Introduction 
Company name: Merial Animal Health Ltd
Address: PO Box 327
Sandringham House
Harlow Business Park
Harlow
Essex CM19 5TG
Telephone: Companion Animals 0870 6000123
Production Animals 0800 592699
Fax: 01279 775888
Email: ukenquiry@merial.com
Website: www.merial.com
Presentation
ENACARD Tablets for Dogs (enalapril maleate) are presented as round
non-scored biconvex uncoated tablets, colour coded according to dosage
strength: 1.0 mg - green; 2.5 mg - blue; 5.0 mg - pink; 10.0 mg - yellow
and 20.0 mg – white.
Uses
For the treatment of mild, moderate and severe congestive heart failure
in dogs caused by mitral regurgitation or dilated cardiomyopathy as an
adjunctive therapy with diuretics. For improved exercise tolerance and
increased survival in dogs with mild, moderate and severe heart failure.
Dosage and administration
ENARCARD Tablets for Dogs should be administered orally at a recommended
dose rate of 0.5 mg/kg once daily. Individual dosages should be
administered on the basis of bodyweight using the appropriate tablet or
combination of tablet sizes.
In the absence of a clinical response within 2 weeks following
initiation of therapy with the product, the dose should be increased,
depending on the patient's response, up to a maximum of 0.5 mg/kg
bodyweight administered twice daily. This dose titration may be
performed over a two to four week period, or more rapidly if indicated
by the presence of continuing signs of congestive heart failure. Dogs
should be observed closely for 48 hours following initial dosing or an
increase in dose.
Therapy with diuretics should be initiated at least one day prior to
starting treatment with the product. Evaluation of the patient should
include assessment of renal function prior to initiation of therapy and
for 2 to 7 days after treatment with the product.
Contra-indications, warnings, etc
For animal treatment only.
Renal function impairment in the target species.
Pre-renal azotaemia is usually a result of hypotension induced by
impaired cardio-vascular performance. On occasion substances that
deplete blood volume, such as diuretics, or which vasodilate, such as
angiotensin-converting enzyme (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
azotaemia. Dogs with no detectable renal disease may develop minor and
transient increases in blood urea nitrogen or serum creatinine when the
product is administered concomitantly with a diuretic. Renal function
should be monitored both before and 2 to 7 days after starting the
treatment with the product. The dose of the diuretic and/or the product
should be reduced or their use should be discontinued if signs of
hypotension or azotaemia develop or if the concentrations of blood urea
nitrogen and/or serum creatinine increase significantly over
pre-treatment levels. Periodic monitoring of renal function should be
continued. Should clinical signs of overdosage occur (e.g. azotaemia)
after the dose is increased from once daily to twice daily, the dose
should be decreased to once daily.
Whilst all clinical data were generated in conjunction with frusemide,
the product may be administered to dogs being treated with thiazide
diuretics.
Do not use in any dog that has evidence of cardiac output failure e.g. aortic stenosis.
The product is not recommended for use in pregnant bitches. Safety in breeding dogs has not been established.
Do not use with potassium-sparing diuretics.
The product has been demonstrated to be generally well tolerated. In
clinical studies, the overall incidence of side effects was not
significantly greater with the product than with vehicle tablets. For
the most part side effects have been mild and transient in nature and
have not required discontinuation of therapy. Clinical signs reported
include azotaemia, lethargy, drowsiness, hypotension, disorientation and
incoordination.
ENACARD Tablets for Dogs given at the recommended dose level has been
shown to have an adequate margin of safety in dogs with heart failure.
The safety of the product has been thoroughly investigated in several
animal species including man to assess its general toxicity. Normal dogs
given 15 mg per kg per day for up to one year showed no adverse effects
or changes.
In case of accidental ingestion, seek urgent medical attention showing
the product label to the doctor or nurse. Physicians should contact a
Poison Control Centre for advice concerning cases of human consumption.
Wash hands after use.
Pharmaceutical precautions
Keep out of the reach and sight of children.
Do not store above 25°C, and avoid transient temperatures above 50°C.
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance
with local requirements.
Legal category
POM-V
Packaging Quantities
Cartons containing four blister strips each containing seven tablets.
Further information
None.
Marketing authorisation number
Vm 08327/4194-98.
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