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Enalapril Maleate Tablet
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Enalapril Maleate Tablet

Enalapril Maleate Tablet

1.General Specification(in stock)
(1)API(Pure powder)
(2)Tablet
2.5mg/5mg/10mg
(3)Solution
150ml/1.05g
2.Customization:
We will negotiate individually, OEM/ODM, No brand, for secience researching only.
Internal Code: BM-2-113
Enalapril maleate CAS 76095-16-4
Main market: USA, Australia, Brazil, Japan, Germany, Indonesia, UK, New Zealand , Canada etc.
Manufacturer: BLOOM TECH Xi’an Factory
Analysis: HPLC, LC-MS, HNMR
Technology support: R&D Dept.-4

 

Enalapril Maleate Tablet is a prescription drug of angiotensin-converting enzyme inhibitor (ACE inhibitor), mainly used to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. Its main active ingredient is enalapril maleate, which is the maleic acid salt form of enalapril. Enalapril is derived from two amino acids, L-alanine and L-proline. Enalapril is hydrolyzed in the body into enalapril, which is a potent angiotensin-converting enzyme (ACE) inhibitor. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to angiotensin II, which has a pressor effect. By inhibiting ACE, enalapril can reduce the production of angiotensin II, thereby lowering plasma levels of angiotensin II. This leads to an increase in plasma renin activity (due to the removal of negative feedback inhibition of renin by angiotensin II), which in turn dilates blood vessels, lowers blood pressure, and reduces the burden on the heart. This tablet is an effective medication for treating hypertension, which can be used alone or in combination with other antihypertensive drugs.

Enalapril Maleate Tablet | Shaanxi BLOOM Tech Co., Ltd Enalapril Maleate Tablet | Shaanxi BLOOM Tech Co., Ltd

Produnct Introduction

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

Enalapril Maleate | Shaanxi BLOOM Tech Co., Ltd
Certificate of Analysis
Compound name Enalapril maleate
Grade Pharmaceutical grade
CAS No. 76095-16-4
Quantity 337.3kg
Packaging standard 25kg/drum
Manufacturer Shaanxi BLOOM TECH Co., Ltd
Lot No. 202501090049
MFG Jan 9th 2025
EXP Jan 8th 2028
Structure

Enalapril Maleate | Shaanxi BLOOM Tech Co., Ltd

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

Enalapril Maleate | Shaanxi BLOOM Tech Co., Ltd

Enalapril Maleate | Shaanxi BLOOM Tech Co., Ltd

product-338-68

Core treatment area: Dual management of hypertension and heart failure

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

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.

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd
Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

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.

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

Medication for special populations: precise dosage adjustment and risk prevention and control

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

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.

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

 

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

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.

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

Extended Applications: From Guideline Recommendations to Clinical Practice

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

Secondary prevention after myocardial infarction

 

Enalapril plays an important role in the secondary prevention of myocardial infarction by inhibiting the RAS system, reducing myocardial remodeling, and lowering the risk of recurrent infarction and death.
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.

Enalapril Maleate Tablet  use| Shaanxi BLOOM Tech Co., Ltd

Medication precautions: from contraindications to adverse reaction management

Contraindications and relative contraindications

Absolute contraindications

Individuals allergic to Enalapril or any ACEI.
Late pregnancy (due to potential causes such as fetal kidney failure, oligohydramnios, and underdeveloped skull in newborns).
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).
Aortic valve stenosis or hypertrophic obstructive cardiomyopathy (should be used with caution to avoid hypotension exacerbating obstruction).

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, or take with food (can slow absorption and reduce the risk of low blood pressure).

 
 

Hyperkalemia

Incidence rate: about 2% -5%, commonly seen in cases of renal insufficiency or in combination with potassium sparing diuretics.
Management: Monitor blood potassium, limit potassium intake, discontinue potassium sparing diuretics, and use potassium reducing resins if necessary.

 
 

cough

Incidence: Approximately 5% -20%, caused by the accumulation of bradykinin that irritates the respiratory tract.
Management: If coughing is severe, ARB drugs (such as losartan) can be switched.

 
 

Vascular edema

Incidence rate: about 0.1% -0.5%, often seen during the first use or dose increase.
Management: Stop medication immediately, administer antihistamines and corticosteroids, and in severe cases, tracheotomy is required.

 

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 can reduce lithium excretion, leading to lithium poisoning.
Avoid combination use or monitor blood lithium concentration.

 

 

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