACARD is indicated for the treatment of mild, moderate or severe heart failure in dogs caused by mitral regurgitation or dilated cardiomyopathy, in combination with standard therapy. For improved tolerance and increased survival in dogs with mild, moderate or severe heart failure.

Enacard (5 mg) Dosage And Administration

The recommended dose of ENACARD is 0.5 mg/kg administered orally s.i.d. (once a day) to dogs. In the absence of adequate clinical response within 2 weeks of initiation of therapy, the dose should be increased to b.i.d. (twice a day). This dose increase may be initiated more rapidly if indicated by signs of heart failure. Dogs should be observed closely for 48 hours following initial dosing or an increase in the dose.

Individual dosages should be administered on the basis of body weight using the appropriate tablet or combination of tablet sizes.

Safety

At the recommended dose level, ENACARD has been shown to have an adequate margin of safety in dogs with heart failure. The safety of ENACARD has been thoroughly investigated in several animal species including mice, rats, monkeys and man to assess its general toxicity. Normal dogs given 15 mg/kg/day for up to one year showed no adverse changes.

Enacard (5 mg) Caution

Renal Function Impairment

Pre-renal azotemia is usually a result of hypotension induced by impaired cardiovascular performance. On occasion, substances that deplete blood volume, such as diuretics or vasodilators (e.g., ACE inhibitors), may contribute to lowering systemic blood pressure. This may create a hypotensive state, exacerbate an existing hypotensive situation, resulting in an azotemic patient. Dogs with no detectable renal disease may develop minor and transient increases in BUN or CRT when ENACARD is administered concomitantly with a diuretic. Dosage reduction and/or discontinuation of the diuretic and/or ENACARD may be required if signs of hypotension become apparent or azotemia develops.

Dogs should be on standard therapy for heart failure at least one day prior to initiating treatment with ENACARD. Clinical manifestations of the heart failure syndrome may include pre-renal azotemia defined as elevations in the blood urea nitrogen (BUN) or creatinine (CRT), or both, provided urinalysis is normal. Renal function should be monitored both before and 2 to 7 days after starting treatment with ENACARD. The dose of diuretic or diuretic and ENACARD should be reduced if clinical signs of azotemia occur, or the concentration of blood urea nitrogen or serum creatinine increases significantly over pre-treatment levels. Periodic monitoring of renal function should be continued.

Should clinical signs of overdosage occur (e.g., azotemia) after the dose is increased from s.i.d. to b.i.d., the dose should be decreased to s.i.d.

Use In Breeding Animals

Not recommended for use in pregnant bitches. Safety in breeding dogs has not been established.

Warnings

Keep this and all drugs out of the reach of children.

In case of human ingestion, clients should be advised to contact a physician immediately.

Physicians may contact a Poison Control Center for advice concerning cases of human ingestion.

Side Effects

ENACARD has been demonstrated to be generally well tolerated. In clinical studies, the overall incidence of side effects was no greater with ENACARD than with placebo. For the most part, side effects have been mild and transient in nature, and have not required discontinuation of therapy. The following side effects have been reported.

Azotemia

In clinical trials, no significant difference in the incidence of azotemia was reported between dogs receiving standard therapy and placebo (8.3%) and dogs receiving standard therapy and ENACARD (9.4%).

General

No significant differences in the incidence of clinical signs, including lethargy, drowsiness, hypotension, disorientation or incoordination, were reported between dogs receiving standard therapy and placebo (0.8%) and dogs treated with standard therapy and ENACARD (3.0%).

Availability

Each tablet strength is supplied in blister cards containing 7 tablets each. Four blister cards are supplied in a carton box.

Storage

Store between 15°C - 25°C and protect product from light and moisture.

Merial Canada Inc., 20000 Clark Graham, Baie d’Urfé Qc H9X 4B6

^® ENACARD is a registered trademark of Merial Limited.

© 2009 Merial Limited.

Merial Limited, a company limited by shares registered in England and Wales (registered number 3332751) with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow, Essex CM19 5QA, England, and domesticated in Delaware, U.S.A. as Merial LLC, and having its place of business at 3239 Satellite Boulevard, Duluth, GA, U.S.A.

037 833412

CPN: 11820123