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. Its chemical name is: Enalapril Maleate; N-[(S)-1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl-L-proline (Z)-2-butenedioate (1:1). Molecular formula: C20H28N2O5C4H4O4.

This product is white tablets.

Used to treat essential hypertension.

Oral administration. The initial dose is 5-10 mg per day, divided into 1-2 doses. For patients with severe renal impairment (creatinine clearance rate less than 30 ml/min), the dose is 2.5 mg per day. The dose can be gradually increased according to the blood pressure level. The general effective dose is 10-20 mg per day, and the maximum daily dose should not exceed 40 mg. This product can be used in combination with other antihypertensive drugs, especially diuretics, and the antihypertensive effect is significantly enhanced, but it should not be used in combination with potassium-retaining diuretics.

Symptoms may include dizziness, headache, drowsiness, dry mouth, fatigue, upper abdominal discomfort, nausea, palpitations, chest tightness, cough, flushing, rash, and proteinuria. Reduce the dosage if necessary. If leukopenia occurs, stop taking the drug.

Patients who are allergic to this product or have bilateral renal artery stenosis should not use this product. Patients with severe renal impairment should use it with caution.

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 in a dark place and sealed. The validity period is tentatively three years.

5 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

• Tax NO.:

  91321200703973749K

• Registered Funds:

  202.679 million yuan

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