Benazepril Hydrochloride Tablets

1 Pharmacology (1) Blood pressure reduction: This product is hydrolyzed into benazeprilat in the liver, becoming a competitive angiotensin converting enzyme inhibitor, preventing angiotensin I from converting 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 blood pressure reduction 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 continuously orally administered benazepril for 2 years at a dose of 150 mg/kg per day, and no carcinogenicity was found. (This dose, calculated in mg/kg, is 110 times the maximum human dose; calculated in mg/m2, is 18 times and 9 times the maximum human dose). No mutagenicity was found in either bacterial tests or in vitro cultured mammalian cell tests. Female and male rats were given benazepril orally at a dose of 50-150 mg/kg per day, and no effect of this product on reproductive capacity was found. (This dose is 37-375 times the maximum human dose calculated by mg/kg; 6-60 times the maximum human dose calculated by mg/m2).

Benazepril Hydrochloride

This product is a film-coated tablet, which appears white after removing the film coating.

Hypertension, congestive heart failure.

1 Hypertension: For patients who do not use diuretics, the recommended daily dose is 10 mg (1 tablet) once a day at the beginning of treatment. If the effect is not good, it can be increased to 20 mg (2 tablets) per day. For some patients who take it once a day, the antihypertensive effect may weaken at the end of the dosing interval. For such patients, the total daily dose should be divided into two doses, or a diuretic can be added. The maximum recommended daily dose of this product for the treatment of hypertension is 40 mg (4 tablets), taken once or divided into two doses. If taking benazepril hydrochloride alone cannot control blood pressure, a diuretic can be added. The combination of benazepril hydrochloride with potassium supplements, potassium salt substitutes or potassium-sparing diuretics can cause elevated blood potassium. Dose adjustment for patients with renal impairment: Patients with creatinine clearance of ≥30ml/min can take the usual dose. For patients with creatinine clearance <30ml/min/1.73m2 (serum creatinine 3mg/dl), the recommended initial dose is 5mg (half tablet) once a day. If necessary, the dose can be increased to 10mg (1 tablet)/day. If blood pressure still needs to be further lowered, a diuretic or another antihypertensive drug can be added (see Precautions: Hemodialysis Patients). 2 Congestive Heart Failure: This product is suitable for adjuvant treatment of patients with congestive heart failure. The recommended initial dose is 2.5mg (1/4 tablet), once a day. 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). When the patient does not experience symptomatic hypotension and other unacceptable side effects, if the symptoms of heart failure are not effectively relieved, the dose can be adjusted to 5mg (half tablet) once a day after 2-4 weeks. Depending on the patient's clinical response, the dose can be adjusted to 10mg (1 tablet) once a day or even 20mg (2 tablets) once a day at appropriate time intervals. This product is effective once a day, 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 grade IV) require a smaller dose than patients with mild and moderate heart failure (NYHA grade II-III). When the creatinine clearance of heart failure patients is less than 30ml/min, the daily dose can be increased to a maximum of 10mg (1 tablet), but a lower initial dose [such as 2.5mg (1/4 tablet)] may be sufficient.

1 Common symptoms include: headache, dizziness, fatigue, drowsiness, nausea, and cough. The most common symptoms 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.

Patients who are allergic to benazepril hydrochloride or any ACE inhibitors. Patients with a history of angioedema. Patients with solitary kidney, transplanted kidney, bilateral renal artery stenosis and renal impairment.

Precautions for children: There is no research data on the safety and effectiveness of this product in children. Precautions for pregnancy and lactation: This product should not be used by pregnant women (see [Contraindications]). 1. Pregnant women Taking ACE inhibitors may cause fetal or neonatal illness or death. There have been dozens of such reports in literature around the world. The use of ACE inhibitors in the second and third trimesters of pregnancy may cause fetal and neonatal damage, including hypotension, neonatal skull deformity, anuria, reversible or irreversible renal impairment, and even death. The resulting polyhydramnios often leads to limb contractures, facial deformation, and lung dysplasia in infants. In addition, there are reports of premature birth, intrauterine growth retardation, and patent ductus arteriosus, but it is not yet certain whether these symptoms are related to the use of ACE inhibitors. The use of ACE inhibitors in early pregnancy is associated with an increased risk of congenital defects. Once pregnancy is confirmed, ACE inhibitors should be stopped immediately and the growth and development of the fetus should be monitored regularly. For women who are preparing to become pregnant, ACE inhibitors (including Lotensin) should also be avoided. Women of childbearing age should be specifically informed of the potential risks of taking ACE inhibitors (including Lotensin). The drug should be administered only after careful consideration and discussion of the relevant risks and benefits. 2. It has been found that benazepril and benazeprilat can be secreted into breast milk in lactating women, but the maximum concentration is only 0.3% in plasma. The amount of benazeprilat that can reach the infant's systemic circulation is negligible. Although it is unlikely to have adverse effects on breastfed infants, it is still not recommended to take this product during lactation. Precautions for the elderly: Elderly patients use this product in the same way as adults.

1. When used in combination with diuretics, the antihypertensive effect is enhanced, which may cause severe hypotension. Therefore, the original diuretics should be discontinued or reduced, and this product should be used at a small dose at the beginning and the dose should be adjusted gradually. 2. When used in combination with other vasodilators, it may cause hypotension. If used in combination, it should be started at a small dose. 3. When used in combination with potassium-retaining diuretics (such as spironolactone, triamterene, and amiloride), it may cause hyperkalemia. 4. When used in combination with non-steroidal anti-inflammatory analgesics, the antihypertensive effect of this product may be weakened by inhibiting prostaglandin synthesis and water and sodium retention. 5. When used in combination with other antihypertensive drugs, the antihypertensive effect is enhanced. Among them, it has a greater additive effect with drugs that cause renin release or affect sympathetic activity, and a less than additive effect when used in combination with beta-receptor blockers.

Store in a cool, dry place.

10mg

36 months

Shenzhen Salubris Pharmaceuticals Co., Ltd.

• Founded in:

  1998-11-03

• Address:

  Area A, 4th Floor, Digital Peninsula, No. 289, Hongliu Road, Fubao Community, Fubao Street, Futian District, Shenzhen

• Tax NO.:

  91440300708453259J

• Registered Funds:

  1,114.816535 yuan

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