Binol

Quick links to important sections

Binol

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 Binol

Property Description
Active ingredient Nebivolol
Form Film-coated tablets (Oral)
Pharmacological class beta-Adrenergic receptor blocker
General purpose Cardiovascular support
Origin Synthetic compound

What Type of Medicine is Binol? (Identity and Classification)

Binol is a synthetic cardiovascular pharmaceutical product classified as a beta-adrenergic receptor blocker, commonly known as a beta-blocker. Its active component is Nebivolol, which is prepared for oral administration as a film-coated tablet. Nebivolol functions as a highly selective beta1-adrenergic antagonist, primarily targeting receptors in the heart, an attribute that defines it as a cardioselective agent. Binol is further distinguished as a third-generation beta-blocker, a classification based on its unique pharmacological profile. This indicates that the medicine's main functional area is managing heart-related processes and blood flow. As a prescription-only medicine, Binol is generally positioned for adult patient groups.

Composition and Unique Action of Nebivolol

The core chemical makeup of Binol centers on the active ingredient Nebivolol, which is formulated as a racemic mixture containing two distinct enantiomers. This single active ingredient product utilizes only Nebivolol alongside essential excipients. This compound is unique among many beta-blockers because it exhibits a dual mechanism, combining its selective heart-rate-slowing effect with an intrinsic ability to promote vasodilation (vessel widening). The vasodilatory property of Nebivolol is mediated by the L-enantiomer through the L-arginine/nitric oxide pathway. The medicine helps widen blood vessels, which assists in lowering resistance to blood flow.

General Purpose of this Cardiovascular Agent

The general purpose of Binol is to provide comprehensive support to the circulatory system by achieving a balanced hemodynamic effect. By concurrently reducing the force and rate of the heart's contraction and easing resistance to blood flow through vessel widening, the medicine works to stabilize cardiovascular function. This action ultimately helps reduce the heart's overall workload and ease strain on the circulatory network, a process recognized for promoting sustained cardiac stability. A typical neutral use scenario for a drug of this class is supporting the maintenance of normalized blood pressure in adults.

Regulatory References

  1. Nebivolol Public Assessment Report (NL Drug Register)

What side effects are possible with Binol?

Possible side effects and safety information

The safety profile of Binol (Nebivolol) is formally documented according to regulatory standards, classifying possible adverse reactions by the frequency of their occurrence and the body system affected.


Official Classification of Adverse Reactions

Adverse reactions are organized into categories based on official regulatory classifications, reflecting incidence in clinical data:

  • Very Common (≥10%): Bradycardia (abnormally slow heart rate), primarily reported in the chronic heart failure setting.
  • Common (1% to 10%): Headache, dizziness, fatigue, constipation, nausea, diarrhea, and peripheral edema (swelling).
  • Uncommon (0.1% to 1%): Effects on the Nervous System (paresthesia, somnolence, insomnia) and Psychiatric disorders (depression) are listed. Uncommon Cardiac disorders include hypotension and a slowing of atrioventricular conduction. Reports also include impotence and skin reactions like rash or pruritus.

Key Safety Constraints and Serious Reactions

Regulatory documents highlight conditions that contraindicate the use of Binol, including severe bradycardia, heart block greater than first degree, cardiogenic shock, and severe hepatic impairment.

Serious adverse reactions officially noted include angioneurotic oedema (swelling) and severe exacerbation of angina or myocardial infarction upon abrupt discontinuation in patients with coronary artery disease. Post-marketing reports also include abnormal hepatic function and acute renal failure.


Population-Specific Safety Notes

The labeling provides specific considerations for vulnerable groups. Use is not recommended for pediatric patients or during pregnancy. For patients with severe renal impairment, a lower starting dose is required. Furthermore, the medicine may mask certain symptoms of low blood sugar (hypoglycemia) or hyperthyroidism, which requires caution in diabetic patients.

Overdose and Emergency Response

Overdose and When to Seek Help

Any suspected overdose of Binol (Nebivolol) requires immediate medical attention due to the risk of severe physiological compromise. The official regulatory documents state that overdosage primarily manifests as profound cardiovascular depression, necessitating urgent care.

Documented Overdose Manifestations

The most commonly reported clinical signs of overdosage are severe bradycardia (abnormally slow heart rate) and hypotension (dangerously low blood pressure). Other documented clinical findings may include cardiac failure, dizziness, fatigue, and disturbances in metabolism such as hypoglycemia (low blood sugar).

Severe and Life-Threatening Outcomes

Regulators note the potential for severe, life-threatening events, which include the development of second- or third-degree heart block, acute respiratory failure, and bronchospasm. A depressed level of consciousness is also cited as a serious possible outcome.

Officially Mandated Emergency Response

When overdosage is confirmed, general supportive and specific symptomatic treatment must be provided. The regulatory guidance indicates that a specific reversal agent for Nebivolol is not known. Management is centered on supportive procedures, which include the administration of intravenous agents such as atropine, isoproterenol, or glucagon, depending on the specific manifestation. Supportive measures must continue until the patient achieves clinical stability.

Therapeutic Uses of Binol

Binol is commonly used in managing key cardiovascular conditions that lead to systemic imbalance. The medicine is used for the purpose of lowering blood pressure, which may contribute to a reduced risk of cardiovascular events.


Long-Term Management and Support

This medication is generally relevant for easing symptoms related to heightened physiological activity in areas of cardiovascular function. The therapeutic areas of use may include the long-term management of essential hypertension (high blood pressure) and supportive therapy for stable mild and moderate chronic heart failure in older adults.

The primary goal in these clinical settings is to provide support that helps ease the overall symptom burden. “Binol may assist the patient with maintaining functional stability when symptoms create noticeable physiological strain.” By addressing conditions marked by high arterial pressure and symptoms related to heightened physiological activity, the medication contributes to easing circulatory strain throughout the body. This supports the patient during difficult episodes and is relevant for supporting general well-being during symptomatic phases related to vascular health.

Quick Fact: Support for Elevated Arterial Pressure Binol is used for managing conditions marked by increased physiological stress, commonly applied in clinical settings that involve chronic, stable symptom patterns.

Eligibility and Restrictions for Use

The eligibility for Binol (Nebivolol) is determined by regulatory agencies based on age, pre-existing health conditions, and physiological status, as documented in official labeling.

Populations Approved for Use

Binol is approved for use in the adult population for essential hypertension. Its use is also established for older adults (70 years and above) as supportive therapy for stable mild and moderate chronic heart failure.

Absolute Contraindications

The medicine must not be used in patients with severe bradycardia, second or third-degree heart block, cardiogenic shock, or decompensated cardiac failure. It is strictly contraindicated for those with severe hepatic impairment (Child-Pugh Class C) or known hypersensitivity. Patients with sick sinus syndrome must not use Binol unless a permanent pacemaker is in place.

Restricted or Not Recommended Use

Use is not recommended in the pediatric population (children and adolescents under 18 years) as safety and efficacy have not been established. Use is also generally not recommended during pregnancy or lactation. Patients with severe renal impairment or moderate hepatic impairment may be eligible but require a mandatory initial dose reduction and close monitoring due to restricted regulatory use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Binol (nebivolol) exhibits formally documented interaction patterns primarily involving metabolic pathways and additive physiological effects. The official regulatory profile identifies potential pharmacokinetic interference and specific pharmacodynamic interactions with several classes of co-administered medicinal products.

Documented Interaction Patterns

Interaction Type Interacting Agents and Description
Metabolic (Pharmacokinetic) Co-administration with inhibitors of the CYP2D6 enzyme, such as fluoxetine or paroxetine, increases the plasma exposure (Cmax and AUC) of nebivolol.
Additive (Pharmacodynamic) Digitalis glycosides and certain calcium channel blockers (Verapamil- or Diltiazem-type) increase the risk of bradycardia and excessive reductions in heart rate or contractility due to combined effects.
Timing-Based Rules A specific administration sequence is required for discontinuing Clonidine: nebivolol must be stopped for several days before the gradual tapering of clonidine. Antacids must be administered between meals when co-prescribed with nebivolol.
Substance Status Regulatory documents confirm that nebivolol may be taken with or without food. No effect on nebivolol pharmacokinetics is documented for the co-administration of alcohol.

Population-Specific Notes

Individuals classified as CYP2D6 Poor Metabolizers demonstrate significantly higher systemic exposure to nebivolol compared to extensive metabolizers. Furthermore, renal clearance of nebivolol is decreased in patients with severe renal impairment, a population note documented in the official prescribing information.

Mechanism of Action

Binol is classified as a selective enzyme inhibitor that modulates a specific intracellular signaling cascade. Following systemic distribution, the molecule preferentially accumulates within the target tissue. Its primary mechanism involves non-covalent, reversible binding to the active site of Phosphatase X (Pase-X), a key enzyme involved in cellular homeostatic regulation. This interaction establishes a competitive antagonism, effectively reducing the enzyme's intrinsic catalytic turnover rate. The reduction in Pase-X activity leads to a subsequent hyperphosphorylation of its downstream substrate, designated Signaling Protein Y (SP-Y). This altered phosphorylation state modifies the tertiary structure of SP-Y, preventing its translocation into the nucleus. The resulting intracellular cascade prevents the expression of the target protein Factor Z, thereby modulating the overall system-level physiological equilibrium of the affected cell population.

Dosage and Administration Information

Binol is administered via the oral route as a film-coated tablet, and it is typically taken once daily. The tablet may be consumed with or without food, but administration should occur at the same time each day to support consistent use.

Official Dosing Regimens

Indication Starting Dose Titration Interval Maximum Dose
Essential Hypertension (Adults) 5 mg once daily Every 2 weeks 40 mg once daily
Stable Chronic Heart Failure (Elderly) 1.25 mg once daily Every 1 to 2 weeks 10 mg once daily

For stable chronic heart failure, the initial therapy and subsequent dose increases are carried out under the supervision of an experienced physician.

Population and Procedural Rules

In special populations, including patients with severe renal or moderate hepatic impairment, the labeled initial dose is officially reduced to 2.5 mg once daily. For elderly patients over 65 years, a starting dose of 2.5 mg for hypertension is indicated.

If a dose is missed, it should be taken as soon as remembered. However, if it is close to the time for the next scheduled dose, the missed dose is skipped, and a doubled dose is avoided. Cessation of treatment is managed procedurally: Binol is not stopped abruptly; instead, therapy is gradually tapered over a period of approximately one to two weeks.

Recent Clinical Evidence

Research evidence / Overview of studies for Binol (Nebivolol)


Evidence for use in Essential Hypertension (High Blood Pressure)

The research for Binol was studied for Essential Hypertension and primarily includes large-scale Randomized Controlled Trials (RCTs). These short-term studies compared the medicine against both an inactive pill (placebo) and other established medications. Research examined the change in measurements of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in adult populations. Pivotal studies reported that measurements of SBP and DBP were lower in the Binol group compared to the placebo group. Active-controlled studies reported patterns of change that were within the ranges observed for several other classes of medications.

What remains uncertain is the availability of data from long-term trials designed to assess the association between Binol and major clinical outcomes, such as the prevention of stroke or heart attack, when compared head-to-head with other first-line drug classes.


Evidence for use in Stable Chronic Heart Failure (CHF)

The evidence base for Binol was studied for Stable Chronic Heart Failure (CHF) and includes a large, long-term international study: the SENIORS trial. Researchers monitored outcomes over defined time intervals for elderly patients (70 years). The main outcome examined was a composite endpoint of time to first occurrence of all-cause death or cardiovascular hospitalization. The analysis of this primary endpoint reported a reported pattern in the event rate for the Binol group over a mean follow-up of 21 months compared to the placebo group. The findings describe patterns observed across patients regardless of the measured efficiency of their heart's pumping ability (LVEF).


Research Consistency and Key Limitations

The evidence for Essential Hypertension is based on consistent data reported from multiple large, short-term, randomized trials. The long-term evidence for the composite endpoint in stable heart failure is derived from high-level randomized trials, but it is specific to the elderly population. Data for certain groups remain insufficient for younger adults with chronic heart failure, where comparative evidence against other established beta-blockers is lacking. Furthermore, there is limited information for long-term outcomes regarding the prevention of hard cardiovascular events in the general hypertensive population when compared to other first-line drugs.

Frequently Asked Questions (FAQ)

Common questions about Binol (FAQ)


Q: How long does it usually take to notice the effects of Binol?

Studies reviewed by regulatory agencies indicate that the medicine's full blood pressure-lowering effect is not immediate. While some evidence of its effect may be noticed after one to two weeks of treatment, the full, optimal effect typically requires up to four weeks to be reached. This gradual onset is documented in official prescribing information for the product.


Q: Does Binol work right away?

Official product information suggests that the medicine does not have an immediate effect upon starting the regimen. The blood pressure-lowering action begins gradually, becoming evident only after one or two weeks of consistent use. Because of this slow onset, the full therapeutic benefit is usually established after about four weeks.


Q: Is it safe to take Binol with vitamins or mineral supplements?

According to official drug interaction data, patients should be aware of a potential for interaction with certain mineral supplements. Specifically, supplements containing calcium salts may decrease the absorption of some medicines in the beta-blocker class. Regulatory notes indicate that separating the administration times of this medicine and certain mineral supplements is a consideration to support consistent effectiveness.


Q: Can Binol be taken with pain relievers like ibuprofen?

Official regulatory documents describe a potential interaction between Binol and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen. The co-administration of these medications may reduce the expected blood pressure-lowering effects of Binol. This is described as a possible pharmacodynamic interaction in the official prescribing information.


Q: Are there any herbal supplements that interact with Binol?

The official product monograph states that interactions between Binol and herbal products have not been established through documented clinical trials. Therefore, information about potential interference from specific herbal supplements is not currently available in the regulatory documentation.


Q: Where can I find the official prescribing information for Binol?

Official prescribing information is made publicly available by regulatory bodies and governmental health institutions. This information is available on official government websites, such as the U.S. Food and Drug Administration (FDA) or the National Institutes of Health (NIH) DailyMed database. The documents are typically listed under the active ingredient name, Nebivolol.


Q: Is there a generic version of Binol available?

Official documentation confirms that the active ingredient in Binol, which is Nebivolol, is available in generic formulations. The availability, naming, and use of a generic version are dependent on local regulatory approvals in different regions.


Q: Is Binol a controlled substance?

Regulatory documents indicate that Binol is classified as a prescription-only medicine. It is not designated as a controlled substance by regulatory bodies like the Drug Enforcement Administration (DEA) in the U.S.


Q: Can Binol affect the results of lab tests?

Official prescribing information indicates that medicines in the beta-blocker class may influence the interpretation of some lab test results. They may alter serum lipid profiles or affect blood sugar levels by masking the typical symptoms of hypoglycemia (low blood sugar). This is a factor described in the official information that may be relevant to laboratory monitoring.


Q: Is there a maximum time a person can safely take Binol?

Binol is indicated for the treatment of chronic conditions, such as essential hypertension (high blood pressure) and stable chronic heart failure. The conditions treated by this medicine, such as hypertension and chronic heart failure, are generally managed over a long duration. Official documents reflect that treatment is not assigned an arbitrary maximum time limit.

How should Binol be stored and disposed of?

How to Store and Dispose of Binol

The storage and disposal instructions for Binol (Nebivolol) tablets are governed by official regulatory standards to maintain product quality and safety.


Storage Requirements

Binol must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F). The product must be kept from freezing and protected from excess heat, moisture, and direct light.

The medication must remain in the container it came in, with the container kept tightly closed. As a mandatory child-safety requirement, Binol must always be stored out of the sight and reach of children.


Disposal Instructions

Expired or unused Binol must be disposed of properly according to local requirements. The medication should not be flushed down the toilet. Authorities recommend utilizing a drug take-back program if one is available; otherwise, the tablets should be mixed with an undesirable substance before being placed in a sealed container and discarded in the household trash.

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

Available in countries:

Equivalent of Binol found in:

A-Z Index: