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Ceva Animal Health has launched an improved spironolactone treatment for congestive heart failure caused by degenerative mitral valve disease in dogs.
Prilactone Next is replacing spironolactone products Prilactone and Tempora, which will be discontinued.
Prilactone is used to prolong the life of dogs with congestive heart failure. It acts to reduce the formation of fibrous tissue in the heart muscle. It is usually given alongside other medication to improve the quality of life and reduce the symptoms of heart trouble, such as coughing and reduced ability to take exercise. A significant extension to good quality life has been shown to occur in dogs treated with Prilactone, available with prescription.
Prilactone is not associated with any particular side effects in most animals.
It is not suitable for treatment of young growing dogs, or pregnant or lactating bitches.
Shrinkage of the prostate gland can occur in adult males, but is not usually of clinical significance.
Available as three different strengths (10, 40 and 80 mg).
Prilactone® 10 mg Tablets for dogs contains 10 mg spironolactone
Prilactone® 40 mg Tablets for dogs contains 40 mg spironolactone.
Prilactone® 80 mg Tablets for dogs contains 80 mg spironolactone.
For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
For oral administration.
2 mg of spironolactone per kg of bodyweight once a day. The product should be administered with food.
Dosage Guide: Prilactone tablets for dogs
Number of tablets
Body weight (kg)
1 to 2.5
2.5 to 5
5 to 10
10 to 15
15 to 20
20 to 30
30 to 40
40 to 50
50 to 60
Do not use in animals used for, or intended for use in breeding.
Do not use the product in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency.
Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and ACE inhibitors. Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this combination. However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia.
Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated. Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy.
As spironolactone has an antiandrogenic effect, it is not recommended to administer the product to growing dogs.
As spironolactone undergoes extensive hepatic biotransformation, care should be taken when using the product to treat dogs with hepatic dysfunction.
May cause skin sensitisation: persons known to be allergic to spironolactone should not handle the product. Wash hands after use. In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
A reversible prostatic atrophy is often observed in entire male dogs.
Do not use during pregnancy and lactation, laboratory studies in species (rat, mouse, rabbit and monkey) have shown evidence of developmental toxicity.
In clinical studies, Prilactone® was co-administered with furosemide and pimobendan without evidence of associated adverse reactions.
Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration. As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.
The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc.) may potentially lead to hyperkalaemia.
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.
After administration of up to 10 times the recommended dose (20 mg/kg) to healthy dogs, dose-dependent adverse effects were noted (see adverse reactions).
In case of an accidental massive ingestion by a dog, there is no specific antidote or treatment. It is therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and monitor electrolytes. Symptomatic treatment, e.g., fluid therapy, should be provided.
Keep out of reach and sight of children. For animal treatment only.
This veterinary medicinal product does not require any special storage conditions. Partially used tablets should be stored in the original blister pack.
Any unused product or waste materials should be disposed of in accordance with local requirements.
Box containing 3 blisters of 10 tablets
Box containing 18 blisters of 10 tablets
Not all pack sizes may be marketed
Spironolactone and its active metabolites (including 7a-thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone, and exert their effects by binding competitively to the mineralocorticoid receptor located in the kidneys, heart and blood vessels.
Spironolactone is a natriuretic drug (historically described as a soft diuretic). In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and subsequently water excretion, and potassium retention.
The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and consequently in a decrease of cardiac preload and left atrial pressure. The result is an improvement in heart function.
In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone. Although the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction.
In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with chronic heart failure.
In a clinical study investigating the survival time in dogs with congestive heart failure, there was a 65% reduction in the relative risk of mortality at 15 months in dogs treated with spironolactone in combination with standard therapy compared to dogs treated with standard therapy alone (mortality was classified as death or euthanasia due to heart failure).
When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “aldosterone escape”.
A slight increase in aldosterone blood levels may be observed in animals on treatment. This is thought to be due to activation of feedback mechanisms and is without adverse clinical consequence. There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates
Prilactone® 10 mg tablets for dogs 30 tablets - EU/2/07/074/001.
Prilactone® 10 mg tablets for dogs 180 tablets - EU/2/07/074/002
Prilactone® 40 mg tablets for dogs 30 tablets - EU/2/07/074/003
Prilactone® 40 mg tablets for dogs 180 tablets - EU/2/07/074/004
Prilactone® 80 mg tablets for dogs 30 tablets - EU/2/07/074/005
Prilactone® 80 mg tablets for dogs 180 tablets - EU/2/07/074/006
All prices include VAT where applicable.
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