Product Overview
[Drug Name]
Generic Name: Benazepril Hydrochloride Tablets
Trade Name: Xindayi Benazepril Hydrochloride Tablets 5mg*28 Tablets
[Main Ingredients]
Benazepril Hydrochloride.
[Properties]
This product is a film-coated tablet, which appears white after removing the film coating.
[Indications/Main Functions]
Used for the treatment of hypertension. Congestive heart failure. As an adjunctive treatment for patients with congestive heart failure (NYHA grade II-IV) who have poor response to digitalis and/or diuretics.
[Specifications]
5mg*28 tablets (Xindayi)
[Usage and Dosage]
1. Adult Dosage (1) Antihypertensive: For those who are not taking diuretics, the recommended initial dose is 10mg orally, once a day; for those who are already taking diuretics (except for severe and malignant hypertension), diuretics should be discontinued for 2-3 days before using this product, and the dose should be given in small doses, and the dose should be increased carefully under observation. If blood pressure cannot be satisfactorily controlled with a single dose per day, the dose can be increased or divided into two doses, with a maintenance dose of 20mg~40mg/day. Patients with poor renal function or water or sodium deficiency start with 5mg once a day. (2) Heart failure: The recommended starting dose is 5mg orally once a day. Blood pressure should be monitored during the first dose. The maintenance dose can be 5mg~10mg once a day. Severe heart failure requires a smaller dose than mild to moderate heart failure. 2. There is no research data on the dosage for children.
[Adverse Reactions]
1. Common reactions include: headache, dizziness, fatigue, drowsiness, nausea, and cough. The most common reactions are headache and cough. 2. Rare reactions include: symptomatic hypotension, postural hypotension, syncope, palpitations, peripheral edema, rash, dermatitis, constipation, gastritis, anxiety, insomnia, paresthesia, arthralgia, myalgia, asthma, etc. Angioneurotic edema is rare.
[Contraindications]
1. Hypersensitivity to benazepril or other angiotensin-converting enzyme inhibitors. 2. History of angioedema. 3. Patients with solitary kidney, transplanted kidney, or bilateral renal artery stenosis and impaired renal function.
[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. Initially use this product at a low dose and gradually adjust the dose. 2. Concomitant use with other vasodilators may cause hypotension. If used together, start with a low dose. 3. Concomitant use with potassium-lowering 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. 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 receptor blockers.
[Precautions]
1. Angioedema: 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 hypovolemia (such as those receiving large amounts of diuretics or dialysis) may experience hypotension when taking this product. Discontinue diuretics or take other measures to replenish body fluids several days before starting this product. 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, if necessary, receive intravenous saline. 3. Neutropenia: Patients with autoimmune diseases and renal insufficiency are more likely to experience leukopenia or neutropenia. For patients with renal insufficiency or leukopenia, check 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 a temporary increase in blood urea nitrogen (BUN) 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. If creatinine clearance is less than 30 ml/min or BUN or creatinine increases while taking this drug, the dose should be reduced and/or diuretics should be discontinued. 5. Other: Elevated serum potassium may occasionally occur, especially in patients with renal insufficiency and concurrent therapy.
[Pediatric Use]
Studies in children are inadequate. In neonates and infants, oliguria and neurologic abnormalities may occur.
[Use in Elderly Patients]
This product has good efficacy and tolerance in elderly patients, but elderly patients and patients with heart failure, coronary artery and cerebral arteriosclerosis should pay attention to blood pressure when taking this product. A sudden drop in blood pressure can cause insufficient blood supply to important organs.
[Overdose]
Hypotension should be corrected first. Expanding blood volume through intravenous infusion of normal saline is an effective measure to restore blood pressure. Benazeprilat can be partially removed by dialysis.
[Pharmacology and Toxicology]
1. Pharmacology (1) Antihypertensive: This product is hydrolyzed into benazeprilat in the liver, becoming a competitive angiotensin-converting enzyme inhibitor, preventing angiotensin from being converted 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) Reduce 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 duration. 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 as mg/kg, is 110 times the maximum human dose; calculated as 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 orally administered benazepril at a dose of 50-150 mg/kg per day, and no effect on reproductive capacity was found. (This dose, calculated as mg/kg, is 37-375 times the maximum human dose; calculated as mg/m2, is 6-60 times the maximum human dose).
