Spironolactone and benazeprilat

Indications

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).

Dosage and Administration

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.

Contraindications

Do not administer CARDALIS in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with renal insufficiency. Do not administer CARDALIS to dogs with hypoadrenocorticism (Addison’s Disease), hyperkalemia, or hyponatremia. Do not administer CARDALIS to animals with known hypersensitivity to ACE inhibitors or spironolactone.

Warnings

Keep CARDALIS in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. In case of accidental overdose, induce vomiting, lavage the stomach (depending on risk assessment), and monitor electrolytes. Symptomatic therapy (e.g. fluid therapy) should be provided as medically necessary. CARDALIS is only for use in dogs with clinical evidence of heart failure. Human Warnings: Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of ingestion by humans.

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.

Adverse Reactions

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 different 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. Contact Information: To report suspected adverse events or to request a copy of the Safety Data Sheet (SDS), please call Ceva Animal Health at 1-800-999-0297. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae. Table 1 - Adverse Reactions

Description

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. CARDALIS is supplied as oblong half scored flavored chewable tablets in three sizes: 20 mg spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone and 5 mg benazepril hydrochloride, and 80 mg spironolactone and 10 mg benazepril hydrochloride. Benazepril belongs to the angiotensin-converting enzyme (ACE) inhibitor class of drugs. Benazepril hydrochloride empirical formula is C 24 H 28 N 2 O 5 · HCl and the molecular weight is 460.95. The chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benazepine-1-acetic acid monohydrochloride and the structural formula is shown below: Spironolactone, and its active metabolites, act as specific aldosterone antagonists. Spironolactone empirical formula is C 24 H 32 O 4 S and the molecular weight is 416.57. The chemical name is 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid y-lactone acetate and the structural formula is shown below: Benazepril Chemical Structure Spiromolactone Chemical Structure

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).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming spironolactone and benazeprilat as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.