Enalapril Maleate Dispersible Tablets

Enalapril maleate is hydrolyzed in the liver to enalaprilat, which is a renin angiotensin converting enzyme inhibitor (ACEI). Renin angiotensin converting enzyme (ACE) is a peptidyl dipeptide hydrolase that converts angiotensin I (AgI) into the vasoconstrictor angiotensin II (AgII). Inhibition of ACE can reduce the formation of AgII in tissues and plasma, reduce aldosterone secretion, and increase plasma potassium concentration. The weakening of the negative feedback effect of AgII on renin secretion will cause an increase in plasma renin activity. ACE can also degrade bradykinin (vasodilating peptide), and inhibition of ACE can increase the activity of the circulating and local kallikrein-kinin system (also the activity of the prostaglandin system). The blood pressure reduction and certain side effects of ACEI are related to this mechanism. For hypertensive patients, enalapril maleate can reduce supine and sitting blood pressure without causing compensatory heart rate acceleration. In hemodynamic examinations, enalapril maleate can significantly reduce peripheral vascular resistance. Enalapril maleate usually has no significant effect on renal blood flow or glomerular filtration rate. For most patients, the antihypertensive effect of enalapril maleate appears about 1 hour after taking the drug, and the peak occurs 4-6 hours after taking the drug. The maximum antihypertensive effect generally occurs 3-4 weeks after taking the prescribed dose. The antihypertensive effect persists with long-term medication at the recommended dose. Short-term drug withdrawal will not cause blood pressure rebound. Hemodynamic examinations of patients with heart failure found that enalapril maleate can reduce peripheral circulatory resistance, increase venous capacity, reduce cardiac preload and afterload (reduce cardiac perfusion pressure), increase cardiac output, and improve cardiac index and stress capacity. Toxicity studies did not find that enalapril maleate had mutagenic or carcinogenic effects in related in vitro and in vivo experiments.

The main ingredient of this product is enalapril maleate, and its chemical name is N-[(S)-1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl-L-proline, (Z)-butenedioate. Molecular formula: C24H32N2O9, molecular weight: 492.52

This product is white or off-white tablets.

hypertension.

When enalapril is used to treat patients with severe renal hypertension due to salt and water loss (e.g., dialysis, vomiting/diarrhea, diuretic therapy), treatment will cause a significant drop in blood pressure at the beginning. If possible, salt and/or fluid loss should be corrected before enalapril is used. Reduce or stop diuretics if necessary. These patients should start with the lowest dose of enalapril 2.5 mg in the morning. During the initial use of the drug, dose increase and/or use of diuretics, observation should be made for at least 8 hours to avoid unforeseen hypotensive reactions. For patients with malignant hypertension, treatment with enalapril must be performed in the hospital. Unless otherwise prescribed by a doctor, take the drug as follows: Hypertension: The usual initial dose is 5 mg (1 enalapril tablet) in the morning. If blood pressure cannot reach normal, the dose can be increased to 10 mg (2 enalapril tablets). The dose can be increased after 3 weeks of medication, and the maintenance dose is generally 10 mg/day, with a maximum dose of 40 mg/day. Dosage for moderate renal dysfunction (creatinine clearance 30-60ml/min) and elderly patients (over 65 years old): The initial dose is 2.5mg (half a tablet of enalapril) in the morning, and the maintenance dose is generally 5-10mg/day (1-2 tablets of enalapril). The maximum dose should not exceed 20mg/day (4 tablets of enalapril). Dosage for patients with severe renal dysfunction (creatinine clearance less than 30ml/min and dialysis): The initial dose is 2.5mg (half a tablet of enalapril) in the morning. Dialysis patients take the medicine after dialysis. The maintenance dose is generally 5mg/day (1 tablet of enalapril). The maximum dose should not exceed 10mg/day (2 tablets of enalapril). The time of taking the medicine is not related to meals. Generally, the full dose is taken once a day in the morning. If necessary, it can be divided into two doses in the morning and evening. The attending physician determines the course of medication.

Enalapril is well tolerated. The following adverse reactions may occur when using enalapril and ACEI drugs. The cardiovascular system may experience a significant drop in blood pressure (hypotension, orthostatic hypotension) accompanied by dizziness, pallor, visual confusion, etc. in the early stages of treatment, when the patient has salt and/or fluid loss (such as when diuretics have been used), heart failure, severe hypertension or renal hypertension, and when the dosage of enalapril and/or diuretics is increased. Loss of consciousness is rare. The following are side effects caused by excessive lowering of blood pressure by ACEI: tachycardia, palpitations, arrhythmia, chest pain, angina, myocardial infarction, transient ischemic stroke, and brain damage. Kidney damage may occasionally occur or worsen. In individual cases, it has led to acute renal failure. Observations have found

Enalapril is contraindicated in the following cases: 1. Hypersensitivity to enalapril maleate or other ACEI drugs or any of their components. 2. Known history of angioedema (such as angioedema caused by previous use of ACE inhibitors, hereditary/congenital angioedema). 3. Renal artery stenosis (bilateral or unilateral in patients with unilateral kidney). 4. Post-renal transplantation. 5. Hemodynamically relevant aortic or mitral stenosis, or hypertrophic cardiomyopathy. 6. Primary aldosteronism. 7. Primary liver disease or liver failure. 8. Pregnancy. 9. Lactation. During treatment with enalapril, concomitant use of polyacrylonitrile or sodium methyl allyl sulfide high-flux membranes (such as AN6

Precautions for children: Enalapril is not recommended for children due to lack of experience in its use in children. Avoid children from taking it by mistake. Precautions for pregnancy and lactation: Contraindicated during pregnancy and lactation. Precautions for the elderly: Elderly patients respond better to ACE inhibitors than young people. For patients older than 65 years old, the starting dose is 2.5 mg and blood pressure and representative laboratory parameters are closely monitored.

Other drugs can affect the efficacy and side effects of enalapril maleate. These drugs include other antihypertensive drugs, antipyretic analgesics, diuretics, anesthetics (tell the anesthesiologist if you use enalapril), antidepressants, anticancer drugs, immunosuppressants, adrenocortical steroids, drugs for gout and drugs for diabetes. Drinking alcohol while taking medication can increase the effects of alcohol. High-salt foods can reduce the efficacy of enalapril maleate and should be avoided. Please inform your doctor if you are taking other drugs at the same time.

Keep sealed.

5mg

24 months

Shandong Luyin Pharmaceutical Co., Ltd.

• Founded in:

  2007-08-16

• Address:

  Shandong Linyi High-tech Industrial Development Zone

• Tax NO.:

  91371300727570960U

• Registered Funds:

  65 million yuan

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