Product Overview
[Drug Name]
Generic Name: Benazepril Hydrochloride Tablets
Trade Name: Xindayi
English Name: Benazepril Hydrochloride Tablets
Chinese Pinyin: Yansuan Beinapuli Pian
[Ingredients]
Benazepril Hydrochloride
[Properties]
This product is a film-coated tablet that appears white after the film coating is removed.
[Indications]
Hypertension, congestive heart failure.
[Dosage and Administration]
1. Hypertension: For patients not taking diuretics, the recommended initial daily dose is 10 mg (1 tablet) once daily. If response is insufficient, the dose can be increased to 20 mg (2 tablets) daily. For some patients taking once-daily dosing, the antihypertensive effect may diminish at the end of the dosing interval. In such patients, the total daily dose should be divided into two doses, or a diuretic should be added. The maximum recommended daily dose for the treatment of hypertension is 40 mg (4 tablets), taken once or twice. If benazepril hydrochloride alone fails to control blood pressure, a diuretic may be added. Concomitant use of benazepril hydrochloride with potassium supplements, potassium substitutes, or potassium-sparing diuretics may cause elevated serum potassium.
Dose Adjustment for Renal Impairment:
Patients with creatinine clearance ≥30 ml/min can take the usual dose. For patients with creatinine clearance <30 ml/min/1.73 m² (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg (half a tablet) once daily. The dose can be increased to 10 mg (one tablet) daily if necessary. If further blood pressure lowering is required, a diuretic or another antihypertensive drug may be added (see Precautions: Hemodialysis Patients).
2. Congestive Heart Failure: This product is indicated as adjunctive therapy for patients with congestive heart failure. The recommended initial dose is 2.5 mg (one-quarter tablet) once daily. Due to the risk of a sharp drop in blood pressure after the first dose, patients should be closely monitored when taking this product for the first time (see Precautions). If the patient does not experience symptomatic hypotension or other unacceptable side effects, and if heart failure symptoms are not effectively relieved, the dose can be increased to 5 mg (half a tablet) once daily after 2-4 weeks. Depending on the patient's clinical response, the dose can be increased to 10 mg (one tablet) once daily or even 20 mg (two tablets) once daily at appropriate intervals. This product is effective with a single daily dose, but some patients respond better if the daily dose is divided into two doses. Controlled clinical studies have shown that patients with severe heart failure (NYHA class IV) require a lower dose than those with mild or moderate heart failure (NYHA class II-III). When the creatinine clearance in a heart failure patient is less than 30 ml/min, the daily dose can be increased to a maximum of 10 mg (one tablet), but a lower initial dose (e.g., 2.5 mg (one-quarter tablet)) may be sufficient.
[Adverse Reactions]
1. Common side effects include headache, dizziness, fatigue, drowsiness, nausea, and cough. The most common side effects are headache and cough. 2. Rare symptoms include: symptomatic hypotension, postural hypotension, syncope, palpitations, peripheral edema, rash, dermatitis, constipation, gastritis, anxiety, insomnia, paresthesia, arthralgia, myalgia, and asthma. Angioneurotic edema is rare.
[Contraindications]
Patients allergic to benazepril hydrochloride or any ACE inhibitor. Patients with a history of angioneurotic edema. Patients with solitary kidney, transplanted kidney, or bilateral renal artery stenosis and impaired renal function.
[Precautions]
1. Angioneurotic edema: If lip or facial edema has occurred while taking this product, discontinue the drug immediately and monitor the patient until the edema resolves. Edema of the glottis, tongue, or larynx may cause airway obstruction and should be discontinued. Immediately initiate appropriate treatment, such as subcutaneous injection of 1:1000 epinephrine solution (0.3ml to 0.5ml). 2. Hypotension: Patients with severe sodium deficiency and volume depletion may experience hypotension when taking this drug (such as those receiving large amounts of diuretics or dialysis). Diuretics should be discontinued or other measures should be taken to replenish body fluids several days before starting this drug. Patients at risk of severe hypotension (such as those with heart failure) should be closely monitored after the first dose until their blood pressure stabilizes. If hypotension occurs, the patient should be placed in the supine position and receive intravenous saline if necessary. 3. Granulocytopenia: Patients with autoimmune diseases and renal insufficiency are more likely to experience leukopenia or granulocytopenia. For patients with renal insufficiency or leukopenia, check the white blood cell count and differential every two weeks for the first three months and regularly thereafter. 4. Renal Insufficiency: A small number of patients may experience transient increases in blood urea nitrogen and creatinine after taking this drug, which resolves with discontinuation of this drug and/or diuretics. For patients with renal insufficiency, renal function should be closely monitored during the first few weeks of treatment and regularly thereafter. When using this drug, if the creatinine clearance is less than 30 ml/min or blood urea nitrogen or creatinine levels are elevated, the dose should be reduced and/or diuretics should be discontinued. Other: Elevated serum potassium may occur occasionally, especially in patients with renal insufficiency and when taking medications to treat hypokalemia. Elevated aminotransferases may occur occasionally. Insufficient blood supply to the brain or coronary arteries may be exacerbated by decreased blood pressure. Hepatic metabolism of this drug is decreased in patients with hepatic dysfunction.
[Special Use in Special Populations]
Precautions for Use in Children:
No safety and efficacy studies are available for this drug in children.
Precautions for Use During Pregnancy and Lactation:
This drug should not be used by pregnant women (see [Contraindications]). 1. Pregnancy: The use of ACE inhibitors by pregnant women may cause fetal or neonatal morbidity or death. Dozens of such cases have been reported in the literature worldwide. Use of ACE inhibitors during the second and third trimesters may cause fetal and neonatal harm, including hypotension, neonatal skull deformity, anuria, reversible or irreversible renal impairment, and even death. The resulting polyhydramnios often leads to limb contractures, facial deformities, and lung hypoplasia in the infant. Premature birth, intrauterine growth retardation, and patent ductus arteriosus have also been reported, but it is unclear whether these symptoms are related to ACE inhibitor use. Use of ACE inhibitors during early pregnancy is associated with an increased risk of birth defects. Once pregnancy is confirmed, ACE inhibitor use should be discontinued immediately, and fetal growth should be monitored regularly. ACE inhibitors (including Lotensin) should also be avoided in women planning pregnancy. Women of childbearing age should be specifically informed of the potential risks of taking ACE inhibitors (including Lotensin). They should only be administered after careful consideration and discussion of the associated risks and benefits. 2. Breastfeeding Women: Benazepril and benazeprilat have been found to be excreted in breast milk, but the maximum concentration is only 0.3% of the plasma level. Negligible amounts of benazeprilat reach the infant's systemic circulation. While adverse effects on breastfed infants are unlikely, use of this medication during breastfeeding is not recommended.
Precautions for Elderly Patients:
This medication should be used in the same manner as adults in elderly patients.
[Drug Interactions]
1. Concomitant use with diuretics may enhance the antihypertensive effect and may cause severe hypotension. Therefore, the existing diuretic should be discontinued or reduced, and this product should be started with a low dose and gradually adjusted. 2. Concomitant use with other vasodilators may cause hypotension. If used together, the dose should be started at a low level. 3. Concomitant use with potassium-sparing diuretics (such as spironolactone, triamterene, and amiloride) may cause hyperkalemia. 4. Concomitant use with nonsteroidal anti-inflammatory analgesics may weaken the antihypertensive effect of this product by inhibiting prostaglandin synthesis and sodium and water retention. 5. Concomitant use with other antihypertensive drugs may enhance the antihypertensive effect. This effect is significantly additive with drugs that induce renin release or affect sympathetic activity, while it is less than additive with beta-blockers.
[Pharmacological Action]
1. Pharmacology (1) Antihypertensive: This product is hydrolyzed into benazeprilat in the liver, becoming a competitive angiotensin-converting enzyme inhibitor, preventing the conversion of angiotensin I to angiotensin II, reducing vascular resistance, reducing aldosterone secretion, and increasing plasma renin activity. Benazeprilat also inhibits the degradation of bradykinin, which also reduces vascular resistance and produces a antihypertensive effect. (2) Reducing cardiac load: This product dilates arteries and veins, reduces peripheral vascular resistance or cardiac afterload, reduces pulmonary capillary entrapment pressure or cardiac preload, and also reduces pulmonary vascular resistance, thereby improving cardiac output and prolonging exercise tolerance and time. 2. Toxicology: Rats and mice were given benazepril orally for 2 years at a dose of 150 mg/kg per day, and no carcinogenicity was found. (This dose, calculated as mg/kg, is 110 times the maximum human dose; calculated as mg/m2, is 18 times and 9 times the maximum human dose). This product was not found to be mutagenic in either bacterial or in vitro mammalian cell culture assays. Oral administration of benazepril to male and female rats at a daily dose of 50-150 mg/kg did not affect reproductive performance. (This dose, calculated as mg/kg, is 37.5 times the maximum human dose; calculated as mg/m², is 6.6 times the maximum human dose.)
[Storage] Store in a cool, dry place.
[Strength] 10 mg
[Packaging] 10 mg x 14 sachets/box
[Expiry Life] 36 months
[Approval Number] National Medicine Standard H20043648
[Manufacturer] Company Name: Shenzhen Xinlitai Pharmaceutical Co., Ltd.
