Benazepril Hydrochloride Tablets

This product is a prodrug, which is hydrolyzed into the active substance benazeprilat, which can inhibit angiotensin converting enzyme (ACE) and prevent angiotensin I from converting into angiotensin II. This can reduce a series of symptoms caused by angiotensin II, namely vasoconstriction and the production of aldosterone (the latter will lead to the reabsorption of sodium and water by the renal tubules and increase cardiac output). Lotensin reduces the reflex sympathetic excitatory heart rate caused by vasodilation. 1. Hypertension Like other ACE inhibitors, Lotensin can also reduce the degradation of vasodilator bradykinin by inhibiting kininase, and this inhibitory effect helps to enhance its antihypertensive efficacy. Lotensin can generally reduce the sitting, supine and standing blood pressure of patients with hypertension at all stages. In most patients, the antihypertensive effect begins to play a role one hour after a single oral dose, and the maximum antihypertensive effect is achieved in 2 to 4 hours. The duration of the antihypertensive effect is at least 24 hours after taking it. When repeatedly administered, the maximum antihypertensive effect of each dose is achieved after one week and is maintained during long-term treatment. The maintenance of antihypertensive effect is independent of the patient's race, age, and baseline plasma renin activity. The antihypertensive efficacy of Lotensin has no significant relationship with the sodium content in the patient's diet. There will be no sudden increase in blood pressure after the sudden discontinuation of Lotensin. In a study of healthy people, a single dose of Lotensin can lead to an increase in renal blood flow, but has no effect on glomerular filtration rate. The antihypertensive effects of Lotensin and thiazide diuretics are synergistic. The combined use of Lotensin and other antihypertensive drugs, including beta-blockers and calcium antagonists, usually results in a stronger antihypertensive effect. 2. Congestive heart failure (CHF) For CHF patients previously treated with digitalis and diuretics, Lotensin can lead to an increase in cardiac output and exercise tolerance, as well as a decrease in pulmonary artery wedge pressure, systemic vascular resistance and blood pressure. Heart rate will decrease slightly. The use of Lotensin in CHF patients can also help reduce adverse reactions such as fatigue and edema and improve NYHA class. Clinical trials have shown that once-daily dosing can improve hemodynamic performance for 24 hours. 3. Progressive chronic renal insufficiency In a 3-year multicenter, double-blind, placebo-controlled clinical trial, 583 patients with kidney disease (with or without hypertension) of different etiologies and serum creatinine of 1.4 to 4 mg/dL (creatinine clearance of 30 to 60 mUmin) were randomly divided into groups and took 10 mg of placebo or Lotensin once a day. In order to control blood pressure, patients in both study groups used other oral antihypertensive drugs as necessary. Compared with the placebo group, the risk of doubling of serum creatinine or need for hemodialysis in the Lotensin group was reduced by 53%. At the same time, Lotensin can also lower blood pressure and significantly reduce proteinuria. For patients with polycystic kidney disease, no delay in the rate of renal function decline was found while taking Lotensin. However, Lotensin can still be used in these patients to control hypertension.

Active ingredient: Benazepril hydrochloride

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

1. Hypertension of all stages. 2. Congestive heart failure. 3. As an adjunctive treatment for patients with congestive heart failure (NYHA grade II-IV) who do not respond well to digitalis and/or diuretics.

1. Hypertension: For patients who have not used diuretics, the recommended daily dose is 10 mg once a day at the beginning of treatment. If the effect is not good, it can be increased to 20 mg per day. The dosage must be adjusted according to the response of blood pressure, and it should usually be adjusted every 1 to 2 weeks. For some patients, 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 should be added. The maximum recommended daily dose of this product for the treatment of hypertension is 40 mg. Take it once or twice. If the blood pressure reduction is not satisfactory when taking this product alone, another antihypertensive drug can be added, such as thiazide diuretics, calcium antagonists or beta-blockers (start with a small dose first). If you have been using diuretics for treatment before, you should suspend diuretic treatment for 2 to 3 days before starting Lotensin treatment, and you can continue it after that if necessary. If you cannot stop diuretic treatment, the initial dose of Lotensin should be reduced (5 mg instead of 10 mg) to avoid hypotension (see [Precautions]). Patients with creatinine clearance of ≥30 ml/min can take the usual dose. For patients with creatinine clearance of <30 ml/min, the initial daily dose is 5 mg, and the dose can be increased to 10 mg/day if necessary. If blood pressure still needs to be further lowered, a diuretic or another antihypertensive drug can be added. 2. Congestive heart failure: This product is suitable for adjuvant treatment of patients with congestive heart failure. The recommended initial dose is 2.5 mg (5 mg, half a tablet), once a day. Due to the risk of a sharp drop in blood pressure after the first dose, patients need to be closely monitored when taking this product for the first time (see [Precautions]). As long as 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 5 mg once a day after 2-4 weeks. Depending on the patient's clinical response, the dose can be adjusted to 10 mg once a day or even 20 mg once a day at appropriate time intervals. This product is effective once a day. For some patients, the response may be 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 or moderate heart failure (NYHA grade II-III). When the creatinine clearance of heart failure patients is less than 30 ml/min, the daily dose can be increased to 10 mg, but a lower initial dose [such as 2.5 mg (5 mg, half a tablet)] may be more ideal. 3. Progressive chronic renal insufficiency (CRI) For patients with progressive chronic renal insufficiency who also have/do not have hypertension, the recommended long-term dose is 10 mg once a day. If other treatments are needed to further lower blood pressure, it can be used in combination with other antihypertensive drugs.

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, asthma, etc. Angioneurotic edema is rare.

1. Those who are known to be allergic to benazepril, related compounds or any excipients of this product. 2. Those with a history of angioedema caused by angiotensin-converting enzyme inhibitors or non-angiotensin-converting enzyme inhibitors. 3. Pregnant women (see [Use in Pregnant and Lactating Women]).

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. Patients who use diuretics or have insufficient body fluids may occasionally have low blood pressure in the early stage of treatment with ACE inhibitors. Stopping diuretics 2-3 days in advance and then starting treatment with this product can reduce the occurrence of hypotension. (See [Usage and Dosage] and [Precautions]). 2. Patients using ACE inhibitors should avoid co-administration with potassium-sparing diuretics (such as spironolactone, triamterene and amiloride), as well as potassium supplementation or potassium-containing electrolyte solutions, as this may lead to a significant increase in serum potassium. If co-administration is necessary, blood potassium levels should be closely monitored. 3. There have been reports of increased serum lithium concentrations and symptoms of lithium poisoning in patients taking ACE inhibitors and receiving lithium treatment at the same time. Therefore, the above combined treatment should be treated with caution, and it is recommended to regularly test serum lithium concentrations. If diuretics are used at the same time, the risk of lithium poisoning may increase. 4. It has been found that the antihypertensive efficacy of ACE inhibitors will be reduced when used simultaneously with indomethacin. However, in a controlled clinical trial, indomethacin did not affect the antihypertensive efficacy of Lotensin. 5. There are rare cases of hypoglycemia in diabetic patients who are taking insulin or oral hypoglycemic drugs while taking ACE inhibitors (including benazepril). Therefore, it is necessary to warn such patients of possible hypoglycemia and monitor them accordingly. 6. Patients who are receiving injection gold preparations (sodium aurothiobutyrate) and ACE inhibitors at the same time have rare nitrite-like reactions (including flushing, nausea, vomiting and hypotension).

Seal and store below 30℃.

5 mg

36 months

Beijing Novartis Pharma Co., Ltd.

• Founded in:

  1987-04-16

• Address:

  No. 31, Yong'an Road, Changping District, Beijing

• Tax NO.:

  9111000060001684X1

• Registered Funds:

  $30 million

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