Enalapril Maleate Tablets

This product is an angiotensin converting enzyme inhibitor. After oral administration, it is hydrolyzed into Enalaprilat in the body, which strongly inhibits angiotensin converting enzyme, reduces the content of angiotensin II, causes systemic vasodilation, and causes blood pressure reduction. It has a significant antihypertensive effect on rat models of renal hypertension II, renal hypertension I, and spontaneous hypertension.

The main ingredient of this product is enalapril maleate.

This product is white tablets.

For the treatment of: 1. All stages of essential hypertension 2. Renal vascular hypertension 3. All levels of heart failure 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. Preventing symptomatic heart failure For patients with asymptomatic left ventricular dysfunction, it is suitable for: delaying the progression of symptomatic heart failure: reducing hospitalization due to heart failure. 5. Preventing coronary ischemic events in patients with left ventricular dysfunction. It is suitable for: reducing the incidence of myocardial infarction: reducing hospitalization due to unstable angina.

The absorption of this product is not affected by food. Therefore, it can be taken before, during or after meals. 1. For essential hypertension, depending on the severity of hypertension, the starting dose is 10 mg to 20 mg once a day. For mild hypertension, the recommended starting dose is 10 mg per day. For the treatment of other degrees of hypertension, the starting dose is 20 mg per day. The commonly used maintenance dose is 20 mg per day. According to the needs of the patient, it can be adjusted to a maximum dose of 40 mg per day. 2. For renovascular hypertension, since the blood pressure and renal function of such patients may be particularly sensitive to angiotensin-converting enzyme inhibitors, treatment should be started with a smaller dose (such as 5 mg or less). Then the dose should be adjusted according to the needs of the patient. For most patients, taking 20 mg of this product once a day can achieve the expected therapeutic effect. It is recommended to use this drug with caution for patients with hypertension who have recently used diuretics for treatment. 3. Combination with diuretics to treat hypertension After starting to take this product, symptomatic hypotension may occur. This possibility is greater for patients who have recently been treated with diuretics. Because these patients may have insufficient blood volume or salt loss, it is recommended to use it with caution. Diuretic therapy should be discontinued 2-3 days before starting to take the drug. If this is not possible, the dose should be started at 5 mg or less to determine its initial effect on blood pressure, and then the dose should be adjusted according to the patient's needs. 4. Dosage for renal insufficiency 4.1 In general, the dosing interval of enalapril maleate should be extended and/or its dosage should be reduced. Renal condition: Mild renal insufficiency; creatinine clearance (ml/min) < 8030ml/min; starting dose (mg/day): 5~10mg/day Renal condition: Moderate renal insufficiency; creatinine clearance (ml/min) le; 301ml/min; starting dose (mg/day): 2.5~5mg/day Renal condition: Severe renal insufficiency (usually such patients will undergo dialysis); creatinine clearance (ml/min) le; 10ml/min; starting dose (mg/day): 2.5mg/day (during dialysis period) 4.2 Please refer to the precautions: Patients on hemodialysis 4.3 Enalapril is dialyzable. The dose during the non-dialysis period should be adjusted according to the blood pressure response. 5. Heart failure/asymptomatic left ventricular dysfunction 5.1 Patients with symptomatic heart failure or asymptomatic left ventricular dysfunction. The starting dose is 2.5 mg. And it should be taken under close medical supervision to determine its initial effect on blood pressure. It is usually used in combination with a diuretic (such as digitalis if appropriate) to treat symptomatic heart failure. After the start of treatment for heart failure, if symptomatic hypotension does not occur or symptomatic hypotension has been effectively treated, the dose should be gradually increased to the usual maintenance dose of 2 mg, taken once or twice, depending on the patient's tolerance. This dose adjustment can be completed over a period of 2-4 weeks. If some signs and symptoms of heart failure still exist, the dose escalation process can be accelerated. For patients with symptomatic heart failure, this dosage regimen can effectively reduce the incidence of death. 5.2 Because there have been reports of hypotension and subsequent renal failure (even more rarely), blood pressure and renal function should be closely monitored before and after starting treatment with this product (see Precautions). For patients treated with diuretics, the dose of diuretics should be reduced as much as possible before starting treatment. The occurrence of hypotension after starting this product does not mean that hypotension will occur again during long-term treatment with this product. It does not prevent the continued use of this drug. Serum potassium should also be monitored (see Drug Interactions).

Enalapril maleate has been shown to be generally well tolerated. In clinical studies, the overall incidence of side effects of enalapril maleate was similar to that of placebo. Most side effects were mild and transient. Discontinuation of treatment is not required. The following side effects are associated with the use of enalapril maleate tablets: 1. Dizziness and headache are more common side effects. 2% to 3% of patients reported feeling tired and weak. Less than 2% of patients reported other side effects, including hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle cramps, rash and cough, renal dysfunction. Renal failure and oliguria are rare. 2. Allergy/angioedema Angioedema has been reported on the face, limbs, lips, tongue, glottis, or larynx, but it is rare (see Precautions). 3. In clinical trials,

This product is contraindicated in patients who are allergic to any component of this product, or in patients who have a history of angioedema due to previous treatment with an ACE inhibitor, or in patients with hereditary or idiopathic angioedema.

Precautions for children: This product has not been studied for use in children. Precautions for pregnancy and lactation: Pregnancy 1. This drug is not recommended for use during pregnancy. If pregnancy is confirmed, use of this product should be stopped immediately unless it is necessary to save the mother's life. 2. Angiotensin-converting enzyme inhibitors used during the second and third 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 incomplete cranial development of the newborn). There have been cases of maternal oligohydramnios (presumably a manifestation of reduced fetal renal function) and can lead to limb spasms, craniofacial malformations, and pulmonary dysplasia. If the patient uses this product, the patient should be informed of its potential harm to the fetus. 3. The use of the drug in the first three months of pregnancy to expose the uterus to this angiotensin-converting enzyme inhibitor will not cause the above-mentioned adverse reactions in the embryo and fetus. 4. In those rare cases where angiotensin converting enzyme inhibitors must be used during pregnancy, a series of ultrasound examinations should be performed to evaluate the situation in the amniotic membrane. If oligohydramnios is found, this product should be discontinued 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. 5. Infants born to mothers who have used this product should be closely observed to find out whether they have hypotension, oliguria and hyperkalemia. Enalapril can pass through the placenta. Peritoneal dialysis can clear it from the fetal blood circulation, which is clinically beneficial. In theory, it can be removed by exchange transfusion. Enalapril and enalaprilat (the hydrolysis product of enalapril) are secreted in small amounts in human milk by breastfeeding mothers. Breastfeeding mothers should be cautious when using this product. Precautions for the elderly: This experiment has not been conducted and there are no reliable references.

1. Antihypertensive treatment: This product may have an additive effect when used simultaneously with other antihypertensive treatments. 2. Serum potassium 2.1 In clinical trials, serum potassium was generally maintained within the normal range. After 48 weeks of treatment of hypertensive patients with enalapril maleate alone, an average increase in serum potassium of about 0.2 mg equivalent/ml was observed. In patients treated with enalapril maleate plus a thiazide diuretic, the potassium excretion effect of the diuretic is often weakened by the effect of enalapril. 2.2 The use of enalapril maleate and potassium excretion diuretics together can reduce diuretic-induced hypokalemia. 2.3 Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, and the simultaneous use of potassium-storing diuretics (such as spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes. 2.4 The use of potassium supplements, potassium-storing diuretics or potassium-containing salt substitutes (especially in patients with renal insufficiency) can cause a significant increase in serum potassium. 2.5 If it is considered appropriate to use the above drugs at the same time, use them with caution and monitor serum potassium frequently. 3. Serum lithium. Like other sodium excretion drugs, lithium clearance may be reduced. Therefore, if lithium salts are taken, serum lithium concentrations should be carefully monitored. 4. Non-steroidal anti-inflammatory drugs. For some patients with renal insufficiency, the combination of angiotensin-converting enzyme inhibitors and non-steroidal anti-inflammatory drugs may lead to further decline in renal function. This effect is usually reversible.

Keep away from light and store in a sealed container.

10 mg

36 months

YANGTZE River Pharmaceutical Group Jiangsu JOINT STOCK Co., Ltd.

• Founded in:

  1994-07-28

• Address:

  No. 2 Tongjiang East Road, Gaogang District, Taizhou City, Jiangsu Province

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  91321200703973749K

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  202.679 million yuan

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