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 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. After administration of up to 10 times the recommended dose (20 mg/kg) to healthy dogs, dose-dependent adverse effects were noted, see section 4.6. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”Store partially used tablets in the original blister pack.
The benefit-risk balance may be found in module 6 of this EPAR.The European Commission granted a marketing authorisation valid throughout the European Union for PRILACTONE to CEVA SANTE ANIMALE on 20 June 2007. Prilactone Next is for use in dogs to manage and treat Congestive Heart Failure. Do not use during pregnancy and lactation because developmental toxicity has been observed in In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration.
(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. Dizziness 3. The mean residence time of the metabolites ranges from 9 to 14 hours and they are preferentially distributed to the gastro-intestinal tract, kidney, liver and adrenal glands. However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated. Following oral administration of 2 to 4 mg/kg, absorption increases linearly over the range.
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION Veterinary medicinal product subject to prescription. This is thought to be due to activation of feedback mechanisms without adverse clinical consequence. As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both 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. Spironolactone is mainly excreted via its metabolites. Although the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction. Symptomatic treatment, e.g., fluid therapy, should be provided. Unlike in humans, an increased incidence of hyperkalaemia (raised blood potassium levels) was not observed in studies in dogs with this combination. As a result, blood can accumulate in the veins and fluid can leak out into the tissues, leading to the heart being unable to deliver oxygen-rich blood to the body adequately.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE Ask your veterinary surgeon how to dispose of medicines no longer required. PRILACTONE 40 mg: White, with a slight brownish mottling, oval tablet of 17 mm length with three PRILACTONE 80 mg: White, with a slight brownish mottling, oval tablet of 20 mm length with three 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. Do not use in animals used for, or intended for use in breeding. Hallucinations 4. The product should be administered with food. For the same reasons, PRILACTONE tablets should not be used in growing dogs. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR 11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR 11. As spironolactone is broken down in the liver, the tablets should be used with caution in dogs with liver disease.PRILACTONE tablets should not be used in dogs used for, or intended for use in breeding, as it has been demonstrated that spironolactone might cause harm to newborn or young laboratory animals.
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