Indications for use
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.
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 insufficienc
Do not use in the case of hypersensitivity to spironolactone or any of the excipients
Special warnings for each target species
Special precautions for use
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 4.3).
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.
A reversible prostatic atrophy is often observed in entire male dogs. Vomiting and diarrhoea may commonly occur.
Use during pregnancy or lactation
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.
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.
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.
Amounts to be administered and administration route
2 mg of spironolactone per kg of body weight once daily, i.e. Tempora 10 mg: 1 tablet per 5 kg of body weight, Tempora 50 mg: 1 tablet per 25 kg of body weight, Tempora 100 mg: 1 tablet per 50 kg of body weight, by oral route. The product should be administered with meal.
The tablets are flavoured. If the dog does not accept the tablet from hand or bowl, then the tablets may be mixed with a small amount of food offered prior to the main meal, or administered directly into the mouth after feeding.
After administration of up to 5 times the recommended dose (10 mg/kg) to healthy dogs, dose-dependent adverse effects were noted, see section 4.6.
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.