Lotrial

Quick links to important sections

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Lotrial

What is Lotrial?

Lotrial is a prescription medication belonging to a class of drugs known as angiotensin-converting enzyme (ACE) inhibitors. It contains the active ingredient enalapril maleate, which is used primarily to manage conditions related to the cardiovascular system.

Mechanism of Action

The medication works by interfering with the body's production of angiotensin II, a naturally occurring substance that causes blood vessels to narrow. By inhibiting this process, Lotrial allows blood vessels to relax and widen. This action results in several physiological effects:

  • Reduction of Blood Pressure: The widening of the blood vessels lowers peripheral resistance, making it easier for blood to flow through the circulatory system.
  • Decreased Cardiac Workload: Because the vessels are more relaxed, the heart does not need to pump as forcefully to circulate blood throughout the body.
  • Improved Blood Flow: The medication helps enhance systemic circulation, which can be beneficial in various clinical contexts involving heart function.

Therapeutic Use

Lotrial is typically utilized in the long-term management of chronic cardiovascular conditions. It is frequently prescribed for the treatment of hypertension (high blood pressure) and as part of a therapeutic regimen for heart failure. In cases of heart failure, it may be used to improve symptoms and reduce the strain on the heart muscle. Additionally, it may be indicated for certain patients with asymptomatic left ventricular dysfunction to help manage the progression of heart-related issues.

Regulatory References

  1. World Health Organization's List of Essential Medicines

What side effects are possible with Lotrial?

Official Classification of Possible Side Effects

The safety profile of Lotrial (Enalapril maleate) is officially classified by government regulatory documents based on the frequency and system-organ class (SOC) of reported adverse reactions. The medicine's risk characteristics are defined by these structured classifications and specific safety constraints.

Frequency Category Examples of Officially Listed Side Effects
Common (1% to <10%) Dizziness, headache, fatigue, nausea, and the characteristic dry, persistent cough
Uncommon (0.1% to <1%) Orthostatic hypotension, syncope (fainting), chest pain, vertigo, rash, and abdominal pain
Rare (0.01% to <0.1%) Angioedema, hepatic failure, acute renal failure, and severe skin disorders

Serious Adverse Reactions and Safety Constraints

Serious Adverse Reactions officially documented in regulatory labels include Angioedema, a potentially severe swelling involving the face, lips, tongue, or throat. Rare but significant documented effects also include acute renal failure and hepatic failure.

Safety constraints and patterns are noted for certain circumstances:

  • Exposure-Related Pattern: Symptomatic hypotension (excessively low blood pressure) is explicitly documented as being most likely to occur after the first dose or following an increase in dosage.
  • Population Constraint: The medicine is officially contraindicated for use during the second and third trimesters of pregnancy due to documented risks to the fetus. It is also restricted in patients with a history of angioedema related to prior ACE inhibitor therapy and those with specific pre-existing conditions like bilateral renal artery stenosis.

Overdose and Emergency Response

The official regulatory documentation for Lotrial (enalapril maleate) overdose defines the risk profile based on the severe physiological effects resulting from excessive pharmacological activity.

Documented Clinical Manifestations and Outcomes

The most prominent manifestation of overdose is marked hypotension, a profound drop in blood pressure. Other clinical signs documented in regulatory sources include central nervous system effects such as stupor, dizziness, and anxiety, along with cardiovascular changes like tachycardia or bradycardia. Severe consequences may include progression to circulatory shock, acute renal failure, and, rarely, death. Overdose is also associated with significant electrolyte disturbances, specifically hyperkalaemia. The overdose profile also notes that patients with pre-existing impaired renal function may require more intensive monitoring.

Mandated Emergency Actions

Emergency medical attention must be sought immediately if an overdose is suspected or confirmed. Treatment is strictly required to be symptomatic and supportive, as no specific antidote is known. The initial documented intervention involves placing the patient in the supine position and initiating an intravenous infusion of normal saline or other means of volume expansion to counteract hypotension. Specialized hospital management is required, as the active metabolite, Enalaprilat, is officially confirmed to be dialyzable via hemodialysis. Close observation and continuous monitoring of renal function and electrolyte levels are an essential part of the official management protocol.

Therapeutic Uses of Lotrial

What Lotrial treats: Main Uses and Benefits

Lotrial is applied across domains where additional symptomatic support is needed, used in situations involving certain distressing symptoms. The medication is commonly used to help with symptoms related to heightened physiological activity in three key areas: managing hypertension (high blood pressure), applied in scenarios involving congestive heart failure (CHF), and relevant for easing symptoms associated with left ventricular dysfunction.

The medicine is used in settings marked by temporary physiological imbalance and is often used during phases when symptoms become more noticeable. It supports patients during episodes of heightened discomfort by providing supportive relief when symptoms interfere with routine activities.

This medication assists with maintaining functional stability and offers symptomatic relief that helps patients cope more steadily with symptom fluctuations associated with these conditions.


Quick Fact: Relevant for Symptoms related to heightened physiological activity


Eligibility and Restrictions for Use

Who can and cannot use Lotrial?

Lotrial (Enalapril maleate) eligibility is strictly defined by regulatory authorities based on age, specific medical history, and physiological status.

Absolute Contraindications (Must Not Use) The medicine is strictly contraindicated for:

  • Patients with a history of angioedema (swelling) related to any prior ACE inhibitor use, or with confirmed hereditary or idiopathic angioedema.
  • Women during the second and third trimesters of pregnancy; treatment must be stopped immediately upon detection of pregnancy.
  • Concurrent use with the medicine sacubitril/valsartan within a 36-hour period, or with aliskiren in patients who have diabetes or moderate to severe renal impairment.
  • Individuals with known hypersensitivity to the active substance or any other ACE inhibitor.

Age and Conditional Eligibility

  • Approved Use: The medicine is approved for adults for all labeled indications. For children, it is approved for the treatment of hypertension only, starting at one month of age.
  • Restricted Use: Use is not recommended for neonates (infants under one month). Patients with renal impairment (kidney disease) or hepatic impairment (liver disease) are conditional eligibility groups and require careful management. Additionally, use in pediatric patients with severely reduced kidney function (GFR < 30 mL/min/1.73 m^2) is not recommended. For breastfeeding, the medicine is generally not recommended.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Lotrial's official regulatory profile documents specific interaction patterns concerning pharmacodynamic and pharmacokinetic effects, as well as mandatory restrictions for co-administration. These rules are defined in prescribing information to manage the risk of adverse outcomes.

Category Documented Regulatory Restriction
Formal Contraindication Co-administration with Neprilysin (NEP) inhibitors (e.g., Sacubitril) is strictly prohibited.
Population-Specific Ban Co-administration with Aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR < 60 ml/min/1.73 m^2).
Timing Separation A mandatory 36-hour separation window is required when switching between Lotrial and NEP inhibitors.

Co-administration with other agents that raise potassium levels, such as potassium-sparing diuretics and potassium supplements, is documented to carry a risk of hyperkalaemia (elevated blood potassium). Similarly, taking Lotrial with potassium-containing salt substitutes requires caution. For co-administered Lithium, the official label documents a reduction in its renal clearance, which can lead to a reversible increase in serum lithium concentrations. Furthermore, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are noted to potentially reduce Lotrial's blood pressure-lowering effect and increase the risk of renal function deterioration. Agents like mTOR inhibitors are documented to increase the risk for angioedema when combined with Lotrial.

Mechanism of Action

Lotrial (enalapril maleate) functions as a prodrug that undergoes hydrolysis, primarily in the liver, to its active metabolite, enalaprilat. Enalaprilat is a competitive inhibitor of the angiotensin-converting enzyme (ACE) peptidyl dipeptidase.

This interaction targets and inhibits the conversion of angiotensin I to the potent vasoconstrictor angiotensin II within the renin-angiotensin-aldosterone system (RAAS). Inhibition of ACE leads to a reduction in systemic circulating and localized tissue levels of angiotensin II. The molecular consequences include decreased signaling through the angiotensin II type 1 (AT1) receptor, which is responsible for mediating vasoconstriction and aldosterone secretion.

Downstream, the decreased angiotensin II levels result in reduced total peripheral arterial resistance through vasodilation, and diminished aldosterone production from the adrenal cortex. Additionally, enalaprilat impedes the breakdown of the vasodilator bradykinin by ACE (also known as kininase II), contributing to enhanced kinin-mediated vasodilation.

The system-level physiological consequence of this dual action is a reduction in systemic vascular resistance and a modulated fluid and electrolyte balance via reduced sodium and water reabsorption in the kidney.

Dosage and Administration Information

How Lotrial is Used: Official Administration Guidelines

Lotrial (Enalapril maleate) is administered according to specific protocols governing its form, route, and dosing schedule. The active substance is available as an oral tablet (Enalapril maleate) for long-term management, and as an intravenous (IV) solution (Enalaprilat, the active metabolite) for use when oral intake is not feasible.

Dosing and Schedule

Administration typically follows a titration schedule, meaning treatment starts at a specified low dose and is gradually increased over days or weeks to reach the optimal labeled maintenance dose range. The dosage frequency is either once daily or in two divided doses (BID), depending on the specific condition and patient response. For hypertension, the usual starting dose is 5 mg once daily, with the maximum labeled daily dose being 40 mg. The oral tablet may be taken with or without food as the absorption is not affected by meals.

Administration Specifics and Adjustments

Patients with impaired kidney function (creatinine clearance le 30 mL/min) and those concurrently receiving diuretics typically require a reduced initial oral dose of 2.5 mg once daily. When the intravenous form is used, the solution must be administered as a slow injection or infused over at least five minutes. For pediatric patients with hypertension (ages one month and older), the starting dose is calculated by weight, not to exceed 5 mg once daily. If a dose is missed, guidance generally advises taking the next dose at the regular scheduled time without taking a double dose to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lotrial

Evidence for use in Managing High Blood Pressure (Hypertension)

Lotrial was studied for its use in managing high blood pressure, a condition where symptoms may vary in intensity. The research focused primarily on large-scale clinical trials and observational studies designed to monitor changes in blood pressure readings over defined time intervals. These studies examined outcomes related to systemic or functional imbalance in adults with hypertension, focusing on research that studied changes in blood pressure readings and what patterns were observed in relation to this primary area of research.

The findings describe patterns observed in the studies where Lotrial was associated with changes in blood pressure levels during the observation period. While this evidence contributes to the broader evidence landscape, it is important to remember that these findings describe group patterns, not personal outcomes.

Evidence for use in Heart Failure Following a Heart Attack

Lotrial was evaluated in research exploring its role in people who have developed heart failure after experiencing a heart attack, which is a condition marked by functional limitations. These studies explored how the drug was observed in a clinical setting in research exploring certain measures related to heart performance. The focus of this research was studied for outcomes reflecting daily functioning or activity level and measures of heart performance.

Long-term Studies and Follow-up

Research was studied for the long-term patterns associated with Lotrial use. These studies monitored patients over multiple years to observe potential extended outcomes and highlighting what studies monitored regarding the duration of observed changes and any long-term patterns. Despite this, the long-term effects are not fully established, and evidence is limited for outcomes tracked beyond specific follow-up durations.

What is Still Uncertain about Lotrial

Research describes several areas where the understanding of Lotrial is still evolving. This includes areas where findings were mixed across different studies or where the evidence is limited. The main uncertainties include the lack of robust comparative evidence against other treatment options for both conditions, especially over the very long term. It is important to understand that research does not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Lotrial (FAQ)


Q: Is Lotrial a diuretic ('water pill') or is it only a blood pressure medication?

Lotrial is classified as an Angiotensin-Converting Enzyme (ACE) inhibitor, meaning it is not a diuretic. It primarily reduces blood pressure and heart strain by blocking the creation of a powerful vasoconstrictor. Official product information notes it may be used in combination with diuretics for treating hypertension and heart failure.


Q: Is Lotrial the same as Enalapril, and what are its other brand names?

Lotrial is a brand name for the active ingredient enalapril maleate. Enalapril is the International Nonproprietary Name (INN) for the drug. Depending on the country, this drug may be available under other brand names, such as Vasotec, Epaned, or Renitec, in addition to generic forms.


Q: How is Lotrial different from Losartan, since both treat high blood pressure?

Lotrial (an ACE inhibitor) and Losartan (an ARB) belong to two different classes of medication. Lotrial works by preventing the body from creating a substance called Angiotensin II, which constricts blood vessels. Losartan works by blocking the specific receptors that Angiotensin II attaches to. Both actions ultimately lead to the relaxation of blood vessels and a reduction in blood pressure.


Q: What is the typical timeframe before noticing a blood pressure drop after starting Lotrial?

Lotrial must be converted into its active form, enalaprilat, to begin working. This active form reaches its peak concentration in the blood within about four hours. The maximum effect on blood pressure is generally observed around 4–6 hours after a dose is taken, according to pharmacokinetics data.


Q: Is it normal to feel a little dizzy or lightheaded when first starting Lotrial?

Yes, regulatory documents list dizziness as a very common side effect. The documentation indicates that effects like syncope (fainting) and orthostatic hypotension (feeling dizzy upon standing up) are a potential pattern of the drug's action, most likely to occur after the initial dose or when the dosage is increased.


Q: Can the dry cough caused by Lotrial eventually go away on its own?

Official product information classifies the dry, persistent cough as a common side effect of ACE inhibitors. However, regulatory labels do not provide specific data or advice on how long the cough typically lasts or if it resolves spontaneously over time.


Q: Are there any serious, rare side effects of Lotrial that patients should be aware of?

Official regulatory warnings highlight several serious but rare adverse reactions. These include angioedema (a severe swelling of the face, tongue, or throat), hepatic failure (liver failure), and acute renal failure (sudden kidney failure). Angioedema is considered a rare but serious adverse reaction requiring immediate medical attention.


Q: Does Lotrial have a potential for causing high potassium levels (hyperkalemia)?

Yes, the potential for elevated blood potassium levels, known as hyperkalemia, is listed in the Warnings and Precautions section of the drug label. The risk is due to Lotrial's effect on the kidney's ability to excrete potassium. Hyperkalemia is also listed as a common side effect in some official reports.


Q: What are the signs of high potassium that someone taking Lotrial might experience?

If potassium levels become too high, symptoms may include nausea, weakness, tingling or tingly feeling, chest pain, and irregular heartbeats. Official information suggests awareness of these symptoms.


Q: Can Lotrial be taken at any time of day, or is a specific time better?

Official regulatory documents indicate that Lotrial is typically administered either once or twice daily and may be taken with or without food. The documents do not specify whether a particular time of day (such as morning versus evening) is optimal for all patients.


Q: Should alcohol intake be limited or avoided while on Lotrial treatment?

Official regulatory information notes that alcohol (ethanol) may have additive effects with Lotrial in lowering blood pressure. This combination can increase the risk of symptoms related to low blood pressure, such as feeling dizzy or lightheaded.


Q: Can Lotrial cause low blood pressure (hypotension) symptoms like fainting?

Yes, symptomatic hypotension (excessively low blood pressure) and syncope (fainting) are listed side effects. Official warnings emphasize that low blood pressure is most likely to occur after the very first dose or when the current dosage is increased.


Q: Can Lotrial cause changes in vision, such as blurred vision?

According to the official adverse reaction data, blurred vision is a listed side effect. In some specific patient populations tracked in regulatory data, it is even categorized as a very common side effect.


Q: Is it normal to experience increased fatigue or weakness when starting Lotrial?

Official product information lists fatigue as a common side effect. Additionally, general patient counseling materials often note that unusual tiredness or weakness is a commonly reported symptom when starting the medication.


Q: What are the signs of potential liver problems related to Lotrial use?

While rare, regulatory information documents the risk of liver problems, including hepatic failure. Signs of potential liver problems may include pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, and jaundice (yellowing of the skin or eyes).


Q: Can Lotrial be taken safely with other heart medications like beta-blockers or calcium channel blockers?

Official labeling for heart failure indicates co-administration with other cardiac medicines, such as beta-blockers, is part of the documented therapeutic strategy. This suggests that the medication is commonly used alongside these other heart drugs.


Q: What are the signs that Lotrial might be affecting kidney function?

Rare but serious effects on the kidney, such as acute renal failure, are documented. Signs of a potential kidney issue can include swelling (edema), urinating less frequently, feeling tired, or being short of breath. Monitoring of kidney health via blood tests is commonly part of the therapeutic plan.


Q: Is there a generic version of Lotrial available, and is it just as effective?

Yes, regulatory authorities have approved generic versions of Enalapril maleate. To gain approval, generic drugs must demonstrate they are biologically equivalent and work the same way as the brand-name drug.


Q: Can dehydration or excessive sweating increase the side effects of Lotrial?

Yes, regulatory warnings note that becoming dehydrated or overheated (for instance, from excessive sweating, fever, or low fluid intake) can increase the risk of side effects. This is because dehydration can lead to excessively low blood pressure (hypotension) or an electrolyte imbalance.


Q: Why do some patients report an altered sense of taste (dysgeusia) with Lotrial?

According to the official list of adverse reactions, an altered sense of taste or dysgeusia is listed as an uncommon side effect of the medication. This is a known, though not frequent, effect of ACE inhibitors.


Q: Can Lotrial cause a persistent headache, and is that a common problem?

The official product label lists headache as a common side effect of Lotrial. However, regulatory documents do not provide specific details on the likelihood of the headache being 'persistent' or lasting for a long duration.


Q: Does Lotrial contribute to skin sensitivity or a rash after sun exposure (photosensitivity)?

Yes, regulatory documentation lists photosensitivity (increased skin sensitivity to sunlight) as an uncommon adverse reaction. This suggests that the medication may increase the risk of developing a rash or adverse skin reaction after sun exposure.


Q: Are there specific dietary restrictions, besides avoiding potassium-rich salt substitutes, when taking Lotrial?

Official patient information focuses primarily on the need to manage potassium intake, specifically avoiding potassium-containing salt substitutes. Patients are generally advised to follow guidance about fluid intake and to maintain a normal diet otherwise.

How should Lotrial be stored and disposed of?

Official Storage and Disposal Instructions

The storage and disposal instructions for Lotrial (enalapril maleate) are formally defined by regulatory labeling to maintain the drug's stability and ensure safety.

Requirement Area Regulatory Statement
Temperature & Environment Tablets must be stored at Controlled Room Temperature (20 C to 25 C). All forms must be protected from moisture and excessive heat and must not be frozen.
Container & Protection Keep the medicine in its original container, and ensure the container is tightly closed to protect from moisture.
Stability (Oral Solution) If the liquid formulation is stored at room temperature, it must be discarded after 60 days, regardless of the labeled expiration date. It may be refrigerated for longer stability.
Child-Safety Mandatory: The medication must be kept out of the sight and reach of children at all times.
Disposal Guidelines Unused or expired medication should be disposed of using a drug take-back program. If unavailable, mix the product with an undesirable substance (e.g., dirt) in a sealed container before throwing it in the household trash. Lotrial is not on the flush list and must not be flushed down the toilet.

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

Available in countries:

Equivalent of Lotrial found in:

A-Z Index: