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Date: Thursday, May 19, 2022 2:52

Release 2.43
Enacard Tablets for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations
Active ingredient: Enalapril Maleate
Product:Enacard Tablets for Dogs
Product index: Enacard
Qualitative and quantitative composition
Active substance: Enalapril maleate.
Pharmaceutical form
Round, non-scored, biconvex, uncoated tablets. Colour coded according to dosage strength; 1 mg - green; 2.5 mg - blue; 5 mg - pink; 10 mg - yellow and 20 mg – white.
Clinical particulars
Target species
Dogs.
Indications for use
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.
Contra-indications
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.
Special warnings for each target species
See other sections.
Special precautions for use in animals
None known but see other sections.
Special precautions to be taken by the person administering the product
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.
Adverse reactions
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, dizziness, drowsiness, hypotension, disorientation and incoordination.
Use during pregnancy, lactation or lay
The product is not recommended for use in pregnant bitches. Safety in breeding dogs has not been established.
Interactions
Whilst all clinical data were generated in conjunction with furosemide, the product may be administered to dogs being treated with thiazide diuretics. Do not use the product with potassium-sparing diuretics.
Amounts to be administered and administration route
The product 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(s) 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.
Renal function impairment in the target species
Pre-renal azotemia 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 azotemia.
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 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 azotemia 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. azotemia) after the dose is increased from once daily to twice daily, the dose should be decreased to once daily.
Overdose
The product at the recommended dose level has been shown to have an adequate margin of safety in dogs with heart failure. Normal dogs given 15 mg/kg/day for up to one year showed no adverse effects or changes.
Pharmacological particulars
Enacard is the maleate salt of enalapril, a derivative of two amino acids, L-alanine and L-proline. Enalapril is the ethyl ester of the parent diacid, enalaprilat. Following oral administration, enalapril is readily absorbed and then hydrolysed to enalaprilat, which is a highly specific, long-acting, non-sulphydryl angiotensin converting enzyme (ACE) inhibitor.  
ATCvet code: QC09AA02
Pharmaceutical particulars
Excipients
Lactose monohydrate, Sodium bicarbonate, Maize starch, Pregelatinised maize starch, Magnesium stearate, Ferric oxide yellow (E172) (1 mg and 10 mg only), Indigo aluminium lake (E132) (1 mg and 2.5 mg only), Ferric oxide red (E172) (5mg only).
Major incompatibilities
No major incompatibility has been identified.
Shelf life
3 years.
Special precautions for storage
Do not store above 25 °C. Avoid transient temperatures above 50 °C.
Immediate packaging
The tablets are presented in an aluminium blister containing seven tablets, in cartons of four blisters.
Disposal
Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/4194-98
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Enacard Tablets for Dogs 1 mg
GTIN:3661103025993
GTIN description:Enacard Tablets for Dogs 2.5 mg
GTIN:3661103026105
GTIN description:Enacard Tablets for Dogs 5 mg
GTIN:3661103026228
GTIN description:Enacard Tablets for Dogs 10 mg
GTIN:3661103026341
GTIN description:Enacard Tablets for Dogs 20 mg
GTIN:3661103026457