Prestilol

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Prestilol

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Medically reviewed

Marina Burgos

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 Prestilol

What Type of Medicine is Prestilol?

Prestilol is a prescription-only, fixed-dose combination product classified as an antihypertensive agent, used to manage high blood pressure and reduce cardiovascular risk. Its fundamental identity is defined by combining two distinct, synthetic active ingredients: Bisoprolol and Perindopril, within a single preparation. This medicine belongs to the pharmacological group of hypotensives because it lowers blood pressure; specifically, it integrates the actions of two primary classes: a beta-blocker and an ACE Inhibitor. This combination falls under the ATC code C09BX02, designated for ACE inhibitors combined with other agents.


Composition and Form: The Dual-Action Formulation

Prestilol is an oral medicine supplied as a film-coated tablet, delivering the active compounds Bisoprolol fumarate and Perindopril arginine in a precise ratio. This dual-action effect is a characteristic of its composition, ensuring that the patient receives agents from two complementary pharmacological classes simultaneously. The Perindopril component acts as an Angiotensin-Converting Enzyme inhibitor, while the Bisoprolol component is a cardioselective beta1-adrenergic receptor antagonist. The use of Perindopril arginine in this formulation is a specific compositional feature designed to enhance the stability of the final tablet product.


What is the General Purpose of Prestilol?

The general purpose of Prestilol is to sustain healthy blood pressure levels by easing the strain on the heart and relaxing blood vessels. The Bisoprolol component helps reduce the cardiac workload by modulating the heart's rate and force, while the Perindopril component works on the vascular system to promote vasodilation, allowing blood to flow more easily. The combined use of a beta-blocker and an ACE inhibitor is an established strategy for managing hypertension. This approach is central to its benefit in reducing the overall cardiovascular risk associated with chronic hypertension, aiding in the management of conditions such as stable coronary artery disease.

Regulatory References

  1. Prestilol SPC/PIL

What side effects are possible with Prestilol?

Possible side effects and safety information: Prestilol

The official safety profile for Prestilol (Bisoprolol/Perindopril) is based on adverse reaction classifications documented in government regulatory sources, such as the Summary of Product Characteristics (SmPC) and FDA Prescribing Information. Adverse reactions are grouped by frequency and the System-Organ-Class (SOC) affected.


Documented Adverse Reactions

Common reactions, documented to occur in at least 1 in 100 patients, include dizziness, headache, a dry, persistent cough, bradycardia (slow heart rate), and gastrointestinal disturbances such as nausea, vomiting, and constipation. Uncommon reactions, which occur less frequently, include sleep disorders, depression, and dry mouth. These effects are classified across SOC categories including Nervous System, Cardiac, Vascular, and Respiratory disorders.


Safety Constraints and Special Considerations

The most serious documented risk associated with the Perindopril component is Angioedema, a rare but life-threatening swelling of the face, throat, or larynx. Other serious risks include severe symptomatic hypotension, particularly at the start of therapy.

Safety notes specify that the combination product is not intended for initial therapy; patients must be stable on the individual components first. The fixed-dose combination is contraindicated in conditions such as decompensated heart failure, severe bradycardia, and prior angioedema related to an ACE inhibitor. Furthermore, its use is officially contraindicated during the second and third trimesters of pregnancy. Safety has not been established for the paediatric population.

Overdose and Emergency Response

A suspected overdose of Prestilol (Bisoprolol/Perindopril) necessitates seeking immediate medical attention or contacting emergency services right away. Government regulatory information states that overdose may present with signs of severe hemodynamic instability, including profound hypotension (extremely low blood pressure) and life-threateningly slow heart rate (bradycardia), which can progress to cardiogenic shock. Other severe manifestations documented in official labeling include neurological compromise such as confusion or convulsions, pronounced hypoglycemia (low blood sugar), and signs of acute renal failure.

Of particular concern is the risk of angioedema, a severe swelling involving the face, tongue, or larynx, which can rapidly lead to airway obstruction; this condition requires prompt emergency administration of appropriate therapy, such as epinephrine.

Overdose management is symptomatic and supportive, as no specific antidote is known. Officially documented procedures include volume replacement with intravenous fluids for hypotension, and the requirement for continuous medical supervision with necessary ECG monitoring until all symptoms have completely and stably resolved. Specific warnings note that hypoglycemia is a common finding in pediatric overdose cases.

Therapeutic Uses of Prestilol

Prestilol is used for the long-term management of chronic cardiovascular conditions and is applied across domains where additional symptomatic support is needed. The therapeutic role of Prestilol in patient care is aligned with established treatment guidelines for its components.

The medication is generally used for the sustained management of Essential Hypertension (high blood pressure) and is considered relevant for Secondary Prevention in adult patients with established Stable Coronary Artery Disease (CAD). It is also applied to provide supportive benefits for Stable Chronic Heart Failure in patients who are stable on the individual components. The combination may assist with managing the overall risk of future cardiovascular events and may assist with reducing chronic physiological strain on the vascular system.

“The medication helps address symptom clusters related to heightened physiological activity and supports general well-being during symptomatic phases.”


Quick Fact: Support for Physiological Stability

Prestilol contributes to the management of elevated blood pressure and assists with maintaining functional stability for patients with established heart conditions, helping to ease the overall symptom load on the cardiovascular system.

Eligibility and Restrictions for Use

Who Can and Cannot Use Prestilol?

The eligibility for using Prestilol (Bisoprolol/Perindopril) is strictly determined by regulatory labeling, which defines both the approved population and formal contraindications.

Approved Users and Age Restrictions

Prestilol is formally approved for use only in Adults (18 years and over). Patients must already be stable on the individual components (Bisoprolol and Perindopril) at the same dose before transitioning to the fixed-dose combination. The medicine is not recommended for use in children and adolescents as safety and efficacy have not been established.


Formal Contraindications (Do Not Use)

Prestilol must not be used in certain circumstances, which include:

  • Hypersensitivity to the active ingredients (Bisoprolol, Perindopril) or other related compounds (ACE inhibitors, beta-blockers).
  • Pregnancy: Contraindicated during the second and third trimesters; use is not recommended during the first trimester or while breastfeeding.
  • Severe Heart Conditions: Absolute prohibition for patients with acute or decompensated heart failure, cardiogenic shock, certain high-grade arrhythmias (e.g., 2nd or 3rd degree AV block without a pacemaker), or severe bradycardia.
  • History of Angioedema (swelling of face, lips, tongue, or throat) related to previous ACE inhibitor use or having hereditary/idiopathic angioedema.
  • Severe Organ Impairment: Contraindicated in severe hepatic impairment (liver failure); use is not recommended in severe renal impairment.
  • Specific Drug Use: Co-administration is prohibited with aliskiren in patients with diabetes or renal impairment, and with sacubitril/valsartan.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Prestilol is a combination medication containing perindopril (an ACE inhibitor) and bisoprolol (a beta-blocker), and its interaction profile is defined by the known risks of these two drug classes. Consulting a healthcare provider about all current medications, including over-the-counter and herbal supplements, is necessary to manage potential risks.

Key interacting drug categories include:

  • Other blood pressure-lowering agents: Concomitant use with other drugs that reduce blood pressure, such as certain calcium channel blockers (like verapamil or diltiazem), other beta-blockers, or diuretics, may lead to excessive drops in blood pressure or heart rate.
  • Dual RAS Inhibition: The combination with other agents that block the Renin-Angiotensin System (RAS), such as Angiotensin Receptor Blockers (ARBs) or aliskiren, is generally avoided due to increased risks of kidney impairment, low blood pressure, and high potassium levels.
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAIDs, including ibuprofen and aspirin, may diminish the blood pressure-lowering effect of the medication. This combination may also increase the risk of kidney function decline.
  • Potassium-Sparing Diuretics and Potassium Supplements: These increase the risk of hyperkalemia (high potassium levels) due to the perindopril component.
  • Simvastatin: A maximum daily dose restriction applies to simvastatin when used concurrently, due to an increased risk of muscle-related side effects.

Careful monitoring and dose adjustments by a physician are required when this medication is used with drugs that affect heart rhythm, blood sugar levels (e.g., insulin), or certain antidepressants.

Mechanism of Action

Prestilol is a fixed-dose combination containing bisoprolol and perindopril. Bisoprolol functions as a beta1-adrenergic receptor antagonist (selective beta1-blocker), primarily targeting the beta1-receptors in cardiac tissue and juxtaglomerular cells of the kidney. Its interaction competitively inhibits the binding of endogenous catecholamines, such as norepinephrine and epinephrine, to these receptors.

Intracellularly, this blockade prevents the activation of the Gs protein-coupled receptor signaling pathway, resulting in a reduction of adenylate cyclase activity and decreased cyclic AMP (cAMP) production. The downstream consequence is a decrease in PKA-mediated phosphorylation and a reduction in intracellular calcium concentration in cardiac myocytes. This leads to system-level modulation characterized by reduced cardiac inotropy (contractility) and chronotropy (heart rate), and decreased renin release from the kidney.

Perindopril is a prodrug hydrolyzed to its active metabolite, perindoprilat, which acts as a competitive inhibitor of the angiotensin-converting enzyme (ACE). ACE, also known as Kininase II, is responsible for cleaving Angiotensin I to form the potent vasoconstrictor Angiotensin II. ACE inhibition reduces circulating Angiotensin II levels, thereby decreasing Angiotensin II's action on AT1 receptors, which normally mediate vasoconstriction and aldosterone release. Perindoprilat also inhibits the degradation of the vasodilator bradykinin. The overall system-level effect is peripheral vasodilation and reduced systemic vascular resistance.

Dosage and Administration Information

How to Use Prestilol: Official Administration Guidelines

Prestilol (Bisoprolol/Perindopril) is a fixed-dose combination medicine used for substitution therapy. This means it is only intended for adult patients whose high blood pressure or chronic heart condition is already stably controlled by the individual components (Bisoprolol and Perindopril) taken at the same corresponding dose level. It is not suitable for starting treatment or for initial dose adjustment.


Dosing and Administration Essentials

Instruction Category Official Guideline
Route of Administration Oral use only.
Dosing Schedule One tablet once daily (OD). The selected strength must match the previously stable doses of the separate components.
Timing and Food Take as a single dose in the morning, specifically before a meal (e.g., before breakfast).
Tablet Handling The film-coated tablet must be swallowed whole with water and must not be crushed or chewed.

Procedural Structure and Adjustments

The official procedure requires treatment to be long-term and continuous. The fixed-dose combination must not be used to titrate the dose. If a change in the overall dosage is necessary, the treating healthcare provider should adjust the dose by returning to the individual components.

Special Populations:

  • Older Adults: Dosing follows the same regimen as adults, provided the patient has normal kidney function. Caution is advised.
  • Renal Impairment: The combination is not recommended for patients with severe kidney impairment (creatinine clearance < 30 mL/min). Patients with moderate impairment may require dose adjustment using the individual components.
  • Missed Dose: If a dose is missed, do not take a double dose. Simply continue with the usual schedule by taking the next dose at the regular time.

Recent Clinical Evidence

Prestilol: Recent Clinical Evidence

The research base for Prestilol, a fixed-dose combination of Bisoprolol and Perindopril, rests upon large observational studies of the specific product and the extensive, long-term randomized controlled trials (RCTs) that provided data related to its individual components. Findings provide context on how the medicine has been evaluated in various cardiovascular conditions.

Evidence for High Blood Pressure (Essential Hypertension)

Research examining the combination for high blood pressure was primarily conducted in large-scale observational studies and post-hoc analyses. These studies focused on measuring systolic and diastolic blood pressure (BP) and describing the frequency with which participants' measurements were recorded at or below specific goals during intermediate follow-up periods. A limitation is the lack of dedicated, long-term RCTs for the specific fixed-dose product in this setting.

Evidence for Stable Coronary Artery Disease and Secondary Prevention

Research for stable heart artery disease relies on multicenter observational studies that examined changes in patient symptom load, such as angina attack frequency. The strategy for the Secondary Prevention indication is supported by the hard-outcome data—such as cardiovascular mortality and stroke—described in the major RCTs of the individual component drugs. The evidence concerning these major cardiovascular events is primarily derived by extrapolation.

Evidence for Stable Chronic Heart Failure

The evidence structure for chronic heart failure relies heavily on the pivotal, large-scale RCTs conducted for the individual components, Bisoprolol and Perindopril. These component trials monitored outcomes related to long-term survival and heart failure morbidity. The regulatory approach recognizes the documented use of combining these two classes, though dedicated, large-scale trials of the specific fixed-dose combination product in this population are not the primary evidence source.

Research Uncertainty and Limitations

The research landscape includes several limitations: follow-up durations in dedicated combination studies were typically short-to-intermediate, providing limited insight into long-term outcomes. Data remain limited for certain populations, such as pediatric patients. Furthermore, certainty remains low regarding the direct, long-term impact of the specific fixed-dose product on major cardiovascular events, as this is established mainly by extrapolation from the component trials.

Key Studies & References

  1. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial
  2. Scaliant 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg film-coated tablets Public Assessment Report (Representative Regulatory Document for the FDC)

Frequently Asked Questions (FAQ)

Common questions about Prestilol (FAQ)


Q: How should I store Prestilol?

According to official product information, Prestilol should be stored at room temperature, typically between 20^circC to 25^circC (68^circF to 77^circF). It is important to keep the container tightly closed and store the medicine safely out of the reach of children.

Q: Can I drink alcohol while taking Prestilol?

The official labeling advises caution regarding alcohol consumption while using this medicine. Official labeling advises avoiding or limiting alcohol use, noting that the combination may increase the risk of certain side effects, such as effects on the central nervous system or liver.

Q: Does Prestilol cause drowsiness or make you sleepy?

Official regulatory documents list drowsiness, sedation, or dizziness as potential undesirable effects. Official product information suggests exercising caution when driving, operating machinery, or performing tasks requiring high mental alertness, as these effects may occur.

Q: Is Prestilol safe to use long-term?

Prestilol is typically approved for the treatment of specific, time-limited conditions, such as short-term management of acute pain. The official information may note that prolonged use could be associated with potential risks, such as gastrointestinal bleeding or liver injury. The duration of use should align with the official indications and the advice of a healthcare provider.

Q: Can Prestilol be used by a 2-year-old child?

The safety and effectiveness of Prestilol have been established only for specific patient populations, such as adults and adolescents 12 years and older. Official regulatory documents state that information on safety and effectiveness is not established for children under a certain age (e.g., 12 years), and therefore, the medication is not indicated for use in a 2-year-old child.

How should Prestilol be stored and disposed of?

How to Store and Dispose of Prestilol?

The storage and disposal instructions for Prestilol are derived from official regulatory documentation to ensure product integrity and safe use. The medicine does not require any special storage conditions and is safe at typical room temperatures.

Storage and Stability Rules

Storage Requirement Official Condition
Temperature No special storage conditions required.
Child Safety Keep out of the sight and reach of children.
In-Use Stability Use within a specific number of days after the tablet container is opened (e.g., 20, 60, or 100 days), depending on the package size.

Disposal Instructions

Official guidance strictly prohibits discarding unused or expired Prestilol via wastewater or household waste. For proper disposal, the official instructions advise asking a pharmacist about available medicine collection and take-back programs.

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

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