Конкор АМ

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Конкор АМ

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Overview of Конкор АМ

Quick Facts

Property Description
Active Ingredients Amlodipine and Bisoprolol
Form Fixed-Dose Combination Tablet
Pharmacological Class Antihypertensive Agent
Mechanism Type Dual: beta1-Blocker and Calcium Channel Blocker
Origin Synthetic

Concor AM: Definition and Pharmacological Class

Concor AM is a specialized fixed-dose combination (FDC) medication, delivered as an oral tablet, and categorized broadly as an antihypertensive agent. This synthetic formulation is intended for potentially improving patient adherence compared to administering the two agents separately.

The medication is unique because it combines two distinct pharmacological classes in one pill. The Bisoprolol component is a highly selective beta1-adrenoceptor blocker, while the Amlodipine component is a dihydropyridine calcium channel blocker (CCB). This combination strategy provides comprehensive management of elevated blood pressure.

Composition: Amlodipine and Bisoprolol – The Complementary Action

The active ingredients contained in the medication are Bisoprolol (specifically, Bisoprolol fumarate) and Amlodipine (as Amlodipine besylate). The addition of Amlodipine to Bisoprolol enhances the overall antihypertensive effect compared to Bisoprolol alone. This complementary action is achieved by Bisoprolol reducing the heart’s workload and rate, and Amlodipine simultaneously promoting vasodilation by relaxing the smooth muscles of the blood vessels.

General Purpose of Concor AM

The primary purpose of Concor AM is the stable and sustained therapeutic management of arterial hypertension. Beyond controlling elevated blood pressure, the drug's balanced physiological action imparts a significant anti-anginal effect, making it a recognized choice for patients also managing stable angina associated with ischaemic heart disease. It is typically utilized as substitution therapy for adult patients whose condition has already been stabilized on the individual components given separately at the same doses.

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What side effects are possible with Конкор АМ?

Possible Side Effects and Safety Information

The safety profile of this fixed-dose combination is formally documented in government regulatory materials, classifying potential adverse reactions by frequency and physiological system. This information is derived from the clinical trial and post-marketing data for its active components, Amlodipine and Bisoprolol.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to incidence. Officially listed common adverse reactions include peripheral edema (swelling, particularly in the ankles or feet), headache, fatigue, dizziness, somnolence, nausea, and abdominal pain. Other effects, such as bradycardia (slow heart rate) and a sense of coldness or numbness in the extremities, are also documented as common, reflecting the activity of the Bisoprolol component.

System-Organ Classes and Serious Reactions

Official labeling groups adverse reactions by System-Organ Class, including Vascular Disorders (e.g., hypotension, flushing), Cardiac Disorders (e.g., palpitations, rhythm changes), and Nervous System Disorders. Serious adverse reactions documented in regulatory documents include the potential for worsening angina or acute myocardial infarction upon starting or increasing the dose, particularly in patients with severe obstructive coronary disease. Furthermore, abrupt discontinuation of the Bisoprolol component must be avoided, as this is associated with the temporary worsening of heart conditions.

Population and Contextual Safety Notes

The safety documentation notes specific considerations for certain patient populations. Use requires special caution and monitoring in patients with hepatic impairment (liver issues). For elderly patients, dosage increases should proceed with care. Efficacy and safety have not been established in the pediatric population (under 18 years of age). The medicine is formally contraindicated in several serious conditions, including severe hypotension, cardiogenic shock, acute heart failure or decompensation, and certain grades of AV block (without a pacemaker).

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Overdose and Emergency Response

Overdose and When to Seek Help

This section details the officially documented manifestations of an overdose with Concor AM (Amlodipine and Bisoprolol) and the required help-seeking actions, as strictly defined by regulatory sources.

Officially Documented Overdose Manifestations

An overdose is associated with severe consequences stemming from the combined action of its two components. Documented manifestations include:

  • Profound Hypotension (severe low blood pressure), which can progress to shock.
  • Bradycardia (slow heart rate) and Atrioventricular (AV) conduction disturbances.
  • Bronchospasm (breathing difficulties) and Acute Heart Failure.
  • Central Nervous System effects such as seizures, dizziness, confusion, and coma.
  • A metabolic effect of hypoglycaemia (low blood sugar) is specifically noted as common in children.

Required Emergency Actions

Regulatory agencies mandate immediate action upon suspicion of an overdose:

Action Required Condition
Contact your doctor or nearest hospital immediately. If more than the prescribed dose has been taken.
Go to A&E or call emergency services immediately. For severe symptoms like a slow heart rate, breathing problems, or severe dizziness/shakiness.

Treatment is primarily symptomatic and supportive, potentially requiring procedures like gastric lavage and the administration of specific agents such as intravenous calcium (for the Amlodipine component) or atropine (for the Bisoprolol component) in a hospital setting.

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Therapeutic Uses of Конкор АМ

What Конкор АМ Treats: Main Uses and Benefits

The medication is commonly used to provide support for the long-term management of chronic cardiovascular conditions in adults, applied in addressing symptoms related to systemic imbalance and heightened physiological activity. The two active components belong to established drug classes widely used for these therapeutic domains.


The therapeutic utility of Concor AM is centered on three core areas: the management of arterial hypertension (high blood pressure), providing symptomatic relief for stable angina pectoris, and is used in conditions where functional stability becomes affected. The treatment may assist with managing symptoms like elevated blood pressure and effort-related chest discomfort.

Quick Fact: Relief for Effort-Related Discomfort

This therapeutic approach contributes to improved comfort and functional stability during routine activities in patients with stable angina.


Key Therapeutic Context

Concor AM is relevant in clinical settings where patients require additional management when single-agent therapy is no longer sufficient. It is also used when patients are already stable on the individual components and require the convenience of a fixed-dose combination. This substitution strategy aids patient adherence. The overall goal is to help maintain a sense of stability when symptoms are more noticeable.

“This single-pill approach helps patients cope more steadily with symptom fluctuations and supports general well-being during symptomatic phases.”

Regulatory References

  1. US National Library of Medicine
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Eligibility and Restrictions for Use

Конкор АМ (Bisoprolol/Amlodipine) is generally prescribed for high blood pressure (hypertension). This combination medicine is not suitable for everyone, and your doctor will carefully assess your medical history before starting treatment.

Contraindications

This medication is strictly contraindicated and should not be used in patients with certain conditions, including:

  • Acute heart failure or episodes requiring intravenous therapy.
  • Cardiogenic shock or severe hypotension (very low blood pressure).
  • Severe asthma or other severe chronic obstructive pulmonary diseases.
  • Second- or third-degree heart block (a serious heart rhythm disturbance) without a pacemaker, or sick sinus syndrome.
  • Symptomatic bradycardia (abnormally slow heart rate).
  • Severe aortic stenosis (obstruction of the heart's main blood outflow tract).
  • Hypersensitivity or allergy to bisoprolol, amlodipine, or other dihydropyridines.

Special Warnings and Precautions

Particular caution is required and close monitoring is necessary if a patient has:

  • Diabetes mellitus, as the medication may mask symptoms of low blood sugar.
  • Impaired liver function or severe kidney impairment.
  • First-degree heart block or Prinzmetal's angina.
  • Psoriasis (a skin condition).
  • Pregnancy or breastfeeding; the use of Конкор АМ is typically not recommended.
  • The drug is not recommended for use in children and adolescents under 18 years of age due to limited safety and efficacy data.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Конкор АМ (bisoprolol/amlodipine) contains two active compounds whose combined effects necessitate careful consideration of co-administered medicines, primarily due to overlapping effects on heart rate and blood pressure, as well as distinct metabolic pathways.

Clinically Significant Cardiovascular Interactions

The most significant risks arise from combining this product with other cardiovascular agents that slow the heart rate or reduce contractility. Contraindicated combinations often include Class I antiarrhythmics (e.g., disopyramide, flecainide) and certain other calcium channel blockers (namely diltiazem and verapamil). These can significantly enhance the product's effect, leading to severe bradycardia or hypotension. The simultaneous use of centrally acting antihypertensive drugs (e.g., clonidine, methyldopa) may worsen existing heart failure conditions.

Interactions Requiring Monitoring

  • Other antihypertensive drugs, diuretics, and nitrates may have additive effects in lowering blood pressure, requiring close monitoring and potential dose adjustment.
  • Medicines for diabetes, including insulin and oral agents, may require careful blood glucose monitoring, as the bisoprolol component can mask key warning signs of hypoglycemia, such as a fast heartbeat.
  • CYP3A4 inhibitors (e.g., macrolide antibiotics like clarithromycin, or antifungals like itraconazole) can increase the concentration of the amlodipine component in the blood. Conversely, CYP3A4 inducers like rifampicin may decrease amlodipine concentrations. This may necessitate dose limitation or careful therapeutic oversight.
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may diminish the blood pressure-lowering effect of bisoprolol.
  • Grapefruit juice is not recommended due to its potential to increase amlodipine exposure.

Patients should inform their physician of all co-administered medications, supplements, and dietary changes.

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Mechanism of Action

The mechanism of Конкор АМ is defined by the synergistic action of its two components on independent pathways regulating systemic arterial pressure. The Bisoprolol component functions as a highly selective antagonist of beta1-adrenergic receptors (beta1-ARs), primarily located in the myocardium and kidney. Blockade of these receptors dampens sympathetic nervous system signaling, initiating a cascade that decreases the rate (negative chronotropy) and force (negative inotropy) of heart contractions, thus reducing cardiac output (CO) and minimizing the heart’s oxygen expenditure. The beta1-AR blockade also contributes to reducing renin release from the kidney.

Simultaneously, the Amlodipine component, a dihydropyridine, acts as an inhibitor of L-type voltage-dependent calcium channels in the vascular smooth muscle. This action prevents the influx of calcium ions (Ca^2+) essential for smooth muscle contraction, causing marked peripheral arterial vasodilation and a subsequent reduction in Total Peripheral Resistance (TPR). The combination's synergy is achieved by Bisoprolol modulating CO while Amlodipine modulates TPR. Furthermore, the negative chronotropic effect of Bisoprolol suppresses the reflex tachycardia that peripheral vasodilation may otherwise trigger through baroreceptor feedback mechanisms, providing coordinated modulation of cardiovascular parameters.

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Dosage and Administration Information

How to Use Конкор АМ: Official Administration Guidelines

The medication is delivered exclusively via the oral route as a fixed-dose combination (FDC) tablet. The tablets are available in multiple strength formats combining Bisoprolol and Amlodipine, such as 5 mg/5 mg and 10 mg/10 mg.


Standard Regimen and Frequency

The typical daily dose is one tablet taken once daily (OD), and it is generally administered in the morning. The tablet may be consumed with or without food. The drug’s primary usage pattern is substitution therapy, which requires the selected tablet strength to precisely correspond to the specific daily doses of the two components the adult patient was already stabilized on and receiving concurrently.


Procedural and Physical Handling

The tablet must be swallowed whole with liquid and should not be crushed, broken, or chewed. If a score line is present on the tablet, its intended purpose is to facilitate ease of swallowing, not to enable dose division.

Population-Specific Use

Official labeling contains specific constraints for certain patient groups. For individuals with severe renal or hepatic impairment, the daily dose of the bisoprolol component within the FDC tablet must not exceed 10 mg. Caution is also advised when making any dose increases in older adult patients. Usage in the paediatric population (under 18 years) is not established.

Treatment Cessation

Treatment must not be discontinued abruptly. A gradual reduction of the dosage is required as part of the official procedural handling of the medication.

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Recent Clinical Evidence

Research Evidence Overview: What Studies Exist for Конкор АМ?

This section provides an honest and accessible summary of the research that was conducted using the fixed-dose combination of amlodipine and bisoprolol (Конкор АМ). Understanding the studies provides insight into the information provided about the medicine, highlighting what is known and what remains uncertain. Research was conducted by looking at different study designs, including clinical trials where groups of people were randomly assigned to different treatments, and observational studies that watched how patients used the medicine in daily life.

Evidence for Managing Essential Hypertension (High Blood Pressure)

Research was applied in studies examining adult patients whose condition involved periods of heightened symptoms while they were using a single active component (monotherapy). The research also explored the use of the medicine when replacing the two individual components given separately.

Studies monitored outcomes related to systemic or functional imbalance, such as changes in Systolic and Diastolic Blood Pressure (BP). Research examined the achievement of predefined Target BP goals in patients. Findings described patterns observed in these studies, particularly regarding the BP measurements over the observed time intervals. Research also explored patient adherence.

Evidence for Use in Stable Angina Pectoris and Ischaemic Heart Disease

Конкор АМ was evaluated in adult patients with Stable Angina Pectoris, a condition where symptoms may vary in intensity and involve periods of heightened symptoms. Research was applied in studies examining patient-reported experiences and focused on replacing the individual drugs with the combination after patient evaluations. Outcomes studied were related to physical discomfort and reflected episodic or acute changes. The research for the FDC in this indication is considered alongside the data available for the two individual active components.

Key Areas Where Research Remains Uncertain

What remains uncertain is the long-term effect on serious health events. Because the follow-up durations were limited in the FDC-specific studies, long-term effects are not fully established regarding hard outcomes such as the sustained reduction in the risk of stroke or heart attack. Data for certain groups remain insufficient, meaning subgroup findings are uncertain.

Key Studies & References

  1. Management of Hypertension With a Fixed-Dose (Single-Pill) Combination of Bisoprolol and Amlodipine (Review discussing FDC advantages and adherence)
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Frequently Asked Questions (FAQ)

Common questions about Конкор АМ (FAQ)


Q: Why is Конкор АМ prescribed for heart conditions?

Regulatory documents state that this medicine is indicated for treating essential hypertension (high blood pressure). It is also used to manage stable angina pectorus, which is chest pain caused by reduced blood flow to the heart.


Q: Is Конкор АМ used for conditions other than high blood pressure?

Official information indicates the drug is formally indicated for the treatment of essential hypertension and stable angina pectorus.


Q: Are there common patient complaints when starting Конкор АМ?

Officially listed common side effects include fatigue, headache, dizziness, and swelling (oedema), particularly in the feet or ankles. These effects are often reported when a patient first begins taking the medicine.


Q: What are the signs of a severe, but rare, side effect associated with Конкор АМ?

Official warnings mention that symptoms such as severe chest pain or shortness of breath require immediate medical evaluation by a healthcare professional. These symptoms could indicate a worsening of underlying heart conditions.


Q: Is Конкор АМ suitable for patients with kidney problems?

Official guidance advises that specific caution and monitoring are necessary for individuals with any degree of renal (kidney) impairment. For individuals with severe impairment, official guidelines specify a dose limit for the bisoprolol component.


Q: Is the medication generally considered safe for long-term use?

Clinical data indicates that this fixed-dose combination is used to treat chronic conditions like hypertension. However, due to limited study follow-up duration, the long-term effect on reducing the risk of hard outcomes, such as stroke or heart attack, is not fully established.


Q: What does the research say about the long-term effectiveness of Конкор АМ?

Studies have examined the medicine's ability to maintain control over blood pressure (BP) and help patients achieve predefined target BP goals over extended periods. Research also monitored outcomes related to physical discomfort in patients with stable angina.


Q: Do people experience withdrawal symptoms if they stop Конкор АМ suddenly?

Abrupt discontinuation of the bisoprolol component must be avoided, as this is associated with a temporary worsening of heart conditions. Official handling procedures specify that a gradual reduction of the dosage is necessary.


Q: Are there reports of differences in effectiveness based on patient age or gender?

Official documents note that caution is advised when increasing the dose in older adult patients. Data for certain subgroups, including age, remains insufficient, meaning research findings related to these specific differences are generally uncertain.


Q: What is the difference between Конкор АМ and taking Amlodipine alone?

The combination adds bisoprolol, which works to reduce the heart rate and the force of heart contractions (cardiac output). This component also helps to suppress the reflexive fast heart rate that the amlodipine component may otherwise trigger.


Q: What is the difference between Конкор АМ and taking Bisoprolol alone?

The combination adds amlodipine, which works to widen blood vessels (peripheral arterial vasodilation). This action reduces the total resistance in the blood vessels, complementing the effects on heart rate and force provided by the bisoprolol component.


Q: How does the official literature define 'therapeutic benefit' for this drug?

Therapeutic benefit is assessed in studies by measuring and achieving predefined Systolic and Diastolic Blood Pressure (BP) goals in patients with hypertension. For patients with stable angina, the benefit is related to monitoring outcomes concerning physical discomfort.


Q: What happens if a person misses a dose of Конкор АМ?

Official instructions specify that a missed dose should not be taken later the same day. The next dose should be taken at the usual scheduled time the following morning.


Q: Is the interaction with alcohol mentioned in the official prescribing information?

Official documents advise that alcohol may intensify the blood pressure-lowering effect of the medicine. This intensification may increase the risk of experiencing dizziness or lightheadedness.


Q: Are there documented interactions between Конкор АМ and herbal supplements?

The official documents do not list specific herbal supplements by name. However, they warn that strong CYP3A4 inducers—substances that can speed up the body's processing of amlodipine—may decrease the concentration of amlodipine in the blood.


Q: Is it true that this drug is not recommended during pregnancy?

Official documentation states that the medicine is not recommended for use during pregnancy, unless a healthcare professional determines its use is strictly necessary.


Q: Are the safety data for Конкор АМ during breastfeeding clear?

Official guidance recommends that the medicine should not be used by women who are breastfeeding.


Q: What are the reasons a person might be advised to stop taking Конкор АМ?

Official documents list conditions that are contraindications (reasons not to continue), such as severe heart failure, cardiogenic shock, and severe low blood pressure. Treatment may also be discontinued if severe or persistent adverse reactions occur.


Q: Does Конкор АМ have any known effects on breathing or asthma?

The medicine is generally contraindicated (should not be used) in patients with severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD). It requires special caution and monitoring in patients with less severe forms of these conditions.


Q: Is there information on whether Конкор АМ can cause changes in mood?

Official safety documents list Psychiatric disorders as a class of reported adverse reactions. These reports include common effects like sleep disturbances, as well as less common effects such as depression.


Q: Do official documents mention any potential effects on sexual function?

Official documentation lists impotence (erectile dysfunction) as a less common adverse reaction reported for the bisoprolol component of the medicine.


Q: What should a patient do if they notice persistent, mild side effects?

Official guidance indicates that patients should report any adverse effects, including those that are persistent or mild, to a healthcare professional for appropriate follow-up.


Q: Why do some people refer to the drug as Bisoprolol/Amlodipine?

The drug contains the two active substances bisoprolol and amlodipine. Referring to a medicine by its active components is a standard and precise practice used in medical and pharmaceutical contexts.


Q: Is the drug only used for substitution therapy?

The official indication states the medicine is for the treatment of essential hypertension and/or stable angina pectorus as substitution therapy. This means it is for adult patients already controlled on the two individual components given concurrently at the same dose level.

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How should Конкор АМ be stored and disposed of?

Storage and Disposal of Konkor AM

Official Storage Conditions

Konkor AM (bisoprolol/amlodipine) must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F). The product must be protected from light and moisture and should be kept in a tightly closed, original container to maintain stability. It is strictly prohibited to freeze the medication, and it should not be stored above 30 C. Always keep the tablets out of the sight and reach of children.


Disposal Instructions

Unused or expired Konkor AM must be disposed of according to local regulatory requirements for pharmaceutical waste. The official instruction prohibits discarding the product via wastewater or routine household trash; instead, it should be taken to a pharmacist or local drug take-back program.

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

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