Product Overview
[Drug Name]
Generic Name: Enalapril Maleate Tablets
Trade Name: Yisu
English Name: Enalapril
Chinese Pinyin: Ma Lai Suan Yi Na Pu Li Pian
[Ingredients]
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: C20H28N2O5 ·C4H4O4.
[Properties]
This product is a white tablet.
[Indications]
For the treatment of essential hypertension.
[Dosage and Administration]
Oral administration. The initial dose is 5-10 mg per day, divided into 1-2 doses. For patients with severe renal impairment (creatinine clearance less than 30 ml/min), the daily dose is 2.5 mg. The dose can be gradually increased depending on blood pressure levels. The generally effective dose is 10-20 mg per day, and the maximum daily dose should generally not exceed 40 mg. This product can be used in combination with other antihypertensive drugs, especially diuretics, to significantly enhance its antihypertensive effect. However, it should not be used in combination with potassium-sparing diuretics.
[Adverse Reactions]
May include dizziness, headache, drowsiness, dry mouth, fatigue, upper abdominal discomfort, nausea, palpitations, chest tightness, cough, flushing, rash, and proteinuria. Reduce the dose as necessary. If leukopenia occurs, discontinue the drug.
[Contraindications]
This product should not be used in patients with allergies or bilateral renal artery stenosis. Use with caution in patients with severe renal impairment.
[Precautions]
1. Some patients, especially those taking diuretics or experiencing hypovolemia, may experience an excessive drop in blood pressure. Therefore, the initial dose should be started at 2.5 mg. 2. Regularly monitor white blood cell counts and renal function.
[Use in Special Populations]
Precautions for use in children: This product has not been studied in children. Precautions During Pregnancy and Lactation: Pregnancy 1. This medication is not recommended for use during pregnancy. If pregnancy is confirmed, discontinue use immediately unless it is absolutely necessary to save the mother's life. 2. ACE inhibitors used during the second and third trimesters of pregnancy can cause fetal and neonatal morbidity and mortality. Use of ACE inhibitors during this period has been associated with various fetal and neonatal injuries (including hypotension, renal failure, hyperkalemia, and/or cranial hypoplasia). Oligohydramnios (presumably a manifestation of decreased fetal renal function) has occurred and can lead to limb spasms, craniofacial malformations, and pulmonary hypoplasia. If patients use this medication, the potential risk to the fetus should be explained. 3. Uterine exposure to this ACE inhibitor during the first trimester of pregnancy does not cause the aforementioned adverse reactions in the embryo or fetus. 4. In the rare cases where angiotensin-converting enzyme inhibitors are necessary during pregnancy, serial ultrasound examinations should be performed to evaluate the amniotic fluid. If oligohydramnios is detected, this drug should be discontinued unless it is absolutely necessary to save the mother's life. Patients and physicians should be aware that when oligohydramnios occurs, the fetus has already suffered irreversible damage. 5. Infants born to mothers who have used this drug should be closely monitored for hypotension, oliguria, and hyperkalemia. Enalapril can cross the placenta, and peritoneal dialysis can remove it from the fetal circulation, which is clinically beneficial. Theoretically, it can be removed by exchange transfusion. Breastfeeding: Enalapril and enalaprilat (a hydrolysis product of enalapril) are secreted in small amounts in human milk. Caution should be exercised when this drug is used by breastfeeding mothers.
Precautions for the Elderly: This study has not been conducted and no reliable references are available.
[Drug Interactions]
1. Antihypertensive Therapy: This drug may have additive effects when used concurrently with other antihypertensive therapies. 2. Serum Potassium 2.1 In clinical trials, serum potassium generally remained within the normal range. After 48 weeks of treatment with enalapril maleate alone in hypertensive patients, a mean increase in serum potassium of approximately 0.2 mEq/mL was observed. In patients treated with enalapril maleate plus a thiazide diuretic, the potassium-excreting effect of the diuretic is often attenuated by the effects of enalapril. 2.2 Concomitant use of enalapril maleate and a potassium-excreting diuretic can mitigate diuretic-induced hypokalemia. 2.3 Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics (such as spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes. 2.4 Use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes (particularly in patients with renal insufficiency) can cause significant increases in serum potassium. 2.5 If concomitant use of these agents is deemed appropriate, use with caution and monitor serum potassium frequently. 3. As with other sodium-excreting drugs, serum lithium clearance may be reduced. Therefore, if lithium salts are taken, serum lithium concentrations should be carefully monitored. 4. For some patients with renal insufficiency, the combined use of angiotensin-converting enzyme inhibitors and nonsteroidal anti-inflammatory drugs may further impair renal function. This effect is usually reversible.
[Pharmacological Action]
This product is an angiotensin-converting enzyme inhibitor. After oral administration, it is hydrolyzed in the body to enalaprilat, which strongly inhibits angiotensin-converting enzyme, reducing angiotensin II levels, causing systemic vasodilation and lowering blood pressure. It has a significant antihypertensive effect in rat models of renal hypertension (II type II), renal hypertension (I type I), and spontaneous hypertension.
[Storage] Store in a sealed container away from light. The shelf life is tentatively three years. Strength: 5 mg
Packaging: 16 tablets in a composite film package
Validity Period: 36 months
Approval Number: National Medicine Standard H32026568
Manufacturer: Yangtze River Pharmaceutical Group Jiangsu Pharmaceutical Co., Ltd.
