Product Overview
[Drug Name]
Generic Name: Enalapril Maleate Tablets
Trade Name: Biyaluo
English Name: Enalapril Maleate Tablets
Chinese Pinyin: Malaisuan Yinapuli Pian
[Ingredients]
Enalapril maleate.
[Properties]
This product is white tablets.
[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 general 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 if necessary. Discontinue the drug if leukopenia occurs.
[Contraindications]
Contraindicated in patients with allergies to this drug 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 tests.
[Use in Special Populations]
Precautions for use in children: This drug has not been studied in children.
Precautions for Pregnancy and Lactation: Pregnancy 1. This drug is not recommended during pregnancy. If pregnancy is confirmed, discontinue use of this drug immediately unless it is absolutely necessary to save the mother's life. 2. Angiotensin-converting enzyme 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 harms (including hypotension, renal failure, hyperkalemia, and/or neonatal cranial hypoplasia). Oligohydramnios (presumably a manifestation of decreased fetal renal function) has occurred in women and can lead to limb spasticity, craniofacial abnormalities, and pulmonary hypoplasia. Patients using this medication should be informed of the potential harm to the fetus. 3. Uterine exposure to this ACE inhibitor during the first trimester of pregnancy does not result in the adverse reactions described above for the embryo or fetus. 4. In the rare case where ACE inhibitor use is necessary during pregnancy, serial ultrasound examinations should be performed to evaluate the amniotic fluid. If oligohydramnios is detected, ACE inhibitor use 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 medication should be closely monitored for hypotension, oliguria, and hyperkalemia. Enalapril can cross the placenta. Peritoneal dialysis can clear it from the fetal circulation, which is clinically beneficial. Theoretically, it can be cleared by exchange transfusion. Enalapril and enalaprilat (a hydrolysis product of enalapril) are secreted in small amounts in human milk by breastfeeding mothers. Caution should be exercised when using this product in breastfeeding mothers.
Precautions for Elderly Patients: This study has not been conducted and no reliable references are available.
[Drug Interactions]
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.
[Pharmacological Actions]
This product is an angiotensin-converting enzyme inhibitor. After oral administration, it is hydrolyzed in vivo to enalaprilat, which strongly inhibits angiotensin-converting enzyme, reduces angiotensin II levels, causes systemic vasodilation, and lowers 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 dark, airtight container.
[Strength] 10 mg
[Packaging] 10 mg x 20 tablets/box
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H44024933
[Manufacturer] Guangdong BIDI Pharmaceutical Co., Ltd.
