Cardalis 80mg/10mg Chew Tablet

DESCRIPTION:

CARDALIS-spironolactone and benazepril hydrochloride chewable tablets

CARDALIS is indicated with concurrent therapy (e.g. furosemide, etc.) for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI). CARDALIS™ (spironolactone and benazepril hydrochloride chewable tablets) for dogs contains two active ingredients, spironolactone and benazepril hydrochloride, in a fixed ratio of 8:1 respectively.

DOSAGE AND ADMINISTRATION:

Always follow the directions provided by your veterinarian. Cardalis administration should begin after pulmonary edema is stabilized. CARDALIS should be administered orally once daily at a dose of 0.9 mg/lb (2 mg/kg) spironolactone and 0.11 mg/lb (0.25 mg/kg) benazepril hydrochloride, according to dog body weight using a suitable combination of whole and/or half tablets. All tablet strengths are scored and the calculated dosage according to dog’s weight should be to the nearest half-tablet increment. CARDALIS should be administered with food.

PRECAUTIONS:

The safety and effectiveness of concurrent therapy of CARDALIS with pimobendan has not been evaluated. Renal function and serum potassium levels should be evaluated prior to initiating treatment with CARDALIS. Regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalemia. Dogs undergoing combined treatment with CARDALIS and NSAIDs should be adequately hydrated to avoid renal toxicity. Concomitant use of desoxycorticosterone pivalate (DOCP) with spironolactone may counter the effect of DOCP as DOCP has an opposing mechanism of action to potassium-sparing diuretics like spironolactone. Closely monitor dogs receiving digoxin and spironolactone. Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration. This may result in digoxin toxicity. Spironolactone and benazepril hydrochloride undergo extensive hepatic biotransformation. Care should be taken when using CARDALIS in dogs with hepatic dysfunction. The safety of CARDALIS has not been evaluated in growing dogs. Spironolactone has an antiandrogenic effect and should be used with caution in growing dogs. The safety of CARDALIS has not been established in pregnant, lactating or breeding dogs.

SIDE EFFECTS

A U.S. clinical field study comprised of a 360-day treatment period evaluated the safety and effectiveness of CARDALIS compared to benazepril hydrochloride in 569 client-owned dogs with left-sided AVVI. Table 1 summarizes the adverse reactions not directly related to the progression of disease that occurred in greater than 5% of the dogs treated with CARDALIS. The following adverse events were seen in fewer than 5% of the study animals, in decreasing order: urine abnormalities, fluid in abdomen, ataxia, weight loss, digestive tract disorder, hypertension, electrolyte disorder, bronchitis, and hyperactivity. Renal insufficiency was reported more frequently in dogs treated with CARDALIS. This finding may be also attributed to the concurrent administration of furosemide. The clinical pathology parameters associated with renal function were not statistically dierent between the treatment groups. The incidence of death, including euthanasia and sudden death, was similar in dogs treated with CARDALIS or benazepril hydrochloride. In most cases, death was attributable to the progression of heart disease or the clinical signs associated with congestive heart failure. Deaths of unknown cause were presumed to be cardiac in nature. Serum magnesium and potassium values were significantly higher in the CARDALIS group, although the mean values remained within the reference range and did not change significantly over time. These electrolyte changes are consistent with the potassium-sparing properties of spironolactone. One dog treated with CARDALIS was removed from the study at Day 7 because it developed hyperkalemia.

STORAGE

Store at controlled room temperature, 20° to 25°C (68° to 77°F), in original container. Excursions permitted between 15°C and 30°C (between 59° and 86°F)

WARNINGS:

Not for use in humans. Keep out of reach of children. In case of accidental ingestion, seek medical advice. The following side effects have been infrequently reported: Lethargy, Drooling, Decreased appetite, Drowsiness, and Diarrhea. Additional Post-Approval adverse events have been reported and include, in decreasing order, of frequency: depression, hypersalivation, vomiting, trembling, ataxia, allergic reactions, weight loss, convulsion, hyperactivity, and panting. If your dog exhibits any of these reactions or any other suspected adverse events, contact your veterinarian.