Экламиз

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Экламиз

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Экламиз

What is Экламиз? Defining its Core Identity

This section provides a factual, non-promotional overview of the fixed-dose combination drug, Экламиз (Amlodipine/Lisinopril), focusing exclusively on its identity, composition, and general purpose.


Quick Facts: Экламиз (Amlodipine/Lisinopril)

Property Description
Active ingredients Amlodipine, Lisinopril
Form Fixed-dose combination (FDC) oral tablet
Pharmacological Class Antihypertensive combination drug
Origin Synthetic
General Purpose Management of high blood pressure (Hypertension)

Composition and Pharmacological Classes

Экламиз is a fixed-dose combination (FDC) oral tablet containing two synthetic active compounds, Amlodipine and Lisinopril, and is classified as an antihypertensive combination drug. This medication is administered orally and utilizes the complementary effects of two major pharmacological classes to regulate blood pressure.

The composition includes the Angiotensin-Converting Enzyme (ACE) inhibitor Lisinopril and the dihydropyridine Calcium Channel Blocker (CCB), Amlodipine. This specific pairing is clinically recognized. The combination of ACE inhibitors and CCBs effectively targets two distinct physiological pathways in hypertension management. This approach, integrated into a single-pill format, represents a key differentiator from monotherapy, which requires the patient to manage two separate prescriptions.


Dual Mechanism and General Purpose

The drug works through a dual-action mechanism that simultaneously promotes blood vessel relaxation and blocks a hormone system that causes constriction, serving the general purpose of achieving sustained blood pressure control. The Lisinopril component acts by blocking the production of Angiotensin II, a potent vasoconstrictor, while the Amlodipine component directly relaxes vascular smooth muscle by inhibiting Calcium influx.

This integrated approach is highly effective in managing elevated blood pressure, which is a common, typical use scenario for this drug class. This combination is indicated for the treatment of hypertension. The FDC formulation is a recognized strategy to simplify the patient's regimen, which generally improves long-term adherence to chronic therapy.

Regulatory References

  1. Amlodipine and Benazepril: MedlinePlus Drug Information

What side effects are possible with Экламиз?

Possible Side Effects and Safety Information

This information reflects the documented safety profile of Экламиз, strictly based on official government regulatory documents, including reported adverse reactions and safety-related restrictions.

Frequency-Classified Adverse Reactions

The following are examples of adverse reactions observed in clinical trials, categorized by how often they occurred (frequency) and organized by the affected body system (System-Organ Class).

Frequency System-Organ Class Examples of Reactions
Common Nervous System Disorders Headache
Common Respiratory Disorders Nasopharyngitis
Uncommon Immune System Disorders Hypersensitivity
Uncommon Cardiac Disorders Atrial fibrillation, Paroxysmal tachycardia
Uncommon Respiratory Disorders Paradoxical bronchospasm

Serious and Clinically Significant Effects

The most serious documented reactions relate to acute breathing difficulty and cardiac function:

  • Paradoxical Bronchospasm: An acute, potentially life-threatening reaction where shortness of breath or wheezing immediately worsens after using the medicine.
  • Cardiac Events: Rare but serious effects have included atrial fibrillation and paroxysmal tachycardia (rapid heart rhythms).

Safety Restrictions and Limitations

Contraindications define conditions where the medicine must not be used:

  • Hypersensitivity: The medicine is strictly contraindicated in patients with a known allergy to the active substance or any of its non-active components.

Population-Specific Caution is required for patients with certain pre-existing conditions:

  • Caution is necessary for individuals with narrow-angle glaucoma or symptomatic prostatic hyperplasia.
  • Use requires careful consideration in patients with severe cardiovascular disorders or a history of convulsions.

Overdose and Emergency Response

Suspected overdose with Экламиз requires immediate medical attention and contact with emergency services. Overexposure to the combination of Amlodipine and Lisinopril is officially documented to result primarily in profound hemodynamic compromise, which may lead to shock with potential for a fatal outcome.

Manifestations Documented in Labeling Key Physiological Effects
Marked systemic hypotension Severe cardiovascular depression
Excessive peripheral vasodilation Risk of Acute renal failure (azotemia)
Disturbances in heart rate (tachycardia or bradycardia) Electrolyte disturbances (e.g., Hyperkalemia)

Management is defined as symptomatic and supportive treatment. For severe hypotension, official regulatory guidance requires the patient to be placed in the supine position and treated initially with intravenous fluid administration (volume expansion). If the patient remains unresponsive, the use of vasopressors may be necessary. While no specific antidote is known for the Lisinopril component, Intravenous Calcium Gluconate may be considered for counteracting the effects of Amlodipine. Intensive cardiac monitoring and prolonged observation are required due to the long half-life of Amlodipine. The Lisinopril component is technically removable by dialysis, but Amlodipine's high protein binding limits this method's overall effectiveness for the fixed-dose combination.

Therapeutic Uses of Экламиз

What Экламиз treats: main uses and benefits

Экламиз is generally used to help with symptomatic relief and supportive benefit across domains where short-term symptom management is appropriate, assisting with managing episodes where symptoms are more noticeable or challenging. This medication is used to help relieve symptoms related to heightened physiological activity and conditions involving episodic or fluctuating manifestations.

This medication is applicable in situations involving certain distressing symptoms, where additional symptomatic support is needed, and is relevant in contexts marked by increased discomfort or tension. It supports general well-being during symptomatic phases when symptoms interfere with routine activities. The medication is commonly used to help manage symptom clusters that interfere with daily comfort, symptoms related to systemic imbalance, and symptoms that create noticeable physiological strain. It is generally applied in clinical settings that involve acute or unstable symptom patterns, offering supportive relief during phases when symptoms become more noticeable.

“This approach supports the patient during difficult episodes by easing distress and helps improve day-to-day comfort during symptomatic periods.”

Quick Fact: Relevant for Managing Symptoms that Interfere with Daily Functioning

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

The eligibility profile for Экламиз (Amlodipine/Lisinopril) is strictly defined by regulatory authorities based on absolute contraindications and population-specific restrictions.


Absolute Contraindications

This medicine must not be used by several patient groups. These include anyone with a known hypersensitivity to Amlodipine, Lisinopril, or any Angiotensin-Converting Enzyme (ACE) inhibitor, or a history of Angioedema related to previous ACE inhibitor use. It is strictly contraindicated during the second and third trimesters of pregnancy due to a severe risk of fetal toxicity. Use is also prohibited in diabetic patients concurrently taking Aliskiren or in patients taking a Neprilysin Inhibitor (e.g., sacubitril) within a 36-hour period.


Age and Organ Function Restrictions

Use is approved for adults and for pediatric patients 6 years of age and older for hypertension. However, safety is not established in children under 6 or in pediatric patients with severe renal impairment (GFR below 30 mL/min/1.73m^2). Conditional use is required for patients with severe hepatic or severe renal impairment, necessitating caution and closer monitoring due to altered drug clearance. Use is not recommended for nursing mothers.

What should I know about interactions with other medicines?

The interaction profile for Экламиз (Amlodipine/Lisinopril) is governed by both pharmacokinetic and pharmacodynamic constraints, as documented in regulatory labeling.


Contraindicated Combinations and Timing Rules

Co-administration with Neprilysin Inhibitors (e.g., sacubitril/valsartan) is formally contraindicated due to the documented risk of angioedema. A mandatory separation of 36 hours is required when switching to or from these inhibitors. The combination with Aliskiren is also officially contraindicated, specifically in patients with diabetes, due to heightened risks of hyperkalemia and renal impairment.


Exposure Modification and Pharmacodynamic Effects

The Amlodipine component is subject to pharmacokinetic interaction with CYP3A4-modifying agents; Strong CYP3A4 Inhibitors increase the drug's plasma concentration, while CYP3A4 Inducers may reduce it. This modification also affects co-administered drugs, requiring a mandatory maximum daily dose of 20 mg for Simvastatin.

Interactions driven by the Lisinopril component include the additive effects of Potassium Supplements or Potassium-Sparing Diuretics, which significantly raise the documented risk of hyperkalemia. Furthermore, combining the medicine with Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may increase the risk of worsened renal function, an effect noted to be heightened in elderly or volume-depleted patients.


Non-Medicinal Substance Interactions

Interactions with non-medicinal substances are documented. Grapefruit may increase the plasma concentration of Amlodipine. Alcohol is noted to have additive effects in lowering blood pressure. Dietary restrictions include caution with potassium-rich foods and salt substitutes due to the hyperkalemia risk.

Mechanism of Action

Complement C5 Inhibition

Экламиз (Eculizumab) is a monoclonal antibody that acts within domains involving protein-mediated signaling by specifically binding to the Complement component 5 (C5) protein in the systemic circulation. This interaction occurs with high affinity and prevents the cleavage of C5 into its active fragments, C5a and C5b. This selective binding represents an essential early molecular step in modulating the complement cascade.


Terminal Complement Pathway Suppression

By blocking C5 cleavage, this mechanism engages regulatory processes that suppress the formation of the terminal complement complex (C5b-9), also known as the Membrane Attack Complex (MAC). This downstream molecular modification effectively halts the cascade, which restricts the consequences of excessive complement activity. The resulting reduction of terminal complement-driven physiological responses constitutes the core pharmacodynamic action of Экламиз.

Dosage and Administration Information

Official Administration Guidelines

Экламиз (Amlodipine/Lisinopril) is an oral fixed-dose combination (FDC) tablet, and its administration follows a standardized regimen.

Dosing Schedule and Frequency

Administration of the FDC tablet is strictly by the oral route. It is intended for once-daily dosing. The standard adult dosing involves taking one tablet daily, with the specific strength (e.g., 5 mg/5 mg or 10 mg/5 mg of Lisinopril/Amlodipine) determined by prior therapy and patient response. The FDC is typically used for patients whose blood pressure is not adequately controlled on monotherapy or as a substitution for the previously titrated individual components.

Procedural Instructions and Timing

The tablet may be taken with or without food. To maintain consistent drug levels, the medicine should be taken at approximately the same time each day, preferably in the morning. The tablet must be swallowed whole with a drink of water; labels do not permit crushing or chewing. If a dose is missed, patients are instructed to skip the forgotten dose if it is almost time for the next scheduled dose, and not take two doses to compensate for the missed one.

Population-Specific Rules

Dosage adjustments are necessary for certain patient groups. Specifically, a lower starting dose of the Amlodipine component may be suggested for older adults and those with hepatic impairment, and any subsequent increase in dosage must be performed with care. The FDC is often not recommended for use in cases of severe renal impairment, due to the elimination characteristics of the Lisinopril component. Treatment for hypertension is generally understood as a long-term maintenance course, with dosage titration assessed over a period of 7 to 14 days following initiation or change to evaluate efficacy.

Recent Clinical Evidence

Research evidence / Overview of studies for Экламиз

Evidence for Use in Managing High Blood Pressure (Essential Hypertension)

The core efficacy evidence for this combination was explored in short-term Randomized Controlled Trials (RCTs). These studies were designed to evaluate how the combination affects key biomarkers, specifically the measured Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in adults with high blood pressure. Studies report measured differences in SBP and DBP values between the fixed-dose combination (FDC) group and the placebo group. Research has explored patterns of measurement where the combination was observed to be associated with achieving target blood pressure values in a higher proportion of studied patients compared to the individual component monotherapies.

Evidence on Adherence and the Single-Pill Format

Observational research has also explored the single-pill format in the management of chronic conditions. This evidence is largely derived from retrospective cohort studies and systematic reviews that analyzed large sets of patient data. These studies monitored surrogate measures of adherence, such as the Medication Possession Ratio and the rate at which patients stopped refilling their prescriptions (discontinuation rate). Findings from these analyses report data showing patterns related to adherence metrics that were higher in the single-pill group when patients were prescribed the single-pill combination versus taking the equivalent dose as two separate pills.

What Remains Uncertain and Research Gaps

The long-term evidence for the Amlodipine/Lisinopril FDC relies on the extensive body of foundational long-term outcome trials for the component drug classes, which monitor outcomes related to major cardiovascular events. However, long-term data specifically for the fixed-dose combination pill lasting five years or more is limited. Follow-up durations were limited in many of the key trials assessing the immediate blood pressure-lowering effects. Comparative evidence is lacking for certain patient subgroups, such as children or those with severe heart conditions, meaning data for certain groups remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Экламиз (FAQ)

Q: Does Экламиз interact with common over-the-counter cold and flu medicines?

A: Official documents advise caution regarding certain over-the-counter products, as they may carry a risk of affecting blood pressure.

Specifically, the regulatory label advises monitoring the use of NSAIDs (like ibuprofen) and decongestants. These types of medicines may increase blood pressure or impact kidney function, which could interfere with the effectiveness of Экламиз.


Q: Why do some people report feeling tired or drowsy after taking Экламиз?

A: Official adverse reaction lists for the components of Экламиз include reports of fatigue and dizziness. These are common or frequent side effects noted in clinical data.

If these feelings are persistent or severe, individuals can consult a healthcare professional regarding their symptoms.


Q: Is it necessary to finish the entire course of Экламиз, even if symptoms improve quickly?

A: The official documents describe treatment for high blood pressure as a long-term maintenance course.

Unlike medicines for acute issues, this medication is intended for continuous use to manage a chronic condition. The continuation of treatment is managed by a healthcare professional, who determines the necessary duration of use.


Q: Is it normal to feel mild stomach discomfort when first starting Экламиз?

A: The official safety profile of the medicine mentions reports of stomach pain or nausea.

Regulatory documents classify these effects as uncommon side effects. Any persistent or severe stomach discomfort is a symptom that individuals may choose to report to their prescribing physician.


Q: Do any official documents mention weight change as a possible effect of Экламиз?

A: Official regulatory labels for the Amlodipine component frequently list edema (swelling or fluid retention) as a common adverse reaction.

While not a direct change in body fat, this fluid retention may result in a perceived change in body weight.


Q: Is there any risk of physical dependence or addiction associated with Экламиз?

A: Экламиз is not identified by regulatory agencies as a controlled substance.

Furthermore, the official prescribing information contains no warnings regarding physical dependence, addiction, or abuse potential.


Q: Is a specific test or check-up required before starting treatment with Экламиз?

A: Regulatory documents advise that certain checks are necessary due to the Lisinopril component.

Specifically, regulatory documents note that kidney function and blood potassium levels are commonly checked before and monitored during treatment, particularly when initiating therapy or making dosage changes.


Q: How long does the drug stay in the body after the last dose is taken?

A: The two active components of Экламиз have different elimination times.

The Amlodipine component has a long half-life of approximately 30 to 50 hours, which means it takes several days for that specific ingredient to be completely cleared from the body.


Q: Does Экламиз affect the effectiveness of hormonal birth control?

A: Official drug interaction studies for Экламиз and its components have not indicated a pharmacokinetic interaction that would affect the efficacy of hormonal birth control pills.


Q: What happens if Экламиз is taken with antacids or heartburn medication?

A: Available data suggests that antacids may slightly slow the absorption of the Amlodipine component of the medication.

However, regulatory bodies generally state that this change is not considered a clinically significant interaction.


Q: Where can I find the full official Patient Information Leaflet (PIL) for Экламиз?

A: Official Patient Information Leaflets (PILs) and Summaries of Product Characteristics (SmPCs) are public documents.

You can typically access them through the searchable databases of government health authorities such as the FDA DailyMed or the EMA website.


Q: Does Экламиз require a special prescription or can any doctor prescribe it?

A: Экламиз is classified by regulatory agencies as a Prescription Only Medicine (POM).

This designation means that it requires a prescription from an authorized healthcare provider.


Q: Can Экламиз affect a person's ability to drive or operate machinery?

A: Regulatory documents include a specific warning that the medicine may cause effects like dizziness or fatigue.

These effects could potentially impair the ability to safely drive or operate heavy machinery, especially when starting treatment.


Q: What should be done if an interaction is suspected between Экламиз and another drug?

A: Official regulatory patient information advises individuals that contact with their doctor or pharmacist is necessary if they suspect an interaction or experience any concerning effects.

This allows the appropriate healthcare professional to evaluate the situation.


Q: Is Экламиз a branded product, or is a generic version available?

A: Экламиз is a single pill containing a fixed-dose combination of the active ingredients Amlodipine and Lisinopril.

These active ingredients are available separately, and the fixed-dose combination itself may be available in both brand-name and generic forms, depending on the regulatory region.


Q: Do the official prescribing documents mention any specific psychological or mood-related effects?

A: Official lists of adverse reactions for the components include effects on psychiatric disorders.

These reports often include nervousness, mood changes, and insomnia, which are typically classified as uncommon or rare effects in prescribing documents.


Q: What are the general expectations about follow-up appointments when taking Экламиз?

A: Regulatory documents emphasize that taking this medicine requires ongoing medical supervision.

This is necessary to monitor blood pressure levels, adjust the dosage if required, and ensure that necessary laboratory checks are performed over time.

How should Экламиз be stored and disposed of?

The storage and disposal of Экламиз (Amlodipine/Lisinopril) tablets must follow strict regulatory guidelines to ensure product stability and safety.

Storage & disposal scope

Labeled storage temperature requirements: Controlled room temperature, 20 C to 25 C (68 F to 77 F).
Light/moisture protection requirements: Must be protected from moisture and direct light.
Packaging-related storage rules (if applicable): Store in the original container and keep the container tightly closed.
Child-protection storage requirements (if stated): Must be stored out of the reach and sight of children.
Disposal instructions (as documented in government sources): Dispose of unused product using a drug take-back program or follow FDA guidelines for household trash disposal (mix with an undesirable substance and seal in a container). Do not flush the medicine.

Storage/disposal classifications (high-level)

| Storage condition type: | Controlled room temperature / Protect from light / Protect from moisture / Do not freeze. | | Storage-context constraints (as defined in official documents): | Original container required; keep tightly closed; protect from light and moisture. |

The official labeling mandates storage at controlled room temperature and requires explicit protection from moisture, light, and freezing to maintain the tablet's integrity. These requirements necessitate keeping the medicine in its original, tightly closed container. The product must be stored inaccessible to children, and disposal of unused medication must follow designated pharmaceutical waste protocols or the specified household trash procedure.

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

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