Cibacène

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Medically reviewed

Laura Arias

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 Cibacène

Property Description
Active ingredient Benazepril hydrochloride
Form Oral tablet
Pharmacological class Angiotensin-Converting Enzyme (ACE) inhibitor
Common use Management of systemic vascular pressure
Origin Synthetic (Chemically synthesized)

What Type of Medicine is Cibacène?

Cibacène is a registered trade name for a synthetic, prescription-only medication whose active component is Benazepril hydrochloride. This substance fundamentally belongs to the Angiotensin-Converting Enzyme (ACE) inhibitor pharmacological class, placing it within the broader group of cardiovascular agents. This classification is clinically recognized for its role in modifying the body's Renin-Angiotensin-Aldosterone System (RAAS). The medicine is used in adults requiring systemic support to manage vascular resistance.

Composition and Origin: Benazepril Hydrochloride

Benazepril hydrochloride is supplied as an oral tablet intended for systemic absorption, reflecting its design for chronic management. The molecule is categorized as a prodrug because it is inactive upon ingestion and requires metabolic conversion in the liver into its highly potent form, Benazeprilat, before it can exert its therapeutic effect. This single-ingredient product acts by inhibiting the ACE enzyme, a foundational action in pharmaceutical management.

What is the General Purpose of ACE Inhibition?

The general purpose of this specific pharmacological action is to mitigate systemic vascular resistance and ease the heart's workload. By inhibiting the ACE enzyme, the medication consequently reduces the formation of Angiotensin II, a major hormone that constricts blood vessels. This effect, which promotes vascular relaxation and widening, provides a targeted physiological approach to managing the pressure within the circulatory system.

Regulatory References

  1. Benazepril - StatPearls - NCBI Bookshelf

What side effects are possible with Cibacène?

Possible Side Effects and Safety Information

Adverse reactions associated with Benazepril hydrochloride (Cibacène) are formally categorized by frequency and the body system affected, based on clinical trials and regulatory documents. These classifications define the officially documented risk profile of the medicine.

Adverse Reaction Scope

Classification Affected Systems and Examples
Common (ge 1% incidence) Nervous/Respiratory: Headache, dizziness, fatigue, somnolence, postural dizziness, and the characteristic dry cough.
Uncommon (< 1% incidence) Gastrointestinal: Nausea, vomiting, constipation. Dermatologic/Nervous: Rash, paresthesia.

Serious Adverse Reactions and Restrictions

Regulatory labeling highlights specific severe risks and constraints for Benazepril:

  • Angioedema: A rare but critical swelling of the face, tongue, glottis, or larynx is a serious safety concern that may be life-threatening. Intestinal Angioedema, presenting as abdominal pain, has also been reported.
  • Fetal Toxicity: Use during the second and third trimesters of pregnancy is strictly contraindicated due to the potential for fetal injury and death.
  • Symptomatic Hypotension: A significant drop in systemic pressure is more likely at the initiation of therapy or during dose increases, especially in individuals with volume or salt depletion.
  • Hepatic Failure: Cases progressing from cholestatic jaundice to fulminant hepatic necrosis, sometimes fatal, have been rarely associated with ACE inhibitors.

Population-Specific Constraints

Specific safety considerations are documented for certain patient groups. Individuals with impaired renal function are at an increased risk of hyperkalemia (high potassium levels). Furthermore, studies cited in regulatory documents note a higher incidence of Angioedema in Black patients compared to non-Black patients. The medication is also contraindicated for patients with a history of Angioedema related to any prior ACE inhibitor use.


Regulatory Safety Summary: The official safety documentation establishes a clear profile of potential risks, defining both common occurrences and the severe, low-incidence safety constraints. This structure ensures that information on the drug's safety is consistently organized by frequency, affected body system, and risk to special populations, allowing for a standardized understanding of the officially documented risk profile.

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory overdose profile for Cibacène (Benazepril hydrochloride) focuses strictly on the clinical consequences of excessive pharmacological effect. The most likely and primary documented manifestation of an overdose is severe systemic hypotension (low blood pressure). Other symptoms cited in one overdose case report included nausea, paresthesia (tingling or numbness), and vertigo (dizziness).


Severe Outcomes and Required Emergency Action

Excessive hypotension is officially documented to carry the risk of leading to progressive azotemia and potentially acute renal failure. These serious renal and cardiovascular complications have been rarely associated with death. The official labeling notes that symptomatic hypotension is more likely in patient groups who are volume or salt depleted or who have pre-existing congestive heart failure.

Action Required Official Regulatory Statement
Urgent Assistance You must seek immediate medical attention by calling emergency services or a Poison Control center if too much is used.
Intervention Management is symptomatic and supportive. For marked hypotension, the patient should be placed in the supine position and administered intravenous physiological saline solution. Vasopressors may be considered if needed to maintain systemic blood pressure.
Specific Antidote No specific antidote is known. Hemodialysis is documented as ineffective for removing clinically significant amounts of the active metabolite, Benazeprilat.

Therapeutic Uses of Cibacène

Cibacène may be part of symptomatic management in conditions presenting with systemic or localized discomfort across cardiovascular and renal domains. Its use extends to these therapeutic areas.


Therapeutic Focus and Benefits

The medication is commonly used to help with conditions categorized as chronic high blood pressure (Hypertension) and chronic heart failure, and for supportive management of diabetic kidney disease. Managing these conditions may help ease the physiological strain on the vascular system.

In clinical scenarios, this medicine is applied in addressing symptoms related to systemic imbalance, particularly by helping to manage symptomatic burdens such as shortness of breath and peripheral swelling that can arise from impaired cardiac function. The application may assist with reducing associated risks and contributes to easing the overall symptom load.


Quick Fact: Supportive Management

Cibacène plays a role in managing the risk of associated cardiovascular events by helping to manage pressure. This supports general well-being during symptomatic phases of the heart and kidney function, especially in high-risk patient groups.

Regulatory References

  1. Official regulatory documents

Eligibility and Restrictions for Use

The eligibility for Cibacène (Benazepril hydrochloride) is strictly defined by regulatory documents, particularly concerning absolute contraindications, age, and organ function.

Category Official Regulatory Status
Contraindications Must not be used in patients with a history of angioedema (swelling of the face, throat, etc.) or documented hypersensitivity to any ACE inhibitor.
Pregnancy Status Contraindicated in pregnancy; use during the second and third trimesters is associated with fetal harm and death, and the medicine must be discontinued immediately upon detection of pregnancy.
Drug Combinations Contraindicated in patients with diabetes taking a medicine containing aliskiren. It is also contraindicated within 36 hours of receiving a neprilysin inhibitor (e.g., sacubitril/valsartan).
Age Limitations Use is not recommended in children younger than 6 years of age. Use is approved for children 6 years and older only with adequate renal function.
Condition Restrictions Not recommended for pediatric patients with a Glomerular Filtration Rate (GFR) less than 30 mL/min/1.73m^2. Adults with severe renal impairment require an adjustment to the initial dose.

These official rules establish firm boundaries for safe use and exclude patients with specific pre-existing conditions, concurrent medications, or physiological states.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

The regulatory profile of Cibacène (Benazepril) documents clinically significant interactions primarily across cardiovascular and electrolyte-modifying product categories. Specific interacting agents include Neprilysin Inhibitors, Lithium, Aliskiren, Non-Steroidal Anti-Inflammatory Agents (NSAIDs), and mTOR Inhibitors. The official labeling emphasizes administration constraints related to reinforced pharmacodynamic effects and altered substance clearance.

Interaction Classifications (High-Level)

Interactions are formally classified as Contraindicated for co-administration with Neprilysin Inhibitors due to the risk of angioedema. Dual blockade of the Renin-Angiotensin System (RAS) with agents like Aliskiren is also restricted, specifically in patients with diabetes, where the combination is contraindicated. Other interactions are designated as Clinically Significant, requiring close attention to patient status.

Resulting Interaction Structure

The most stringent constraint is the 36-hour mandatory separation period required when switching between Cibacène and a Neprilysin Inhibitor. Co-administration with Lithium is noted for a pharmacokinetic interaction involving reduced renal clearance, which raises serum Lithium levels and risk of toxicity. Pharmacodynamic risks involve increased hyperkalemia with Potassium-Sparing Diuretics or high-potassium supplements, and excessive hypotension with other diuretics. Furthermore, the combination with NSAIDs is associated with an increased risk of renal function deterioration, particularly in elderly or volume-depleted patients. This interaction structure imposes critical do-not-combine rules and strict timing requirements as defined by regulatory authorities.

Mechanism of Action

Cibacène (cibenzoline succinate) acts as a Class Ia antiarrhythmic agent, exhibiting selective accumulation within cardiac tissue, specifically targeting the cardiac sodium channels (I Na). Its primary interaction is as a state-dependent inhibitor, preferentially binding to and blocking the channel in its inactivated or open state during phase 0 of the cardiac action potential .

This blockade decreases the maximal rate of depolarization (V max) of the action potential, thereby slowing conduction velocity throughout the atrium, ventricle, and His-Purkinje system. Intracellularly, this leads to a reduction in the excitability of the myocardial cells. The drug also demonstrates a secondary, less pronounced potassium channel blocking activity (I K), which prolongs the repolarization phase (phase 3) and increases the effective refractory period (ERP).

This dual electrophysiological modulation—reduced conduction velocity and prolonged refractory period—results in system-level physiological modulation by stabilizing the cardiac membrane and interrupting re-entrant electrical pathways, thereby regulating the cardiac rhythm cycle.

Dosage and Administration Information

Administration of Cibacène

Cibacène is an oral medication that is typically taken once daily. To maintain consistent levels of the medication in the bloodstream, it is recommended to take the tablet at the same time each day.

Method of Intake

The tablets should be swallowed with a sufficient amount of liquid, such as a glass of water. They can be taken regardless of meal times, as food intake does not significantly alter the absorption of the active ingredient. For individuals who have difficulty swallowing, some formulations may be scored to allow the tablet to be broken into equal halves.

Consistency in Routine

Establishing a routine helps in managing the treatment effectively. Most patients find it helpful to take the medication in the morning. If a dose is missed, the regular schedule should be resumed the following day; it is not recommended to alter the subsequent dose to compensate for the one that was missed.

Duration of Use

Management of the conditions for which this medication is prescribed usually requires long-term adherence. The duration of the treatment is determined based on individual health requirements and the clinical response to the therapy. Continuous use as directed is a standard part of managing chronic cardiovascular conditions.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cibacène (Benazepril)

Evidence for use in Chronic High Blood Pressure (Hypertension)

Research exploring Cibacène (Benazepril) for high blood pressure primarily relies on Randomized Controlled Trials (RCTs). These studies were designed to evaluate changes in systemic pressure by monitoring systolic and diastolic blood pressure readings in adults with mild-to-moderate hypertension and those with additional cardiovascular risk factors. The findings from these trials describe patterns related to the measured reduction in both systolic and diastolic BP. Studies also monitored and reported measurements on the long-term risk of major cardiovascular events, such as stroke, with data indicating consistency with the established research patterns for the Angiotensin-Converting Enzyme (ACE inhibitor) drug class.

Evidence for Supportive Management in Chronic Kidney Disease (CKD)

The research examining Cibacène's role in chronic kidney disease involves long-term clinical trials and extension studies. Studies monitored specific outcomes related to kidney function, such as the rate of change in the estimated Glomerular Filtration Rate (eGFR), and the measured change in levels of protein excretion (albuminuria) in the urine. Findings describe patterns observed related to the measured change in the eGFR decline rate and the measured change in protein excretion in certain high-risk CKD populations. The evidence base for this condition may vary depending on the underlying cause of the chronic kidney disease.

Evidence for use in Chronic Heart Failure

Cibacène was studied for its use in chronic heart failure. Evidence is derived from RCTs and meta-analyses that explored the role of the ACE inhibitor class. Research examined outcomes related to systemic or functional imbalance, including the frequency of heart failure-related hospitalizations and overall cardiovascular mortality. Studies monitored and reported patterns related to the frequency of hospitalization and mortality risk when ACE inhibitors were used. The evidence for morbidity and mortality benefits heavily relies on the overall established ACE inhibitor class effect.

Research Gaps and Areas of Uncertainty

One key limitation is that some of the most comprehensive data on preventing long-term cardiovascular events relies on evidence for the overall ACE inhibitor drug class or from studies where Benazepril was used in combination therapy. Therefore, limited information is available for Benazepril as a stand-alone agent against all comparative treatments in all subgroups. Evidence for long-term outcomes in the pediatric population is not fully established due to the short duration of the available trials.

Key Studies & References

  1. BENAZEPRIL HYDROCHLORIDE tablet, coated - Official Prescribing Information (FDA/DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Cibacène (FAQ)


Q: What is Cibacène used for?

Cibacène (benazepril) is a medication classified as an ACE inhibitor. It is officially indicated to help manage high blood pressure (hypertension) and, in certain patients, to manage congestive heart failure.


Q: When is the best time to take Cibacène?

The medication is generally taken by mouth once a day. The specific timing of the dose may be directed by a healthcare provider. It can typically be taken either with food or without food.


Q: Are there side effects I should know about?

Like many medications, Cibacène may cause side effects. Common ones reported on the product label include dizziness, headache, and a persistent dry cough. A healthcare professional can provide guidance on managing and reporting potential side effects.


Q: Can I stop taking Cibacène if my blood pressure feels better?

No, you should not stop taking this medication suddenly without first discussing it with your healthcare provider. Abrupt discontinuation of blood pressure medications may lead to an unwanted rise in blood pressure. Treatment decisions should always be made in consultation with a doctor.

How should Cibacène be stored and disposed of?

How to Store and Dispose of Cibacène (Benazepril)

The official storage and disposal requirements for Cibacène tablets, based on regulatory labeling, focus on maintaining the product's integrity and ensuring safety.

Storage Requirements

Condition Requirement
Temperature Store at room temperature.
Protection Keep away from excess heat and moisture.
Packaging Keep the container tightly closed and store in the original packaging.
Prohibited Area Do not store in the bathroom.

Disposal and Safety

The medicine must be kept strictly out of the sight and reach of children; safety caps must always be locked. For disposal, follow authorized official pathways, such as a medicine take-back program, or use FDA-recommended procedures for safe household trash disposal of unused product.

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

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