Ко-Дальнева

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Ко-Дальнева

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Overview of Ко-Дальнева

Quick Facts

Property Description
Active Ingredients Amlodipine, Indapamide, Perindopril
Pharmaceutical Form Tablet (Fixed-Dose Combination)
Pharmacological Class Antihypertensive Combination Drug (ACE Inhibitor, CCB, Thiazide-like Diuretic)
Origin Synthetic Compound
Route of Administration Oral (Systemic)

What Type of Medicine is Ко-Дальнева?

Ко-Дальнева is a pharmaceutical product, manufactured as a single, synthetic oral tablet, used for the systemic management of arterial hypertension. It is defined as an antihypertensive combination drug and specifically a fixed-dose combination (FDC), delivering three distinct active agents in one unit. The FDC strategy is utilized for enhancing patient adherence and simplifying treatment regimens.

Active Components and Pharmacological Classes

The tablet combines three essential active ingredients using their International Nonproprietary Names (INN): Amlodipine, a Calcium Channel Blocker (CCB); Indapamide, a Thiazide-like Diuretic; and Perindopril, an Angiotensin-Converting Enzyme (ACE) Inhibitor. This specific combination of three core antihypertensive drug classes is an effective therapeutic choice when blood pressure control is difficult to achieve with fewer agents. This rational combination works by addressing multiple physiological pathways that contribute to high blood pressure.

General Purpose of the Triple Combination

The primary purpose of Ко-Дальнева is to provide reliable and sustained control over blood pressure, primarily in individuals whose hypertension requires a strategic, multi-mechanistic approach. The integration of these three agents addresses hormonal, vascular, and volume factors simultaneously. The key differentiating benefit of this FDC is the reduction in pill burden, which supports consistent long-term adherence—a critical factor for the management of chronic hypertension and minimizing overall cardiovascular risk.

Regulatory References

  1. antihypertensive drugs
  2. Thiazide Diuretics (NIH Bookshelf)
  3. ACE Inhibitors (NIH Bookshelf)
  4. Co-Dalneva SmPC (HALMED)
  5. Indapamide (NIH Bookshelf)
  6. Perindopril (NIH Bookshelf)
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What side effects are possible with Ко-Дальнева?

Possible Side Effects and Safety Information

The safety profile of Ко-Дальнева is based on regulatory information for the fixed-dose combination of mathbfAmlodipine, mathbfIndapamide, and mathbfPerindopril. Adverse reactions are classified by frequency and system-organ-class, according to authoritative governmental documents.

Frequency-Classified Adverse Reactions (Selected)

Frequency Examples of Adverse Reactions (Selected)
Very Common (ge 1/10) Oedema (swelling)
Common (ge 1/100 to <1/10) Dizziness, Headache, Cough, Nausea, Fatigue, Hypokalaemia (low potassium)
Very Rare (<1/10,000) Angioedema, Myocardial infarction, Pancreatitis, Stevens-Johnson Syndrome

Serious Safety Warnings

Official regulatory documents emphasize the risk of Serious Adverse Reactions (SARs). These include Angioedema (swelling of the face, tongue, and throat, potentially fatal), Severe Hypotension (very low blood pressure) which may rarely lead to secondary events such as myocardial infarction or stroke, and Hepatic Encephalopathy in patients with pre-existing severe liver impairment.

Population-Specific Safety Constraints

  • Pregnancy: The medicine is contraindicated during the mathbf2^nd and mathbf3^rd trimesters of pregnancy and not recommended during the mathbf1^st trimester.
  • Renal/Hepatic Impairment: The drug is contraindicated in patients with severe renal impairment (Creatinine clearance <30 mL/min) and severe hepatic impairment.
  • Lactation: Use is contraindicated during breastfeeding.

General Safety Information

Hypotension and dizziness are formally documented as being more likely to occur after the first dose or when the dose is increased. Safety restrictions also mandate that the drug must not be used in patients with a history of angioedema related to previous ACE inhibitor therapy or with certain concurrent medications like mathbfsacubitril/valsartan.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for a Ко-Дальнева overdose is characterized by severe physiological manifestations derived from the combined effects of the three active components. Urgent medical help must be sought immediately if an overdose is suspected.

Overdose Manifestations and Immediate Action

Domain Official Regulatory Statement
Documented overdose presentations Overdose may present with profound hypotension, bradycardia, tachycardia, irregular heartbeat, confusion, sleepiness (somnolence), muscle cramps, and a decrease in urine output (oliguria).
Physiological systems affected Cardiovascular system (leading to shock), Renal system (acute renal failure), Central Nervous System, Fluid and Electrolyte balance, and Metabolic status.
Emergency-response statements Seek immediate medical attention or reach out to the nearest hospital immediately due to the risk of severe, life-threatening outcomes.

Overdose Classifications (High-Level)

Classification Type Official Regulatory Statement
Severity classification Overdose may lead to severe and life-threatening outcomes, including cardiogenic shock, acute renal failure, and death.
Overdose-context constraints Management is restricted to supportive and symptomatic treatment as there is a lack of specific antidote. Continuous hospital monitoring is mandated.

Official overdose statements:

  • Management procedures include gastric lavage, administration of activated charcoal, and use of inotropic support and calcium infusion as appropriate.

Connection to the overall overdose profile:

The regulatory documents strictly define the Ko-Dalneva overdose profile by listing the documented clinical manifestations, such as severe hypotension and CNS effects, and identifying the life-threatening risk of shock and vital organ failure. These official statements directly establish the conditions under which urgent medical help must be sought, emphasizing that management is restricted to supportive measures due to the lack of a specific antidote.

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Therapeutic Uses of Ко-Дальнева

What Ko-Dalneva Treats: Main Uses and Benefits

Ko-Dalneva is a prescription medication utilized in adult patients to support the management of high blood pressure, a medical condition known as hypertension. The goal of treatment is to reduce blood pressure to within an acceptable range, which serves to decrease the potential risk of serious cardiovascular events.

This medication is typically reserved for individuals who require a combination of therapeutic agents for effective blood pressure control. It is intended for patients who are already receiving the constituent components—perindopril, indapamide, and amlodipine—at the same fixed doses but in separate tablets, allowing for a simplified treatment regimen.

By helping to achieve and maintain a regulated blood pressure level, Ko-Dalneva assists in the comprehensive management plan for hypertension. It is an option when a triple fixed combination is medically indicated.


Quick Facts

  • Primary Use: Supports the management of high blood pressure (hypertension).
  • Patient Profile: Appropriate for adult patients who require the combined effect of perindopril, indapamide, and amlodipine for blood pressure control.
  • Therapeutic Goal: Helps to achieve and sustain blood pressure reduction to lessen cardiovascular risk.
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Eligibility and Restrictions for Use

The eligibility for using Ко-Дальнева (Perindopril/Indapamide/Amlodipine) is strictly defined by regulatory guidance, based on the risks associated with its three active components. This medication is formally indicated only as substitution therapy for adult patients (aged 18 and older) whose blood pressure is already controlled by the free combination of the three components at the same fixed doses.

Contraindications and Prohibited Populations

Use is strictly prohibited in patients with:

  • Severe Organ Impairment: Severe renal impairment (Creatinine clearance < 30 mL/min) or severe hepatic impairment (including hepatic encephalopathy).
  • Angioedema History: A history of angioedema (severe swelling of the face, tongue, or throat) related to previous ACE inhibitor use, or hereditary/idiopathic angioedema.
  • Hypersensitivity: Allergy to the active components, any ACE inhibitor, sulfonamide-derived drugs, or dihydropyridine derivatives.
  • Pregnancy and Lactation: Use is contraindicated during the second and third trimesters of pregnancy and is not recommended during the first trimester or breastfeeding.
  • Concomitant Use: Patients taking Sacubitril/Valsartan or Aliskiren (in patients with diabetes or impaired kidney function) must not use this medicine.

Age and Conditional Restrictions

  • Pediatric Use: The safety and efficacy of the medication have not been established in children and adolescents under 18 years of age.
  • Moderate Renal Impairment: Use is restricted, with certain high-dose strengths being contraindicated for patients with moderate kidney impairment ( CrCl 30-60 mL/min).
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What should I know about interactions with other medicines?

Official Interaction Profile

The interaction profile for Ко-Дальнева is defined by regulatory restrictions relating to its three active components. Official documentation specifies combinations that are strictly prohibited and those that require mandatory separation due to specific safety risks.

Formal Regulatory Restrictions

  • Contraindicated Combinations: Co-administration with Sacubitril/Valsartan is formally prohibited due to the increased risk of angioedema. Similarly, the use of intravenous Dantrolene is contraindicated. Co-administration with Aliskiren is contraindicated in patients with diabetes mellitus or specific levels of renal impairment.
  • Timing Separation: A mandatory 36-hour wash-out period is specified between the last dose of the perindopril component and the first dose of Sacubitril/Valsartan.
  • Exposure Modification: Co-administration with strong CYP3A4 inhibitors is documented to increase the plasma concentration (exposure) of the amlodipine component. A regulatory restriction requires Simvastatin to be limited to a maximum of 20 mg per day when co-administered to mitigate myopathy risk.
  • Pharmacodynamic Risk: The combination increases the risk of hyperkalemia when used with potassium-sparing diuretics or potassium supplements. Co-administration with Lithium is documented to increase serum lithium levels due to reduced renal excretion.
  • Substance Interactions: The use of Grapefruit or Grapefruit Juice may cause a slight increase in amlodipine plasma concentrations. Alcohol consumption may potentiate the hypotensive effects of the medicine.
  • Patient Contraindications: The medicine is contraindicated in patients with both severe renal impairment and severe hepatic impairment.
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Mechanism of Action

Ко-Дальнева is a fixed-dose combination composed of perindopril, indapamide, and amlodipine, modulating systemic pressure via three distinct, complementary pharmacodynamic mechanisms.

Perindopril, a prodrug converted to the active metabolite perindoprilat, functions as a competitive Angiotensin-Converting Enzyme (ACE) inhibitor. This interaction prevents the enzymatic cleavage of angiotensin I to the potent vasoconstrictor angiotensin II. The resulting reduced angiotensin II concentration leads to diminished systemic vascular resistance and decreased aldosterone secretion from the adrenal cortex. ACE inhibition also impedes the degradation of bradykinin, a vasodilator, further promoting vasodilation.

Amlodipine is a dihydropyridine calcium channel blocker (CCB). It selectively binds to and inhibits the voltage-dependent L-type calcium channels in the smooth muscle of peripheral arterioles. By reducing the influx of extracellular calcium ions, amlodipine decreases myocyte contraction and causes peripheral arterial vasodilation, which lowers total peripheral resistance.

Indapamide is a thiazide-like diuretic. Its primary mechanism involves inhibition of the Na^+ / Cl^- symporter located in the cortical segment of the distal convoluted tubule of the nephron. This blockade reduces the reabsorption of sodium and chloride ions, leading to an increase in the renal excretion of water, sodium, and chloride. This systemic reduction in circulating fluid volume contributes to decreased load on the cardiovascular system.

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Dosage and Administration Information

How to use Ко-Дальнева — Administration Guidelines

Instruction Detail
Route of administration The fixed-dose combination (FDC) is for oral use only.
Dosing schedule The standard regimen is one tablet per day as a single dose. This FDC is indicated as substitution therapy for adult patients already controlled on the component medicines at the same doses.
Timing in relation to meals The tablet is to be taken preferably in the morning and before a meal.
Preparation requirements The tablet should be swallowed whole; it is not intended to be crushed or split to ensure the integrity of the fixed dosage.
Age-group administration rules Use in paediatric patients (under 18 years) is not recommended as the safety and efficacy have not been established.
Missed-dose rules If a dose is forgotten, the missed dose is skipped and the next dose is taken at the usual scheduled time the following day. A double dose must not be taken to compensate for the forgotten dose.
Special procedural conditions If a change in the overall dosage is required, the dose titration is performed with the individual components (monotherapies or dual FDCs). The FDC product is not used for this adjustment.

Connection to the Overall Use Protocol

This instruction set establishes that Ко-Дальнева functions as a stable maintenance agent in a long-term treatment plan. The procedural constraints—its designation as substitution therapy and the requirement to use individual components for any necessary dose titration—define its precise role in the treatment protocol. Furthermore, the intake before a meal reflects a specific condition tied to the pharmacokinetics of the active ingredients, ensuring consistent administration.

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Recent Clinical Evidence

Research evidence / Overview of Studies for Ко-Дальнева


Evidence for Use in Essential Arterial Hypertension

Research has examined the combination of Amlodipine, Indapamide, and Perindopril in Randomized Controlled Trials (RCTs) and systematic reviews to understand its use in research contexts involving fluctuating or unstable symptoms related to high blood pressure. These studies primarily monitored outcomes monitoring physiological strain or stress, such as changes in standard blood pressure measurements taken in a clinic, as well as more detailed 24-hour readings (ABPM). The studies evaluated adult patients with essential hypertension, often focusing on those whose blood pressure remained high despite treatment with fewer medications.

Findings from these trials described changes in blood pressure levels that were observed when comparing the triple combination to a dual-drug combination. Comparison to dual combinations reported measurements of difference in systolic and diastolic blood pressure. However, the evidence base contributes to the broader evidence landscape for hypertension treatment research, but long-term effects are not fully established for this specific fixed combination.


Evidence for Use as Substitution Therapy and Adherence

Another major focus of the research studies explored how the single-pill combination compares to taking the same three medicines as separate tablets. These investigations included Randomized Comparative Trials as well as real-world observational studies applied in studies examining patient-reported experiences, where treatment persistence and patient adherence was observed in adult patients already stable on the individual components.

The comparative trials report how symptoms evolved in the observed populations, indicating that the blood pressure control achieved with the fixed-dose combination was generally similar to the results reported for the equivalent free, three-pill regimen. Real-world evidence, gathered in observational settings evaluating daily-life functioning, indicated patterns related to adherence among participants who switched to the single pill. The data show patterns related to patient behavior, but certainty remains low regarding how this observed change in adherence translates directly into long-term clinical outcomes.


What is Still Uncertain About Ко-Дальнева Research

While research provides context but not individual predictions, there are still areas where the evidence landscape is incomplete:

  • Long-term outcomes related to cardiovascular morbidity and mortality, specifically from trials using this FDC tablet, are not fully established.
  • The specific impact of changes in adherence patterns on clinical outcomes (e.g., hospitalization rates or mortality rates) is not fully established by the available real-world observational studies alone.
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Frequently Asked Questions (FAQ)

Common questions about Ко-Дальнева (FAQ)


Q: Why is this blood pressure medicine combined from three separate ingredients?

A: According to official product information, this medicine is a fixed-dose combination that works via three distinct and complementary methods. It combines an ACE inhibitor, a calcium channel blocker, and a diuretic (or water pill). This multi-mechanistic approach addresses hormonal, vascular, and fluid factors simultaneously to support sustained blood pressure control.

Q: Is this drug intended for lifelong management of high blood pressure?

A: High blood pressure is generally a chronic condition that requires consistent attention. Official documentation indicates that this medicine is used for long-term treatment as a stable maintenance agent. It is used to support sustained control over blood pressure levels as part of a patient’s overall management plan.

Q: Does this medicine treat hypertension, or does it only control the symptoms?

A: This medicine is defined as a treatment used to manage and control hypertension. Like most medications for chronic conditions, it works to maintain blood pressure within a target range, thereby lowering associated risks. It is important to know that it is not considered a cure for the condition itself.

Q: What are the different strengths available for Ко-Дальнева?

A: The medicine is supplied as a fixed-dose combination in various strengths. Each tablet combines the three active components: Perindopril, Indapamide, and Amlodipine. These strengths reflect different fixed ratios of the components, which are selected after the appropriate dose of the individual components has been established.

Q: Is this medication considered a blood thinner, or does it work differently?

A: Regulatory documents classify this medicine as an antihypertensive combination drug. It works to lower blood pressure by widening blood vessels and reducing excess fluid. It is not considered an anticoagulant or "blood thinner," which are medicines used to prevent blood clots.

Q: How fast does the full blood pressure-lowering effect usually develop?

A: Studies related to the combination indicate that a significant reduction in blood pressure is typically evident within 4 weeks of consistent daily use. The full intended effect is generally maintained with consistent daily intake.

Q: How is the required dose of the medicine typically determined by healthcare professionals?

A: This medicine is formally designated as substitution therapy for patients who are already controlled on the individual components. This means the required daily dose is first established by taking the three ingredients separately. The fixed-dose combination is then considered to simplify the regimen once the patient is stable on the corresponding doses of the individual components.

Q: Is it normal to not feel any physical difference after starting this medication?

A: Since high blood pressure often has no symptoms, successfully managing it may produce no noticeable change in sensation. The medicine is designed to work quietly to control blood pressure. The absence of new symptoms is often a positive indication that treatment is being tolerated.

Q: How does the medicine maintain stable blood pressure throughout a 24-hour period?

A: The medicine is designed for once-daily use to provide sustained control. This is possible because the active components are processed by the body in a way that gives them a long duration of action or half-life. This ensures that blood pressure-lowering effects are maintained consistently for a full 24-hour period.

Q: Why can this drug cause swelling in the ankles or legs (peripheral edema)?

A: Official documents list peripheral oedema (swelling of the ankles or legs) as a side effect that is frequently observed. This is primarily linked to the Amlodipine component, which works by relaxing and widening the small blood vessels.

Q: What are the signs of a serious allergic reaction, such as angioedema, related to this drug?

A: The official safety information emphasizes that angioedema is a rare but serious risk. Signs to be aware of include swelling of the face, lips, tongue, or throat. Any difficulty breathing or swallowing is also considered a critical sign. Seeking immediate medical attention is necessary.

Q: Can this medication cause temporary changes to a person’s sense of taste?

A: Official documentation indicates that taste disturbances (dysgeusia) have been reported as an uncommon side effect. This is usually associated with the Perindopril component of the medication.

Q: Does Ко-Дальнева affect blood sugar levels, and is monitoring required?

A: According to regulatory sources, hyperglycemia (high blood sugar) is listed as an uncommon side effect. This potential effect is linked to the Indapamide component of the medicine.

Q: What should be known about sun exposure or photosensitivity while taking this medication?

A: Photosensitivity reactions (increased sensitivity to sunlight) have been reported, primarily due to the Indapamide component. Official recommendations indicate that limiting exposure to direct sunlight or artificial UV light is advised during treatment.

Q: Does the medicine have an impact on the results of routine kidney function tests?

A: The Perindopril component is known to potentially cause minor changes in blood urea and creatinine levels. These increases are commonly monitored through routine blood tests when beginning or adjusting treatment, as they reflect changes in kidney function.

Q: Is it possible for this medicine to cause skin rash or persistent itching?

A: Regulatory sources list skin rash and itching (pruritus) as uncommon side effects linked to the components of this medicine. Any severe rash or swelling should be brought promptly to the attention of a healthcare professional.

Q: Is muscle pain or cramping a known side effect of Ко-Дальнева?

A: Muscle cramps and muscle pain (myalgia) are documented as common or uncommon side effects in the official product information. These effects are often associated with the Indapamide or Amlodipine components of the combination.

Q: What is a 'rebound effect' if the medicine is suddenly stopped?

A: Official guidance indicates that sudden discontinuation is discouraged as it may cause the return or worsening of high blood pressure. While the Amlodipine component is not typically associated with withdrawal symptoms, the blood pressure control relies on the daily presence of all three drugs.

Q: Can this medication cause vision changes or eye discomfort?

A: Visual impairment is listed as an uncommon side effect in regulatory documents, mainly linked to the Amlodipine component. Any concerns about changes to vision should be brought to the attention of a healthcare provider.

Q: What is the general caution regarding using this drug if I have a history of gout?

A: The Indapamide component may cause an increase in uric acid levels (hyperuricemia). This requires caution in patients who have a history of gout.

Q: Does this drug affect the heart rate or cause palpitations?

A: Official safety documents report that palpitations (an awareness of a fast or pounding heartbeat) are a common side effect. This is generally associated with the Amlodipine component of the medication.

Q: Is a history of heart valve issues, like aortic stenosis, a contraindication?

A: Official regulatory documents state that this medicine is contraindicated or requires extreme caution in people with certain heart valve conditions. This includes specific conditions such as aortic stenosis.

Q: Can common non-steroidal anti-inflammatory drugs (NSAIDs) interact with this medicine?

A: Regulatory warnings indicate that the use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) can increase the risk of kidney problems when taken with ACE inhibitors (like Perindopril). NSAIDs may also be associated with a reduced blood pressure-lowering effect of the medicine.

Q: Is it important to limit salt intake while on this medicine?

A: The reduction of salt intake is commonly considered as part of the overall management strategy for high blood pressure. This is particularly relevant when taking this medicine due to the presence of the diuretic component, which works by regulating the body's salt and fluid balance.

Q: Can this medication interact with anti-depressant drugs?

A: The official interaction profile notes that co-administration with tricyclic antidepressants may increase the risk of orthostatic hypotension (dizziness upon standing due to low blood pressure).

Q: What kind of monitoring is typically done when starting treatment with this combination drug?

A: Official warnings and precautions state that routine monitoring is commonly performed when using this medicine. This generally involves blood and urine tests to check kidney function and electrolyte levels (like potassium), in addition to monitoring blood pressure response.

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How should Ко-Дальнева be stored and disposed of?

How to Store and Dispose of Ко-Дальнева

The storage and disposal of this medicine must comply strictly with the conditions defined in official regulatory labeling.

Storage Requirements

Ко-Дальнева tablets must be stored out of the sight and reach of children.

The product must be maintained at a temperature below 30°C and should not be stored above this limit. To preserve the stability of the active components, the medicine must be stored in its original container to ensure protection from light and moisture.

For certain pack sizes, the labeled in-use stability after the first opening is 100 days. Do not use the medicine after the expiry date printed on the packaging.

Disposal Instructions

Unused or expired Ко-Дальнева must be disposed of according to local requirements for pharmaceutical waste. The medicine must not be discarded via wastewater or household waste to prevent environmental contamination.

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

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