Cardalis

Quick links to important sections

Cardalis

Method of action: Antihypertensive

Treatment option:

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cardalis

What is Cardalis? Overview

Property Description
Active ingredients Benazepril hydrochloride, Spironolactone
Form Chewable tablets (oral administration)
Pharmacological class Combined Cardiovascular Agent (ACE inhibitor + MRA)
Target Species Canine patients (dogs)
Origin Synthetic fixed-dose combination

The Definitional Identity of Cardalis (Composition and Type)

Cardalis is a veterinary prescription drug formulated as a fixed-dose combination of two distinct, synthetic active compounds: Benazepril hydrochloride and Spironolactone. This product is administered via the oral route in the form of palatable chewable tablets specifically developed for canine patients. Cardalis is clinically recognized for its fixed ratio of Spironolactone to Benazepril, which ensures a consistent, simultaneous delivery of two complementary therapeutic actions. This integration streamlines the complex, long-term management required for the target patient group.

Pharmacological Classification and General Therapeutic Role

The medicine is classified as a combined cardiovascular agent within the broader category of antihypertensive agents, utilizing a dual mechanism to support heart function. It contains Benazepril, which functions as an Angiotensin-Converting Enzyme (ACE) inhibitor, and Spironolactone, which is a mineralocorticoid receptor antagonist (MRA). The association of these two agents is pharmacologically beneficial because both act on different points of the Renin-Angiotensin-Aldosterone System (RAAS), resulting in a more complete suppression of the damaging hormonal cascade. Research has consistently demonstrated that this combined action provides integrated circulatory support by addressing both blood vessel resistance and the hormone-driven damage to cardiac tissue.

Distinguishing Features and Target Audience

The most critical distinguishing feature of Cardalis is the delivery of the ACE inhibitor and the MRA together, which achieves a broad-spectrum neurohormonal blockade that is superior to using an ACE inhibitor alone. This specific combination is approved for use in canine patients. Developed exclusively for this target audience, the chewable tablet format, often featuring a palatable flavor, is designed to maximize patient adherence, which is essential for the consistent, successful management of chronic conditions.

Regulatory References

  1. Cardalis FOI Summary (NADA 141-538)

What side effects are possible with Cardalis?

Possible Side Effects and Safety Information

The regulatory safety profile for Cardalis is characterized by documented adverse reactions, frequency classifications, and specified constraints, as outlined in official prescribing information from government authorities.


Adverse Reaction Scope

Adverse events are primarily grouped under Gastrointestinal Disorders, Nervous System Disorders, and Renal and Urinary Disorders.

Classification Examples of Documented Adverse Reactions
Common Vomiting, Diarrhea, Anorexia, Lethargy, and Renal Insufficiency (Azotemia)
Very Rarely Reported Pruritus, Ataxia (Incoordination), and Fatigue

Serious Adverse Reactions: Acute Renal Failure (Azotemia) is documented as a clinically significant concern. Reactions related to renal function, such as elevated blood urea nitrogen (BUN) or creatinine, may be observed more frequently at the start of therapy or during dose escalation.


Safety Constraints and Special Populations

Specific safety limitations are defined in the regulatory documents:

  • Contraindications: The product is strictly contraindicated in patients with Hypoadrenocorticism (Addison's Disease), Hyperkalemia (high potassium levels), or Hyponatremia (low sodium levels). It is also contraindicated during Pregnancy and Lactation.
  • Caution: Use requires caution in patients with pre-existing Hepatic Dysfunction or Renal Impairment. The combination may also cause changes in electrolyte status (specifically increased serum potassium).
  • Monitoring: Regulatory safety notes recommend regular monitoring of renal function and serum potassium levels during treatment, particularly in dogs with pre-existing renal issues.

Overdose and Emergency Response

Overdose Manifestations and Required Actions

The official regulatory profile for Cardalis overdose is based strictly on documented clinical and physiological findings from dose-escalation studies. Documented manifestations observed in the target species at elevated doses include gastrointestinal effects such as vomiting and diarrhoea, alongside systemic signs like lethargy, fatigue, and ataxia (incoordination). Physiological findings include a slight, dose-related decrease in red cell mass and specific hypertrophy of the adrenal glands.

Emergency Response and Management

Regulatory documentation explicitly states that no specific antidote or treatment is known for Cardalis overdose. Therefore, management must consist entirely of symptomatic treatment and supportive care. Procedures to reduce absorption, such as induced vomiting and gastric lavage, are recommended in canine overdose situations based on risk assessment.

Required monitoring centers on potential serious outcomes, including transient hypotension and the risk of severe electrolyte disorder; mandatory monitoring of electrolytes and renal function is required following initial intervention.

When to Seek Urgent Help

Immediate emergency actions are mandated for two distinct scenarios. For a suspected canine overdose, emergency services must be contacted immediately to facilitate the necessary management procedures. In the event of accidental human ingestion, it is required that medical advice be sought immediately, and the product label must be presented to the physician, as this exposure may present symptoms such as drowsiness, nausea, and skin rashes.

Therapeutic Uses of Cardalis

What Cardalis Treats: Main Uses and Benefits

Cardalis is considered relevant in the management of clinical signs of congestive heart failure (CHF) in dogs due to atrioventricular valvular insufficiency (AVVI). This medication is primarily used as a supportive component in the long-term care of chronic degenerative valvular disease in older dogs. The therapeutic application focuses on addressing the symptoms related to systemic imbalance and **heightened physiological stress.

The primary therapeutic use is to help manage a cluster of symptoms including coughing, labored breathing (dyspnea), and exercise intolerance. These are symptoms that interfere with daily functioning. The medication is commonly used when symptoms intensify, providing support that helps ease the overall symptom burden during symptomatic phases.

This application assists with maintaining functional stability and contributes to easing the overall symptom load, supporting patients during difficult episodes of heightened discomfort.


Quick Fact: Relief for Respiratory Distress and Fatigue The medication is relevant for easing symptoms like coughing and labored breathing related to fluid buildup, and for managing exercise intolerance that creates noticeable physiological strain.

Regulatory References

  1. DailyMed drug label for Cardalis

Eligibility and Restrictions for Use

Who Can and Cannot Use Cardalis?

Eligibility for Cardalis is strictly defined by regulatory documents, confining its use to canine patients (dogs) diagnosed with congestive heart failure due to chronic degenerative valvular disease (Atrioventricular Valvular Insufficiency - AVVI). The official labeling contains multiple absolute contraindications and restrictions that define who must not use the medicine.


Contraindicated Populations and Conditions

Official regulatory documents prohibit the use of Cardalis in the following groups:

  • Dogs with hypersensitivity to Benazepril, Spironolactone, or excipients.
  • Dogs with hypoadrenocorticism (Addison's Disease).
  • Dogs with severe electrolyte imbalances (hyperkalaemia or hyponatraemia).
  • Dogs with cardiac output failure caused by structural obstructions like aortic or pulmonary stenosis.
  • Dogs that are pregnant, lactating, or intended for breeding.

Restricted and Conditional Use

Growing dogs are not recommended to use the medicine. Additionally, use requires caution in dogs with hepatic dysfunction (liver impairment). Dogs with renal impairment are eligible only with regular monitoring of kidney function and serum potassium. The product is also restricted from concurrent use with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in dogs with renal insufficiency.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Cardalis documents specific constraints based on the potential for drug-drug interactions, primarily linked to its Spironolactone component. This interaction structure is defined by both pharmacokinetic and pharmacodynamic concerns established in government labeling.

Interaction Classification Interacting Entity / Category Official Statement Summary
Contraindicated Combination Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Co-administration is strictly prohibited in patients with renal insufficiency
Pharmacodynamic Risk Potassium-Sparing Agents (e.g., beta-blockers, ARBs) Concomitant use may lead to additive hyperkalaemia (elevated serum potassium levels) and hypotensive effects
Pharmacokinetic Effect Digoxin Spironolactone is documented to decrease Digoxin elimination, resulting in raised digoxin plasma concentration

The Spironolactone component may also cause both induction and inhibition of cytochrome P450 enzymes, potentially affecting the metabolism of a variety of co-administered substances. Concomitant use of NSAIDs may additionally reduce the anti-hypertensive and natriuretic effects of the drug. Caution is noted for specific patient populations: those with hepatic dysfunction due to the extensive biotransformation of Spironolactone, and those with renal impairment who carry an increased risk of hyperkalaemia during combined treatment. Furthermore, the drug must be administered with food to ensure consistent bioavailability of spironolactone metabolites.

Mechanism of Action

Pharmacodynamic Mechanism: How Cardalis Works

Cardalis modulates the Renin-Angiotensin-Aldosterone System (RAAS) by intervening at two sequential points. The active metabolite of Benazepril acts as a competitive inhibitor of the Angiotensin-Converting Enzyme (ACE), reducing the conversion of Angiotensin I to Angiotensin II. Concurrently, Spironolactone acts as a competitive antagonist of the Mineralocorticoid Receptor (MR). This dual blockade ensures comprehensive pathway modulation.

The reduction in Angiotensin II activity initiates mechanisms that influence vascular tone, leading to systemic vasodilation and a reduction in vascular resistance. Simultaneously, blocking the MR limits Aldosterone's influence on the kidneys, reducing sodium and water reabsorption and thereby modulating fluid-electrolyte balance and circulating volume. Furthermore, the anti-aldosterone mechanism contributes to the attenuation of hormone-induced fibrosis and adverse structural changes in cardiovascular tissues. These actions collectively establish a modified, lower-resistance state within the circulatory system.

Dosage and Administration Information

How to Use Cardalis

Cardalis is administered according to a specific, fixed-dose regimen for the long-term management of clinical signs related to congestive heart failure. The usage pattern is strictly based on the patient's body weight to ensure delivery of both active ingredients—Spironolactone and Benazepril hydrochloride—at a fixed, simultaneous ratio.


Official Administration Guidelines

Category Administration Instruction
Route of Administration Oral use, administered as a chewable tablet
Dosing Schedule Once daily (q24h), based on body weight
Target Dose Spironolactone at 2 mg per kilogram (mg/kg) body weight and Benazepril HCl at 0.25 mg/kg body weight
Timing & Preparation Must be administered with food (either mixed with a small amount of food or with the main meal). The scored tablets are divisible, allowing for the dose to be rounded to the nearest half-tablet increment

Procedural Context and Constraints

The usage of Cardalis is structurally defined by the constraint that it is a fixed-dose combination product, intended only for patients who require both agents at the mandated 8:1 ratio. The administration is intended for chronic, long-term use, and official instructions specify that administration should begin after pulmonary edema is stabilized.

Furthermore, official documentation defines certain usage constraints regarding patient population: the safety of the product has not been established in pregnant, lactating, or breeding canines, and it should not be administered to growing dogs.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cardalis

The research for Cardalis, which is a fixed-dose combination of benazepril and spironolactone, was evaluated in studies exploring long-term outcomes in cardiovascular conditions. Regulatory bodies reviewed evidence primarily from large-scale, controlled field studies, which also included pharmacodynamic research.


Evidence for Use in Managing Congestive Heart Failure (CHF)

The primary body of evidence describes research that explored the management of clinical signs of congestive heart failure due to Atrioventricular Valvular Insufficiency (AVVI). This condition's manifestations are outcomes related to systemic or functional imbalance.

  • What researchers studied: The core evidence was derived from a large-scale, long-term randomized controlled trial (RCT) that specifically explored the combination drug. The study designs utilized an active-controlled approach, meaning the combination drug was observed alongside the ACE inhibitor component (Benazepril) alone in separate patient groups. All patients in the pivotal trial received concurrent background therapy, specifically the diuretic Furosemide, throughout the trial period.
  • What the studies reported (Neutral Summary): Studies monitored several outcomes, with a key focus on a composite endpoint of treatment failure. This endpoint included the occurrence of cardiac-related death or euthanasia and documentation of heart failure worsening. Findings describe patterns observed in the studies concerning the measured survival time and the rates at which patients reached this composite endpoint. Trials also reported how symptoms evolved in the observed populations, and data show patterns related to how certain physiological markers shifted during the study period.

Research Gaps and Areas of Uncertainty

A review of the evidence highlights certain areas where the scientific picture is less clear, reflecting the inherent limitations of any clinical research.

  • Unstudied Concurrency: The clinical research on this combination has not evaluated use with Pimobendan, another cardiovascular medication. Since that specific therapeutic combination was excluded from the main trial, the evidence is limited regarding this potential use scenario.
  • Subgroup Limitations: Data for certain groups remain insufficient. The research evaluating this combination has not included certain specific subgroups, including growing dogs or those used for breeding, such as pregnant or lactating patients.

Frequently Asked Questions (FAQ)

Common questions about Cardalis (FAQ)

Q: How quickly does Cardalis start working?

Official product information on how the drug is processed in the body shows that the active components are absorbed quickly. Pharmacological data indicate that peak concentrations of the active metabolites are measurable within a few hours. The effect that inhibits the angiotensin-converting enzyme (ACE) is designed to persist for 24 hours.

Q: What happens if I miss a dose of Cardalis?

The official guidance for a missed dose recommends administration as soon as it is remembered. However, if it is almost time for the next scheduled dose, it is recommended to skip the missed dose and resume the regular schedule. Two doses should not be given at the same time.

Q: Is Cardalis known to cause a dry cough?

Based on the documented adverse event reports in the official safety profile for this product, a dry cough is not listed as an observed or reported side effect.

Q: Does Cardalis interact with supplements or herbal products?

Regulatory documents state that one of the drug's components, spironolactone, has the capacity to both increase and decrease the activity of cytochrome P450 enzymes. These enzymes are responsible for processing many different substances in the body. This mechanism indicates a potential for the metabolism of other co-administered substances, including supplements, to be affected.

Q: Can I stop taking Cardalis if I feel better?

Official context indicates that this product is intended for chronic, long-term management of the treated condition. The product label states that any decisions regarding the length or cessation of treatment should be made in consultation with a prescribing professional.

Q: What should I do if I accidentally take too much Cardalis?

Official regulatory warnings advise that in the event of an accidental overdose, professional attention is required. The clinical response described in official warnings includes monitoring electrolyte levels, and may require interventions such as inducing vomiting or providing symptomatic therapy under professional care.

Q: Does Cardalis cause weight gain?

Weight gain is not listed as a documented adverse reaction in the official safety data. Clinical studies have reported weight loss as an adverse reaction observed in a small percentage (less than 5%) of study animals.

Q: Does Cardalis work by thinning the blood?

The mechanism of action described in official documents involves modulating the body's Renin-Angiotensin-Aldosterone System (RAAS). This action promotes the widening of blood vessels (vasodilation) and better fluid balance. It does not work by affecting blood coagulation or thinning the blood.

Q: Does Cardalis affect blood sugar levels?

Official precautions note that caution should be used when the drug is administered to patients who have uncontrolled conditions where blood sugar can be out of balance. This includes specific mention of conditions like diabetes mellitus.

Q: Is it common for Cardalis to cause dizziness?

Dizziness is not explicitly listed as a common side effect in the safety documents. However, official information has very rarely reported adverse reactions such as ataxia, which refers to a loss of coordination, and general signs of fatigue.

How should Cardalis be stored and disposed of?

Storage and Disposal Requirements for Cardalis

Cardalis must be stored at controlled room temperature, specifically between 20^circ to 25 C (68^circ to 77 F), with permitted excursions from 15 C to 30 C. The product must be kept in its original container to maintain integrity.

Stability and Safety

The shelf life is 2 years when packaged for sale. After the bottle is opened, the product has a restricted shelf life of 6 months. The medicine must be kept in a secure location, out of the sight and reach of children and pets, as required by official labeling.

Disposal

Disposal of any unused product or waste material must be carried out in accordance with local requirements. The product should not be disposed of via household wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Cardalis found in:

A-Z Index: