Cardalis Chewable Tablets

Description

Cardalis is an FDA-approved prescription cardiac medication for dogs containing spironolactone and benazepril hydrochloride in a fixed 8:1 ratio.

Cardalis is indicated with concurrent therapy, such as furosemide, for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI).

Cardalis administration should begin after pulmonary edema has been stabilized. The medication is given orally once daily with food according to the dog's body weight and veterinarian directions.

Uses & Benefits

• Manages clinical signs of mild, moderate, or severe congestive heart failure due to AVVI
• FDA approved specifically for use in dogs
• Combines two cardiac medications in one chewable tablet
• Contains spironolactone and benazepril hydrochloride in a fixed 8:1 ratio
• Designed for use with appropriate concurrent heart failure therapy
• Scored tablets allow dosing to the nearest half tablet
• Flavored chewable formulation for oral administration
• Administered once daily with food

How It Works

Cardalis combines spironolactone and benazepril hydrochloride, which act at different points within the renin angiotensin aldosterone system (RAAS).

Spironolactone and its active metabolites act as aldosterone antagonists by binding to mineralocorticoid receptors.

Benazepril hydrochloride is converted in the body to benazeprilat, an angiotensin converting enzyme (ACE) inhibitor. Benazeprilat inhibits ACE, reducing the conversion of angiotensin I to angiotensin II.

The combination provides complementary activity within the RAAS as part of veterinarian-directed management of congestive heart failure due to AVVI.

Indications

Cardalis is indicated with concurrent therapy, such as furosemide, for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI).

Cardalis is only for use in dogs with clinical evidence of heart failure.

Ingredients

Active Ingredients:

Spironolactone
Benazepril hydrochloride

The active ingredients are provided in a fixed 8:1 ratio of spironolactone to benazepril hydrochloride.

Available tablet formulations provide:

• 20 mg spironolactone / 2.5 mg benazepril hydrochloride
• 40 mg spironolactone / 5 mg benazepril hydrochloride
• 80 mg spironolactone / 10 mg benazepril hydrochloride

Inactive Ingredients:

Refer to the manufacturer label for complete inactive ingredient information.

Directions

Cardalis administration should begin after pulmonary edema has been stabilized.

Administer Cardalis orally once daily with food.

The recommended dosage is:

• Spironolactone: 0.9 mg/lb (2 mg/kg)
• Benazepril hydrochloride: 0.11 mg/lb (0.25 mg/kg)

The appropriate dose is determined according to the dog's body weight using a suitable combination of whole and/or half tablets.

All tablet strengths are scored. The calculated dose should be rounded to the nearest half tablet increment.

Administer Cardalis consistently with food because food affects the absorption of spironolactone.

Weight / Dosage

The prescribing veterinarian will determine the appropriate tablet strength and number of whole or half tablets according to the dog's body weight and treatment plan.

Administer exactly as prescribed by your veterinarian. Follow the prescription label exactly and veterinarian directions. Do not adjust the dose, frequency, concurrent medications, or duration of administration unless directed by your veterinarian.

Cautions

• Federal law restricts this drug to use by or on the order of a licensed veterinarian.
• Cardalis is for oral use in dogs only.
• Cardalis is only for use in dogs with clinical evidence of heart failure.
• Do not administer Cardalis with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with renal insufficiency.
• Do not administer to dogs with hypoadrenocorticism, also known as Addison's disease.
• Do not administer to dogs with hyperkalemia.
• Do not administer to dogs with hyponatremia.
• Do not administer to animals with known hypersensitivity to ACE inhibitors or spironolactone.
• Keep securely out of reach of children, dogs, cats, and other animals to prevent accidental ingestion or overdose.
• Not for use in humans. Consult a physician in case of accidental human ingestion.

Possible Side Effects

Adverse reactions observed in clinical evaluation of Cardalis included:

• Decreased appetite or anorexia / Vomiting / Lethargy / Diarrhea / Renal insufficiency / Collapse / Hepatopathy / Urinary incontinence

Other adverse events reported in fewer than 5% of study animals included urine abnormalities, abdominal fluid accumulation, ataxia, weight loss, digestive tract disorders, hypertension, electrolyte disorders, bronchitis, and hyperactivity.

Renal insufficiency was reported more frequently in dogs receiving Cardalis during the clinical study, although concurrent furosemide administration may also have contributed.

Cardalis may increase serum potassium and magnesium concentrations due to the potassium-sparing properties of spironolactone.

Contact your veterinarian if your dog experiences a severe, persistent, or concerning reaction while receiving Cardalis.

Precautions

Renal function and serum potassium levels should be evaluated before beginning treatment with Cardalis. Regular monitoring of renal function and serum potassium is recommended during treatment because of the potential for hyperkalemia.

The safety and effectiveness of concurrent treatment with Cardalis and pimobendan have not been evaluated.

Dogs receiving Cardalis together with NSAIDs should be adequately hydrated to help avoid renal toxicity.

Concomitant use of desoxycorticosterone pivalate (DOCP) with spironolactone may counter the effect of DOCP because the medications have opposing effects on potassium regulation.

Dogs receiving digoxin and spironolactone should be closely monitored. Spironolactone can decrease digoxin elimination and increase plasma digoxin concentrations, which may increase the risk of digoxin toxicity.

Spironolactone and benazepril hydrochloride undergo extensive hepatic biotransformation. Use with appropriate veterinary supervision in dogs with hepatic dysfunction.

The safety of Cardalis has not been evaluated in growing dogs. Spironolactone has antiandrogenic activity and should be used with caution in growing dogs.

The safety of Cardalis has not been established in pregnant, lactating, or breeding dogs.

Storage

Store Cardalis at controlled room temperature of 20°C to 25°C (68°F to 77°F) in the original container. Temperature excursions are permitted between 15°C and 30°C (59°F and 86°F). Keep securely stored out of reach of children and animals.

Disposal

Dispose of unused or expired Cardalis tablets and packaging according to applicable local requirements. Keep discarded medication securely out of reach of children and animals.