Prilactone Next Tablets are indicated for use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by degenerative mitral valve disease in dogs.
Prilactone Next 10mg Tablets are presented as oblong shaped beige tablets that can be divided into two equal parts. Prilactone Next 50mg and 100mg Tablets are presented as clover shaped beige tablets that can be divided into two or four equal parts.
Do not use in animals used for or intended for use in breeding.
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency.
Do not use in cases of hypersensitivity to spironolactone or any of the excipients.
See use during pregnancy, lactation or lay.
Special warnings for each target species
Special precautions for use in animals
Kidney function and plasma 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 plasma 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 (see Contraindications).
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.
The chewable tablets are flavoured. In order to avoid accidental ingestion, store these tablets out of the reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The product may cause skin sensitization. Persons known to be allergic to spironolactone or other components of the final formulation should not handle this product.
Handle this product with great care to avoid unnecessary exposure, taking all recommended precautions.
Wash hands after use.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
A reversible prostatic atrophy is often observed in entire male dogs. Vomiting and diarrhoea may commonly occur.
Use during pregnancy, lactation or lay
Spironolactone had developmental toxicity in laboratory animals.
The safety of the product has not been assessed in pregnant and lactating bitches.
Do not use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
In clinical studies, the product was co-administered with ACE-inhibitors, 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 (see special precautions for use in animals).
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of up to 5 times the recommended dose (10 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.