Prilium Powder for Oral Solution for Dogs.
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.
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.
Laboratory studies in rats and rabbits did not produce any evidence of teratogenic, embryotoxic or maternotoxic effects, or effects on reproductive performances, when imidapril was administered at the therapeutic dose.
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.
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.
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.
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.
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