Amlopril

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Amlopril

Method of action: Antihypertensive

Treatment option: Hypertension

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 Amlopril

Property Description
Active ingredient Amlodipine and Benazepril
Form Oral Tablet
Pharmacological class Calcium Channel Blocker (CCB) and Angiotensin-Converting Enzyme (ACE) Inhibitor
General purpose Sustained blood pressure control
Origin Synthetic

Amlopril: Definition and Pharmacological Classification

Amlopril (the generic name for the combination of Amlodipine and Benazepril) is a prescription-only medication classified as a Cardiovascular agent and a fixed-dose combination product designed for oral intake. It serves as an Antihypertensive agent used to manage elevated blood pressure. Fixed-dose combinations are clinically recognized for supporting reliable patient compliance in treating chronic conditions. This medication is a synthetic pharmaceutical that strategically utilizes two separate mechanisms for treatment.

Composition and Active Ingredients (Amlodipine and Benazepril)

The medication is composed of two primary active ingredients: Amlodipine and Benazepril, provided as their respective salts in the final oral tablet form. These components belong to two different, vital pharmacological classes. Amlodipine is a Calcium Channel Blocker (CCB), while Benazepril functions as an Angiotensin-Converting Enzyme (ACE) Inhibitor. This formulation is widely recognized under various trade names globally, such as Lotrel in the United States.

General Purpose of this Dual-Acting Formulation

The overall purpose of this dual-acting formulation is to provide comprehensive and sustained blood pressure control. By combining the direct artery-relaxing action of a CCB with the hormonal system influence of an ACE inhibitor, Amlopril ensures simultaneous modulation of different physiological factors that contribute to hypertension. This synergy offers a robust strategy in antihypertensive therapy, effectively reducing overall systemic vascular resistance and easing the workload on the heart.

Regulatory References

  1. MedlinePlus Drug Information, 2024

What side effects are possible with Amlopril?

Possible Side Effects and Safety Information

The safety profile of amlodipine (Amlopril) is documented based on the frequency and type of adverse reactions observed in clinical trials and post-marketing experience.

Frequency-Classified Adverse Reactions

The following are classified by regulatory authorities based on their frequency of occurrence:

Frequency Classification Examples of Reactions
Common (1/100 to <1/10) Edema (swelling), fatigue, headache, dizziness, somnolence, nausea, abdominal pain, palpitations, flushing.
Uncommon (1/1,000 to <1/100) Insomnia, tremor, syncope (fainting), dry mouth, vomiting, alopecia (hair loss), rash, arthralgia (joint pain), muscle pain.
Very Rare (<1/10,000) Myocardial infarction, arrhythmia (including ventricular tachycardia and atrial fibrillation), leukopenia (low white blood cells), pancreatitis, hepatitis, jaundice, angioedema.

Serious Adverse Reactions

Adverse reactions considered serious, though very rare, include myocardial infarction (heart attack), arrhythmia, hepatitis, and severe skin reactions such as exfoliative dermatitis and toxic epidermal necrolysis. Patients with severe obstructive coronary artery disease may experience increased angina or acute myocardial infarction upon initiation of therapy.

Safety Restrictions and Population Considerations

Amlopril is contraindicated in individuals with a known hypersensitivity to amlodipine or other dihydropyridine derivatives.

Caution is advised in specific patient groups:

  • Severe Hepatic Impairment: Due to the drug’s extensive metabolism, a lower starting dose is typically considered for individuals with severe liver problems.
  • Heart Failure: Caution is required, particularly in patients with New York Heart Association (NYHA) Class III and IV heart failure, due to the risk of increased pulmonary edema.

Regulatory documents note that some common effects, such as edema and headache, may be dose-related.

Overdose and Emergency Response

Amlopril overdose primarily manifests as signs of profound hemodynamic instability. Officially documented presentations include severe hypotension (extremely low blood pressure) and extensive peripheral vasodilation, which may be accompanied by changes in heart rate such as tachycardia (rapid heart rate) or bradycardia (slow heart rate). Other clinical signs documented in official labeling include drowsiness, confusion, and elevated blood sugar (hyperglycemia).

An overdose carries the risk of life-threatening systemic outcomes, including progression to shock and documented cases of refractory shock, which can lead to acute renal failure or death in severe circumstances. Immediate medical attention must be sought right away for any suspected overdose. Emergency services should be contacted if the individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

No specific antidote is known for Amlopril overdose. The management strategy provided in regulatory documents is exclusively symptomatic and supportive treatment. This often involves administering crystalloid infusion and using pressor agents (such as norepinephrine or high-dose dopamine) if hypotension is persistent. Due to the long half-life of Amlodipine, an overnight hospital stay may be required for monitoring, even in less serious cases.

Therapeutic Uses of Amlopril

What Amlopril Treats: Main Uses and Benefits

Amlopril (amlodipine/benazepril) is a combination medication used exclusively in the management of high blood pressure (hypertension). This combination is commonly used in the management of elevated blood pressure, a condition that, if left untreated, may lead to damage to the brain, heart, and kidneys.

Sustained Management of High Arterial Pressure

This medication is applied in conditions marked by persistent high pressure load in the arteries, addressing both systolic and diastolic measurements that are difficult to control, and helping to alleviate chronic vascular tension. The combination approach contributes to comprehensive blood pressure control in patients who require more intensive management, thereby supporting improved overall physiological stability.

Support for Long-Term Organ Protection

Amlopril is used as a foundational measure to mitigate the long-term risks associated with hypertension, which often presents without noticeable symptoms. It provides important support to the cardiovascular system, which contributes to support against the progression of silent damage to the heart, blood vessels, and kidneys. This intervention provides support for an important benefit by assisting in managing the risk for major complications, such as stroke and heart attack.


Quick Fact: Support for Persistent High Pressure

The medication is commonly used to help manage persistent high pressure load and chronic vascular tension, supporting improved overall physiological stability.

Regulatory References

  1. NIH MedlinePlus overview of Amlodipine and Benazepril

Eligibility and Restrictions for Use

Who Can and Cannot Use Amlopril?

Amlopril (amlodipine/benazepril) is a combination medication with strict eligibility rules defined by regulatory bodies.

Contraindicated Populations (Must Not Use)

Use of Amlopril is contraindicated for patients with a known history of angioedema, whether related to a previous ACE inhibitor or of unknown cause, or those with hypersensitivity to either amlodipine, benazepril, or any other ACE inhibitor. The medicine must be discontinued immediately if pregnancy is detected due to the risk of fetal toxicity. Additionally, it is forbidden for patients with diabetes who are taking aliskiren or for anyone who has received a neprilysin inhibitor (e.g., sacubitril/valsartan) within the last 36 hours.

Eligibility and Restrictions

Use is established for adults to manage hypertension. For the pediatric population, safety and efficacy have not been established. The medicine is not recommended in patients with severe renal impairment (Creatinine Clearance le 30 mL/min). Use requires special caution in patients with impaired hepatic function, certain cardiac valve conditions, or those who are volume- or salt-depleted.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines officially documented interaction patterns for Amlopril (amlodipine/benazepril) as stated in regulatory prescribing information.


Contraindicated Combinations and Timing Constraints

Co-administration with Aliskiren is contraindicated for patients with diabetes due to a documented increase in the risk of hyperkalemia and renal impairment. Use of Sacubitril/Valsartan (a neprilysin inhibitor) is also contraindicated; a mandatory 36-hour period must separate the administration of Amlopril from this agent.


Pharmacokinetic and Exposure-Modifying Interactions

Interacting Substance Interaction Type Official Outcome/Restriction
Strong CYP3A4 Inhibitors (e.g., Ketoconazole) Pharmacokinetic inhibition of Amlodipine metabolism Increases Amlodipine systemic exposure.
Simvastatin Amlodipine inhibits Simvastatin metabolism Simvastatin dose must be limited to 20 mg daily.
Grapefruit Juice Pharmacokinetic inhibition May slightly increase Amlodipine plasma concentrations.

Pharmacodynamic Interactions

Co-administration with Potassium-sparing Diuretics or Potassium Supplements increases the officially documented risk of hyperkalemia. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) may cause a loss of the antihypertensive effect and increase the risk of renal dysfunction. Other antihypertensive agents may lead to additive hypotensive effects.

Mechanism of Action

Blocking the Calcium Gate: Vascular Relaxation

This mechanism of action centers on Amlodipine's role as a calcium channel blocker. It acts by targeting the L-type voltage-dependent calcium channels in the plasma membranes of arterial smooth muscle cells, functioning as an antagonist. This interaction prevents the influx of extracellular calcium ions ( Ca^2+) into the cells, directly disrupting the excitation-contraction coupling pathway. The resulting physiological effect is the inhibition of muscle contraction, leading to arterial smooth muscle relaxation (vasodilation).

Reducing Systemic Resistance: Afterload Reduction

By causing the peripheral arteries to relax, the drug reduces the overall systemic vascular resistance (SVR). This systemic change is known as afterload reduction and is the key physiological consequence of the drug's action. The mechanism modulates contractile processes, resulting in a state of lower peripheral resistance, which reduces the mechanical effort required for the heart to circulate blood. This targeted vasodilation modifies the flow dynamics within the systemic circulation.

Dosage and Administration Information

How to Use Amlopril (Amlodipine/Benazepril)

The usage of Amlopril, a fixed-dose combination, includes specific administration, dosing, and procedural constraints.


Administration Scope

Feature Instruction
Route of administration Oral administration only.
Dosing schedule Initial dose: 2.5 mg Amlodipine / 10 mg Benazepril once daily. Maintenance dose range: up to 10 mg Amlodipine / 40 mg Benazepril once daily.
Timing in relation to meals May be taken with or without food.
Age-group administration rules For older adults and those with hepatic impairment, the initial dose of the Amlodipine component is recommended to be 2.5 mg.
Missed-dose rules If a dose is missed, take the next scheduled dose at the regular time and do not take a double dose.
Special procedural conditions Dose titration should only occur after a minimum of two weeks of therapy, as the full effect is largely attained within this period. This fixed combination is not indicated for initial therapy of hypertension.

Instruction Classifications

Classification Detail
Administration method type Oral Capsule
Frequency pattern Once Daily
Use-context constraints Must be administered at the same time each day.

Resulting Procedural Structure

The administration protocol consists of a once-daily oral regimen, independent of meal timing. The treatment begins with the lower 2.5 mg/10 mg strength and requires a two-week waiting period before any dose increase is considered. This extended titration period allows for assessment of the full effect. The fixed combination is intended for maintenance use, typically after monotherapy failure, rather than for the initiation of hypertension treatment.

Recent Clinical Evidence

Research evidence / Overview of studies for Amlopril

This overview presents a summary of the medicine’s clinical evaluation based on official research evidence, including findings from randomized controlled trials, systematic reviews, and data referenced by authoritative health bodies.


Evidence for use in Managing High Blood Pressure (Hypertension)

The research base for this combination consists primarily of large-scale, double-blind Randomized Controlled Trials (RCTs). These studies included comparisons of this combination against single-drug treatments and sometimes against other combinations. The trials focused on measuring changes in Systolic and Diastolic Blood Pressure (BP), taken both in a clinic setting and over 24-hour periods. Findings describe patterns where trials consistently reported measurements of BP change in adults with systemic hypertension, including those whose pressure was not adequately controlled on monotherapy.


Research Examining Cardiovascular Outcomes in High-Risk Patients

Research exploring long-term clinical outcomes was examined in large, dedicated RCTs. These studies were designed to monitor major clinical outcomes over extended periods, focusing on patients considered high-risk with conditions such as diabetes or coronary artery disease. The research tracked a composite endpoint that included nonfatal heart attack, nonfatal stroke, and measures of cardiovascular survival.

Trials explored the event rate patterns when the amlodipine/benazepril combination was compared to an alternative dual-therapy regimen (an ACE inhibitor plus a diuretic). The evidence describes group patterns from this comparison, but comparative evidence against all possible regimens is lacking. The largest long-term trial had a mean observation period of approximately three years.


Research on Blood Pressure Variability (BPV) and Specific Measures

Research explored metrics using smaller-scale trials, focusing on outcomes related to physiological strain. These studies examined changes in Blood Pressure Variability (BPV) and the profile of the Morning Blood Pressure Surge. Trials reported specific numerical patterns in the measured change of BPV parameters and described measurements related to morning BP profiles observed in the populations studied. However, the follow-up durations were limited for these studies, which focused on intermediate outcomes (BPV metrics) rather than definitive long-term clinical endpoints.

Key Studies & References Amlodipine and Benazepril: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Amlopril (FAQ)


Q: Is Amlopril used for anxiety or just blood pressure?

A: Amlopril is formally indicated, based on regulatory information, for the treatment of hypertension (high blood pressure). It is not indicated or approved for the treatment of anxiety.


Q: Can Amlopril cause fatigue or dizziness?

A: Yes, official product information lists fatigue and dizziness as commonly reported side effects. This means they occurred in 1% to 10% of patients during clinical trials.


Q: Is Amlopril safe for older adults?

A: Amlopril is used in adults, including older individuals. However, regulatory documents specify that a lower initial dose of the Amlodipine component may be considered for older adults.


Q: Can I drink alcohol while taking Amlopril?

A: Official studies show that the Amlodipine component does not significantly change how your body processes ethanol (alcohol). However, because both Amlopril and alcohol can lower blood pressure, combining them may lead to additive hypotensive effects, increasing the chance of dizziness or lightheadedness.


Q: How long do I have to take Amlopril for?

A: Amlopril is indicated for the treatment of hypertension, which is a chronic condition. Therefore, it is generally used for long-term, sustained management of blood pressure.


Q: What are the long-term side effects of taking Amlopril?

A: Regulatory documents classify side effects based on how often they occur (common, uncommon, rare) during clinical trials, rather than separating them into short-term or long-term categories. While all known serious adverse reactions are documented, the overall safety profile is continuously monitored based on these reported frequencies.


Q: Is Amlopril safe for people with diabetes?

A: Amlopril is explicitly contraindicated (must not be used) in patients who have diabetes and are also taking the drug aliskiren. If you have diabetes and are not taking aliskiren, the appropriateness of use is determined by a healthcare professional.


Q: Does Amlopril increase sun sensitivity?

A: Postmarketing reports for the active ingredient Benazepril have included instances of photosensitivity, which is an increased sensitivity to the sun. Protecting the skin from sun exposure may be recommended.


Q: Can Amlopril cause frequent urination?

A: Official postmarketing reports associated with the active ingredient Benazepril have included instances of frequent urination.


Q: Can Amlopril cause muscle cramps or joint pain?

A: Muscle pain and joint pain are listed as uncommon side effects. Muscle cramps have also been reported in postmarketing experience.


Q: Will Amlopril cure my high blood pressure?

A: Amlopril is indicated to treat and lower blood pressure, which is a key part of managing hypertension. Hypertension is a chronic condition, and medications like Amlopril are used for sustained control, not to provide a cure.


Q: Is Amlopril a controlled substance?

A: No, Amlopril (amlodipine/benazepril) is a prescription medicine but is not classified or listed as a scheduled controlled substance by regulatory agencies.


Q: How long does Amlopril stay in your system?

A: The time it takes for the concentration of the Amlodipine component to decrease by half in the bloodstream (known as the half-life) is long, typically ranging from 30 to 50 hours.


Q: Can Amlopril affect sexual function?

A: Yes, official adverse reaction reports for Amlopril’s components include decreased libido (sexual desire) and impotence (erectile dysfunction).


Q: Is Amlopril a first-line treatment for hypertension?

A: The Amlopril fixed-dose combination product is not indicated or approved for use as the initial therapy to start treatment for hypertension. It is typically used for maintenance therapy after other treatments have been tried.


Q: Does Amlopril have a coating or special release mechanism?

A: Amlopril is provided as a capsule containing the active ingredients. The regulatory label describes the physical form of the medicine but does not note a special enteric or extended-release coating.


Q: Why does Amlopril have to be taken every day at the same time?

A: The instruction to take the medicine at the same time ensures consistent daily dosing. This maintains a stable concentration of the active drugs in your body, which is required for effective and sustained 24-hour blood pressure control.


Q: Can Amlopril cause acid reflux or stomach issues?

A: Official adverse event reports have documented conditions like esophagitis (inflammation of the esophagus) and gastritis (inflammation of the stomach lining) in patients, which can contribute to stomach issues or acid reflux symptoms.


Q: What should I do if my blood pressure gets too low while on Amlopril?

A: The label notes that symptomatic hypotension (very low blood pressure that causes symptoms) is possible. The general regulatory information notes that if severely low blood pressure occurs, medical attention is required for supportive management and assessment of hydration status.


How should Amlopril be stored and disposed of?

How to Store and Dispose of Amlopril

Storage and disposal requirements for Amlopril (amlodipine/benazepril) are governed by official regulatory labeling to ensure product integrity.

Storage Requirement Official Condition
Temperature Store at controlled room temperature (59 F to 86 F or 15 C to 30 C).
Protection Keep in a dry place; protect from moisture and excessive heat.
Container Rule Keep in the original container and maintain it tightly closed when not in use.

All medicine must be stored out of the sight and reach of children. The product labeling instructs that unused or expired Amlopril must be thrown away, and guidance from a pharmacist or healthcare professional should be sought for proper disposal methods, such as utilizing authorized drug take-back programs.

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

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