Enalapril maleate tablet belongs to a prescription-only oral pharmaceutical agent categorized as an angiotensin-converting enzyme inhibitor, commonly abbreviated as ACE inhibitor in clinical practice. This oral tablet preparation is primarily indicated for the standardized treatment of persistent hypertension, symptomatic congestive heart failure, as well as asymptomatic left ventricular systolic dysfunction in adult patients. The core pharmacologically active constituent of this tablet is enalapril malete, a stable maleic acid salt derivative synthesized based on the parent molecular structure of enalapril.
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| Product Name | Enalapril Maleate Tablet | Enalapril Maleate Oral Solution |
| Product Type | Tablet | Liquid |
| Product Purity | ≥99% | ≥99% |
| Product Specifications | 2.5mg/5mg/10mg | 150ml/1.05g |
| Product Form | Take Orally | External application |
Enalapril Maleate COA
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| Certificate of Analysis | ||
| Compound name | Enalapril maleate | |
| Grade | Pharmaceutical grade | |
| CAS No. | 76095-16-4 | |
| Quantity | Customized | |
| Packaging standard | Customized | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090049 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.49% |
| Loss on drying | ≤1.0% | 0.32% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.90% |
| Single impurity | <0.8% | 0.47% |
| Total microbial count | ≤750cfu/g | 80 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 500ppm |
| Storage | Store in a sealed, dark, and dry place below 2-8°C | |
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The decreased angiotensin II removes its original negative feedback restraint on renal renin secretion, thus inducing a compensatory elevation in plasma renin activity. A series of subsequent physiological reactions including systemic peripheral vasodilation follow, which effectively reduce systemic blood pressure and simultaneously alleviate excessive preload and afterload burden imposed on cardiac muscle tissue. As a reliable first-line antihypertensive therapeutic tablet, it can be administered as monotherapy for mild to moderate hypertension or applied in combined medication regimens together with other categories of antihypertensive agents to achieve better blood pressure control outcomes.
Core treatment area: Dual management of hypertension and heart failure
Hypertension Treatment: From Basic Mechanisms to Clinical Applications
The core mechanism of enalapril maleate tablet, as an angiotensin-converting enzyme inhibitor (ACEI), is to inhibit ACE and block the conversion of angiotensin I to angiotensin II. Angiotensin II is one of the strongest vasoconstrictors in the body, and its reduced production can directly lead to peripheral vasodilation, lower peripheral vascular resistance, and thus lower blood pressure. In addition, ACE inhibition can reduce aldosterone secretion, promote water and sodium excretion, and further assist in lowering blood pressure.
Widely applicable: covering various types such as primary hypertension, renal vascular hypertension, malignant hypertension, etc.Among them, renal vascular hypertension is caused by renal artery stenosis leading to overactivation of the renin-angiotensin system (RAS), and Enalapril can exert specific antihypertensive effects by inhibiting the RAS system.Dose flexibility: The initial dose is usually 5-10mg per day, divided into 1-2 oral doses. For patients with severe renal impairment (creatinine clearance rate<30ml/min), the initial dose should be reduced to 2.5mg/day to avoid adverse reactions such as hypotension caused by drug accumulation.
Advantages of combination therapy: When used in combination with diuretics (such as hydrochlorothiazide), it can significantly enhance the antihypertensive effect, especially for refractory hypertension. However, it is necessary to avoid the combination with pond potassium diuretics (such as spironolactone) to prevent hyperkalemia.
Heart Failure Treatment: From Symptom Relief to Prognostic Improvement
The position of enalapril maleate tablet in the treatment of heart failure stems from its dual regulatory effect on the neuroendocrine system: on the one hand, it reduces the production of angiotensin II and aldosterone by inhibiting the RAS system, thereby alleviating cardiac afterload; On the other hand, by inhibiting the degradation of bradykinin and enhancing the release of nitric oxide (NO) and prostaglandins (PG), it exerts vasodilation and anti myocardial remodeling effects.
Symptomatic heart failure: used to improve survival rate, delay heart failure progression, and reduce hospitalization frequency. Research shows that Enalapril can reduce the mortality rate of heart failure patients by 27% and the hospitalization rate by 31%.
Asymptomatic left ventricular dysfunction: For asymptomatic patients with a left ventricular ejection fraction (LVEF) ≤ 35%, Enalapril can delay the onset of heart failure and reduce the risk of hospitalization.
Dose adjustment: The initial dose is usually 2.5mg twice a day, gradually increasing to the target dose (usually 10-20mg twice a day) based on tolerance. The maximum dose should not exceed 40mg/day.
Medication for special populations: precise dosage adjustment and risk prevention and control
Patients with renal insufficiency
Patients with renal insufficiency should pay special attention to dosage adjustment when using Enalapril, as the drug is mainly excreted through the kidneys. Reduced renal function can lead to drug accumulation, increasing the risk of adverse reactions such as hypotension and hyperkalemia.
Mild renal insufficiency (creatinine clearance rate 30-60ml/min): No need to adjust the initial dose.
But close monitoring of blood pressure and renal function is required.Moderate renal insufficiency (creatinine clearance rate<30ml/min): The initial dose is reduced to 2.5mg/day, and the maximum dose does not exceed 10mg/day.
Dialysis patients: Medication should be administered after dialysis to avoid blood pressure fluctuations caused by rapid drug clearance during the dialysis process.
Elderly patients
Elderly patients with reduced physiological function have increased sensitivity to Enalapril, which can lead to adverse reactions such as hypotension and dizziness.
Initial dose: Start from a low dose (2.5-5mg/day) and gradually increase to the target dose based on tolerance.
Monitoring indicators: Regularly monitor blood pressure, blood potassium, creatinine, and urea nitrogen levels.
Combination therapy: Avoid using drugs that may worsen hypotension, such as alpha blockers.
Child patients
The use of Enalapril in children requires dosage adjustment based on weight and age, mainly for the treatment of hypertension and heart failure associated with certain congenital heart diseases.
Children over 1 month old: The initial dose is 0.08mg/kg/day, and the maximum dose does not exceed 0.6mg/kg/day.
Newborns and infants: Use with caution as the drug clearance rate is low due to incomplete kidney function development.
Extended Applications: From Guideline Recommendations to Clinical Practice
Secondary prevention after myocardial infarction
The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommend that for patients with ST segment elevation myocardial infarction (STEMI) without contraindications, ACEI treatment should be initiated within 24 hours of onset.The European Society of Cardiology (ESC) guidelines list ACEIs as Class I recommended drugs for long-term treatment after myocardial infarction.
Protective effect of diabetes nephropathy
Enalapril maleate tablet can reduce glomerular hypertension, hyperperfusion and hyperfiltration by inhibiting RAS system, thus delaying the progress of diabetes nephropathy.
The guidelines of the American diabetes Association (ADA) recommend that ACEI or ARB (angiotensin receptor antagonist) should be used for the treatment of type 1 and type 2 diabetes patients with microalbuminuria.
According to the guidelines of KDIGO, ACEI is listed as the first-line treatment drug for diabetes nephropathy.Enalapril can also be used to treat certain types of cardiovascular diseases, such as aortic valve stenosis, hypertrophic cardiomyopathy, etc., but it needs to be used under the guidance of a specialist doctor.
Medication precautions: from contraindications to adverse reaction management
Contraindications and relative contraindications
Absolute contraindications
Individuals allergic to Enalapril or any ACEI.
Late pregnancy.
History of angioedema (due to ACEI induced severe allergic reactions such as laryngeal edema).
Relative contraindications
Bilateral renal artery stenosis (which can lead to rapid deterioration of renal function).
Hyperkalemia (due to ACEI reducing aldosterone secretion and exacerbating hyperkalemia).
Common adverse reactions and management
hypotension
Incidence rate: about 5% -10%, often seen during initial treatment or dose increase.
Management: Reduce dosage, administer in divided doses.
Hyperkalemia
Incidence rate: about 2% -5%, commonly seen in cases of renal insufficiency or in combination with potassium sparing diuretics.
cough
Incidence: Approximately 5% -20%, caused by the accumulation of bradykinin that irritates the respiratory tract.
Vascular edema
Incidence rate: about 0.1% -0.5%, often seen during the first use or dose increase.
Management: Stop medication immediately.
Drug interactions
Combined use with diuretics
Enhance the blood pressure lowering effect, but pay attention to low blood pressure and electrolyte imbalance.At the beginning of treatment, diuretics can be stopped for 1-2 days before starting Enalapril treatment.
Combined use with nonsteroidal anti-inflammatory drugs (NSAIDs)
NSAIDs can weaken the antihypertensive effect of Enalapril and increase the risk of renal dysfunction.Avoid combination therapy or closely monitor blood pressure and kidney function.
Combined with lithium agent
Enalapril is capable of significantly inhibiting the renal excretion of lithium ions within the human body, which may cause excessive lithium accumulation in blood tissues and subsequently trigger severe lithium poisoning with toxic systemic symptoms. Clinicians should avoid simultaneous combined administration of enalapril and lithium-containing preparations as much as possible; if concurrent medication is unavoidable, regular dynamic monitoring of serum lithium concentration is required throughout the treatment cycle.
references
Enalapril malate: A new long-acting angiotensin converting enzyme inhibitor for treatment of hypertension, 1985
Efficacy of enalapril malate in patients with chronic congestive heart failure, 1988
Safety and tolerability of long-term enalapril malate monotherapy in elderly hypertensive patients, 2001
FAQ
Q1: What drug class does enalapril malate belong to?
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A1: It is an oral angiotensin-converting enzyme (ACE) inhibitor for cardiovascular treatment.
Q2: What are its primary clinical indications?
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A2: This oral enalapril malate is clinically approved for three primary cardiovascular disorders, including primary and secondary hypertension of various severities, chronic congestive heart failure with obvious cardiac insufficiency symptoms, as well as left ventricular systolic dysfunction that develops as a sequela after acute myocardial infarction.
Q3: What common mild adverse reaction should patients watch out for?
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A3: Dry persistent cough represents the most distinctive and prevalent typical adverse side effect triggered by long-term administration of enalapril malate. The root pharmacological cause lies in the sustained inhibition of angiotensin-converting enzyme, which hinders the normal degradation process of bradykinin inside respiratory mucosal tissues, resulting in abnormal buildup and drastically elevated bradykinin levels that irritate airway sensory nerves and induce recurrent unproductive cough without sputum production.
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