What Are the Side Effects of Enalapril?

Enalapril maleate, the indications are for treatment: 1. Primary hypertension in each phase Renovascular hypertension 3. Heart failure at all levels for patients with symptomatic heart failure. It is also suitable for: improving survival rate: delaying the progression of heart failure; reducing hospitalization due to heart failure 4 Prevention of Symptomatic Heart Failure For asymptomatic patients with left ventricular dysfunction, it is suitable for: delaying the progression of symptomatic heart failure: reducing hospitalization due to heart failure. 5. Prevention of coronary ischemic events in patients with left ventricular dysfunction. Applies to: reduce the incidence of myocardial infarction: reduce hospitalization caused by unstable angina pectoris.

Enalapril maleate, the indications are for treatment: 1. Primary hypertension in each phase Renovascular hypertension 3. Heart failure at all levels for patients with symptomatic heart failure. It is also suitable for: improving survival rate: delaying the progression of heart failure; reducing hospitalization due to heart failure 4 Prevention of Symptomatic Heart Failure For asymptomatic patients with left ventricular dysfunction, it is suitable for: delaying the progression of symptomatic heart failure: reducing hospitalization due to heart failure. 5. Prevention of coronary ischemic events in patients with left ventricular dysfunction. Applies to: reduce the incidence of myocardial infarction: reduce hospitalization caused by unstable angina pectoris.

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Drug Name

Enalapril maleate

Drug type

Essential medicines

Use classification

Angiotensin I converting enzyme inhibitor

Enalapril maleate ingredients

The main ingredients of this product are: Enalapril maleate.
Its chemical name is: N-[(s) -ethoxycarbonyl-3-phenylpropyl] -L-alanyl-L-proline maleate.
Its structural formula is:

Molecular formula: C ₂₀ H ₂₈ N ₂ O ₅ .C ₄ H ₄ O ₄
Molecular weight: 492.52

Characteristics of Enalapril Maleate

This product is white or off-white film.

Enalapril maleate indications

use to cure:
1. Primary hypertension in each phase Renovascular hypertension 3. Heart failure at all levels for patients with symptomatic heart failure. It is also suitable for: improving survival rate: delaying the progression of heart failure; reducing hospitalization due to heart failure
4 Prevention of Symptomatic Heart Failure For asymptomatic patients with left ventricular dysfunction, it is suitable for: delaying the progression of symptomatic heart failure: reducing hospitalization due to heart failure
5. Prevention of coronary ischemic events in patients with left ventricular dysfunction. Applies to: reduce the incidence of myocardial infarction: reduce hospitalization caused by unstable angina pectoris.

Enalapril maleate specifications

(1) 5mg (2) 10mg

Dosage of Enalapril Maleate

The absorption of this product is not affected by food. Therefore, it can be taken before, during or after a meal.
Essential hypertension is based on the severity of hypertension. The starting dose is 10 mg to 20 mg. 1 time daily. For mild hypertension. The recommended starting dose is 10 mg daily. Treatment of other levels of hypertension. The starting dose is 20 mg daily. The usual maintenance dose is 20 mg per day. According to the needs of the patient. Adjustable to a maximum dose of 40 mg daily.
Renovascular hypertension may be particularly sensitive to angiotensin-converting enzyme inhibitors due to blood pressure and renal function in such patients, and treatment should be started at smaller doses (such as 5 mg or less). Then adjust the dose according to the needs of the patient. For most patients. Take 20 mg of this product. Once a day, you can get the expected effect. For patients with hypertension recently treated with diuretics. It is recommended to use this medicine with caution (see next section).
Combined with diuretics to treat hypertension After starting to take this product. Symptomatic hypotension may occur. This is more likely for patients who have recently been treated with a diuretic. Because these patients may have insufficient blood volume or loss of salt. It is recommended to use it with caution. Diuretic therapy should be discontinued before starting 2-3 days. If not possible. Begin with a dose (5 mg or less). To determine its initial effect on blood pressure, then adjust the dose to the patient's needs.
Dosage of renal insufficiency In general, the interval between taking enalapril maleate and / or reducing the dose should be extended.
Kidney conditions Creatinine clearance (ml / min) Starting dose (mg / day)
Mild renal insufficiency 30ml / min 5-10mg / day
Moderate renal insufficiency30> 10ml / min 2.5-5mg / day
Severe renal insufficiency 10ml / min 2.5mg / day
Usually this type of patient will undergo dialysis during the dialysis period. * Please note: Patients on hemodialysis ** Enalapril is dialyzable. The dose during the non-dialysis period should be adjusted according to the blood pressure response.
Heart failure / asymptomatic left ventricular dysfunction Patients with symptomatic heart failure or asymptomatic left ventricular dysfunction. The starting dose was 2.5 mg. It should be taken under close medical supervision. To determine its initial effect on blood pressure. Symptomatic heart failure is usually treated with a diuretic (if applicable) digitalis. After the start of treatment for heart failure. If no symptomatic hypotension has occurred or has been effectively managed, the dose should be gradually increased to the usual maintenance amount of 2 mg according to the patient's tolerance and taken once or twice. This dose adjustment. Can be completed in 2-4 weeks. If there are still some signs and symptoms of heart failure. The dose escalation process can also be accelerated. For symptomatic heart failure patients. This dosage regimen is effective in reducing the incidence of death.
Hypotension and subsequent renal failure have been reported (more rarely). Therefore, blood pressure and renal function should be closely monitored before and after starting this product (see Precautions). For patients treated with diuretics. The dose of the liniment should be minimized before starting treatment. Hypotension occurred after starting this product. It does not mean that hypotension will occur in the long-term treatment of this product. It does not prevent the continued use of this medicine. Serum potassium should also be monitored (see Drug Interactions).

Adverse reactions of enalapril maleate

Enalapril maleate has generally been well tolerated. In clinical research. The overall incidence of enalapril maleate was similar to placebo. Most side effects are mild and transient. There is no need to stop treatment.
The following side effects are related to the use of enalapril maleate:
1. Dizziness and headaches are more common side effects. 2% to 3% of patients report feeling tired and weak. Other side effects were reported in less than 2% of patients, including hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle spasms, rash and cough, and renal dysfunction. Renal failure and oliguria are rare.
2. Allergic / angioedema has been reported to occur on the face, limbs, lips, tongue, glottis, or throat. But rare (see note).
3 The very rare side effects that occur in controlled clinical trials or after the drug is marketed are:
(1) Cardiovascular myocardial infarction or cerebrovascular accident may be secondary to low blood pressure in high-risk patients (see Precautions).
Chest pain; palpitations; arrhythmia; angina; Raynaud's phenomenon.
(2) Intestinal obstruction of gastrointestinal system: pancreatitis: liver failure; hepatitis-hepatocellular or cholestatic: jaundice: abdominal pain: vomiting; indigestion: constipation; anorexia; gastritis.
(3) Nervous system / mental depression: insanity: lethargy; insomnia; neuropathy: paresthesia: dizziness; abnormal dreams.
(4) Respiratory pulmonary infiltration: bronchospasm / asthma: dyspnea; runny nose; sore throat and hoarseness.
(5) Skin hyperhidrosis; erythema polymorpha; exfoliative dermatitis; Steven-Johnson syndrome; toxic epidermal necrosis; pemphigoid; itching; urticaria; baldness.
(6) Other impotence; flushing; taste change; tinnitus: glossitis; blurred vision.
A syndrome with some or all of the following symptoms has been reported: fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, positive antinuclear antibodies, increased erythrocyte sedimentation, eosinophilia, and white blood cells Increased, can also appear rash. Photosensitivity and other skin diseases.
Important changes in laboratory standard clinical parameters in laboratory tests are rarely associated with taking enalapril maleate, but with elevated blood urea and serum creatinine, and increased liver enzymes and / or serum bilirubin. These are often restored after deactivation. Hyperkalemia and hyponatremia have also occurred.
Reduced hemoglobin and hematocrit have also been reported.
Since the listing of Enalapril maleate. A few cases have reported neutropenia, thrombocytopenia, myelosuppression, and granulocytopenia. These conditions cannot be ruled out to be related to the use of enalapril maleate.

Enalapril maleate taboo

Patients who are allergic to any component of this product, or patients who have previously been treated with an angiotensin-converting enzyme inhibitor and have a history of angioedema, and patients with hereditary or spontaneous angioedema. Disable this product.

Notes on Enalapril Maleate

1. Symptomatic hypotension rarely occurs in uncomplicated hypertensive patients. Hypertensive patients taking enalapril maleate. Due to diuretic therapy, diet limited salt. Insufficient blood volume due to dialysis, diarrhea or vomiting. Hypotension is more likely to occur (see Drug Interactions and Side Effects). In patients with heart failure with or without renal insufficiency. The occurrence of symptomatic hypotension has been observed. Patients with more severe heart failure. Most likely to happen. This can be reflected in the use of high-dose diuretics, hyponatremia or functional renal insufficiency. Such patients should begin treatment under medical monitoring. And whenever the dose of enalapril maleate or / and diuretics is adjusted. Should be followed closely. The same treatment applies to patients with ischemic heart disease or cerebrovascular disease, because excessive blood pressure drops in these patients can lead to myocardial infarction or cerebrovascular accidents.
If hypotension occurs. The patient should lie on his back and infuse saline as necessary. Transient hypotension is not a contraindication to continued medication. Usually after blood volume expansion, once blood pressure rises. Can be administered.
Some patients with normal or low blood pressure heart failure, after taking it. A further decrease in systemic blood pressure may occur. This effect is expected. It is usually not necessary to stop treatment. Symptoms such as hypotension. It is necessary to reduce the dose and / or stop using diuretics and / or this product.
2. Aortic stenosis / hypertrophic cardiomyopathy is the same as all vasodilators. Angiotensin-converting enzyme inhibitors should be used with caution in patients with left ventricular outflow tract infarction.
3 The hypotension that occurs after treatment with angiotensin-converting enzyme inhibitors for renal insufficiency can further damage some patients' renal function. This condition has been reported to cause acute renal failure. But usually they are reversible.
Patients with renal insufficiency may need to reduce the dose and / or reduce the frequency of medication (see Dosage and Administration). Some patients with bilateral renal artery stenosis or sole kidney and renal artery stenosis. There has been an increase in blood urea and serum creatinine. Reversal of treatment is usually reversed: especially for patients with renal insufficiency.
Some patients with no previous significant kidney disease usually have mild and transient increases in blood urea and serum creatinine when they are used with enalapril maleate and diuretics. It may be necessary to reduce the dose and / or discontinue diuretics and / or enalapril maleate.
4 Allergic / angio-neuroedema is reported. Patients using angiotensin-converting enzyme inhibitors (including enalapril maleate) have reported facial problems. Angioedema of the limbs, lips, tongue, glottis, and larynx can occur at any time during the treatment period. At this time, this product should be discontinued immediately and given appropriate supervision. To ensure that the symptoms completely subsided before the patient was discharged. Although antihistamines are useful for relieving symptoms, when swelling is confined to the face and lips, they usually disappear without treatment.
Angioedema with laryngeal edema may lead to death. When edema occurs in the tongue, glottis, or throat. May cause airway obstruction, appropriate treatment should be given immediately, including such as subcutaneous injection of 1: 1000 epinephrine solution (0.3 ml to 0.5 ml) and / or immediate measures to keep the airway open.
According to reports, compared with non-black races. Black people take angiotensin-converting enzyme inhibitors to cause angioedema.
People with a history of angiotensin-converting enzyme inhibitors who are not associated with angiotensin-converting enzyme inhibitor treatment may have an increased risk of angio-neuroedema with angiotensin-converting enzyme inhibitors (see Contraindications).
5. Allergic-like reactions when desensitizing with the venom of the Hymenoptera When desensitizing patients treated with angiotensin-converting enzyme inhibitors with the venom of the Hymenoptera. A life-threatening allergic reaction may occur. This situation is rare. This reaction can be avoided by temporarily discontinuing angiotensin-converting enzyme inhibitors before each desensitization.
6. Hemodialysis patients use high-permeability membrane (such as AN69) for dialysis. Patients treated with angiotensin-converting enzyme inhibitors. Allergic reactions have been reported. For these patients, another type of dialysis membrane or another type of antihypertensive drug should be considered.
7. Cough is reported. Cough can be caused by angiotensin-converting enzyme inhibitors. It is characterized by sputum-free and persistent. May disappear after withdrawal. In the differential diagnosis of cough. The possibility of cough caused by angiotensin-converting enzyme inhibitors should be considered.
8. Surgery / Anesthesia For patients undergoing major surgery or anesthesia with anesthetic drugs that may cause hypotension, enalapril blocks the production of angiotensin II due to compensatory renin release if hypotension occurs. And the consideration is due to the above mechanism. The blood volume should be expanded to correct it.
Serum potassium-see drug interactions

Enalapril maleate tablets for pregnant and lactating women

1. This medicine is not recommended during pregnancy. If it is found to be pregnant, unless it is necessary to save the mother's life. Otherwise, stop using this product immediately.
Angiotensin-converting enzyme inhibitors used during the third and last trimesters of pregnancy can cause morbidity and death in the fetus and newborn. The use of angiotensin-converting enzyme inhibitors during this period is associated with various injuries to the fetus and newborn (including hypotension, renal failure, hyperkalemia, and / or neonatal skull hypoplasia). Too little maternal amniotic fluid (presumably manifested by reduced fetal kidney function) can lead to limb spasms, craniofacial deformities, and lung dysplasia. If patients use this product. The patient should be explained about the potential harm to the fetus.
Taking the uterus in contact with this angiotensin-converting enzyme inhibitor during the first three months of pregnancy does not cause the above-mentioned adverse reactions to occur in the embryo and fetus.
In rare cases, angiotensin-converting enzyme inhibitors must be used during pregnancy. A series of ultrasound examinations should be performed to evaluate the condition inside the amniotic membrane. If too little amniotic fluid is found. The use of this product should be stopped. Unless it is necessary to save the mother's life. Patients and doctors should be aware that when oligohydramnios occurs. The fetus has suffered irreversible damage.
Close observation should be made on infants born to mothers who have used this product. To find out if there is hypotension, oliguria and hyperkalemia. Enalapril can pass the placenta, and peritoneal dialysis can clear it from the fetal blood circulation. This is clinically beneficial. In theory. It can be removed by changing blood.
2. Nursing mothers Enalapril and Enalapril (hydrolysates of Enalapril) are secreted in small amounts in human milk. Nursing mothers should use caution when using this product.

Enalapril maleate for children

Studies on the use of this product in children have not been conducted.

Enalapril maleate tablets for elderly

This experiment was not performed and there are no reliable references.

Enalapril maleate drug interactions

1. Antihypertensive treatment This product may have an additive effect when applied simultaneously with other antihypertensive treatments.
2. Serum potassium In clinical trials, serum potassium has generally remained within the normal range. After 48 weeks of treating hypertensive patients with enalapril maleate alone, the average increase in serum potassium was about 0.2 mg equivalent / ml. In patients treated with enalapril maleate plus a thiazide diuretic, the potassium-releasing effect of diuretics is often attenuated by the effect of enalapril.
Enalapril maleate is used with potassium-releasing diuretics to reduce hypokalemia caused by diuretics.
Risk factors for the occurrence of hyperkalemia include renal insufficiency, diabetes mellitus, and simultaneous use of potassium-storing diuretics (such as amphetamine, ampicillin, or amlodipine), potassium supplements, or potassium-containing alternative table salts.
The use of potassium supplements, potassium diuretics, or potassium-containing substitutes (especially in patients with renal insufficiency) can cause significant increases in serum potassium.
If it is considered appropriate to apply the above-mentioned agents at the same time, caution should be used and the serum potassium should be monitored frequently.
3 Like other sodium-releasing drugs in serum, lithium clearance may be reduced. therefore. If taking lithium salt. The serum lithium concentration should be carefully monitored.
4 Non-steroidal anti-inflammatory drugs For some patients with renal insufficiency, when angiotensin-converting enzyme inhibitors are used in combination with non-steroidal anti-inflammatory drugs, renal function may be further reduced, and this effect is usually reversible.

Enalapril maleate overdose

Information on human overdose of this drug is limited, so far. The most significant feature of overdose is marked hypotension, which begins to occur 6 hours after taking the drug. At the same time, the renin-angiotensin system is blocked. Coma appears. It has been reported after taking 300 mg and 440 mg doses. Serum enalapril levels were 100- and 200-fold higher than normal cases, respectively.
For overdose treatment. Intravenous saline is recommended. If possible. Angiotensin II can also be entered. If it is just used up. You should induce vomiting. Enalapril can be removed from the systemic circulation by hemodialysis (see Precautions. Patients on hemodialysis).

Enalapril maleate pharmacology and toxicology

This experiment was not performed and there are no reliable references.

Pharmacokinetics of Enalapril Maleate

This experiment was not performed and there are no reliable references.

Enalapril maleate storage

Shaded and sealed.

Enalapril maleate packaging

Composite film packaging. (1) 5mg: 8 tablets per plate, 2 plates per box; 16 tablets per plate, 1 plate per box; 16 tablets per plate, 2 plates per box. (2) 10mg: 8 tablets per plate, 2 plates per box; 16 tablets per plate, 1 plate per box; 16 tablets per plate, 2 plates per box; 16 tablets per plate, 3 plates per box; 16 tablets per plate, 4 plates per box.

Expiration Date of Enalapril Maleate

(1) 5mg: 36 months; (2) 10mg: 24 months

Enalapril Maleate

"Chinese Pharmacopoeia" 2010 edition two ^[1]