Product Overview
[Drug Name]
Generic Name: Benazepril Hydrochloride Tablets
Trade Name: DiPuLi Benazepril Hydrochloride Tablets 10mg*30 Tablets
Pinyin Full Code: DiPuLi YanSuanBeiNaPuLiPian 10mg*30 Tablets
[Main Ingredient]
The main ingredient of this product is benazepril hydrochloride, whose chemical name is: (1'S,3S)-3-{[1'-(ethoxycarbonyl)-3'-phenylpropyl]-amino}-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid monohydrochloride. Molecular Formula: C24H28N2O5·HCl. Molecular Weight: 460.96
[Properties]
See package insert for details.
[Indications/Main Functions]
For the treatment of hypertension and congestive heart failure. As adjunctive therapy for patients with congestive heart failure (NYHA class II-IV) who have an inadequate response to digitalis and/or diuretics.
[Precautions]
See the package insert for details.
[Drug Interactions]
· Patients with known hypersensitivity to benazepril, related compounds, or any of the excipients of this product. · Patients with a history of angioedema caused by or not caused by angiotensin-converting enzyme inhibitors. · Pregnant women (see [Use in Pregnant and Lactating Women]). · Concomitant use of ACE inhibitors (including this product) or angiotensin receptor blockers (ARBs) with aliskiren in patients with type 2 diabetes (see [Drug Interactions]). · Concomitant use of ACE inhibitors (including this product) with neprilysin inhibitors (e.g., sacubitril). This product should not be taken within 36 hours before starting treatment with sacubitril-valsartan sodium tablets (a drug with neprilysin inhibitory properties) or within 36 hours after stopping treatment with sacubitril-valsartan sodium tablets (see [Precautions] and [Drug Interactions]).
[Specifications]
10mg*30 tablets
[Dosage and Administration]
Hypertension: For patients not taking diuretics, the recommended initial daily dose is 10mg, taken once daily. If response is inadequate, the dose can be increased to 20mg daily. Dose adjustments must be made based on blood pressure response, typically every one to two weeks. For some patients, the antihypertensive effect may diminish toward 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 hypertension is 40mg, taken once or twice. If blood pressure is not adequately lowered with this drug alone, another antihypertensive agent, such as a thiazide diuretic, calcium antagonist, or beta-blocker, may be added (starting with a low dose). For patients previously taking diuretics, particularly those with excessive sodium and/or fluid depletion, careful consideration should be given to the dosing schedule or a dose reduction should be considered when starting this drug. This includes reducing or suspending diuretics for a period of time (e.g., 2-3 days) before starting Lotensin® treatment, or reducing the initial Lotensin dose to 5 mg to avoid hypotension (see [Precautions]). Fluid and/or sodium depletion should be corrected before starting treatment with this product. Patients with creatinine clearance ≥30 ml/min can take the usual dose. For those with creatinine clearance <30 ml/min, the initial daily dose is 5 mg, which can be increased to 10 mg/day if necessary. If further blood pressure reduction is required, a diuretic or another antihypertensive agent can be added. Congestive Heart Failure: This product is indicated as adjunctive therapy for patients with congestive heart failure. The recommended initial dose is 2.5 mg (5 mg, half a tablet) once daily. Due to the risk of a rapid drop in blood pressure after the first dose, patients should be closely monitored when first taking this product (see [Precautions]). If heart failure symptoms are not effectively relieved after 2-4 weeks, the dose can be increased to 5 mg once daily, provided the patient does not experience symptomatic hypotension or other unacceptable side effects. Depending on the patient's clinical response, the dose can be adjusted to 10 mg once daily or even 20 mg once daily at appropriate intervals. This product is effective with a single daily dose. However, some patients may 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 lower doses than those with mild or moderate heart failure (NYHA class II-III). For patients currently receiving diuretics, particularly those with excessive sodium and/or fluid losses, caution is recommended when adding this product, and specialized monitoring is recommended. Depending on the clinical situation, it may be necessary to consider reducing or temporarily discontinuing diuretic therapy before initiating this product. Correction of blood volume and/or sodium depletion should be performed before initiating this product. For patients with heart failure whose creatinine clearance is less than 30 ml/min, the daily dose can be increased to a maximum of 10 mg, but a lower initial dose, such as 2.5 mg (5 mg, half a tablet), may be more ideal. Progressive chronic renal insufficiency (CRI): For patients with progressive CRI with or without hypertension, the recommended long-term dose is 10 mg once daily. If additional treatment is required to further lower blood pressure, it can be used in combination with other antihypertensive drugs.
[Adverse Reactions]
See the package insert for details.
[Contraindications]
· Known hypersensitivity to benazepril, related compounds, or any of the excipients of this product. · Patients with a history of angioedema caused by or not caused by angiotensin-converting enzyme inhibitors. · Pregnant women (see [Use in Pregnant and Lactating Women]). · Concomitant use of ACE inhibitors (including this product) or angiotensin receptor blockers (ARBs) with aliskiren in patients with type 2 diabetes (see [Drug Interactions]). · Concomitant use of ACE inhibitors (including this product) with neprilysin inhibitors (e.g., sacubitril). This product should not be taken within 36 hours before starting treatment with sacubitril/valsartan sodium tablets (a drug containing neprilysin inhibitory properties) or within 36 hours after stopping treatment with sacubitril/valsartan sodium tablets (see [Precautions] and [Drug Interactions]).
